INSTITUTIONAL REVIEW BOARD
73 Tremont St.
Boston, MA 02108
Phone: (888) 634-4387
Fax: (617) 725-4166
Email:irb@suffolk.edu
Policy and
Procedure Manual
POLICIES AND PROCEDURES FOR THE
PROTECTION OF HUMAN SUBJECTS IN RESEARCH
Version 3/30/2014
Human Research Protections Program Policy Manual
2014
Prologue
RESPONSIBLE CONDUCT OF RESEARCH (RCR)
All members of the research community, including faculty, research staff, students, adjunct faculty,
and visiting faculty and researchers, are expected to adhere to the highest ethical and professional
standards as they pursue research activities - complying with all legal, regulatory, and ethical
requirements established by Suffolk University, regulatory bodies, funding sources, and professional
organizations.
While expectations of ethical conduct are high, educational opportunities regarding the responsible
conduct of research have historically been limited. Many researchers have received little to no
training in conducting and mentoring research beyond those specific to their own disciplines. In
contrast, the risks of research misconduct can be catastrophic on both a personal and institutional
level.
The Office of Research Integrity, U.S. Department of Health and Human Services, encourages
researchers to make a special effort to understand, discuss, and teach others about the responsible
conduct of research. It is understood that responsible conduct of research can be taught and learned
in many ways and that the standards can vary from discipline to discipline.
Recognizing that responsible conduct of research (RCR) is essential for promoting public trust in
research and in the University, programs and materials that will increase the knowledge of and
facilitate the practice of responsible research will be made available to the Suffolk University
community. This manual represents one of numerous methods in which the Office of Research
Integrity’s recommended instructional areas of RCR may be addressed. While this manual provides
policy and guidance specifically related to the conduct of human subject research and the protection
of human research subjects, it goes without saying that all professional standards are expected to be
adhered to when conducting research in academic area under the auspices of Suffolk University. The
professional standards related to the responsible conduct of research are as follows:
1. Data Acquisition, Management, Sharing and Ownership – Proper and ethical collection,
representation, and retention of data; communicating clearly, honestly, and respectfully with
all members of the research community.
2. Conflicts of Interest and Commitment - Appropriately disclosing any relationships, financial or
personal, that might be perceived to compromise one's scholarly judgment.
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3. Publication Practices and Responsible Authorship - Appropriate credit and acknowledgments,
citations, co-authorship, description of methods, representing accurately and honestly the
actual observations and findings in whatever medium they are presented; using statistics and
other methods of data analysis and evaluation in an appropriate and responsible manner.
4. Mentor/Trainee Responsibilities - Facilitating the training and development of students and
other junior members of the community, insuring that they have the opportunity to achieve
their full potential; demonstrating respect, protecting their rights and welfare, and fulfilling
the spirit and intent of requirements of all applicable laws, regulations, policies, and
guidelines.
5. Peer Review - Treating all members of the research community with impartiality, respect and
fairness, disclosing real or perceived conflicts of interest, and maintaining confidentiality.
6. Collaborative Research - Facilitating the exchange of knowledge among researchers at all
levels of experience by encouraging a climate of intellectual collaboration and trust;
communicating clearly.
7. Research with Human Participants - Demonstrating respect for all people engaged in research
as participants by protecting their rights and welfare and fulfilling the spirit and intent of
requirements of all applicable laws, regulations, policies, and guidelines.
8. Research with Animal Subjects - Treating animals used in research and instruction with
attention to their welfare and in compliance with all applicable laboratory animal care laws,
regulations, policies, and guidelines.
9. Research Misconduct - Understanding consequences of fabrication, falsification, and
plagiarism and responsibilities and protections for reporting.
10. Fiscal Responsibility and Stewardship of Resources - Demonstrating stewardship of resources
by appropriate use of research funds, care and maintenance of equipment and other research
materials, and compliance with all applicable laws, regulations, policies, and guidelines for the
use and disposal of hazardous substances
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1The Human Research Protection Program
MISSION STATEMENT
The primary mission of Suffolk University’s Human Research Protection Program (HRPP) is to provide a
comprehensive and systematic mechanism designed to protect the rights, dignity and welfare of
individuals who are the subjects of research conducted by Suffolk University faculty, staff, or students.
Suffolk University is committed to following the ethical standards described in the Belmont Report, all
applicable federal, state and local regulations related to the conduct of human subject research, as
well as University policies and procedures. The Suffolk University HRPP also ensures that transnational
research activities are consistent with the ethical principles outlined herein and meet levels of
participant protection equivalent to that normally afforded to research participants while complying
with local laws and taking into consideration cultural contexts.
The HRPP at Suffolk University provides the structure, resources, and implements the policies and
procedures to accomplish this mission and commitment. The processes of education, together with the
processes involved in reviewing and monitoring research activities described in the HRPP, serve to
ensure the safe and ethical conduct of research that will protect human subjects in an atmosphere of
mutual trust and integrity in the pursuit of knowledge and human benefit.
Under the HRPP, protecting the rights and welfare of research participants is the University’s first
priority and the goal is to promote a research environment where ethical, productive investigation is
valued. Protecting research participants is the responsibility of all members comprising the Suffolk
University community and is not limited to the Institutional Review Board (IRB). Striving to exceed the
federal requirements and continually seeking new safeguards for protecting research participants while
advancing scientific progress must be integral to the mission of the HRPP and Suffolk University.
STATEMENT OF PRINCIPLES
Suffolk University is a teaching and research institution committed to promoting the ethical conduct of
human subjects research in accordance with the guiding principles outlined in the Belmont Report, the
Nuremberg Code and federal regulations codified in the 45 CFR 46 Common Rule as well as Subparts B
through D under the auspices of the Department of Health and Human Services (DHHS). Suffolk
University holds a Federal-wide Assurance (FWA) with the Office of Human Research Protections
(OHRP) that articulates the institution’s commitment to complying with government, state and local
policies governing human subject research.
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POLICY
The HRPP includes the Suffolk University Institutional Review Board and other relied upon duly
constituted IRBs as set forth in the Federal-wide Assurance with the Office of Human Research
Protections (OHRP). Suffolk University (SU) policy requires that research activities involving human
subjects are conducted in accordance with applicable federal law and regulations that include, but are
not limited to the Code of Federal Regulations 45 CFR 46; other applicable federal regulations;
applicable Massachusetts state statutes and regulations; the ethical principles of The Belmont Report;
and local Suffolk University IRB policies and procedures. Human subjects research conducted in
foreign countries must adhere to all US regulatory and institutional policies; regulations set forth by
the International Harmonisation Council and other international standards related to human subjects
research; and regulations governing human subjects research in the country or territory in which the
research takes place. It is incumbent upon investigators to be familiar with those regulations
governing human subjects research conducted in countries outside of the United States or from
countries outside of the US from which participants may be recruited.
The DHHS regulations are codified in Title 45 Part 46 of the Code of Federal Regulations. Those "basic"
regulations became final on January 16, 1981, and were revised effective March 4, 1983, and June 18,
1991. The June 18, 1991, revision involved the adoption of the Federal Policy for the Protection of
Human Subjects. The Federal Policy (or "Common Rule," as it is sometimes called) was promulgated by
the seventeen federal agencies that conduct, support, or otherwise regulate human subject research;
the FDA also adopted its provisions. As is implied by its title, the Federal Policy is designed to make
uniform the human subject protection system in all relevant federal agencies and departments.
Federal regulations provide additional protections for various vulnerable populations. The University
also assures compliance with the 45 CFR 46, Subparts B through D, which provide these additional
protections related to research, development, and related activities involving vulnerable populations
such as fetuses, pregnant women, prisoners, and children, as well as other potentially vulnerable groups
such as students, subjects with limited English language proficiency, or individuals with diminished
cognitive capacity. Investigators conducting research in these populations must comply with all of the
requirements of Subpart A as well as the requirements of any relevant Subpart listed below:
 Subpart B - Additional protections for pregnant women, human fetuses, and neonates
 Subpart C - Additional protections for prisoners; and
 Subpart D - Additional protections for children
FDA regulations on the protection of human subjects are codified at Title 21 Parts 50 and 56 of the
Code of Federal Regulations.
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The ethical review of research performed by faculty, students, or employees of Suffolk University is
conducted by the IRB. The IRB is comprised of faculty and staff representing various academic
disciplines within Suffolk University and community representatives who are not affiliated with the
University. The IRB operates on the basis of the aforementioned federal regulations and guidelines
with respect to the review and approval of research protocols involving human subjects.
APPLICABILITY
The policies and procedures contained herein supersede any previously published Suffolk University
policies pertaining to the protection of research subjects and apply to all Suffolk University faculty,
staff, employees, and students of involved in the design, conduct, or reporting of human subjects
research to include development, testing and evaluation, or related activities. They also provide the
foundation for the University’s systematic and comprehensive Human Research Protection Program
that affords protections for all research participants. Unless specifically exempted by 45 CFR 46, all
research involving human subjects (as defined herein) and all other activities which, even in part,
involve such research, must be reviewed and approved by the Suffolk University (SU) Institutional
Review Board (IRB) regardless of the source of funding for the project.
Since the participation of humans in research and training projects may raise fundamental ethical and
civil rights questions, no distinctions in the review, approval, and monitoring of research activities will be
made between funded and unfunded projects, sponsored and unsponsored projects, or between
projects carried out by students, faculty, or other University employees, on-campus or off-campus, in the
United States or overseas. Whether working with public, industry, or private Sponsors, Suffolk University
applies the requirements of the HRPP to all participants.
Sponsored Research
Sponsors can be a company, institution, individual donor or organization responsible for the initiation,
management, or financing of a research study. Both the sponsor and Suffolk University have
obligations to protect research participants.
In studies where Sponsors conduct research site monitoring visits or conduct monitoring activities
remotely, Suffolk University will enter into a written agreement with the Sponsor to ensure that the
Sponsor promptly reports any findings that could affect the safety of participants or influence the
conduct of the study.
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When a Sponsor has the responsibility to conduct data and safety monitoring, Suffolk University will
enter into a written agreement with the Sponsor that addresses provisions for monitoring the data
to ensure the safety of participants and for providing data and safety monitoring reports to Suffolk
University.
Prior to initiating research, Suffolk University must have a written agreement with the Sponsor about
plans for disseminating findings from the research and the roles that investigators and Sponsors will
play in the publication or disclosure of results.
When participant safety could be directly affected by study results after the study has ended, Suffolk
University must have a written agreement with the Sponsor that the investigator or Suffolk University
will be notified of the results in order to consider informing participants.
PROGRAM OVERVIEW
Suffolk University has established the Human Research Protection Program (HRPP) to safeguard and
promote the health and welfare of human research subjects by ensuring that their rights, safety and
well-being are protected. This is accomplished by:
 Providing timely and high quality review and monitoring of human subjects research;
 Facilitating excellence in human subjects research by providing accurate guidance and education
to Suffolk University investigators, IRB members, and research officials; and
 Ensuring compliance with all regulatory and ethical obligations involved in Human
Subjects Research conducted at or under the auspices of Suffolk University.
The HRPP is a multi-tiered program involving the administration of the University, the Institutional
Official, the Institutional Review Board, other research administrative and compliance staff,
investigators, and research support staff.
The HRPP includes mechanisms to:
 Establish a formal process to monitor, evaluate and continually improve the protection of human
research participants.
 Dedicate resources sufficient to effectively carry out responsibilities to ensure the protection of
human research participants
 Educate investigators and research staff about their ethical responsibility to protect
research
participants.
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 Respond directly to concerns of research participants.
Research involving human participants is a privilege, not a right, and institutional identity provides
legitimacy for the investigator; thus the University not only has the right, but a responsibility to
evaluate the research of its faculty, staff, and students to ensure that institutional policies regarding
human research protections are followed by those conducting research under the auspices of Suffolk
University.
CONFLICTS OF INTEREST
Federal regulations and guidelines (National Science Foundation, National Institutes of Health, Food
and Drug Administration) require disclosure of personal financial interests by Principal Investigators,
Clinical Investigators (co- or sub- investigators), and others involved in the conduct of research in any
way that could bias the design, conduct or implementation, management, and reporting of research
data. The regulations further require that the University have a mechanism for investigators to disclose
real or potential conflicts and for the development of a management plan that manages, eliminates, or
reduces the potential conflict, if necessary. Suffolk University policy and procedures related to
conflicts of interest in human subject research are specifically outlined in Appendix _.
SUBMISSION OF HUMAN SUBJECT RESEARCH APPLICATIONS TO THE IRB
All Suffolk University faculty, staff, and students who conduct human subject research, must utilize the
University's IRB for review, approval and continued oversight of the research. In certain circumstances,
individual or institutional conflicts of interest may require the utilization of an independent IRB.
Requests for use of an independent IRB must be made to the University IRB and approved by the
Associate Vice Provost for the Office of Research and Sponsored Programs. In cases where a Suffolk
University investigator is working in collaboration with investigators from other FWA institutions,
research compliance staff may assist in facilitating the completion of an IRB Authorization Agreement
with one or more institutions engaged in the research.
IRB Review and Approval of Research Involving Human Subjects
No intervention or interaction with human subjects in research, including recruitment, may begin until
the IRB has reviewed and unconditionally approved the research. Specific determinations as to the
definition of research or human subject, and their implications for the jurisdiction of the IRB under this
policy, are determined by the IRB. All determinations of exemption or non-exemption are made by the
IRB.
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The implications of engaging in activities that qualify as research that are subject to IRB review without
obtaining such review are significant. Results from such studies may not be published unless IRB
approval is obtained prior to collecting the data. It is also against Suffolk University policy to use that
data to satisfy thesis or dissertation requirements.
If an Investigator begins a project and later finds that the private identifiable data gathered about living
individuals could develop or contribute to the existing knowledge base, or that he or she may wish to
publish the results, the investigator must then submit a proposal to the IRB for review or a
determination of whether the activity is human subject research as soon as possible.
Conduct of Research without IRB Approval
The IRB occasionally is made aware of research using human subjects that is being conducted without
IRB review and approval of the research. Conducting research without IRB review represents noncompliance. Noncompliance occurs when research involving human participants is conducted in a
manner that disregards or violates federal regulations, the policies and procedures of the Institutional
Review Board, the requirements and determinations of the reviewing IRB, or institutional policies
governing the conduct of human subject research. Multiple sources exist whereby the IRB may be
made aware of non-exempt human subject research being conducted without IRB review and approval.
When such information becomes available to the IRB, the procedures outlined in Chapter 9. Previously
collected data that was intended to be collected for research purposes but was collected without IRB
approval cannot be retrospectively approved for use in research.
RESEARCH AS A SHARED RESPONSIBILITY
The responsibility for ensuring compliance with an activity that constitutes human subjects research
rests primarily with the investigator. Since the University will hold investigators responsible and
accountable if non-exempt human subject research is conducted without IRB review and approval,
investigators are urged to request a confirmation that an activity does not constitute human subject
research from the IRB or Office of Research and Sponsored Programs (ORSP) compliance staff.
The University, administrators at all levels, investigators and their research staffs, and the IRB, all share
the collective responsibility for ensuring the ethical conduct of research. This collaboration must exist
in a culture of trust, complete openness, and honesty by upholding the highest ethical principles in the
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conduct of research. By upholding such standards, we build public support for the pursuit of greater
knowledge garnered in a safe research environment.
The value of research depends upon the integrity of study results. One of the ethical justifications for
using human subjects in research is the social value of advancing scientific understanding and
promoting human welfare. If a research study is so methodologically flawed that little or no reliable
information can result, it is unethical to place subjects at risk or even to inconvenience them through
participation in such a study.
Review of Research for Scientific or Scholarly Merit
Review of Research for Scientific or Scholarly Merit
Evaluation of each research study, including scientific review, will be relative to the complexity of
the study. It is the responsibility of the IRB to determine that risks are minimized through sound
research design and reasonable in relation to anticipated benefits. The IRB will seek the expertise of
consultants or ad hoc reviewers if members lack the scientific expertise to make these
determinations without such consultation. The IRB is constituted to include broad representation as
reflected in the membership roster registered with OHRP.
Considerations of the soundness of research design are essential to the assessment of risks and
benefits to subjects, in keeping with the basic ethical of “beneficence” as discussed in The Belmont
Report. While some research may directly benefit research subjects, some research benefits science
or society through the advancement of scientific knowledge or from the development of novel
medical, psychotherapeutic, educational and social processes.
During its initial and continuing review of a human subject research protocol it is the responsibility of
the IRB to assess whether the research design will yield useful data to ensure that subjects are not
placed at risk without reason.
The IRB uses a combination of methods to ensure a complete review of each proposed protocol’s
scientific or scholarly validity. Evaluation of the research proposal includes consideration of research
design, subject selection process, randomization process, end point analysis, and the importance of the
knowledge to be gained from the research. Prior to granting approval of a research protocol, IRB
members consider the following questions in their review for scientific or scholarly validity:
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Will the investigator use procedures that are consistent with sound research design?
Will the investigator use procedures that do not unnecessarily expose subjects to risk?
Will the research design permit the investigator to answer the research question?
What is the importance of the knowledge expected to result from the research?
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The Role of Department Chair
Department chairs or other responsible officials are required to review research protocols from faculty,
students, or staff under their authority to confirm that the research is scientifically sound and has
scholarly merit. Review by the principal investigator’s department chair should occur prior to IRB
submission. The department chair should consider whether the investigator will use procedures that
are consistent with sound research design. It is the responsibility of the department chair to contact the
investigator to address and resolve any significant issues or concerns relative to the scientific or
scholarly validity or research design prior to department approval and subsequent submission to the
IRB. Requests for modifications, if not resolved prior to IRB review and if the request is confirmed by
the IRB, will be incorporated with any additional requests from the convened IRB and conveyed in
writing to the principal investigator.
Departmental approval is documented by the electronic signatures (on the submission form for new
and continuing review applications) of the department chair. The signature of a department
chairperson (or designee) on an IRB protocol submission certifies that the proposed research protocol
and consent form have been reviewed for scientific validity and quality and are recommended to the
IRB for approval. In addition, the signature of the chairperson (or designee) certifies that the
department and the investigator have the resources necessary to ensure the protection, care and
safety of research participants during the conduct of the research, and to complete the research.
Such resources may include staffing and personnel in terms of availability, number, expertise, and
experience; psychological, social, or medical services, including counseling or social support services
that may be required because of research participation; ancillary care and equipment needed to
protect participants; and resources for participant communication, such as language translation
services.
The Role of the Primary Reviewer
The primary reviewer, an IRB member who presents the protocol to the convened board, reviews the
comments of the department chair and any other pre-IRB-submission reviewers to ensure that prior
recommendations either were addressed by the investigator or are noted as requiring further
consideration by the board. While the board’s review does not require the level of disciplinary
expertise necessary for merit or peer review by a funding agency, IRB members are oriented to
perform a thorough and detailed review of the study and, if possible, to discuss and resolve any
unanswered questions with the investigator before presentation to the convened board. All members
are oriented in the use of appropriate review checklists which prompt reviewers to consider whether
each of the criteria for IRB approval of research has been met (45 CFR 46.111).
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The Role of Consultants
A consultant who is independent of the investigator and protocol may serve as an ad hoc reviewer
when the IRB needs added scientific or scholarly expertise in a specific area. The expert must receive
all relevant information available to the IRB in order to perform an in-depth review of the research,
and must understand the background, aims and methods of the research. The consultant is asked to
attend the IRB meeting to present his/her findings relative to the scientific merit of the study and risks
and benefits to subjects, and to answer questions; however, if the consultant is unavailable to attend
the meeting, s/he may provide written comments for distribution to the IRB members in attendance.
The IRB does not delegate its responsibility to judge whether the regulatory criteria for IRB approval
are met.
Recognizing and maintaining the dignity and welfare of individuals who participate in research is a
central concern of everyone involved with the protection of human subjects. The University’s
primary goal is to develop a fair and explicit process in which subjects voluntarily decide to
participate in a study based on an intelligent and knowledgeable assessment of the risks and benefits
of the proposed research.
QUALIFICATIONS OF PRINCIPAL INVESTIGATORS/PROJECT DIRECTORS
The University’s Federal-wide Assurance (FWA) represents the University’s agreement to comply with
all federal, state and local regulations regarding the ethical conduct of human research and as such,
the University is held legally and ethically responsible for conducting human subjects research
consistent with applicable laws and regulations and in accordance with sponsor requirements
presented in the terms and conditions of an award.
The status of principal investigator (PI) is granted by the university as a matter of privilege. A PI is that
individual designated by the University as responsible for the preparation, supervision, and conduct of
a research proposal involving human subjects, for determining the direction of the research and
scholarship whether or not the project is funded, and for selecting, training, and supervising students
and staff members involved in any aspect of the research. Principal Investigators bear primary
responsibility for protecting the rights and welfare of the subjects of their research and for complying
with all applicable provisions of the Institution’s Assurance, to include obtaining appropriate IRB review
and approval for research proposals. Also inherent in this responsibility is compliance with all federal
and state laws, rules, and regulations concerning protection of human research subjects.
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The individual designated by the University as the PI takes on the full obligations associated with the
project, including all programmatic, administrative, financial management, and compliance
responsibilities. If sponsored, the PI is responsible for the prudent and effective administrative and
financial management of the project in accordance with the terms and conditions of the award and
consistent with all university policies, while maintaining the highest ethical standards.
A co-principal investigator (Co-PI) is a project team member who is designated by the University as
responsible for some portion of the programmatic, administrative, financial management, and
compliance duties associated with a research project.
Student Conduct of Research with Faculty Mentors
The IRB has developed a policy that distinguishes between pedagogy and research and identifies which
categories of student research need to be reviewed.
This information is intended to clarify institutional requirements and procedures with respect to
student research projects involving human subjects. The IRB hopes to provide some consistency,
eliminate confusion and misunderstandings, and make the process as streamlined as possible while still
adhering to federal regulations. Students engaged in human subject research must be directed by a
member of the faculty. When student research is proposed, a faculty member must serve as the PI.
Student investigators may serve in the role as Co-PI, but ultimately the PI is responsible for monitoring
the conduct of the research and ensuring compliance with all University policies and regulations
related to the research.
Both graduate and undergraduate students at Suffolk University conduct research with human
subjects. One of the many purposes of this policy is to clarify when student research must be reviewed
by the IRB. Generally, student research involving human subjects falls into one of two categories: (1)
research practica, and (2) directed or independent research projects. The IRB distinguishes between
these two broad categories as a starting point for determining whether IRB review is necessary for a
student project involving human subjects.
Research Practica
Research Practica are class projects designed to provide students an opportunity to practice various
research methods such as interview, observation and survey techniques, as well as data analysis.
Research practica do not require IRB review.
Research conducted by students, graduate or
undergraduate, as a part of classroom assignments does not usually fall under the federal regulation of
research because it is not intended to or likely to lead to generalizable results. Rather, the activities
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are resources of teaching which facilitate learning of concepts and the opportunity to practice various
procedures, including research methods (interviewing, observation and survey techniques, as well as
data analysis).
Data that are collected during a research practicum project may be used in independent research
projects at a future time. In such a case, the IRB should be consulted, because an IRB application for
use of existing data may be required.
Although the IRB does not usually review these types of class projects, faculty are encouraged to be
familiar with each student's project to guide them through the research process and ensure they have
some appreciation for the principles of respect for persons, beneficence and justice outlined in the
Belmont Report. Explicit recognition of the existence of the IRB and introduction to its goals and
concerns should be an integral part of student instruction in the design and conduct of research .
Student research projects that meet ALL of the conditions stated below may be conducted under the
supervision of the faculty member without submitting a protocol to the IRB. Projects that do not meet
all of these conditions must be submitted to the IRB for review.
1. The class project must meet the definition of classroom research/student research. This is defined
as a project which:
 is a normal part of the student’s coursework
 is supervised by a faculty member
 has as its primary purpose the development of the student’s research skills and does not present
more than minimal risk to participants or to the student investigator
 does not include any persons as research subjects under the age of 18
 does not include any persons as research subjects who are classified as a vulnerable
population according to Subparts B, C, or D of the 45CFR46.
 is not “genuine research” that is expected to result in publication or some other form of public
dissemination
NOTE: This policy applies to student class assignments only. Those independent research projects
conducted by students, such as theses, honors projects, and independent study projects, that collect
data through interactions with living people or access private information do fall under the jurisdiction
of the IRB. Application to the IRB for these student research projects must include overall
responsibility of a faculty member who will be named as the Principal Investigator of the project.
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2. Student research projects must meet all the criteria for an Expedited Review as defined in the
Federal Regulations: http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm. If the
faculty member has concerns or doubts, he/she should consult with Suffolk University research
compliance staff.
Please note, that even if the intent is to not produce generalizable knowledge, if a special population or
sensitive topic area is part of the project, the student’s project does require IRB approval.
Categories of sensitive information include information:
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Relating to sexual attitudes, preferences or practices;
Relating to use of alcohol, drugs or other addictive products;
Pertaining to illegal conduct;
That if released could reasonably damage an individual’s financial standing, employability, or
reputation within the community;
That would normally be recorded in a patient’s medical record and the disclosure of which
could reasonably lead to social stigmatization or discrimination;
Pertaining to an individual’s psychological well-being or mental health;
Genetic Information.
Categories of special subject population:
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Minors (under eighteen years of age)
Fetuses or products of labor and delivery
Pregnant women (in studies that may influence maternal health)
Prisoners
Individuals with a diminished capacity to give informed consent
Other special populations as may be defined herein and depending on the research context
(these may include individuals with limited English language proficiency, socio-economically
disadvantaged individuals, or Suffolk University students)
Faculty teaching research methods and overseeing student research projects are expected to
understand the philosophy, ethics, and practice of protecting human subjects in research; to adhere to
these principles during the conduct and supervision of classroom research projects; and to teach these
practices and principles to students. Faculty will be responsible for ensuring that all student research
projects are conducted in accordance with federal regulations and principles regarding protection of
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human subjects in research. It is the responsibility of the supervising instructor/faculty member to
determine whether projects are subject to review. It is always best to err on the safe side and seek
consultation from research compliance staff if a question arises regarding human subjects, research
and classroom activities.
Even in the case where a project is not subject to review, the instructor/faculty member is responsible
to uphold all applicable (e.g., American Psychology Association, American Sociological Association,
American Counseling Association, National Institute of Health, etc.) ethical standards and guidelines in
course-related research activities when it comes to the treatment of human subjects.
Faculty who will be Principal Investigators on classroom research projects must complete a basic
course in the protection of human subjects through CITI which may be found at the following website
address: https://www.citiprogram.org/
Directed or Independent Research Projects using Human Subjects
Directed or Independent Research Projects are those research projects conducted by students,
graduate or undergraduate, which involve human subjects, employs systematic data collection, is
intended to contribute to generalizable knowledge, and does not fall under the definition of research
practicum. These projects include, but are not limited to, independent undergraduate research
projects and honors theses, masters' theses, and dissertations. Student projects in this category must
be reviewed and approved by the IRB. It is possible that a research project may be exempt from
ongoing IRB review, but it must meet explicit criteria and the IRB must certify the exemption.
Students who are engaged in this type of research activity and their faculty mentors must be mindful
of the fact that protocols submitted for IRB review by student investigators must meet the same
application standards and undergo the same criteria for review as a faculty research project, therefore
IRB review timelines should be factored in accordingly.
Considerations When Teaching or Mentoring Students in the Conduct of Human
Subjects Research
Consistent with University policy, all teaching assignments involving human subjects must respect the
rights and welfare of all individuals involved. The following information for faculty members provides
guidance concerning student classroom projects:
1. Consider the nature and intent of the activity. If the course assignment involves systematic data
collection and if the intent of the activity is to develop or contribute to generalizable knowledge -- an
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indication of which is intent to publish the data -- then the student classroom project is probably
research and needs to be individually reviewed and approved by the IRB.
2. IRB approval cannot be made retroactive. If there is any likelihood that the results of the project
might later be used for research that does lend to generalizable knowledge (for example, a
presentation to a group other than the class), IRB approval must be sought prior to conducting the
research. IRB approval cannot be granted retroactively.
3. Minimize risks whenever possible. Faculty members should help students understand that they are
obligated to minimize risks for human subjects with whom they interact during the completion of their
assignments. This can be accomplished by:
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Having students take the on-line training through CITI on human subject protection before
collecting information from others.
Encouraging the use of anonymous data collection so that data is not linked to specific
individuals.
Having information identifying individuals kept separately from the information collected from
those individuals.
Collecting project data at the end of the course, or within a short time afterward, and request
all copies in the student’s possession be destroyed.
Encouraging the use of consent scripts versus signed consent documents.
STUDENTS AND EMPLOYEES AS RESEARCH SUBJECTS
Students and employees, should be recruited through general announcements or advertisements,
rather than through individual solicitations. Personal solicitations increase the likelihood that
participation will be the result of being unduly influenced, either because of the relationship between
the recruiter and the prospective subject, or methods of communication employed by the recruiter
that may act to persuade prospective subjects to participate, thus compromising the voluntariness of
the agreement to participate.
Investigators should detail any extra precautions taken to safeguard the rights and welfare of subject
populations. In the case of using employees or a student “subject pool,” the IRB should ensure that
consent for participation is sought only under circumstances which minimize the possibility of coercion
or undue influence, and that genuinely equivalent alternatives to participation are available.
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Suffolk University Students as Research Subjects
It is not uncommon for research projects to involve students, either those enrolled in a specific course
or those enrolled in University programs. For instance, it is common practice for psychology students
to serve as subjects in behavioral research. The obvious concern is that their participation may not be
truly voluntary, because of a desire to appear particularly cooperative or highly motivated, or because
participation in research is a course requirement.
Faculty investigators need to exercise special caution when they desire to have students in a class to
participate in research at the same time. Unintended coercion must be avoided by (1) ensuring that
participation is voluntary, (2) that no one knows who is and is not participating, and (3) a time and
effort equivalent alternative is provided for those who wish not to participate. Course grades should
not be based on research participation. Basing grades on research participation is coercive and
prohibited.
OHRP provides guidance with respect to student participation in research and what could potentially
be considered coercion or undue influence as it relates to the participation of Suffolk University
students in research.
The investigator must seek consent only under circumstances that minimize the possibility of
coercion or undue influence. Any participation of students in research must be voluntary.
Reasonable levels of extra credit or rewards may be offered for participating in research. If extra
credit or rewards are offered for participation, students must be provided with and informed of nonresearch alternatives involving comparable time and effort to obtain the extra credit in order for the
possibility of undue influence to be minimized. Even if research participation is a course
requirement, students must be informed of non-research alternatives involving comparable time and
effort to fulfill those requirements in order for the possibility of undue influence to be minimized.
Moreover, students must not be penalized for refusing to participate in research. Participation in
research as a course requirement without offering an alternative comparable in time and effort is
prohibited.
Faculty should think very carefully about the implications of using students as participants in research.
Although students often provide a ready source of potential participants, they are not always as
representative or appropriate to the research as other subject pools.
If students are determined to be appropriate participants, then several key issues need to be
considered.
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1. Coercion: If the instructor of the course is also the Principle Investigator (PI) on the project,
recruitment of students into the project by the instructor could be viewed as coercive. Students may
fear that their grades would be jeopardized by their non-participation in the research, especially since
the instructor could identify who has participated and who has not. Therefore, it is important that
measures are built into the research to ensure students that their participation is strictly voluntary and
that they may withdraw their participation at any time without penalty.
2. Consent: Even though potential participants are enrolled in the PI's class, informed consent is
still required. The PI must explain the procedures; disclose all the risks and benefits, and any
other information, which may influence the potential participant's decision to willingly
participate.
3. Extra Credit: If extra credit is offered in exchange for participation, an alternate means of
earning equivalent extra credit for an equivalent commitment of time and effort should be made
available to the entire student pool.
4. Use of Class Time: The use of class time for research purposes must be justified. Researchers
proposing the use of class time for research should include an explanation of the benefits of the
research to the students. Specifically, the researcher should explain how participation in the research
would be a learning experience for the students and how the research is relevant to the course of study
being taught in that class.
5. Use of Class Assignments in Research: Instructors should not use their students' class
assignments (e.g., journals, term papers, etc.) in research without the signed consent of the
students.
An investigator should not have access to the data collected until after the class grades have been
posted. Investigators should ask a colleague not affiliated with the research or class to administer
the evaluation and hold the data until after the grades are posted.
Various safeguards have been institutionalized through this policy to reduce the possibility of undue
influence or coercion, while still permitting students to participate as subjects in research. These
include the requirement to:
1. Include in the course description and syllabus information regarding the possibility of students
being used as subjects in research activities related to the course and its use as a venue for the
conduct of research by a faculty member or student.
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2. Post IRB approved advertisements throughout the University to recruit subjects from a broad base
of students.
3. Offer students the opportunity to participate in “mass screenings” with follow-up with those who
meet research criteria. It should be clearly stated that participation in the screening, as well as
participation in the research is voluntary.
4. Avoid personal solicitations by students or faculty for fellow students or faculty to participate in a
project for which the students are serving as research assistants or for a faculty’s own research.
5. Provide alternatives and equal methods for meeting course credit (or extra credit) requirements,
such as attending a series of research presentations by faculty, writing a brief paper, conducting
one’s own research.
Special Protections and Special Considerations
Suffolk University recognizes that students may be subject to institutional vulnerability, i.e. as a
result of their status as students, they may be subjected to the formal authority of others. This
increases the risk that participation will not be truly voluntary and that they may be exploited or
recruited on the basis of providing a convenient sample. For this reason, applications for nonexempt research exclusively targeting Suffolk University students must include sufficient rationale
for doing so and inclusion of a broader population should be considered if the research warrant
such consideration..
As with any research involving a potentially vulnerable subject population, the IRB must pay special
attention to the potential for coercion or undue influence and consider ways in which the
possibility of exploitation can be reduced or eliminated.
In-person solicitation of students for non-exempt research is strictly prohibited. All solicitation of
students for non-exempt research should be accomplished using general announcements (for
example, notices posted throughout the University or department).
Another concern with the involvement of students in research is confidentiality. As with any other
study population, research involving the collection of data on sensitive topics such as mental
health, sexual activity, of the use of illicit drugs or alcohol presents risks to subjects of which they
should be made aware and from which they should be protected, to the greatest extent possible.
The intimacy of the university setting amplifies this problem.
Use of a Student Subject Pool
Investigators may use a “student subject pool” such as SONA to identify students who might be
willing to participate in research, even when the exact nature of the research to be conducted has
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not yet been determined. While extra credit or other rewards are often offered as an incentive to
encourage participation, students who sign up for such pools have not legally consented to
participate in a research study since they have not been provided with sufficient information
concerning the exact study in which they would participate. Thus, signing up to be in a subject pool
is only a first and preliminary step by which individuals can indicate their willingness to be
considered for research participation. The student must also provide informed consent, unless the
consent requirement is waived by the IRB, once he or she is being considered for a specific study.
Individuals in the pool must be free to decline participation in any available research projects
without penalty.
Suffolk University Employees as Research Subjects
University employees, such as faculty, office staff, and postdoctoral fellows, are similar to students
in that they are vulnerable to perceived, even if not intended, pressures to appear cooperative and
supportive of their colleague’s work. Accordingly, many of the same procedures described above to
reduce the likelihood of coercion in recruiting student volunteers apply equally to University
employees.
EXTERNAL RECRUITMENT REQUESTS AND RESEARCH CONDUCTED AT SUFFOLK
UNIVERSITY BY NON-AFFILIATED INVESTIGATORS
The University requires research investigators who are not affiliated but who wish to recruit Suffolk
University faculty, staff or students as research subjects to:
1. Obtain Suffolk University IRB approval in addition to seeking prior approval of their institution’s
IRB. In the event the investigator is an independent investigator who is not affiliated with an
institution which holds an FWA, the investigator will be required to submit a full IRB application to
the Suffolk University IRB.
2. Comply with all relevant IRB determinations, federal and state regulatory requirements, and
human subject protection standards.
Accordingly, Suffolk University requires that all external applicants contact a member of the
University’s research compliance staff in the Office of Research and Sponsored Programs.
Applications from external applicants who have received approval from their respective IRB should
submit the following materials for consideration by the Suffolk IRB in order for the IRB to give
adequate consideration to the request:
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1. A copy of the investigator’s IRB-approved protocol, IRB approval letter, and any applicable IRB
stamped recruitment materials to be distributed on the Suffolk University campus
2. A letter from the investigator’s institution that addresses the following:
 The rationale for having an interest in recruiting Suffolk University faculty, staff, or students
as participants.
 A list of other institutions/organizations from which recruitment is taking place for the study.
 Information regarding how results will be published, i.e. in segmented or
aggregated form.
Before posting of recruitment flyers at Suffolk University is approved, the investigator must affirm
that the identity of Suffolk University not be linked to any results.
Applications will be reviewed by the Suffolk University IRB Chair, another designated IRB member, or
the Full Board, when full review is required. In some cases, student affairs, human resources, union
representatives, program or area directors, deans or department chairs will be consulted as well.
Suffolk University is committed to providing all stakeholders with the opportunity to provide
comment and be aware of research conducted on campus.
Generally, on campus recruitment of Suffolk University faculty, staff, or students as research
participants by external investigators will not be authorized unless deemed to be in the best interests
of Suffolk University or in collaboration with a faculty or staff member of Suffolk University.
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2 Purpose
The purpose of this manual is to establish institutional policy for the conduct of research
involving human subjects, establish the authority of the Institutional Review Board (IRB) at
Suffolk University, and promulgate procedures which govern the implementation of the
Human Research Protection Program (HRPP).
SCOPE
The policies and procedures contained in this manual are applicable to all faculty, staff,
employees, and students of Suffolk University who propose to use humans as subjects in
research, development, and related activities.
HRPP MISSION STATEMENT
“Good science and good ethics go hand-in-hand.”
The overarching mission of the HRPP at Suffolk
University is to protect the rights and welfare of
“Good science and good
human subjects recruited to participate in research
ethics go hand-in-hand.”
conducted under the auspices of the institution. In
this regard, the University’s HRPP strives to adhere
to the highest ethical standards in its protection of human research subjects.
DELEGATION OF RESPONSIBILITY FOR OVERSIGHT OF THE HRPP
The Associate Vice Provost (AVP) of the Office of Research and Sponsored Programs (ORSP),
is a non-faculty, full-time administrator, who has been given the authority and
responsibility to establish, maintain, and oversee the HRPP. The Director of ORSP also
serves as the Institutional Official and administratively reports to the Vice Provost for
Faculty Development.
As Suffolk University’s Institutional Official, the AVP of the ORSP signs the Federalwide
Assurance of Compliance (FWA) on behalf of the institution and is ultimately responsible
for:
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 Creating, establishing and maintaining the policies and procedures for the HRPP and
related research policies and procedures on behalf of Suffolk University
 Overseeing the protection of human participants, regulatory compliance, and the
implementation of the HRPP for Suffolk University
 Ensuring that open channels of communication are maintained between all
components of the HRPP
 Overseeing research investigators and staff, research management, and conduct
 Ensuring the independence of the IRB, including the authority to act without undue
influence
 Ensuring that the HRPP is functional, adequately staffed and funded by annually
reviewing the resources allocated to the HSPP and participating in the annual
preparation of the budget for the HSPP
 Ensuring adequate and ongoing training for all member of the IRB and professional
development opportunities for the Research Compliance Manager
 Requiring periodic reviews of the HRPP
AUTHORITY OF THE INSTITUTIONAL OFFICIAL
In this federally-mandated role, the Institutional Official (IO) assumes operational authority
for Suffolk’s Human Research Protection Program (HRPP) and is directly responsible for
assuring that the program is functional, adequately staffed and funded, and respected
throughout the research community.
The IO, on behalf of the University, is authorized to establish and has established an
Institutional Review Board (IRB) to assist in complying with applicable laws, regulations and
University policy in the review, approval and monitoring of human research. The research
compliance staff in ORSP is responsible for the day-to-day operations of the IRB. The IRB
functions in coordination with University officials and other review committees but at all
times maintains its independence to appropriately review, approve and monitor human
research.
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The IO retains regulatory authority to review decisions made by the IRB. In the case of an
approval decision, should the IO conclude that a project does not fully comply with policies
or obligations of the University, the project may be disapproved, suspended, or terminated
on behalf of Suffolk University. In the case of a decision by the IRB to disapprove, suspend,
or terminate a project, the IO or any other officer or agency, state government, or federal
government may not reverse the decision. In a case where an institutional conflict of
interest occurs, the IO may refer the study to an external IRB for review and oversight.
Role and Responsibilities
The IO shall ensure that Suffolk University’s IRB complies with all applicable ethical
principles, federal and state laws and institutional policies and procedures regarding the
protection of human research participants. In so doing, the IO sets the "tone" for an
institutional culture of respect for human research participants, and ensures effective
institution-wide communication and guidance related to human subject research.
Research Compliance Manager and Compliance Program Support Staff
The ORSP compliance staff is charged with managing the implementation of the HRPP by
developing methods and mechanisms for protecting human research participants. In
carrying out the mission of the HRPP the University endeavors to:
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Create an atmosphere of respect for, and awareness of, the rights and welfare of
human research participants at Suffolk University.
Continue to provide investigators with current information related to the
application of the federal regulations and ethical principles with respect to their
particular areas of research in an effort to keep investigators abreast of evolving
standards.
Educate students, faculty, and staff who conduct research about the ethical
principles and federal regulations guiding research with humans.
Assess the effectiveness of the IRB in its review of research activities, facilitation of
compliance of researchers with the federal regulations, and protection of research
participants.
Develop new approaches that better serve the overarching mission of the HSPP,
such as state-of-the-art educational materials, more efficient methods for
processing applications, tracking and monitoring research activities, and assessing
the overall effectiveness of the HRPP.
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The primary administrative responsibility for the day-to-day operation and implementation
of the HRPP lies with the Research Compliance Manager (RCM) who provides training,
administrative, and operational support to Suffolk University’s Institutional Review Board.
The Research Compliance Manager together with the ORSP Staff Assistant implements the
Human Research Protection Program (HRPP) for the University. The Research Compliance
Manager advises the Institutional Official on all aspects of human research, develops and
updates this manual as necessary, formulates institutional policies to support the effective
and efficient administration of the HRPP, and otherwise undertakes policymaking and policy
implementation initiatives as necessary and appropriate. The RCM acts on behalf of the
Institutional Official to conduct noncompliance reviews and serves as the designated contact
person for ORSP under the University’s FWA. The RCM is also responsible for implementing
University-wide educational programs related to the responsible conduct of research and
the human subject protections program.
The Research Compliance Manager is responsible for the oversight and management of
research compliance issues within the University to ensure University employees carrying
out human subjects research are complying with federal regulations, state laws and internal
policies and procedures. In carrying out these responsibilities related to the HRPP the RCM:
 Acts as the principal point of contact for the research community for information
regarding regulatory compliance issues related to the welfare of humans involved in
research
 Provides education and other resources to support research integrity (e.g., responsible
conduct of research, conflicts of interest and other compliance requirements).
 Develops a culture of regulatory compliance through training, education, strategic risk
assessments, audits and other monitoring processes.
ORSP Staff Assistant
The ORSP Staff Assistant provides administrative support to both grant pre-award activities
and research compliance activities within ORSP. In providing support to research
compliance activities the Staff Assistant:
 Supports Research Compliance Manager in carrying out the day-to-day administrative
responsibilities of the University research compliance program
 Provides IRBNet technical support to the Suffolk research community
 In consultation with the Research Compliance Manager, creates IRB agenda
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Takes IRB meeting minutes
Updates and revises website content under the direction of the RCM
Maintains current and archived IRB protocol records
Stamps and uploads approved IRB materials to IRBNet
Sends protocol continuing review reminder notifications to investigators
Provides IRBNet workshops for group and/or one-on-one sessions
Provides support and instructions for CITI training
Creates and maintains various research compliance databases
INSTITUTIONAL RVIEW BOARD CHARTER
The Institutional Review Board is the administrative body that performs many of the core
functions of the HRPP. The Chair and members of the IRB are appointed by the AVP of the
ORSP who assigns their authority and responsibility pursuant to the policies prescribed in
this Manual. The charge emphasizes that the IRB is functionally independent and has ready
and direct access to the highest officials of the institution, if needed, to ensure protection
for human research participants.
Suffolk University has one registered IRB that reviews all human subject research. The IRB
must be registered with OHRP in accordance with Subpart E of the 45 CFR 46. The authority
of the IRB, membership requirements, and responsibilities are discussed in Chapter 3. The
IRB is responsible for the initial and continuing review of research, review of modifications,
and approval of all research subject to the HRPP, determining serious or continuing
noncompliance, requiring modification (to secure approval), disapproving research, applying
applicable ethical standards, and making initial and ongoing determinations of exemption
from continuing IRB review.
The Institutional Review Board (IRB) for Suffolk University is responsible for the review and
approval of all research involving human subjects conducted under the auspices of the
institution. The IRB is charged with protecting the rights and welfare of human research
subjects recruited to participate in research activities and to ensure compliance with
applicable federal, state and local regulations related to the protection of these subjects. In
addition, the IRB may be asked by organizational officials to review research protocols on
behalf of other institutions with which they have formal affiliation agreements.
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Suffolk University utilizes a centralized program to review all human subject research. The
IRB is staffed, trained and allocated resources to ensure adequate support of all IRB
functions.
Investigator Responsibilities
The individual ultimately responsible for the conduct of a research protocol is the Principal
Investigator (PI). Responsibilities of a PI include ensuring that:
 All Suffolk University human subject research has received initial prospective review and
approval by the IRB.
 Continuing review and approval of the research has been accomplished within the time
frame stipulated by the IRB.
 The research is conducted at all times in compliance with all applicable regulatory
requirements and the determinations of the IRB.
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Research data is properly safeguarded at all times.
 Protocol deviations, unanticipated events, and adverse events are promptly reported to
the IRB.
 All members of the research team are properly trained in the protection of human
subjects and training is current
Other Members of the Research Team
Every member of the research team is responsible for protecting human participants. Coinvestigators, study coordinators, research assistants, Academic Sponsors, student/staff
investigators, and all other research staff have the following strict obligations to:
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Comply with all IRB determinations and procedures
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Adhere rigorously to all protocol requirements
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Inform the PI, and thus IRB, of unanticipated problems
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Ensure the adequacy of the informed consent process
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Take necessary measures to ensure adequate protection of study participants
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Ensure adequate safeguarding and confidentiality of study data
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GUIDING DOCUMENTS AND PRINCIPLES
In establishing its policies and procedures, the University is guided by the ethical principles
outlined in two key historical source documents: the Nuremberg Code and The Belmont
Report.
The ethical principles outlined in the Nuremberg Code and the Belmont Report are codified in
the Code of Federal Regulations 45 CFR 46 and Code of Federal Regulations 21 CFR 50.
Together, these four documents serve as essential references for the Suffolk University IRB in
carrying out its review and approval of human subject research.
THE NUREMBERG CODE
The basic ethics of the Nuremberg Code continue to serve as a cornerstone for modern
regulations regarding the use of human participants in experimentation. Its principles
emphasize a profound respect for the voluntary nature of research participation, the idea
of true informed consent, and the personal ethical responsibilities of the investigator to
ensure human welfare.
THE BELMONT REPORT
THE BELMONT REPORT
The National Research Act, passed by Congress in 1974, created the National Commission
for the Protection of Human Subjects of Biomedical and Behavioral Research.
One of the charges to the Commission was to identify the basic ethical principles that should
underlie the conduct of biomedical and behavioral research involving human subjects and to
develop guidelines which should be followed to assure that such research is conducted in
accordance with those principles. In carrying out the above, the Commission was directed to
consider: (i) the boundaries between biomedical and behavioral research and the accepted
and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the
determination of the appropriateness of research involving human subjects, (iii) appropriate
guidelines for the selection of human subjects for participation in such research and (iv) the
nature and definition of informed consent in various research settings. The Belmont Report
attempts to summarize the basic ethical principles identified by the Commission in the
course of its deliberations. It is a statement of basic ethical principles and guidelines that
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should assist in resolving the ethical problems that surround the conduct of research with
human subjects.
The Belmont Report was published in the Federal Register in 1979 and provides the basis for
current federal regulations. It describes three basic ethical principles for the conduct of
research involving human subjects and stresses the notion that ethical research requires a
careful balancing of these three principles.
Respect for persons involves recognition of the personal dignity and autonomy of
individuals, and special protection of those persons with diminished autonomy.
Beneficence entails an obligation to protect persons from harm by maximizing anticipated
benefits and minimizing possible risks of harm.
Justice requires that the benefits and burdens of research be distributed fairly.
These principles remain the basis for the HHS human subject protection regulations and
today, the Belmont Report continues as an essential reference for institutional review
boards that review HHS-conducted or sponsored research proposals involving human
subjects in order to ensure that the research meets the ethical foundations of the
regulations.
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The first ethical principle, respect for
persons, consists of two primary considerations.
The first is that the individual human research
participant be treated as an autonomous
being—a person who makes decisions or
deliberates for him or herself about personal
goals and then acts upon them. The second is
that those persons who have diminished
capacity or who are not able to make and carry out decisions for themselves, such as
children, must be protected from coercion by others and from activities that might
potentially harm them. In research, respect for persons demands that participants enter
into a research program voluntarily and with good information about the research goals.
The investigator must ensure that the participant has received a full disclosure of the nature
of the study, the risks, benefits and alternatives, with an extended opportunity to ask
questions. The principle of autonomy finds expression in the informed consent document.
The Belmont Report’s
three ethical principles:
-respect for persons
-beneficence
-justice
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The second ethical principle is beneficence, which refers to the obligation on the part of
the investigator to attempt to maximize benefits for the individual participant and/or
society, while minimizing risk of harm to the individual. An honest and thorough risk/benefit
calculation must be performed. The principle of beneficence obligates both society and the
individual investigator. Society has to give forethought to the longer term benefits and
risks that result from increased knowledge and from the development of novel new
therapeutic devices or procedures that are the outcome of research.
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The third ethical principle, justice, demands the equitable selection of participants. The
principle of justice also requires avoiding participant populations that may be unfairly
coerced into participating and equality in distribution of benefits and burdens among the
population group(s) likely to benefit from the research.
DEFINING RESEARCH WITH HUMAN SUBJECTS
The definition of research with human subjects is provided in the 45 CFR 46. Application of
the definition is not always a straightforward task however, because it includes both very
specific constructs, e.g. research development, and rather vague ones, e.g. reasonableness.
However, it is the tool we must use when determining whether or not a study is research
with human subjects.
One helpful question that may be used to aid in determining whether a project is research is
the question of investigator intent. If it is the intent of the investigator when data is
collected on human subjects to publish the results of their project in a journal, or present
some aspect of the project at an academic meeting, then it likely will be classified as
research. While determining intent is often a key and practical factor to use in classifying a
project as “research”, there is a distinction between a publication that is merely educational
in intent, such as a case study report, and those that are designed for the purpose of
contributing to generalizable knowledge.
Definition of Research
Research is defined in 45 CFR 46 as follows: “a systematic investigation, including research
development, testing, and evaluation, designed to develop or contribute to generalizable
knowledge." This definition includes pilot studies, feasibility studies, and other preliminary
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research as well as demonstration and service programs that may include research activities.
Case studies in general, do not meet the definition of research but should be discussed with
research compliance staff in order to make such a determination.
Human Subject
Human subject means "a living individual about whom an investigator (whether professional
or student) conducting research obtains:
1. data through intervention or interaction with the individual, or
2. identifiable private information."
Interventions and Interactions
Interventions include both physical procedures through which data are gathered and
manipulations of the subject or the subject’s environment that are performed for research
purposes. The former, while not common in social and behavioral sciences, does occur. For
example, multiple resonance imaging might be used in a study of language acquisition.
Interactions include communication or interpersonal contact between the subject and the
investigator. Communication does not have to be face-to-face and may even be entirely
virtual.
Identifiable Private Information
Private information must be individually identifiable (i.e. the identity of the subject is or may
be readily ascertained by the investigator or associated with the information) in order for
obtaining the information to constitute research involving human subjects.
There are two kinds of private information included in the federal definition.
1. information about behavior that occurs in a context in which an individual can
reasonably expect that no observation or recording is taking place, or
2. information that has been provided for specific purposes by an individual and which the
individual can reasonably expect will not be made public, such as a medical or school record.
RESEARCH ON SOCIAL, BEHAVIORAL, AND EDUCATIONAL PROCESSES
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Research on social, behavioral, and educational processes involves the study of human
functioning at the level of the individual, small group, institution, organization, or
community. At the individual level, this research may involve the study of factors such as
cognition, memory, language, perception, personality, emotion, motivation, and others. At
higher levels of aggregation, it includes the study of variables such as the structure and
dynamics of small groups (e.g. couples, families, work groups, etc.); institutions and
organizations (e.g. schools, religious organizations, etc.); communities (defined by
geography or common interest); and larger demographic, political, economic, and cultural
systems. Research on behavioral, social and educational processes also includes the study of
the interactions within and between these two levels of aggregation, such as the influence
of cultural factors on cognitive processes or emotional responses. Finally, this research also
includes the study of environmental factors such as climate, noise, environmental hazards,
and residential environments and their effects on social, behavioral and educational
functioning.
OFF-SITE DATA COLLECTION AND/OR COOPERATIVE RESEARCH
Suffolk University faculty and/or students often collect research data at off-campus
locations. This section provides guidance to investigators with respect to:
 information collected from participants off-campus
 use of information obtained from participants off-campus
 gathering or obtaining data in collaboration with investigators affiliated with other
institutions
If the research activity occurs while the investigator is an employee or student at Suffolk
University; if the research activity occurs under the auspices, aegis, or control of the
University community; or, if Suffolk University’s name will appear in the byline or in the text
of a publication or presentation, then the activity is Suffolk University research, to be
reviewed by the Suffolk University IRB, no matter where or how the data are obtained. In
other words, the location of the research activity is not relevant in deciding if you need IRB
review from Suffolk University. The location of data collection only determines who else
might need to review the research, in addition to the Suffolk University IRB.
Cooperative research projects are those projects involving more than one institution. When
conducting cooperative research, each institution is responsible for safeguarding the rights
and welfare of human subjects. Institutions participating in a cooperative research project
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may enter into a joint review arrangement, rely upon the review of another qualified IRB, or
make similar arrangements to avoid duplication of effort.
If a Suffolk University investigator plans to conduct research at another site covered by an
FWA, the protocol may be subject to review by both institutions' IRBs. Most organizations
retain their right to review. Organizations holding a federal-wide assurance (FWA) will often
require that all stakeholders in a program keep some authority over their site, program, and
the rights/welfare of the individuals enrolled or employed. When multiple institutions are
involved, you may find that several approvals are needed.
When to Seek IRB Approval from another Institution or Institutions
One basis for determining if review is needed from both Suffolk University and another
institution is based on a concept called "engagement in research."
ENGAGEMENT IN RESEARCH
The Office of Human Research Protections (OHRP) provides guidance on determining
circumstances under which an institution is considered to be engaged in research.
In general, an institution is considered engaged in a particular non-exempt human subjects
research project when its employees or agents for the purpose of the research project
obtain: (1) data about the subjects of the research through intervention or interaction with
them; (2) identifiable private information about the subjects about the subjects of the
research; or (3) the informed consent of human subjects for the research.
An institution’s employees or agents refer to individuals who: (1) act on behalf of the
institution; (2) exercise institutional authority or responsibility; or (3) perform institutionally
designated activities. “Employees and agents” can include staff, students, contractors, and
volunteers, among others, regardless of whether the individual is receiving compensation.
When planning research with human subjects at or with another institution, the Research
Compliance Manager should be contacted in advance so the process of approving the
collaboration can be initiated. Institutions are considered engaged in research when:
 An award is received through a grant, contract, or cooperative agreement directly from
HHS for non-exempt human subjects research (i.e. an awardee institution), even where
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all activities involving human subjects are carried out by employees or agents of
another institution.
 When an institution’s employees or agents intervene for research purposes with any
human subjects of the research by performing invasive or noninvasive procedures.
 When employees or agents of an institution intervene for research purposes with any
human subject of the research by manipulating the environment. [Examples of
manipulating the environment include controlling environmental light, sound, or
temperature; presenting sensory stimuli; and orchestrating environmental events or
social interactions].
 When employees or agents of an institution interact for research purposes with any
human subject of the research. [Examples of interacting include engaging in protocol
dictated communication or interpersonal contact; collecting biological specimens; and
conducting research interviews or administering questionnaires].
 When employees or agents of the institution obtain the informed consent of human
subjects for the research.
 When employees or agents of an institution for research purposes, obtain identifiable
private information or identifiable biological specimens from any source.
Institutions Engaged in Human Subjects Research
If both Suffolk University and a collaborating site are engaged in the research, the
institutions need to either:
1. Review the research separately, or
2. Designate one of the institutions' IRBs to assume oversight for the review and
continuing review of the research.
In those instances where one institution defers to another institution’s IRB for review, an IRB
Authorization Agreement should be completed between or among those institutions
involved. The purpose of an IRB Authorization Agreement is to conserve resources, improve
efficiencies and avoid “unnecessary duplication of effort” in the review of collaborative
research projects.
If the other institution does not have an IRB or comparable committee, the Suffolk
University IRB will need documentation that the institution’s policies for protecting human
subjects are at least equivalent to those of Suffolk University.
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It is important to note that, in general, institutions whose employees or agents obtain
identifiable private information or identifiable specimens for non-exempt human subject
research are considered engaged in the research, even if the institution’s employees or
agents do not directly interact or intervene with human subjects. In general, obtaining
identifiable private information or identifiable specimens includes, but is not limited to:
 Observing or recording private behavior;
 Using, studying, or analyzing for research purposes identifiable private information or
identifiable specimens provided by another institution; and
 Using, studying, or analyzing for research purposes identifiable private information or
identifiable specimens already in the possession of the investigators.
[In general, OHRP considers private information or specimens to be individually identifiable
as defined in 45 CFR 46.102(f) when they can be linked to specific individuals by the
investigator(s) either directly or indirectly through coding systems].
Answering the question of when approval from another institution is required is sometimes
difficult, as procedures can vary depending on the policies of the off-site location. It is
helpful to remember that permission is granted for a specific research activity, under
specific circumstances; not to an individual who wants to conduct "research" (in general). If
one focuses on obtaining permission to perform the procedures of the activity, in a
particular context, it becomes easier to understand who should be asked for approval.
Consider these common examples:
1. If the off-site location has a federal-wide assurance (e.g., almost all colleges, universities,
and hospitals have one) then the off-site institution will have an IRB that they work with
(either onsite or off-site). If the off-site location has a federal-wide assurance, their IRB will
need to review and approve the study. Institutional officials may also want to review the
study. It is always prudent to contact the off-site IRB Administrator or Human Subjects
Compliance Officer for more information about their institution's policies.
2. If the off-site location does not have a federal-wide assurance, the signing authority for
the institution will need to read your research protocol. The Suffolk University IRB will need
to receive a letter from that individual stating that he/she has read the proposal and he/she
grants permission for participant recruitment at their location and/or collection of data at
their location.
Every study must be considered on a case-by-case basis.
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IRB AUTHORIZATION AGREEMENT
An IRB Authorization Agreement may be required in those instances where two or more
individuals representing different institutions work together on a human subjects research
project, and the components of the research project may be distributed across more than
one institution (i.e., collaboration) or some or all of the research procedures may occur at
more than one site (i.e., multiple performance sites). This section describes the procedures
for implementing IRB Authorization Agreements and IRB review in these situations, after a
decision has been made that an authorization agreement is necessary and appropriate.
An IRB Authorization Agreement (IAA) is a formal, written document that provides a
mechanism for an institution engaged in research to delegate institutional review board
(IRB) review to an independent IRB or an IRB of another institution. Suffolk University
usually enters into an IRB Authorization
Agreement when a Suffolk University investigator
is collaborating on a project with an investigator
Any institution holding an
from another institution or institutions. The IAA
FWA may reserve the right to
allows Suffolk to either defer IRB oversight of a
review research protocols
protocol to another institution, or to assume IRB
involving research data
oversight of a protocol on behalf of another
collected on their employees,
institution. The Research Compliance Manager
students, or from their site, or
typically assumes responsibility for coordinating
for research conducted at
the completion of an IAA. The Institutional Official
their site regardless of
is the signatory official for an IAA. The format for
investigator affiliation
an IRB Authorization Agreement can be found at
http://www.hhs.gov/ohrp/assurances/forms/irba
uthorizpdf.pdf
Institutions may use different descriptive terms, e.g., reliance agreement, cooperative
agreement, IRB authorization agreement (IAA), or memorandum of understanding (MOU).
Agreements may cover single studies, categories of studies, or all human subjects research
under an organization’s Federalwide Assurance (FWA). MOUs are generally used when
covering an entire research program; IRB Authorization Agreements are generally used to
cover a designated protocol or protocols.
The type of agreement used is often based on the nature of established financial, legal, or
collaborative relationships between Suffolk University and another entity or institution. The
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benefit of using an IRB Authorization Agreement is to decrease the duplication of IRB
reviews for the same study between or among engaged institutions. Delays in protocol
activation times may also be reduced, and the University may increase its research portfolio
size without increasing the burden on the Suffolk University IRB.
As mentioned previously, institutions generally retain the right to conduct IRB review of
research in which their faculty, staff, or students may be involved. Institutions may have
several concerns regarding the delegation of IRB review to an outside entity. Key concerns
raised by institutions regarding delegating IRB review have included 1) ensuring quality and
thoroughness of external review, as well as lack of precise metrics to measure IRB quality; 2)
local context issues; 3) institutional liability; 4) complexity of shared control and
accountability; and 5) costs of delegating review and/or loss of revenue for the relying
institution.
Detailed agreements delineating roles and responsibilities of all parties are important tools
to facilitate collaboration and trust in the delegation of IRB review.
Institutions entering into agreements for IRB review must each maintain the agreements on
file and submit them to OHRP and/or FDA upon request.
INDIVIDUAL INVESTIGATOR AGREEMENT
An individual investigator agreement allows an institution with an FWA to extend the
applicability of its FWA to cover collaborating investigators who do not work at an institution
that holds an FWA.
Institutions may engage in research covered under an FWA with physicians, mental health
providers, social workers, and others in private practice, who frequently do not have an FWA
but may be research collaborators. Also, in some cases, the investigator may be an
employee of an institution that does not routinely engage in research and therefore does
not hold an FWA.
Types of Collaborating Individual Investigators
Human subject research conducted by an assured institution may involve the following two
types of collaborating individual investigators:
A collaborating independent investigator is:
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not an employee or agent of Suffolk University;
 conducting collaborative research activities outside the facilities of Suffolk University;
and
 not acting as an employee of any institution with respect to his or her involvement in the
research being conducted by Suffolk University.
A collaborating institutional investigator is:

not an employee or agent of Suffolk University;

conducting collaborative research activities outside the facilities of Suffolk University;
 acting as an employee or agent of a non-assured institution with respect to his or her
involvement in the research being conducted by Suffolk University; and
 employed by, or acting as an agent of, a non-assured institution that does not routinely
conduct human subjects research.
Conditions for Extending Suffolk University’s FWA to Cover Collaborating
Individual Investigators
In order for Suffolk University to extend its FWA to cover a collaborating independent or
institutional investigator the following conditions must be satisfied:
1. The principal investigator of Suffolk University directs and appropriately supervises all of
the collaborative research activities to be performed by the collaborating individual
investigator outside Suffolk University.
2. The extension of the coverage of the FWA is put in place by use of an appropriate
written agreement, such as an Individual Investigator Agreement, for each collaborating
individual investigator who will be engaged in the research being conducted by Suffolk
University. Suffolk University must maintain the Individual Investigator Agreement on file
and provide copies to OHRP upon request.
3. For collaborating institutional investigators, the appropriate authorities at the nonassured institution state in writing that the conduct of the research is permitted at their
institution.
4. Suffolk University IRB approves the extension of the assurance through either the
Individual Investigator Agreement or other written agreement that may be used by Suffolk
University.
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5. The following documents are to be made available to the collaborating individual
investigator:
 The Belmont Report: Ethical Principles and Guidelines for the Protection of Human
Subjects of Research or other internationally recognized equivalent (see section B.1. of the
Terms of the Federalwide Assurance (FWA) for International (Non-U.S.) Institutions on the
OHRP website at http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html)
 the HHS regulations for the protection of human subjects at 45 CFR part 46 (see
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html) or other procedural
standards designated by a non-U.S. institution under its FWA (see section B.3. of the Terms
of the Federalwide Assurance (FWA) for International (Non-U.S.) Institutions on the OHRP
website at http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html)
 The FWA and applicable Terms of the FWA for the assured institution; and
 Suffolk University’s policies and procedures for the protection of human subjects.
6. The collaborating individual investigator understands and accepts the responsibility to
comply with the standards and requirements stipulated in the documents referenced in the
preceding paragraph and to protect the rights and welfare of human subjects involved in
research conducted under the Individual Investigator Agreement.
7. The collaborating individual investigator agrees to comply with all other applicable
federal, international, state, and local laws, regulations, and policies that may provide
additional protections for human subjects participating in research conducted under the
Individual Investigator Agreement.
8. The collaborating individual investigator agrees to abide by all determinations of the
Institutional Review Board (IRB) and agrees to accept the final authority and decisions of the
IRB, including but not limited to directives to terminate participation in designated research
activities conducted under the Individual Investigator Agreement.
9. The collaborating individual investigator agrees to complete any educational training
required by the Suffolk University IRB prior to initiating research covered under the
Individual Investigator Agreement.
10. The collaborating individual investigator agrees not to enroll subjects in research under
the Individual Investigator Agreement prior to the research being reviewed and approved by
the IRB.
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11. The collaborating individual investigator agrees to report promptly to the IRB any
proposed changes in the research conducted under the Individual Investigator Agreement.
The collaborating institutional investigator agrees not to initiate changes in the research
without prior IRB review and approval, except where necessary to eliminate apparent
immediate hazards to subjects.
12. The collaborating individual investigator agrees to report immediately to the IRB any
unanticipated problems involving risks to subjects or others in research covered under the
Individual Investigator Agreement.
13. The collaborating individual investigator, when responsible for enrolling subjects, agrees
to obtain, document, and maintain records of informed consent for each such subject or
each subject’s legally authorized representative as required under HHS regulations at 45 CFR
part 46 (or any other international or national procedural standards covered in Suffolk
University’s FWA and stipulated by the IRB.
14. The collaborating individual investigator acknowledges and agrees to cooperate with the
IRB in its initial and continuing review, record keeping, reporting, and certification for the
research covered by the Individual Investigator Agreement. The collaborating institutional
investigator agrees to provide all information requested by the IRB in a timely fashion.
The format for an Independent Investigator Agreement may be found at:
http://www.hhs.gov/ohrp/assurances/forms/unaflsuppdf.pdf
INTERNATIONAL RESEARCH
Anyone who conducts international research understands that it is a difficult and time
consuming enterprise. A host of difficulties, expected and unexpected could potentially
arise. Meeting IRB requirements can become difficult depending on the location. Consult
with the Research Compliance Manager as soon as possible to obtain guidance on obtaining
the appropriate international approvals.
Contact the Research Compliance Manager if a visit is planned to a non-US location for
which the State Department has expressed concerns about personal safety or the
exportation of US intellectual property (for up-to-date information about foreign relations
for specific countries, visit
http://www.state.gov/countries/
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Research by Suffolk University investigators conducted abroad is subject to review by the
Suffolk University IRB, taking into account the norms of the culture in which it will take
place. If foreign institutions will be responsible for the conduct of any components of the
research, their policies for the protection of human subjects must be reviewed by the IRB, or
if the project is federally funded by the sponsor.
The International Compilation of Human Research Standards enumerates over 1,000 laws,
regulations, and guidelines that govern human subjects research in 104 countries, as well as
the standards from a number of international and regional organizations. This Compilation
was developed for use by researchers, IRBs/Research Ethics Committees, sponsors, and
others who are involved in human subject research around the world. These standards
should be consulted when drafting your IRB application to ensure standards governing
research in a particular foreign country or territory are adequately addressed. These
standards may be found at:
http://globalhealthreviewers.tghn.org/international-compilation-human-researchstandards/
TRAINING IN THE PROTECTION OF HUMAN RESEARCH SUBJECTS
Initial Certification Training
All study personnel involved in human subject research must complete education in the
protection of human research subjects through the Collaborative Institutional Training
Initiative (CITI) prior to the submission of the research protocol to the IRB. This training
requirement applies to all study personnel involved in the research and includes all
investigators—principal, co-principal, or other investigators; all persons involved in the
consent process—discussing participation or obtaining consent; and all persons engaged in
the design, conduct, analysis, or reporting of the research (to include students and other
personnel involved in collecting survey information via any method).
The IRB will not process a protocol unless all study personnel have completed the required
training and it is documented with submission of the IRB application in IRBNet. Although
some human subject research is exempt from IRB review, the requirement still exists for
investigators conducting such research to complete training in the protection of human
subjects.
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CITI Training modules are organized by various “Learner Groups” based on the type of
research being undertaken. For example, social and behavioral researchers should select
the Basic Social and Behavioral Course for completion. CITI training modules may be
accessed at the following website location:
https://www.citiprogram.org/
Initial training completed in human subject protections is valid for a period of three years.
Individuals who have documentation of human subject protections training completed at
another institution within the three year period can use that training to meet initial training
requirements of Suffolk University.
CITI Refresher Training
Training in the protection of human subjects must be completed every three years. The
refresher training modules may be accessed through CITI from the Suffolk University
website. It is the responsibility of the Principal Investigator to monitor the training
requirements of all members of the study team. No member may be assigned to the study
team until training requirements have been completed.
Educational Seminars
The Research Compliance staff offers various training sessions, lectures, and educational
seminars for faculty, staff, and students conducting research with human subjects. These
training sessions and workshops are available upon request. Training and workshops are
currently available on the following topics:
 Basic overview of the functional components of the responsible conduct of research
(RCR) research
 The history of abuses in human subject research underpinning the ethical principles of
the Belmont Report, its relationship to the IRB review process, the role and functions of the
IRB, and the types of IRB review
 How to complete an IRB application
 Introduction to IRBNet as the platform for submitting, reviewing, and monitoring the
status of IRB research protocols
 The protections afforded by Certificates of Confidentiality and how to apply for one
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These seminars are particularly useful for students who may conduct human subject
research for a thesis or dissertation. In addition to the topics above, workshops may be
custom designed and tailored to meet the needs of a particular group.
E-College
E-college is an on-line educational resource for the University community that provides
training and education in various areas related to human subject research, animal research,
financial conflicts of interest, and the responsible conduct of research. These resources are
located on the ORSP Research Compliance website.
Also available for investigators’ use as an educational resource is OHRP’s Investigator 101 CD
held in ORSP.
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3 The Institutional Review Board (IRB)
Suffolk University maintains a single Federal Wide Assurance (FWA) with OHRP that commits
the institution to complying with federal regulations related to human research subject
protection. This assurance (FWA00007700) is applicable to all funded and non-funded research
that is conducted by Suffolk University faculty, staff and students. It stipulates that research
conducted under the auspices of Suffolk University will be guided in the ethical principles
established by the Belmont Report and other appropriate ethical standards recognized by
federal departments and agencies that have adopted the Federal Policy for the Protection of
Human Subjects, known as the Common Rule (45 CFR 46, Subpart A). Suffolk University has
assured its compliance with applicable Subparts B through D that require additional
protections for specified vulnerable populations: pregnant women and fetuses, prisoners, and
children, respectively.
The requirement that each federally funded institution engaged in human experimentation
must utilize an IRB encourages institutional accountability for the practice of the highest ethical
standards for the review and conduct of its research. The IRB functions as an agent of Suffolk
University with its purpose being to uphold the values of the University by demonstrating
respect for all people engaged in research as participants by protecting their rights and welfare
and fulfilling the spirit and intent of requirements of all applicable laws, regulations, policies,
and guidelines.
ROLE AND AUTHORITY OF THE IRB
The role of the Suffolk University IRB is to protect the rights and welfare of human research
participants recruited for research activities conducted under the auspices of the University.
The IRB conducts prospective review of proposed research and monitors continuing research in
order to safeguard the rights and welfare of participants. In carrying out this responsibility, the
IRB:
1. Determines and certifies that all projects reviewed by the Board conform to the
regulations and policies set forth by HHS regarding the health, welfare, safety, rights and
privileges of human research participants; and
2. Assists investigators in conducting ethical research which complies with HHS regulations
in a way
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that permits the safe conduct of the research activity.
Except when an expedited review procedure is used, the IRB will review proposed research at
convened meetings at which a majority of the members of the IRB are present, including at
least one member whose primary concerns are in nonscientific areas. In order for the research
to be approved, the research must be approved by a majority of those members present at the
meeting.
The IRB has the authority to approve, require modifications in, place restrictions on, or
disapprove all research activities that fall within its jurisdiction as specified by both the federal
regulations and local institutional policy. The IRB has the authority to observe and/or monitor
human subject research to whatever extent it considers necessary to protect human
participants. In so doing, the IRB also has the authority to require progress reports, oversee the
conduct of studies, and to suspend or terminate approval of a study due to noncompliance.
Research that has been reviewed and approved by the IRB may be subject to review and
disapproval by officials of the institution. However, those officials may not approve research if
it has been disapproved by the IRB. Research that has been reviewed and approved by the IRB
is subject to continuing IRB review and must be reevaluated at least annually, or more
frequently if specified by the IRB.
Members who have a conflicting interest with a particular research study under review, may
not participate in the IRB's initial or continuing review of that project, except to provide
information requested by the IRB.
COMPOSITION AND MANAGEMENT OF THE IRB
The IRB will be comprised of at least five members, with varying backgrounds to promote
complete and adequate review of research activities commonly conducted at Suffolk
University. The IRB must be sufficiently qualified through the experience and expertise of its
members, and the diversity of the members, including consideration of race, gender, and
cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect
for its advice and counsel in safeguarding the rights and welfare of human subjects. Therefore,
every effort will be made to ensure that the IRB is demographically and ethnically diverse and
that the IRB does not consist of members representing one discipline. Additionally, IRB
membership will include:
1. At least one member whose primary concerns are in a scientific area.
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2. At least one member whose primary concerns are in a nonscientific area.
3. At least one member who is not otherwise affiliated with the institution and who is not part
of the immediate family of a person who is affiliated with Suffolk University.
In addition to possessing the professional competence necessary to review specific research
activities, the IRB will ascertain the acceptability of proposed research in terms of institutional
commitments and regulations, applicable law, and standards of professional conduct and
practice and therefore membership will reflect persons knowledgeable in these areas.
IRB membership will include individuals who have expertise in dealing with vulnerable
populations. Such populations may be recruited for participation in research conducted by
Suffolk University faculty, staff and students. These populations include, but are not limited to
children, prisoners, pregnant women, handicapped or mentally disabled persons, individuals
with limited English language proficiency and Suffolk University students and employees.
It is possible for a member to fill two roles, for example, a member could be unaffiliated with
the institution and also have a primary concern in a non-scientific area. This individual would
satisfy two of the membership requirements of the regulations. The IRB however, must reflect
a membership that has a diversity of representative capacities and disciplines.
Discretionary Use of Outside Experts
The IRB may invite individuals with special expertise external to the IRB to assist in the evaluation
of complex issues on specific protocols. These experts are considered non-voting consultants to
the IRB and do not affect the determination of a quorum.
Terms of Membership
Generally speaking, terms for membership will be for a period of two years with a maximum of
two-re-appointments authorized. Membership on the IRB as a regular member will not exceed
a total of three consecutive terms.
Meeting Attendance and Determination of Quorum
A quorum will be constituted by more than half of the number of the regular voting
membership, including one member whose primary focus is in a non-scientific area. When a
quorum of regular members is not present, the IRB Chair may delegate full responsibilities of
membership (including voting privileges) to an alternate member who is in attendance for the
duration of the meeting.
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No legally valid IRB action may be taken without a properly constituted quorum. If a quorum is
lost during a meeting, then the Board cannot conduct official business until the quorum is
restored. If the quorum is not restored, the meeting is concluded and the remaining business
continues at the next scheduled meeting.
Meeting attendance is one of the most crucial services of Board members and alternates. It is
imperative that Board members notify in advance, the RCM or ORSP Staff Assistant, as to their
non-availability for meetings.
Removal of Member for Cause
When a Board member consistently fails to attend IRB meetings or fails to meet expectations,
the IRB Chair and Research Compliance Manager may meet with the Board member to
determine the cause. If the IRB member indicates an inability to continue to function
effectively as an IRB member, the Research Compliance Manager will work with the AVP of
ORSP and/or the IRB Chair in order to obtain a suitable replacement. Members who do not
satisfactorily fulfill their responsibilities, as judged by the IRB Chair or Institutional Official, may
be asked to step down from IRB membership.
Besides failing to attend meetings, other causes for removal of a member may be due to
breach of confidentiality, conflicts of interest with respect to his or her role as an IRB member,
or a report of noncompliance to OHRP with respect to his or her own research.
Selection and Appointment of Members and Alternates
The Chair of the IRB and the AVP of the Office of Research and Sponsored Programs shall
develop a slate of individuals recommended to replace outgoing IRB members and alternates.
The Director appoints, in writing, new members and alternates for a two-year, renewable
period. Reappointment will be determined on the basis of experience, availability, attendance,
and participation in on-going professional development training related to the protection of
human research participants.
No candidate who has been the subject of a report of non-compliance to OHRP may be
appointed or re-appointed as a member of the IRB. A member currently serving on the IRB
who is the subject of a report of non-compliance will be dismissed for cause.
Alternate members may be appointed in writing to serve and participate on the IRB in the
absence of regular members. If applicable, each alternate will be assigned by name as proxy
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for a regular voting member. Alternates for regular voting members will be assigned, when
possible, on the basis of possessing similar background and/or experience.
Alternates who are formally appointed and listed on the membership roster may substitute,
but ad hoc substitutes are not permissible as members of the IRB. A member who is unable to
be present at the convened meeting may participate by video-conference or conference
telephone call. Such members may vote and be counted as part of the quorum. Opinions of
absent members that are transmitted by mail, telephone, telefax or e-mail may be considered
by the attending IRB members but may not be counted as votes or toward the quorum for
convened meetings.
The RCM will maintain a file on each IRB member that contains their appointment letter, most
current curricula vitae, and verification of CITI training. Attendance of members at other
formal training in the protection of human subjects is also to be maintained in their file.
ORSP will maintain an accurate and up-to-date registration of IRB members with OHRP as well
as a posting of the membership roster on the ORSP Research Compliance website. Registration
of IRB members includes identification by name, earned degrees, representative capacity,
indications of experience such as certifications or licenses sufficient to describe each member’s
chief anticipated contributions to IRB deliberations; and any employment or other relationship
between each member and Suffolk University.
REGISTRATION OF THE IRB
The Suffolk University IRB is designated under the University’s Federalwide Assurance with
OHRP and as such, must be registered with the Department of Health and Human Services.
Registration information will be submitted by the IO or RCM who are both designated and
authorized to act on behalf of Suffolk University with respect to IRB registration requirements.
The IRB will be registered electronically through http://ohrp.cit.nih.gov/efile
ORSP will maintain an accurate and up-to-date registration of IRB members with OHRP in
accordance with 45CFR46, Subpart E, as well as a posting of the membership roster on the
ORSP Research Compliance website.
Registration of IRB members includes identification by name, earned degrees, representative
capacity, indications of experience such as certifications or licenses sufficient to describe each
member’s chief anticipated contributions to IRB deliberations; and any employment or other
relationship between each member and Suffolk University.
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IRB registration must be renewed every three years. However, registration information must
be updated within 90 days after changes occur with respect to the contact person who
provided the IRB registration information or the IRB Chair.
Any renewal or update that is submitted to and accepted by OHRP begins a new three-year
effective period.
DUTIES OF IRB MEMBERS
The IRB is an appointed Institutional Committee. As such, IRB members serve Suffolk University
as a whole, rather than a particular department. Therefore, IRB members and ad hoc
consultants must not allow their own interests or that of their department to supersede their
duty to protect the rights and welfare of research subjects.
The primary duty of each IRB member is the protection of the rights and welfare of the
individual human beings who are serving as the subjects of research. The IRB member must
understand that he or she is not serving on the IRB to expedite the approval of research, but
rather as a gatekeeper between the investigator and the research subjects. In order to fulfill
their duties, IRB members are expected to be well versed in regulations governing human
subject protection, biomedical and behavioral research ethics, and the policies of Suffolk
University germane to human subjects protection.
The task of making the IRB a respected part of the institutional community will fall primarily on
the shoulders of the IRB members. The IRB must be perceived to be fair and impartial, immune
from pressure either by the institution’s administration, the investigators whose protocols are
brought before it, or other professional and nonprofessional sources.
 Non-affiliated members. Provide input regarding their knowledge about the local community
and are prepared to discuss issues and research from that perspective.
 Nonscientific members. Provide input on areas germane to their knowledge, expertise and
experience, professional and otherwise. For example, members who are lawyers should
present the legal views of specific areas that may be discussed, such as exculpatory language or
state requirements regarding consent. Nonscientific members should advise the IRB if
additional expertise in a nonscientific area is required to assess if the research proposal
adequately protects the rights and welfare of subjects.
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 Scientific members. Contribute to the evaluation of a study on its scientific and statistical
merits and standards of practice. These members should also be able to advise the IRB if
additional expertise in a nonscientific area is required to assess if the research proposal
adequately protects the rights and welfare of subjects.
Primary Reviewers. In addition to the duties described above, each regular voting member will
be expected to act as a Primary Reviewer for assigned studies at convened meetings. The
Primary Reviewer presents his or her findings resulting from review of the application materials
and provides an assessment of the soundness and safety of the protocol and recommends
specific actions to the IRB. He or she leads the IRB discussion of the study. Primary Reviewers
may be required to review additional material requested by the IRB for the purpose of study
approval.
APPOINTMENT OF IRB CHAIR AND VICE-CHAIR
An IRB Chair and an IRB Vice Chair will normally be appointed from the regular voting
membership by the Institutional Official. Appointment of the Chair will be made on the basis of
demonstrated professional competence, experience, and an ability to carry out the duties of
the chair without competing or conflicting interests.
IRB Chair and Vice Chair will be appointed to one-year terms and are eligible for reappointment
at one-year intervals. At least annually during each appointment year, the Associate Vice
Provost of the ORSP, shall decide upon reappointment with the advice of the IRB membership.
Best practices in the field are such that the IRB chair should not serve in the capacity as chair
for a period extending beyond six years.
The IRB Chair and Vice Chair serves as voting members of the IRB and, as for all members,
they must have the knowledge, skills and abilities necessary to carry out the functions of the
IRB. In addition, IRB members who serve as Chair or Vice Chair must have the leadership and
administrative skills necessary to conduct meetings and to exercise the authorities and
responsibilities of their positions. Such individuals must also be highly motivated to fulfill the
duties of these positions with the commitment of time/effort necessary for these essential
functions.
Authority and Responsibilities of the IRB Chair and Vice-Chair
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Responsibilities of the IRB chair include those defined herein. In the absence of the IRB chair,
the vice chair shall assume the responsibilities of the IRB chair.
Ongoing Responsibilities:
 Review and approve, when appropriate, expedited submissions in accordance with
regulatory requirements.
 Review (or defer to the primary reviewer or other IRB-designee to review) all on-site
serious adverse event reports (SAEs) and unexpected problems affecting the safety of
subjects and, as necessary, determine if one or more of the following is necessary:
 Immediate action to address the safety of subjects
 Call an emergency meeting of the IRB
 Appoint qualified IRB members as IRB-designees with authority for expedited reviews and
other actions as defined in this Manual.
 Appoint qualified ORSP staff members as administrative-designees with review and
signature authority as defined herein.
 Maintain a thorough understanding of federal regulations pertaining to human subject
protections, the Suffolk University IRB written procedures, and other applicable state,
and local regulations. Assure that regulations and policies are applied in all IRB matters
with a commitment to foster ethically and scientifically sound human subject research.
 Respect the diverse backgrounds, perspectives and sources of expertise of all IRB
members and foster such respect among the IRB members.
 Uphold IRB judgments no matter how these are received or perceived by Principal
Investigators.
Responsibilities Prior to Each Convened Meeting:
 Review IRB meeting schedule and agenda composed by ORSP research compliance staff.
 Ensure coverage by the Vice-Chair when not able to serve as Chairperson for the meeting
and notify the IRB Administrator when not able to serve.
 Inform the Research Compliance Manager about the assignment of reviewers to studies
requiring convened IRB review.
 Assist the IRB reviewers and other IRB members with any concerns in preparing for the
meeting, as necessary.
 Recommend consults when appropriate to assist in IRB reviews.
Responsibilities During IRB Meetings: .
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 Preside over IRB meetings and ensure that meetings are conducted in an efficient, orderly
and fair manner with respect given to the opinions of all members. Robert's Rules of
Order should be used as a guidebook for conducting the meeting.
 Ensure a quorum for each study review and ensure that this quorum is properly
documented.
 Ensure that all regulatory-required elements of review are addressed during the meeting
and that there is meaningful and substantive discussion of relevant matters and/or
questions. When time does not permit the thorough review of a protocol, a motion to
table until the next meeting should be made and appropriately recorded in the meeting
minutes.
 Ensure that assigned reviewers present a clear and concise review of study materials
including consent documents and recruitment items and process.
 Ensure that all IRB-required changes to consent and other documents are documented.
 Ensure that the IRB discusses specific findings, as required by regulations, whenever there
is the involvement of vulnerable populations, e.g. children, prisoners, pregnant women
and fetuses.
 Accept appropriate motions from voting members of the IRB.
 As necessary, ensure that the specific elements pertaining to the motion are clearly
understood by the IRB and accurately recorded in the meeting minutes.
 Ensure that IRB decisions are made in accordance with federal, state and local regulations
and with the Suffolk University IRB written procedures.
 Ensure that minutes of IRB meetings and votes of the IRB members accurately reflect
discussions and actions.
The IRB Chair also may delegate any of his/her responsibilities as appropriate to other qualified
individual(s). Any such delegation of responsibility is documented in writing and maintained by
the Research Compliance Manager or ORSP Staff Assistant.
The IRB Chair designates the board members qualified to conduct expedited reviews. Qualified
members will be selected based on 1) at least six months of IRB experience, research
experience, any life experiences or background applicable to human subject research, and 2)
any other qualification the IRB Chair deems appropriate. A list of the designated board
members is maintained by the ORSP Staff Assistant. All IRB members will be trained and
qualified to conduct expedited reviews in accordance with the criteria contained in 45 CFR
46.110.
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The IRB Vice-Chair may assist or act on behalf of the IRB Chair in particular IRB matters and at
IRB meetings, either as a general procedure, or on a case-by-case basis.
MEETING SCHEDULE AND APPLICATION DEADLINES
The IRB shall meet at least once per month throughout the year. Meeting dates and
submission deadlines shall be made public to the University at the beginning of each semester
by
posting
the
schedule
on
the
Research
Compliance
website
at
http://www.suffolk.edu/explore/16531.php
 Full IRB Review. Protocols requiring full IRB review are to be submitted no later than 30 days
prior to the scheduled convening date of the IRB. Deadlines for protocol submission for each
scheduled meeting of the IRB are also posted on the website.
 Expedited Review and Application for Exemption. There are no submission deadlines for
protocols that undergo expedited review or that are reviewed for exemption.
Administrative Support
The Office of Research and Sponsored Programs (ORSP) provides staff support to the IRB by recording
the minutes of its meetings, providing announcements and agendas for its meetings, serving as a
repository of all IRB correspondence and records, and the like. The Office of Research and Sponsored
Programs serves as the first and primary point of contact for inquiries and submissions to the IRB.
ORSP will initially screen all IRB applications to include requests for exemption from IRB review. The
RCM has been granted the authority to approve Human Research Exemption Requests. If the RCM is
uncertain whether exemption should be granted, the request will be forwarded to the IRB Chair for
determination.
Applications for expedited and convened review will also be screened by the RCM for proper
completion and then discussed with the IRB Chair for appointment of an expediting team comprised of
a primary and secondary reviewer or to the full IRB for review as the situation dictates. Expediting
teams may also refer applications for convened review. The IRB may solicit ad hoc reviewers with
specific expertise to assist in protocol reviews on a case-by-case basis. Ad hoc reviewers may
participate, but not vote, in the designated reviews.
TRAINING OF NEW IRB MEMBERS
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There are various mechanisms by which newly appointed members receive training and become
oriented with respect to the Board’s functions, policies, and procedures. Regular voting members of
the IRB and IRB Chairs are expected to complete both IRB Orientation training and CITI Training in
human subjects protection.
Orientation training is scheduled for new members on an as needed basis. Training is scheduled and
conducted by the Research Compliance Manager in conjunction with the current IRB Chair.
Orientation training provides a foundation for serving as an IRB member and covers a wide range of
topics which may include: review of The Belmont Report, Suffolk University Policy on the Protection of
Human Research Participants, Decision Flowcharts, Criteria for IRB Approval of Research, Criteria for
Exemption from IRB Review, Expedited Review Criteria, and the Checklists for IRB Review of Protocols.
Members are also introduced to the two types of applications (Human Subjects Research Application &
Human Subjects Research Application for Exemption); the consent document & Consent Checklist;
requirements for child assent; requirements for continuing review, protocol modifications and final
reports; and adverse event reporting.
In addition to orientation training, newly appointed IRB members are required to complete the same
training as that required of investigators through the Collaborative Institutional Training Initiative (CITI).
This training may be accessed via the Suffolk University Research Compliance website at:
https://www.suffolk.edu/explore/16524.php
Participation in on-going professional development training activities, to include workshops and
conferences, is also an expectation of IRB membership and a pre-requisite for re-appointment.
IRB members (to include the Chair and Vice Chair) and alternates will be expected to remain abreast of
evolving issues related to human subject research protections through attendance at professional
conferences, workshops and local training events. Resources to attend such professional development
opportunities will be made available through ORSP.
Continuing Education of IRB Members
Brief 15-20 minute educational sessions are regularly scheduled and presented to members at
each convened IRB meeting. These educational sessions are researched and presented by
other board members and appear on the agenda for each meeting. The sessions cover topics
generally selected by board members based on those topics that have presented challenges to
the board or have recently undergone revision or update by ORSP. These may include
regulatory issues, protocol specific questions, or the most recent headline or topic appearing in
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Research Compliance News. IRB members are also provided various opportunities to attend
conferences and seminars sponsored or presented by PRIM&R and other professional
organizations related to the human subject research protections or research ethics.
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4 Initial Submission and Review of Research
Protocols
Regulations recognize three categories of research protocol review: full board convened review,
expedited review, and exempt from IRB review. Reference to the flowchart below will aid in
determining the type of review a research protocol will undergo. The determination for the category
of review is usually made by the research compliance but may sometimes require consultation with
the IRB Chair. Investigators should consult with the Research Compliance Manager prior to
completing the requisite documents to ensure the appropriate materials are submitted for the
category of review required.
Research Involving Human Participants
For additional assistance, contact the
Research Compliance Manager
Office of Research and Sponsored Programs
(617)557-2006
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GENERAL INSTRUCTIONS FOR FIRST TIME SUBMISSION OF IRB APPLICATIONS IN
IRBNet
Suffolk University utilizes an electronic platform called IRBNet for submission of IRB applications as
well as for the management and monitoring of approved human subjects research protocols. All
activity related to an application and subsequently approved study, will be documented in IRBNet.
All documents necessary for the completion of an IRB application, continuing review, modification,
final report, and report of unanticipated event can be located in the IRBNet Library Manager or in
the Investigator’s Toolbox located on the ORSP Research Compliance website.
For a first time submission of an IRB application the primary investigator must take the following
actions:
1. Complete the appropriate CITI training at http://www.citi.org (if training was already completed
within the last 3 years, you may skip this step)
 print the completion certificate or save to the desktop for submission with the human subject
research application
2. Register as a New User for IRBNet at http://www.irbnet.org
3. Once registered as a new user in IRBNet, an investigator will have access to all forms needed for
submission of the application to Suffolk University IRB (they are located in the Library Manager –
select “Documents for Investigators).
 complete the appropriate application for (Human Subjects Research Application (HSRA) for
non-exempt applications or Human Subjects Research Application for Exemption) (HSRAE) for
exempt protocols. It might be beneficial to touch-base with Research Compliance to determine
whether the project meets exemption criteria
 complete the appropriate informed consent documents (standard document or request for
waiver; if audio or videotaping, complete the separate consent document for doing so in
addition to standard informed consent document). Note: For research conducted exclusively
on the internet and where the internet platform is used for consent purposes, you must submit
a request for a waiver of documentation of informed consent.
 complete a data and safety monitoring plan for all non-exempt research.
4. When all forms and materials are completed, submit the following by uploading into IRBNet:
 HSRA or HSRA for Exemption
 a research protocol (the elements that should be included in a research protocol may be found
in THE Investigator’s Toolbox on the Research Compliance website).
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 all recruitment materials (to include flyers, in person scripts, telephone scripts, email scripts,
etc)
 applicable informed consent documents (if audio or videotaping, separate consent documents
are required for participant consent to audio or videotape)
 all research instruments
 data and safety monitoring plan
 CITI training certificate
5. Once documents are uploaded, electronically sign the package and send to Department Chair or
Dean for electronic signature through IRBNet.
All protocols must be electronically endorsed by the principal investigator, faculty advisor (in the
case of student investigators), and a cognizant administrator (Department Chair or Dean). Protocols
not electronically signed will not be reviewed. In addition to proper endorsements, investigators
must complete and submit documentation of training to prior to submitting a protocol for review by
the IRB.
PRELIMINARY SCREENING AND REVIEW OF PROTOCOLS
A preliminary screening of protocols is accomplished by the ORSP Staff Assistant and Research
Compliance Manager. Protocols are reviewed for completion and accuracy of the basic application
and for the inclusion of all requisite supporting documents.
The ORSP Staff Assistant initially screens all protocols and materials uploaded to IRBNet for review
for completeness. If items are missing, the Staff Assistant will notify the PI and Co-PI (if applicable)
via project email, of any materials required to complete the application. All training certifications
and electronic signatures must be entered for the application to be processed.
The Research Compliance Manager completes a more thorough administrative review of all research
protocols submitted for review by the IRB usually within three days and notifies the PI and Co-PI of
any glaring issues that need to be addressed prior to proceeding for IRB review. These may include
incomplete responses on the application form; inconsistencies noted in the application and the
protocol or other documents; missing informed consent documents or documents to support a
request for waiving documentation of informed consent, elements of informed consent, or informed
consent in its entirety; missing recruitment materials or other required documentation such as
letters of support when children (minors) are recruited as subjects from schools or other programs
outside of school, etc. General requirements related to the criteria for IRB approval of research will
also be reviewed by the Research Compliance Manager.
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Suggestions may be made to principal investigators for administrative revisions involving points of
clarification or elaboration on items that may be viewed as potentially problematic during IRB
review.
The type of review that a study undergoes is commensurate with the level and type of risk to
participants involved. These risks include the probability and severity of possible harm to the
participants’ physical, psychological, social, or economic welfare. Various categories of vulnerable
populations as well as departure from a complete and documented informed consent process could
also warrant review of the research by the full board at a convened meeting. Certain categories of
minimum risk research may be processed via expedited review.
Federal regulations define minimal risk as risk that is “no greater in probability and severity than that
ordinarily encountered in daily life or during the performance of routine physical or psychological
examinations or tests”.
This definition of minimal risk serves as a benchmark to determine whether proposed studies require
review by a convened IRB.
FULL BOARD CONVENED REVIEW
There are a number of conditions in which a convened review by the full Board is warranted.
Protocols requiring convened review are to be completed on a Human Subjects Research Application
which may be located in IRB Net Library Manager or on the ORSP website in the Research
Compliance Investigator’s Toolbox at
http://www.suffolk.edu/explore/16524.php
Applications for convened review by the full IRB must be received within approximately 30 days of a
scheduled IRB meeting. The meeting dates and submission deadlines are posted on the Research
Compliance website at http://www.suffolk.edu/explore/16531.php
Review by the full Board at a convened meeting is required when:
 A protocol involves more than minimal risk of harm to subjects (to include physical,
emotional, social, psychological, or financial risk)
 An alteration or waiver of informed consent or elements of informed consent is requested
by the investigator (required for all non-exempt research when on-line consent is used)
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 A certificate of confidentiality is requested or required by the IRB
 Research involves the exclusive recruitment of vulnerable populations as defined in 45 CFR
46.
 The protocol involves the use of deception
Primary/Secondary Reviewer System
A primary and secondary reviewer is assigned in advance of a full board meeting by the IRB Chair,
Vice Chair, or Research Compliance Manager. In selecting the primary reviewer, consideration is
given to the individual’s knowledge of the subject area embodied in the proposal. If no IRB member
has adequate knowledge or experience to review a given protocol, the IRB Chair, in consultation with
the Research Compliance Manager, will engage a consultant with appropriate expertise and
experience to conduct the review.
The primary and secondary reviewers conduct in-depth review of all items required for IRB
submission of a new application, including the protocol, informed consent document(s), and all
supplemental materials (including, if applicable, the grant application). In addition, for continuing
review applications, the primary reviewer reviews the complete project file, that includes all
modifications and reports of unanticipated problems involving risks to subjects or others. Primary
and secondary reviewer responsibilities include reviewing the grant application and other
institution’s IRB approvals for cooperative research projects.
The primary and secondary reviewers are strongly encouraged to communicate with the Research
Compliance Manager to provide feedback to the investigator in advance of the board meeting for
additional information or clarification. The primary reviewer leads the discussion of the new project
or continuing review application. The primary reviewer may not have a conflict of interest regarding
the project under review and must notify the chair of any conflict.
Primary and secondary reviewers are expected to complete all appropriate review checklists to
ensure that all criteria for approval of research have been fulfilled. Each reviewer is to post
completed checklists to the IRB Net to assist in documenting minutes and electronic communications
with the investigator. These include the following checklists:
 Criteria for IRB Approval of Research
 Elements of Informed Consent
 Special Protections of Vulnerable Populations (pregnant women and fetuses, prisoners,
children (minors)
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If a primary or secondary reviewer is unable to attend the regularly scheduled meeting, it is their
responsibility to notify the ORSP Staff Assistant as soon as possible so that the secondary reviewer
is prepared in time to present the review at the meeting.
IRB MEETING PROCEDURES

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The IRB meeting is called to order when a quorum of members is in attendance.
A quorum consists of more than half of the members.
Approval of an action requires a majority vote of the members when a quorum is present.
The meeting ends when business is finished or is suspended whenever a quorum of
members is no longer present for deliberations.
IRB meetings are conducted by the IRB chair and the meeting agenda is arranged to place
less controversial issues at the beginning of the meeting.
Education informational items, information on expedited and exempt reviews, continuing
reviews and amendments are discussed by the chair and assigned primary and secondary
reviewer(s). Members receive this information with adequate time to review prior to the
meeting and sufficient time is allowed to discuss any issues they may wish to raise
concerning this information.
More comprehensive or complex issues, including initial, continuing review and
amendments that may require significant committee discussion are placed at the end of the
agenda.
Each presenter is asked to organize and present the item within ten minutes, adequate discussion
and the IRB action follows. If the reviewer requires additional time for presentation, the chair and
committee are notified prior to the start of the presentation. Primary and secondary reviewers are
requested to complete the appropriate review checklist and, if necessary, contact the investigator
to resolve questions prior to presentation. If the primary reviewer believes that the issues related
to the protocol cannot be resolved in a reasonable amount of time, the reviewer may recommend
that the protocol be deferred and the reviewer will continue to work directly with the investigator
to resolve any outstanding issues.
At the discretion of the chair and/or primary reviewer, the investigator(s) may be invited to attend
the meeting for the purpose of additional clarification or discussion. The investigator(s) is (are)
required to leave the meeting for subsequent discussion and voting.
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At the discretion of the chair, voting may be by written ballot, a show of hands, or voice vote. The
official meeting minutes will record, without individual identification, the number of votes to
approve, disapprove, or abstain. If vote(s) to disapprove is cast, the minutes should reflect the
reason(s) for the disapproving vote(s). In the event a member of the IRB elects to abstain, the
minutes record such and identify the individual who did not vote. A majority vote of the members
present at the meeting is required for approval. Proxy votes, written, electronic, or telephone, are
not allowed.
Investigators are notified either by letter or electronically, of the decision of the IRB and any
changes required. If minor specific changes are required by the IRB, the changes may be reviewed
and approved by the chair or designee, once returned to the IRB Administrator. Minor specific
changes (e.g., address change, addition or deletion of study personnel, change in number of
subjects to be recruited, substitution of specific words and/or phrases etc.) may be approved by
the IRB chair or his/her designee without return to the full board for review.
PROTOCOL BRIEFING GUIDE FOR CONVENED MEETINGS
In order to approve research, IRBs must determine that all of the following requirements are
satisfied in accordance with HHS regulations at 45 CFR 46.111:
1. Risks to subjects are minimized
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procedures used are consistent with sound research design
procedures do not unnecessarily expose subjects to risk
whenever appropriate, procedures are used that are already being performed on the
subjects for diagnostic or treatment purposes
2. Risks to subjects are reasonable in relation to anticipated benefits the importance of the
knowledge that may reasonably be expected to result
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Consider only those risks and benefits that may result from the research (as
distinguished from risks and benefits of therapies subjects would receive even if not
participating in the research)
Do not consider possible long-range effects of applying knowledge gained in the
research (for example, the possible effects of the research on public policy)
3. Selection of subjects is equitable

In making this assessment the IRB should take into account the purposes of the
research and the setting in which the research will be conducted
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consider special problems of research involving vulnerable populations, such as
children, prisoners, pregnant women, mentally disabled persons, or economically or
educationally disadvantaged persons
4. Informed consent will be sought from each prospective subject or the subject’s legally
authorized representative
5. Informed consent will be appropriately documented (consent, assent and parental
permission (if applicable)

Is written in a language understandable to subjects
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Contains all required elements or request for waiver
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Contains no exculpatory language
6. When appropriate, the research plan makes adequate provision for monitoring the data
collected to ensure the safety of subjects
7. Adequate provisions to protect the privacy of subjects and to maintain the
confidentiality of data are included
8. When some or all of the subjects are likely to be vulnerable to coercion or undue
influence, such as children, prisoners, pregnant women, mentally disabled persons, or
economically or educationally disadvantaged persons, additional safeguards have been
included in the study to protect the rights and welfare of these subjects
When applicable, IRBs must determine that the additional protections of subpart B (Additional
Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research), subpart C
(Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as
Subjects), or subpart D (Additional Protections for Children Involved as Subjects in Research) of
45 CFR part 46 have been met.
Other considerations : Frequency and type of continuing review
EXPEDITED REVIEW
Expedited review is a procedure through which certain kinds of research may be reviewed and
approved without convening a meeting of the IRB. Federal regulations make provisions for certain
categories of research to be reviewed through an expedited procedure if the research involves no
more than minimal risk. Expedited review is intended to enable the institution to conserve
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administrative resources, provide timely reviews, and focus the convened meetings of the IRB on
those research activities involving greater risks or ethical complexities.
The IRB may also use the expedited review procedure to review minor changes in previously
approved research during the period covered by the original approval. Under an expedited review
procedure, review of research may be carried out by the IRB Chairperson or by one or more
experienced members of the IRB designated by the Chairperson. The reviewer(s) may exercise all
the authorities of the IRB, except disapproval. Research may only be disapproved following review
by the full committee.
Though protocols designated for expedited review are assigned a primary and secondary reviewer,
all members must be provided access to the protocol for review in IRBNet prior to the convened
meeting at which the protocols are scheduled to be briefed in the event any member desires to
review the protocol.
Expedited reviewers must use the same criteria for IRB approval of research as those used during
review and approval by the convened IRB.
Protocols reviewed under an expedited review procedure must appear on the agenda and be
briefed by the expedited review team at a regularly scheduled IRB meeting using the outline below:

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Title of protocol
Investigator
Purpose
Study population
Brief summary of methodology
Research protocols that qualify for expedited review must meet two conditions: the first is that
the research must be determined to be less than minimal risk and the second condition is that the
proposed research must be included in the list of eligible categories of exempt research as
established by the DHHS and the FDA for this purpose.
The expedited review procedure may be carried out by the IRB Chair, or by one or more
experienced IRB members appointed by the Chair. Expedited reviewers possess all the same
authorities as the full IRB to approve, modify, or attach conditions to proposed research activities,
except the authority to disapprove a research activity. A research activity may be disapproved only
after review in accordance with the ordinary, non-expedited procedure set forth in 45 CFR
46.108(b).
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Expediting teams including a primary and secondary reviewer, and which may or may not include
the IRB Chair, are assigned to review those protocols submitted that meet expedited review
criteria. Reviews are done on an ongoing basis, meaning that the review is accomplished
independently of the IRB meeting schedule.
When an expedited review procedure is used, a list of protocols approved under the expedited
review procedure will appear on the agenda of the next regularly scheduled convened meeting of
the full IRB and are briefed by a member of the expediting review team.
Protocols that qualify for expedited review undergo a preliminary review by ORSP staff
immediately upon receipt, and if found to be accurate and complete, they are then processed for
review by the designated review team. Expediting teams may, after review, refer applications for
convened review.
Consultants may assist the IRB Chair in making decisions in expedited review, but expedited review
cannot be performed solely by persons who are not members of the IRB.
PROCEDURES FOR IRB MEMBERS COMPLETING EXPEDITED REVIEWS
All expedited review of IRB protocols are to be completed in accordance with the provisions of
45CFR46.110. In order for a protocol to be reviewed under an expedited procedure, it must
present no more than minimal risk to subjects.
A primary and secondary reviewer system will be used for the expedited review process. After an
initial administrative review has been completed by the Research Compliance Manager, the IRB
Chair will assign a primary and secondary reviewer to each protocol undergoing an expedited
review procedure based on the topic of the research and the subject matter expertise of board
members, experience level, and a determination that there is no conflict of interest present.
Once assigned, the protocol should be reviewed within five working days. As part of the review
process, each reviewer should use the following checklists as a guide in determining whether to
approve a protocol: Criteria for IRB Approval of Research, Expedited Review Checklist, Informed
Consent Checklist. If an investigator is requesting a Waiver of Informed Consent or a Waiver of
Documentation of Informed Consent, then the protocol is to be referred to the full board for
review. If, during the conduct of the review, it is determined that a protocol presents more than
minimal risk to subjects, it must be referred to the full board for review.
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Once checklists have been completed, they are to be uploaded into IRBNet. Be sure to enter
review comments on both the checklists and into the comments section of IRBNet. Select the
appropriate protocol status (i.e. approved, request for information, modifications required, etc)
and mark your review complete (even if information is requested or modifications are required).
Conditional approvals are not used for the expedited review process.
Special Note for Continuing Reviews completed using an expedited review procedure: Continuing
review is designed to ensure that risks to subjects continue to be minimized and that research is
being conducted in accordance with IRB approval of the initial protocol and any subsequently
approved modifications. Therefore, when a protocol undergoes continuing review, the following
statement is to be included in the comments section of the review checklist:
“This protocol was evaluated to ensure risks to subjects continue to be minimized and remain
reasonable in relation to any anticipated benefits and the knowledge expected to result. The
information provided by the investigator is consistent with the research protocol.”
If information or modifications are required, the IRB Chair will consolidate the comments from any
administrative reviews with those of both primary and secondary reviewers, and send a project
email to the investigator requesting information and/or modifications.
When a response is received from the investigator, the primary and secondary reviewer should
review again to ensure all issues noted in their respective reviews have been adequately
addressed. At this time, reviewers can revise their comments entered into IRB Net and if the
investigator has sufficiently responded to concerns, mark the protocol as approved.
The primary reviewer must send a project email through IRB Net to the Research Compliance
Coordinator and copy the IRB Chair and ORSP Staff Assistant with the following review information
for the minutes: the protocol IRBNet ID, the title of the protocol, type of review (i.e. new,
continuing review, modification, etc), the category under which the expedited review was
approved (list all that may apply), and a brief summary of the protocol. The format and content
example of what the project email should include is provided below:
IRBNet ID – Title of Protocol – Type of Review (i.e. New) – Approved under category (determine
category of review) of the expedited review process by Name of Primary Reviewer and Name of
Secondary Reviewer
Submitted by: Investigator Name
Protocol Summary: (e.g.) This study consists of a household survey which includes demographic
and consumption data to determine the impact of participation in the microcredit organization
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Zidisha. Zidisha is an online peer-to-peer micro-lender that offers loans in various African
countries, the majority of lending occurs in Kenya. Individuals voluntarily apply for Zidisha loans
through its website to improve their small businesses. Human Subjects include both borrowers and
non-borrowers of Zidisha to compare the impact of Zidisha borrowing on the economic, nutritional,
and self-reported “happiness” levels of those surveyed. Four-hundred to 800 participants aged 20+
will be recruited in person. Participants will be interviewed about their satisfaction regarding
particular types of loans. The data will be used for program evaluation, as well as an assessment of
micro-loans as opposed to other types of loans. This is a minimal risk study that involves no
deception. Request for a waiver of consent is appropriate due to cultural sensitivities involved.
This information will be entered by ORSP staff into the comments section of IRB Net for what will
appear in the minutes.
ORSP will complete and upload all protocol approval letters and make assignments to the IRB
Meeting agenda. Please note: protocols cannot be assigned to a meeting agenda until the primary
reviewer sends a project email through IRBNet with his or her protocol summary to ORSP for
upload into the minutes.
APPLICABILITY
In order to be eligible for expedited review, a research activity must be determined to be no more
than “minimal risk,” a regulatory concept defined in the Common Rule as follows:
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the
research are not greater in and of themselves than
those ordinarily encountered in daily life or during the
performance of routine physical or psychological
Minimal risk means that the
examinations or tests.
Reviewers should take into account any protective
measures included in the research design as part of
the process of determining if the proposed research
involves no more than minimal risk. However, some
social and behavioral studies involve more than
probability and magnitude
of harm or discomfort
anticipated in the research
are not greater in and of
themselves than those
ordinarily encountered in
daily life or during the
performance of routine
physical or psychological
examinations or tests.
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minimal risk, even though they include such protective measures.
Research activities that (1) present no more than minimal risk to human subjects, and (2) involve
only procedures listed in one or more of the following categories, may be reviewed by the IRB
through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The
activities listed should not be deemed to be of minimal risk simply because they are included on this
list. Inclusion on this list merely means that the activity is eligible for review through the expedited
review procedure when the specific circumstances of the proposed research involve no more than
minimal risk to human subjects. The categories in this list apply regardless of the age of subjects,
except as noted.
The expedited review procedure may not be used where identification of the subjects and/or their
responses would reasonably place them at risk of criminal or civil liability or be damaging to the
subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless
reasonable and appropriate protections will be implemented so that risks related to invasion of
privacy and breach of confidentiality are no greater than minimal. The expedited review procedure
may not be used for classified research involving human subjects.
Categories one (1) through seven (7) pertain to both initial and continuing IRB review.
Categories of Research for Which Expedited Review Procedure Can Be Used
1 Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not
required. (Note: Research on marketed drugs that significantly increases the risks or decreases
the acceptability of the risks associated with the use of the product is not eligible for expedited
review.)
(b) Research on medical devices for which (i) an investigational device exemption application (21
CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the
medical device is being used in accordance with its cleared/approved labeling.
2 Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
(a) from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the
amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more
frequently than 2 times per week; or
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(b) from other adults and children, considering the age, weight, and health of the subjects, the
collection procedure, the amount of blood to be collected, and the frequency with which it will
be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml
per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
3 Prospective collection of biological specimens for research purposes by noninvasive means.
Examples:
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hair and nail clippings in a non-disfiguring manner
deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction
permanent teeth if routine patient care indicates a need for extraction
excreta and external secretions (including sweat)
uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing
gumbase or wax or by applying a dilute citric solution to the tongue
placenta removed at delivery
amniotic fluid obtained at the time of rupture of the membrane prior to or during labor
supra- and subgingival dental plaque and calculus, provided the collection procedure is not
more invasive than routine prophylactic scaling of the teeth and the process is accomplished
in accordance with accepted prophylactic techniques
mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings
sputum collected after saline mist nebulization.
4 Collection of data through noninvasive procedures (not involving general anesthesia or sedation)
routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where
medical devices are employed, they must be cleared/approved for marketing. (Studies intended to
evaluate the safety and effectiveness of the medical device are not generally eligible for expedited
review, including studies of cleared medical devices for new indications.)
Examples:
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physical sensors that are applied either to the surface of the body or at a distance and do not
involve input of significant amounts of energy into the subject or an invasion of the subjects’
privacy
weighing or testing sensory acuity
magnetic resonance imaging
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electrocardiography, electroencephalography, thermography, detection of naturally
occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler
blood flow, and echocardiography
moderate exercise, muscular strength testing, body composition assessment, and flexibility
testing where appropriate given the age, weight, and health of the individual.
5 Research involving materials (data, documents, records, or specimens) that have been collected,
or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
(NOTE: Some research in this category may be exempt from the HHS regulations for the protection of
human participants. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
6 Collection of data from voice, video, digital, or image recordings made for research purposes.
7 Research on individual or group characteristics or behavior (including, but not limited to, research
on perception, cognition, motivation, identity, language, communication, cultural beliefs or
practices, and social behavior) or research employing survey, interview, oral history, focus group,
program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some
research in this category may be exempt from the HHS regulations for the protection of human
subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
8 Continuing review of research previously approved by the convened IRB as follows:
(a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects
have completed all research-related interventions; and (iii) the research remains active only for
long-term follow-up of subjects; or
(b) where no subjects have been enrolled and no additional risks have been identified; or
(c) where the remaining research activities are limited to data analysis.
9 Continuing review of research, not conducted under an investigational new drug application or
investigational device exemption where categories two (2) through eight (8) do not apply but the IRB
has determined and documented at a convened meeting that the research involves no greater than
minimal risk and no additional risks have been identified.
EXEMPT FROM IRB REVIEW
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The Common Rule exempts some biomedical and many social and behavioral research studies from
its regulatory requirements, including the requirement of IRB review.
Research that is exempt from IRB review is to be submitted on a Human Subject Research
Application for Exemption. Under the terms of our Assurance, it is the responsibility of the
Institutional Review Board (IRB) or other designated institutional official(s), not the investigator, to
determine whether research activities qualify for exemption. ORSP initially screens all requests for
exemption from IRB review and has the authority to approve such requests. If ORSP is uncertain
whether exemption should be granted, the request will be forwarded to the Chair for determination.
Any research pertaining to survey or interview procedures or observations of public behavior that
involves children that would normally be exempt under category 2, cannot be exempt from IRB
review (the exception is when observation of public behavior is done by someone other than the
investigator).
By regulatory definition, children are persons who have not attained the legal age for consent to
treatments or procedures involved in the research, under applicable law of the jurisdiction in which
the research will be conducted. Generally the law considers any person under 18 years old to be a
child (minor).
The categorization of human subjects research as "exempt" from IRB review or appropriate for
"expedited" IRB review is intended to streamline IRB procedures with no diminution of
protection for human subjects.
Research activities in which the only involvement of human participants will be in one or more of the
following categories are exempt from the policies outlined in the federal regulations regarding the
protection of human subjects and review by the IRB:
Unless otherwise required by department or agency heads, research activities in which the only
involvement of human subjects will be in one or more of the following categories are exempt from
federal policy:
1. Research conducted in established or commonly accepted educational settings, involving normal
educational practices, such as
 research on regular and special education instructional strategies, or
 research on the effectiveness of or the comparison among instructional techniques, curricula,
or classroom management methods.
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2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures or observation of public behavior, unless:
 information obtained is recorded in such a manner that human subjects can be identified,
directly or through identifiers linked to the subjects; and
 any disclosure of the human subjects' responses outside the research could reasonably place
the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing,
employability, or reputation.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures, or observation of public behavior that is not exempt under
paragraph (b)(2) of this section if:
 the human subjects are elected or appointed public officials or candidates for public office; or
 federal statute(s) require(s) without exception that the confidentiality of the personally
identifiable information will be maintained throughout the research and thereafter.
4. Research involving the collection or study of existing data, documents, records, pathological
specimens, or diagnostic specimens, if these sources are publicly available or if the information is
recorded by the investigator in such a manner that subjects cannot be identified, directly or through
identifiers linked to the subjects.
5. Research and demonstration projects which are conducted by or subject to the approval of
department or agency heads, and which are designed to study, evaluate, or otherwise examine:
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Public benefit or service programs;
Procedures for obtaining benefits or services under those programs;
Possible changes in or alternatives to those programs or procedures; or
Possible changes in methods or levels of payment for benefits or services under those
programs.
6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods
without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or
below the level and for a use found to be safe, or agricultural chemical or environmental
contaminant at or below the level found to be safe, by the Food and Drug Administration or
approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the
U.S. Department of Agriculture.
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Determination of Exemption
A request for exemption means that the researcher believes that a proposed research activity does
not require IRB review and approval. The University, however, is still obligated to review all such
activities, whether funded or not, and certify that the research meets the federal, state, local and
Suffolk University IRB requirements for exemption. In order to fulfill requirements for the proper
review of research, investigators cannot “self-exempt” from IRB review.
Evaluation and certification of a protocol for exemption status will be performed by the Research
Compliance Manager, IRB Chair or another designated member of the IRB. In order for the Chair or
designee to make this determination, the PI must submit the appropriate Human Subjects Research
Application for Exemption. The RCM is delegated the authority to make exemption determinations in
accordance by the IRB Chair in accordance with this policy to make a determination of exemption.
Other experienced, qualified IRB member designees may also be utilized to make a determination of
exemption if the Chair is not readily available or if the Chair determines that he/she has a conflict of
interest, the appearance of a conflict of interest or a member is better qualified to make the
determination. If the activity does not qualify for exemption, the investigator is notified by the RCM,
in writing, that the criteria for exemption are not met.
Research will be determined to be exempt only when the sole involvement of human subjects will be
in one or more of the categories listed in 45 CFR 46.101(b)(1-6) or 21 CFR 56.104(a-d). The IRB will
not create new categories of exempt research.
1. The Chair/designee will not consider any research exempt that involves prisoners, sensitive
aspects of subject’s behavior, sensitive surveys, or that takes place in settings where subjects have a
reasonable expectation of privacy.
2. The Chair/designee will not consider any research exempt that involves survey or interview
procedures or observation of public behavior of children (minors) except for research involving
observation of public behavior when the investigator(s) does not participate in the activities being
observed.
3. The Chair/designee will not consider any research exempt that involves a test article regulated by
the FDA unless the research meets the criteria for exemption described in 45 CFR 46.101(b)(6).
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4. The IRB Chair or designee will review the proposed research and will validate or decline the
investigator’s request for exemption, ensure that risks to individuals are minimized, and confirm that
the research meets ethical standards. The IRB will document the review and action of the IRB Chair
or designee including the category specified in 45 CFR 46.101(b)(1-6) or 21 CFR 56.104(a-d) justifying
the classification of exempt.
5. The IRB will promptly notify the PI in writing (via email) of its decision regarding the research. If it
is determined that the research is not exempt or if modifications are required such as submission of
a consent document or strengthening of protections in place to minimize risks to participants, the
IRB will include in its written notification a statement of the reason for its decision and give the PI an
opportunity to respond in person or in writing. Final approval of exempt research is pending
resolution of all minor modifications identified by the IRB reviewer.
6. If the IRB chair or member determines that an application does not qualify for exemption, the
application will be processed either through Expedited Review or by full IRB review.
7. At the time of approval of exempt protocols, PIs are reminded of the responsibility to report all
modifications and unanticipated problems involving risks to subjects or others in accordance with
IRB Standard Operating Procedures.
8. Applications for exempt research are reviewed in the same manner as expedited protocols.
Exemption of Research Involving Children
Research that involves children and falls into categories 1 - 6 described below may be found to be
exempt by the IRB. However, the exemption category 2 at 45 CFR 46.101(b)(2) above, pertaining to
survey or interview procedures or observations of public behavior, does not apply to research
involving children, except for research involving public behavior when the Investigator does not
participate in the activities being observed.
Exemption of Research Involving Prisoners
Research under categories 1-6 is not exempt if it involves prisoners. These applications must be
submitted for IRB Committee review. Research involving prisoners can be approved under expedited
review procedures. However, because of the vulnerability of prisoners, OHRP recommends that all
research involving prisoners be reviewed by the convened IRB. If the research is reviewed under the
expedited review procedure, OHRP recommends that the IRB member(s) reviewing the research
include a prisoner or prisoner representative.
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CRITERIA FOR IRB APPROVAL OF RESEARCH
In order to approve research, the IRB must determine that all of the requirements of 45 CFR 46.111
are satisfied. In addition, for research involving pregnant women, fetuses or neonates; prisoners; or
children, the IRB must determine that the research satisfies the requirements of 45 CFR 46 subparts
B, C, or D, respectively.
The criteria for IRB approval of research applies to both full board reviews and those that qualify for
expedited review and for all conditions that require submission to the IRB. These include:
 initial review
 continuing review
 reviews conducted due to problems, unanticipated events, deviations, or non-compliance
 modifications
Each member at a convened meeting is responsible for determining if the regulatory criteria for
approval are met. For expedited review, the designated primary and secondary reviewers assume
this responsibility.
The specific criteria used for the IRB review and approval of research are summarized below:
1. Risks to participants are minimized
2. Risks are reasonable in relation to anticipated benefits
3. Selection of subjects is equitable
4. Informed consent is sought in accordance with and to the extent required by the regulations
5. Informed consent is documented in accordance with and to the extent required by the regulations
6. The research plan makes adequate provisions for monitoring the safety of participants
7. Adequate provisions are made to protect privacy of participants and maintain confidentiality of
data collected about the participants
8. Additional safeguards are in place for participants likely to be vulnerable to coercion or undue
influence
The regulatory criteria for approval are written to balance the ethical principles outlined in the
Belmont Report and call for judgments to be made by the IRB that are based on subjective elements
such as “reasonable”, “adequate”, “sound” and “equitable.”
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Studies Approved by the IRB but not Implemented
When an IRB approves a study, continuing review should be performed at least annually. The clock
starts on the date of approval, whether or not subjects have been enrolled. A written progress report
should be received from the investigator for all studies that are in approved status prior to the date
of expiration of IRB approval. If subjects were never enrolled, the investigator's progress report
would be brief. Such studies may receive continuing IRB review using expedited procedures. If the
study is finally canceled without subject enrollment, records should be maintained for at least three
years after cancellation.
ISSUES CONSIDERED BY THE IRB DURING THE PROTOCOL REVIEW PROCESS
Study Design
The IRB will examine the study design in terms of its impact on the rights and welfare of the human
subjects. The responsible conduct of research dictates that “...if a research study is so
methodologically flawed that little or no reliable information will result, it is unethical to put subjects
at risk or even inconvenience them through participation in such a study.” Many experts agree that
the IRB should approve only research that is both valid and of value. The IRB may request an expert
consultant review or defer to scientific review committees, including the investigator’s departmental
review, in order to determine whether a study design places subjects at unnecessary risk.
Regulations allow the IRB to approve a study design that involves deception or withholding of
information, if the strategies are justified and the protocol provides for a post-study debriefing of the
subjects.
Minimization of Risk
IRB members must consider whether the research plan ensures that risks to subjects are minimized
by using procedures consistent with sound research design that do not unnecessarily expose subjects
to risk, and whenever appropriate, by using procedures already being performed on subjects for
diagnostic and treatment purposes.
Investigators are expected to design and implement protocols that comply, at a minimum, with
applicable regulatory and institutional policy requirements, as well as the principles of the Belmont
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Report (i.e., respect for person, beneficence, justice). To ensure this requirement is met,
investigators and IRB members during the review process should thoughtfully consider the following:
 Are there potential direct benefits of this research to the subject? If so, the potential direct
benefits should be described and indicate if all, or only some, of the subject groups may derive
this potential benefit.
 Are the potential benefits of the research to society (e.g. how might the research lead to
improvement in management of a problem; increased knowledge of a social issue; improved
safety; educational outcome; technical advancement) adequately described?
 Is a description of the foreseeable risks to the subjects included? (Rarely is a study completely
risk-free. Consider physical, psychological, social/reputation, legal, financial, privacy risks, etc.)
Each identified risk, should include the following:
1. Likelihood of the risk
 "common" (i.e. approximate incidence greater than 25%)
 "likely" (i.e. approximate incidence of 10-25%)
 "infrequent" (i.e. approximate incidence of 1-10%)
 "rare" (i.e. approximate incidence of less than 1%)
2. Seriousness of the risk to the subject; and
3. What measures will be taken to minimize the risk
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Are any direct risks to the public or community, which could result from this research (e.g.
potential dissemination to others of transferred genetic material , exposure of others to
radiation from radioisotopes administered to a subject) described?
The highest level of risks of harm to the subjects that could occur as a result of the research
How the risks to the subject are reasonable in relation to the anticipated benefits.
Systematic Assessment of Risks and Benefits
The IRB will assess whether the risks to subjects are reasonable in relation to the anticipated
benefits, if any, to the subjects, and the importance of the knowledge reasonably expected to result
from the research. The IRB will consider only those risks and benefits that may result from the
research. The federal regulations do not allow the IRB to evaluate the possible long range effect of
applying the knowledge gained through the research. The IRB is required to review any possible
benefits a subject may derive from participation in research, and/or the benefits of new knowledge
that may justify asking a person to undertake the risks of the study.
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The IRB should balance the level of acceptable risk and the amount of expected benefits from any
given study or procedure. Specifically, the amount of acceptable risk should represent a ceiling for
which no further risk would be acceptable given the probability and magnitude of the benefit. In
making this assessment the IRB needs to consider what is the expected chance for benefit and how
large of a benefit is expected. So the concept of acceptable risk is a sliding scale where acceptable
risk may increase with expected benefits.
In order to accomplish this in any systematic way, there should first be a determination of the
validity of the presuppositions of the research; then the nature, probability and magnitude of risk
should be distinguished with as much clarity as possible. The method of ascertaining risks should be
explicit, especially where there is no alternative to the use of such vague categories as small or slight
risk. It should also be determined whether an investigator's estimates of the probability of harm or
benefits are reasonable, as judged by known facts or other available studies.
Finally, assessment of the justifiability of research should reflect at least the following
considerations:
 Brutal or inhumane treatment of human subjects is never morally justified.
 Risks should be reduced to those necessary to achieve the research objective. It should be
determined whether it is in fact necessary to use human subjects at all. Risk can perhaps never
be entirely eliminated, but it can often be reduced by careful attention to alternative
procedures.
 When research involves significant risk of serious impairment, the IRB should be extraordinarily
insistent on the justification of the risk (looking usually to the likelihood of benefit to the
subject -- or, in some rare cases, to the manifest voluntariness of the participation).
 When vulnerable populations are involved in research, the appropriateness of involving them
should itself be demonstrated. A number of variables go into such judgments, including the
nature and degree of risk, the condition of the particular population involved, and the nature
and level of the anticipated benefits.
 Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in
the informed consent process.
As an additional protection, even if the risks are balanced by the anticipated benefits, a study may
not be independently approved by an IRB if the anticipated benefits are not at least as favorable to
the subjects as available alternative approaches.
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Most human subject research conducted at Suffolk University involves no more than minimal risk.
Minimal risk means "that the probability and magnitude of harm or discomfort anticipated in the
research are not greater in and of themselves than those ordinarily encountered in daily life or
during the performance of routine physical or psychological examinations or tests." (This definition
establishes the threshold for determining which level of IRB review might apply to a particular
research protocol.)
There is a slight nuance in the regulatory definition of minimal risk with respect to research involving
prisoner populations or other incarcerated individuals. With respect to research involving such a
vulnerable population, minimal risk is defined as “the probability and magnitude of physical or
psychological harm that is normally encountered in the daily lives, or in the routine medical, dental,
or psychological examination of healthy persons.”
Equitable Selection of Subjects
The selection of subjects should be equitable and free of any coercion, both explicit and implied. In
terms of equitable selection of subjects the IRB will consider the purpose of the research and the
setting of the research. The principle of justice outline in the Belmont Reports requires that the
selection of research subjects be scrutinized in order to determine whether some classes (e.g.,
welfare patients, particular racial and ethnic minorities, persons confined to institutions, or students)
are being systematically selected simply because of their easy availability, their compromised
position, or their manipulability, rather than for reasons directly related to the problem being
studied.
The IRB will closely examine research involving vulnerable subject populations, such as children,
prisoners, subjects with cognitive disorders, or socio-economically disadvantaged subjects.
Investigators should detail any extra precautions taken to safeguard the rights and welfare of
vulnerable populations.
Women and members of minority groups and their subpopulations must be included in all clinical
research, unless a clear and compelling rationale and justification established to the satisfaction of
the IRB that inclusion is inappropriate with respect to the health of the subjects or the purpose of the
research. Exclusion under other circumstances may be made based on a compelling rationale and
justification. Cost is not an acceptable reason for exclusion except when the study would duplicate
data from other sources. Women of childbearing potential should not be routinely excluded from
participation in clinical research.
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The inclusion (recruitment process) of women and members of minority groups and their
subpopulations must be addressed in developing a research design or contract proposal appropriate
to the scientific objectives of the study/contract. The research plan/proposal should describe the
composition of the proposed study population in terms of sex/gender and racial/ethnic group, and
provide a rationale for selection of such subjects. Such a plan/proposal should contain a description
of the proposed outreach programs for recruiting women and minorities as participants. Payment
for participation in research is not considered a benefit.
Recruitment of Subjects
In fulfilling its responsibilities, an IRB is expected to review all the research documents and activities
that bear directly on the rights and welfare of the subjects of proposed research. The protocol, the
consent document, advertisements and other recruitment materials are examples of documents that
the IRB should review. The IRB should also review the methods that investigators propose to use to
recruit subjects.
Recruitment Tools
All recruitment tools, methods, and materials are required to be reviewed and approved by the IRB
prior to implementation of their use. The materials may not be used to recruit subjects until the
investigator receives final IRB approval.
Recruitment materials (advertisements, etc.) are not valid and may not be used without an IRB
approval stamp containing the approval and expiration dates. Only IRB approved advertisements
may be used in the conduct of subject recruitment. Recruitment materials should be included with
both initial and continuing review applications.
Recruitment tools such as SONA and Social Sci are approved methods of recruiting subjects by the
IRB, however, it is incumbent upon the investigator, if using such tools to be knowledgeable of the
capabilities and limitations of such recruitment platforms, as these platforms may also be used for
consent purposes, administration of questionnaires or surveys and storage of data. Reliance on the
use of such tools must not in any way compromise regulatory requirements for the protection of
human subjects in research or other compliance requirements.
When recruiting subjects from another institution with an IRB, investigators are required to gain IRB
approval from that institution. In institutions without an IRB, investigators are required to obtain a
letter of agreement on organizational letterhead indicating the research can be conducted at the site
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and the agency or institution will review, abide by and comply with the procedures approved by the
Suffolk University IRB.
Media Advertising
Direct advertising for research subjects, i.e., advertising that is intended to be seen or heard by
prospective subjects to solicit their participation in a study, is not in and of itself, an objectionable
practice. Direct advertising includes, but is not necessarily limited to: newspaper, radio, TV, bulletin
boards, posters, and flyers that are intended for prospective subjects. Not included are: (1)
communications intended to be seen or heard by health professionals, such as "dear doctor" letters
and doctor-to-doctor letters (even when soliciting for study subjects), (2) news stories and (3)
publicity intended for other audiences, such as financial page advertisements directed toward
prospective investors.
When direct advertising is to be used, the IRB should review the information contained in the
advertisement and the mode of its communication, to determine that the procedure for recruiting
subjects is not coercive and does not state or imply a certainty of favorable outcome or other
benefits beyond what is outlined in the consent document and the protocol. The IRB should review
the final copy of printed advertisements to evaluate the relative size of type used and other visual
effects. When advertisements are to be taped for broadcast, the IRB should review the final
audio/video tape. The IRB may review and approve the wording of the advertisement prior to taping
to preclude re-taping because of inappropriate wording. The review of the final taped message
prepared from IRB-approved text may be accomplished through expedited procedures. The IRB may
wish to caution the clinical investigators to obtain IRB approval of message text prior to taping, in
order to avoid re-taping because of inappropriate wording.
Any advertisement to recruit subjects should be limited to the information the prospective subjects
need to determine their eligibility and interest. When appropriately worded, the following items may
be included in advertisements.
1.
2.
3.
4.
5.
6.
The name and address of the investigator and/or research facility;
The condition under study and/or the purpose of the research;
In summary form, the criteria that will be used to determine eligibility for the study;
A brief list of participation benefits, if any (e.g. participation in a support group at no cost);
The time or other commitment required of the subjects; and
The location of the research and the person or office to contact for further information.
Screening Tests to Determine Eligibility for Enrollment
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For some studies, it may be necessary to use screening tests to assess whether prospective subjects
are appropriate candidates for inclusion in studies and the IRB may determine that this is an
appropriate activity “preparatory to research.” While an investigator, with IRB approval, may discuss
availability of studies and the possibility of entry into a study with a prospective subject without first
obtaining consent, informed consent must be obtained prior to initiation of any procedures that are
performed solely for the purpose of determining eligibility for research.
Screening procedures for research eligibility are normally considered part of the subject selection
and recruitment process and, therefore, require IRB oversight. The IRB should receive a written
outline of the screening procedure to be followed and how consent for screening will be obtained.
The IRB may find it appropriate to limit the scope of the screening consent to a description of the
screening tests and to the reasons for performing the tests including a brief summary description of
the study in which they may be asked to participate. Unless the screening tests involve more than
minimal risk or involve a procedure for which written consent is normally required outside the
research context, the IRB may decide that prospective study subjects need not sign a consent
document. If the screening indicates that the prospective subject is eligible, the informed consent
procedures for the study, as approved by the IRB, would then be followed.
Scripts
The first contact prospective study subjects make is often with a research assistant who follows a
script to determine basic eligibility for the specific study. The IRB should assure the procedures
followed adequately protect the rights and welfare of the prospective subjects. In some cases
personal and sensitive information is gathered about the individual. The IRB should have assurance
that the information will be appropriately handled. A simple statement such as "confidentiality will
be maintained" does not adequately inform the IRB of the procedures that will be used.
Examples of issues that are appropriate for IRB review: What happens to personal information if the
caller ends the interview or simply hangs up? Are the data gathered by a marketing company? If so,
are names, etc. sold to others? Are names of non-eligibles maintained in case they would qualify for
another study? Are paper copies of records shredded or are readable copies put out as trash? The
acceptability of the procedures would depend on the sensitivity of the data gathered, including;
personal, medical and financial.
Identification of Subjects and Confidentiality
The IRB is required to review the method for prospective identification and recruitment of subjects.
The IRB will examine the means of identifying and contacting potential subjects and the methods for
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ensuring the subjects’ privacy and confidentiality. Investigators are required to submit plans for
ensuring the privacy and confidentiality of subjects.
Anonymity vs Confidentiality of Research Data
Anonymity means that there is never a means of linking the information collected to a particular
individual. It is the best protection we can afford participants. The next best is confidentiality.
To demonstrate confidentiality of research data, the exact procedures that will be used should be
described in detail in the IRB application and consent form. A similar explanation should be included
in informed consent documents.
Concerns about confidentiality pertain to the methods used to ensure that information obtained by
researchers about their subjects is not improperly divulged. It is in the interest of researchers and
essential to the conduct of research on sensitive topics that researchers be able to offer subjects
some assurance of confidentiality. These assurances should be given honestly, which sometimes
requires the researcher and the IRB to make explicit provisions for preventing breaches of
confidentiality.
In most research, assuring confidentiality is only a matter of following some routine practices such
as:
 substituting codes for identifiers
 removing face sheets (containing such items as names and addresses) from survey instruments
containing data
 properly disposing of computer sheets and other papers
 limiting access to identified data
 impressing on the research staff the importance of confidentiality, and
 storing research records in locked cabinets
Some studies may require more elaborate procedures to either give subjects the confidence they
need to participate and answer questions honestly, or to enable researchers to offer strong, truthful
assurances of confidentiality. Such elaborate procedures may be particularly necessary for studies in
which data is collected on sensitive matters such as sexual behavior or criminal activities.
Where data is collected about sensitive issues (such as illegal behavior, alcohol or drug use, or sexual
practices or preferences) protection of confidentiality consists of more than preventing accidental
disclosures. There have been instances where the identities of subjects or research data about
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particular subjects have been sought by law enforcement agencies, sometimes under subpoena, and
with the threat of incarceration of the uncooperative researcher. Under federal law (and some state
laws), researchers can obtain an advance Certificate of Confidentiality that will provide protection
even against a subpoena for research data [Public Health Service Act §301(d)]. More detailed
information on Certificates of Confidentiality may be found in Appendix _.
The Informed Consent Process
The IRB will carefully review the informed consent process; when, where and how consent is
obtained, and any provisions for the on-going consent of subjects. Generally, the IRB will not dictate
the procedure to be used to obtain informed consent, but reserves the right to do so if deemed
necessary.
The IRB will consider the circumstances under which consent is sought to ensure investigators
provide the prospective participant or representative sufficient opportunity to consider whether or
not to participate and that minimize the possibility of coercion or undue influence. This requirement
applies to all non-exempt human subjects research not eligible for a waiver of the consent
requirements.
Coercion and Undue Influence
Coercion occurs when an overt or implicit threat of harm is intentionally presented by one person to
another in order to obtain compliance. For example, an investigator might tell a prospective subject
(student) that they will fail if he or she does not participate in the research.
By contrast, undue influence often occurs through an offer of an excessive or inappropriate reward
or other overture in order to obtain compliance. For example, an investigator might promise
psychology students extra credit if they participate in the research. If that is the only way a student
can earn extra credit, then the investigator is unduly influencing potential subjects. If however, the
investigator offers comparable non-research alternatives for earning extra credit, the possibility of
undue influence is minimized.
In addition to undue influence that can arise with the offering of rewards, undue influence also can
be subtle. For example, patients might feel obligated to participate in research if their physician is
also the investigator, or students might feel pressure to participate in research if everyone else in the
class is doing so. Because influence is contextual, and undue influence is likely to depend on an
individual’s situation, it is often difficult for IRBs to draw a bright line delimiting undue influence. It is
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up to the IRB to use its discretion in determining which circumstances give rise to undue influence.
For example, an IRB might consider whether the informed consent process will take place at an
appropriate time and in an appropriate setting, and whether the prospective subject may feel
pressured into acting quickly or be discouraged from seeking advice from others.
Because of their relative nature and lack of clear-cut standards on the boundaries of inappropriate
and appropriate forms of influence, investigators and the IRB must be vigilant about minimizing the
possibility for coercion and undue influence. Reasonable assessments can be made to minimize the
likelihood of undue influence or coercion occurring. For example, the IRB may restrict levels of
financial or nonfinancial incentives for participation and should carefully review the information to
be disclosed to potential subjects to ensure that the incentives and how they will be provided are
clearly described. Known benefits should be stated accurately but not exaggerated, and potential or
uncertain benefits should be stated as such, with clear language indicating how much is known about
the uncertainty or likelihood of these potential benefits.
The IRB should be especially attentive to reviewing research protocols when some or all of the
subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners,
pregnant women, mentally disabled persons, or economically or educationally disadvantaged
persons. Non-exempt research involving Suffolk University students as subjects must also consider
that students may be subject to institutional vulnerability and thus require special protections in
such circumstances. In these instances, additional safeguards are to be included in the study to
protect the rights and welfare of students. Inducements that would ordinarily be acceptable in some
populations may become undue influences for these vulnerable or potentially vulnerable subject
groups.
Deception and Incomplete Disclosure
Deception is a method sometimes used in social science research that can improve the internal
validity of a research study. The intention of deception is to produce a false belief in the participants
during the course of the study. Incomplete disclosure of information may also be used in research
where telling the subject about some aspect of the study in detail might “prime” them and interfere
with the ability to measure the outcome of interest. The use of deception and incomplete disclosure
in human subject research raises special concerns for the IRB to consider with regard to informed
consent and analysis of risks and benefits. Unethical uses of deception in research can cause distress
to those being deceived, and may undermine public trust in research.
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The IRB may allow for the modification or alteration of the general requirements for informed
consent for research involving deception or incomplete disclosure for studies involving minimal risk
as defined by federal regulations.
When studies involve the use deception or incomplete disclosure, the IRB must determine whether
the deception or incomplete disclosure is necessary to make the research scientifically valid and
feasible. The IRB will consider whether the study population is appropriate for the study procedures
that involve deception or incomplete disclosure of information, and will consider potential
implication of harms that may result from the use of these methods. The IRB will not allow for
deception or incomplete disclosure that might affect the subject’s willingness to participate in the
study.
Deception
Deception is when an investigator gives subjects false information about some aspect of the
research. As a rule, deception of subjects is not considered ethical in human subject research and
especially In relation to the idea of informed consent. In rare circumstances, the IRB may approve
the use of deception when it is absolutely necessary for the outcome of the study and does not put
the subjects at inappropriate risk. In such instances, PIs must debrief subjects upon completion of
their participation and this debriefing should disclose the deception used and why the use of
deception was necessary.
Incomplete Disclosure
Incomplete disclosure is when the investigator withholds some information about the real purpose
of the study, or the nature of the research procedures.
Potential Risks and Harms of Deception or Incomplete Disclosure
It is important for both investigators and the IRB to fully consider the risks and harms that could
potentially result from deception of participants in research or from incomplete disclosure of all of
the aspects or aims of the study. Participants may:
 Feel coerced to have acted against one’s will
 Might not have chosen to participate if fully informed
 If observed, subject may feel invasion of privacy
 Experience damage to self-esteem; feeling ashamed, guilty, stressed, embarrassed
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 Feel burdened by gaining knowledge about self that otherwise might not want to know
 Feel loss of control, may be distrustful/suspicious
General Guidelines
1. Deception/incomplete disclosure is typically only acceptable in studies with no more than minimal
risk.
2. The deception/incomplete disclosure should have no adverse effects on welfare.
3. The IRB must determine that the value of the study is sufficient to warrant waiving some aspects
of the requirement for full disclosure in the informed consent process.
4. There is no alternative to address the scientific question in a valid manner but to use
deception/incomplete disclosure. Other effective, non-deceptive approaches are not feasible.
5. Participants are not deceived about any aspect of the study that would affect their willingness to
participate.
6. Debriefing is done, when appropriate, and the deception/incomplete disclosure is explained to
the participant before the end of participation in the research.
7. When appropriate, subjects could be informed prospectively of the use of deception/incomplete
disclosure and consent to its use: see the suggested consent language:
“In some research studies, the investigators cannot tell you exactly what the study is about before you
participate in the study. We will describe the tasks in the study in a general way, but we can’t explain
the real purpose of the study until after you complete these tasks. When you are done, we will
explain why we are doing this study, what we are looking at, and any other information you should
know about this study. You will also be able to ask any questions you might have about the study’s
purpose and the tasks you did. Though we may not be able to explain the real purpose of the study
until after you complete the tasks, there are no additional risks to those that have been described in
this consent form.”
Include the following in the Consent Procedures section of the research protocol:
1. Explain the reason for the use of deception/incomplete disclosure in the study design; specifically
how providing specific information to prospective participants about the purpose and methods of
the research would compromise the scientific validity of the research.
2. Describe the extent of deception/incomplete disclosure in detail, including how it relates to the
study aims and study design.
3. Describe how the research involving deception/incomplete disclosure involves no more than
minimal risk to the subjects. Discuss any level of increased harm a participant might experience as a
result of the deception/incomplete disclosure.
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4. Explain how there are no feasible alternative methods to conduct the research that do not
involve deception/incomplete disclosure.
5. If applicable, describe methods for prompt disclosure and debriefing for each participant as soon
as is possible after their participation is complete, and how the debriefing will ensure that the subject
leave the research setting with a clear and accurate understanding of the deception/incomplete
disclosure. Submit a script or written statement of the debriefing if feasible. Describe how
participants may withdraw their data at this time if they wish. If debriefing is not planned, discuss
why this is the case.
Surveys, Questionnaires, Interview Materials, or other Testing Instruments
These materials should be reviewed to ensure that they adequately reflect the purpose and
procedures in the study and handle sensitive issues appropriately. If the materials ask for
information that, according to local law, would require reporting (e.g., elder, spouse, or child abuse),
the consent form should explain this exception to the promise of subject confidentiality. There are,
however, a variety of psychological and other measures which are considered “standard” and, while
they cannot be modified, reviewers should still indicate if use of a given measure is appropriate for a
particular study. In particular, reviewers should consider if survey answers, if known, would impact a
subject’s reputation, insurability, etc.
In terms of surveys administered to children (minors) for research purposes, the No Child Left Behind
Act of 2001 (Public Law 107-110)13 identifies 8 categories of protected information for survey
research within the school setting:
1.
2.
3.
4.
5.
6.
7.
Political affiliations of student or student's parent;
Mental or psychological problems of student or student's family;
Sex behavior or attitudes;
Illegal, anti-social, self-incriminating or demeaning behavior;
Critical appraisals of others with whom students have close family relationships;
Legally recognized privileged or analogous relationships;
Religious practices, affiliations or beliefs of student or student's parent; and income.
Under the Act, research involving any of the eight identified categories requires written parental
informed consent prior to participation of a child.
Payment to Research Subjects
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The Institutional Review Board (IRB) should determine that the risks to subjects are reasonable in
relation to anticipated benefits and that the consent document contains an adequate description of
the study procedures as well as the and benefits.
It is not uncommon for subjects to be paid for their participation in research, however, payment to
research subjects for participation in studies is not considered a benefit; it is a recruitment incentive.
The protocol must also include, if applicable, a plan for the payment of research subjects, to include
the amount, nature, method, and schedule of payment.
The amount and schedule of all payments should be presented to the IRB at the time of initial
review. The IRB should review both the amount of payment and the proposed method and timing of
disbursement to assure that neither are coercive or present undue influence.
The IRB must sometimes address difficult questions related to payment of research subjects. For
example, how much money should research subjects receive, and for what should subjects receive
payment - their time, inconvenience, discomfort, or some other consideration?
The IRB must consider whether any aspect of the proposed remuneration could result in undue
influence, thus interfering with the potential subjects’ ability to give voluntary informed consent. In
no case should remuneration be viewed as a way of offsetting risks; that is, it should not be
considered a benefit to be weighed against study risks. The level of remuneration should not be so
high as to cause a prospective subject to accept risks that he or she would not accept in the absence
of the remuneration. This same principle would apply to remuneration offered to parents whose
children are prospective subjects.
Remuneration for participation in research should be just or fair. However, the specifics of each
protocol will influence how those determinations are made. Both investigators and the IRB need to
be familiar with the study population and the context of the research in order to make reasonable
judgments about how compensation will affect participation. Wherever the remuneration is set, it
will influence the decisions of some more than others. In particular, it will be more important to
those for whom it will make a significant financial difference. Thus investigators should be cautious
that payments are not so high that they create an “undue influence” or offer undue inducement that
could compromise a prospective subject’s examination and evaluation of the risks or affect the
voluntariness of his or her choices.
Protocols submitted to the IRB should indicate and justify proposed levels and purposes of
remuneration, which also should be clearly stated in the accompanying consent forms. The IRB may
need to request of the investigator some plan for monitoring subject recruitment to ensure that such
inducements do not result in inequitable subject recruitment (e.g., recruiting only economically
disadvantaged individuals).
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The IRB and investigators should ensure that the consent process includes a detailed account of the
terms of payment, including a description of the conditions under which a subject would receive
partial or no payment (e.g., what will happen if he or she withdraws part way through the research,
or the investigator removes a subject from the study for cause).
Finally, in studies of considerable duration or that involve multiple interactions or interventions,
OHRP recommends that payment be prorated for the time of participation in the study rather than
delayed until study completion, because the latter could unduly influence a subject’s decision to
exercise his or her right to withdraw at any time. For example, if the study is conducted over a period
of 6 months, there might be a monthly or bi-monthly payment. Or, if the study involves 12 sessions,
there might be payment after every two sessions.
In certain circumstances non-monetary incentives (e.g., extra credit for students, access to services
or programs) also can create undue influence on a potential subject’s decision about research
participation.
The IRB must ensure that non-financial incentives are not so great as to diminish the voluntariness of
consent or cloud someone’s appreciation of risks or potential benefits that might be gained from
participating in a study. Moreover, it must be clear that choosing to not participate will not
adversely affect an individual’s relationship with the institution or its staff or the provision of services
in any way (e.g., loss of credits or access to programs).
Overt coercion (e.g., threatening loss of services or access to programs to which the potential
subjects are otherwise entitled) is never appropriate. However, it might be permissible to provide
incentives to participate that do not constitute undue influence. Using enrollment incentives to
recruit subjects may be ethically permissible as long as the IRB has determined that, although they
may be a factor in a subject’s decision to participate, they have not served to unduly influence the
subject to participate. To make this determination, the IRB should know who the subject population
will be, what incentives are being offered, and the conditions under which the offer will be made.
Any credit for payment should accrue as the study progresses and not be contingent upon the
subject completing the entire study. Unless it creates undue inconvenience or a coercive practice,
payment to subjects who withdraw from the study may be made at the time they would have
completed the study (or completed a phase of the study) had they not withdrawn. For example, in a
study lasting only a few days, the IRB may find it permissible to allow a single payment date at the
end of the study, even to subjects who had withdrawn before that date.
All information concerning payment, including the amount and schedule of payment(s), should be
set forth in the informed consent document.
The IRB will review the PI’s justification for and calculation of the amount to be paid to the research
subjects to ensure it is appropriate given the proposed research activities (i.e., complexity, duration)
and the population to be recruited (e.g., socioeconomic status, age).
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In general, payments must be equal and provided to all research subjects. The research subjects
should not be led to believe that the payment is either a benefit of participation or a reward for the
quality of their performance. In addition, payments should not be so large as to coerce prospective
research subjects to consent to participate or to continue to participate in the research project
against their better judgment. Payment cannot be proposed as a means to offset research risks—
risks that are otherwise unacceptable cannot be made acceptable by offering payments to subjects.
The IRB must also review and approve all proposed communication about payment in the informed
consent document, as well as advertisements, information sheets, or other documents related to the
research project. Only after the IRB has provided its approval in writing to the PI can research
subjects be recruited and the research project be initiated in accordance with the approved protocol.
Accounting for payments to research subjects on sponsored projects
When a proposal is developed for a sponsored program that includes payments to research subjects,
the PI must segregate those costs in a separate budget line. All costs associated with such payments
will be charged against this budget category if an award in made for the project.
Payment of Suffolk University employees as a research subject
University employees, including undergraduate or graduate student employees, may not be paid to
participate in a research project. Moreover, university employees generally should not be included as
participants in research projects conducted by Suffolk University PIs. The IRB administrator in ORSP is
available to consult with PIs on the question of employee participation in research projects.
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Conflicts of Interest
A conflict of interest refers to a divergence between an individual's personal financial, relational, or
other interests and his/her professional obligations to Suffolk University whether through teaching,
involvement in research, contracting, purchasing, or performing other administrative duties such that
an independent observer might reasonably determine that the individual's professional actions or
decisions are adversely affected, distorted or otherwise compromised by the individual's personal
interest. The term conflict of interest is broader and encompasses more professional activities than
the term financial conflict of interest in research, defined below, the identification and management
of which is the subject of this section of the member handbook.
IRB members, alternate members and all staff and leaders of the HRPP shall sign an agreement
defining that they understand and acknowledge that, as part of their duties or their activities at
meetings or in the office environment, they are bound by the University's conflict of interest policies.
This agreement shall also be signed by guests at IRB meetings and by consultants and others who
provide input into an IRB review prior to their participation in that review.
Included in these policies is that unless requested by the IRB Chair or designee in charge of the
meeting, IRB members, alternate members, ad hoc members, guests, HRPP staff, consultants or
others may not participate in IRB deliberations of studies with which they, their spouses, or
dependent children have a financial or personal interest in the sponsoring agency(s) or other
interested parties or for which they may reasonably anticipate future financial benefit or support.
Individuals with any of the conflicts defined above may not vote or serve as a reviewer of the study
being discussed and may not be counted in the meeting quorum (if applicable). At the request of the
IRB Chair or Chair-designee, however, such members or guests may be present at an IRB meeting to
answer questions but may not be present during deliberations or voting on the study [45 CFR
46.107(e), 21 CFR 56.107(e)].
IRB members, alternate members, ad hoc members, consultants and guests may not participate in IRB
deliberations and they may not vote or serve as a reviewer of studies in which they, their spouses or
dependent children serve as Principal Investigator, co-investigator or key personnel. At the request of
the IRB Chair or Chair-designee, such individuals may be present at an IRB meeting to answer
questions but may not be present during deliberations or voting on the study.
IRB members, alternate members, ad hoc members, consultants and guests are expected to inform
the IRB Chair or Chair-designee whenever a conflict of interest is applicable by policies defined above
or by reasonable perceptions that financial or other considerations may compromise or have the
appearance of compromising the individual's professional judgment and the independence of his/her
input into the review process.
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In addition, there may be no undue influence by University administrators, Principal Investigators,
key personnel or other employees of the University on the selection of IRB reviewers.
Members having any potential conflict of interest regarding the discharging of duties as voting IRB
members should:
1) Announce the conflict and recuse themselves from participation during review of that research
study except to provide information on request
2) Leave the meeting during the discussion and not vote on any motion to approve or disapprove
the study in question
[NOTE: When a person with a conflict of interest leaves the meeting, he/she cannot be counted
towards a quorum. If the quorum is lost, the review of the study shall be tabled.]
Financial Conflict of Interest in Research
Financial conflict of interest in research is the existence of a significant financial interest that an
independent observer might reasonably determine could affect or compromise, or appears to
affect or compromise, the design, conduct, reporting or management of research. The effect or
compromise contemplated might relate to the collection, analysis, and interpretation of data, the
hiring of staff, the procurement of materials, the sharing of results, the choice of protocol, the
involvement or consenting of human participants, and/or the use of statistical methods.
Investigators who conduct federally sponsored human subjects research projects must comply with Suffolk
University’s Financial Conflict of Interest (FCOI) Policy. This policy is located on the University website at
http://www2.suffolk.edu/files/ORSP/SuffolkUniversity_Financial_Conflict_of_Interest_in_Federally_Funded
_Research_Policy.pdf
"Financial interest" includes but is not necessarily limited to:
A significant financial interest (SFI) exists if the following situations apply to the investigator and/or
the investigator's spouse and dependent children, involving companies that reasonably appear to
be related to the investigator’s institutional responsibilities:
For publicly traded companies, if income in excess of $5000 (in the aggregate) is received during
the twelve months preceding the disclosure. Examples of income include salary, consulting fees,
honoraria, paid authorship, stock, stock options, or other ownership interests (based on public
prices or other reasonable measures of fair market value).
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For non‐publically traded companies, if income in excess of $5000 (in the aggregate) is received
during the twelve months preceding the disclosure, or when any equity interest is held (e.g., stocks,
stock options, or other ownership interests).
If any income is received from intellectual property rights and interests (e.g., patents, copyrights).
Any travel paid for by any entity other than a federal, state or local government, an institution of
higher education, an academic teaching hospital, a medical center or a research institute associated
with an institution of higher education must be disclosed.
This disclosure will include, at a minimum, the purpose of the trip, identity of the
sponsor/organizer, destination, and duration. In accordance with the University’s FCOI policy, the
Director of the ORSP will determine if further information is needed, including a determination or
disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the
federally funded research.
The IRB shall be concerned about the potential for biased judgment and/or other abuse when
investigators or study staff have a financial obligation or interest that may pose a conflict of
interest which competes with the obligation to protect the rights and welfare of human subjects.
The primary goal of this conflict of interest policy is to prevent conflicting interests from adversely
affecting the protection of subjects and/or the credibility of the Suffolk University human research
protection program if publicly disclosed. The process to manage conflicts of interest (whether real
or perceived) shall not vary according to funding source and shall involve three steps:
Conflicts of interest (which may include those of the Principal Investigator, key personnel, the University
or affiliated institutions) must be disclosed to the IRB by the Principal Investigator or any individual listed
as "Key Personnel" within the study.
If the conflict exists prior to IRB review of the study, the conflict must be disclosed prior to the IRB
deliberation. If the conflict is initiated after IRB review, the conflict must be disclosed to the IRB within 5
working days after its onset.
To ensure the reporting of conflicts in applications for new studies, the IRB shall require that the Principal
Investigator and all key personnel, and each member of the faculty and study staff who has contact with
potential or consented subjects, disclose, in signed statements within their application, all potential
financial conflicts of interest on the part of investigators or institution. With this disclosure, Principal
Investigators may recommend to the IRB how the potential conflict of interest should be minimized or
resolved.
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Among personal financial conflicts of interest that are related to the sponsoring agency(s), any
entity allied with the sponsoring agency(s) or other interested entities and that must be disclosed
are:
1. Salary, consulting fees, honoraria, royalty payments, dividends, loans or other compensation for
services, payments or consideration with value that exceed $10,000 in any preceding 12 month
period or in an anticipated 12 month period
2. Serving in a management position such as director, officer, partner or trustee
3. Having an ownership interest, equity in the form of stock, stock options or any other investment
equal to or exceeding $10,000 (current market value) or a 5% or greater ownership interest
4. Having any intellectual property rights such as patents (actual, planned or applied for), licensing
agreements or a copyright or royalties with the study or the sponsoring agency(s)
5. Having any intellectual property rights not directly involved in the study but that may benefit
from the study
Principal Investigators must also recognize that financial conflicts of interest may arise that are not
directly related to the Principal Investigator but are related to the University or affiliated
institutions. Among such potential conflicts that must be disclosed by the Principal Investigator
are:
1. The research involves a drug, device or other invention created at the University or affiliated
institution or by an employee currently or formally at the University or affiliated institution who is
not the Principal Investigator or key personnel of the study
2. The research involves a drug, device or other invention created by someone other than the
Principal Investigator or key personnel for which the University or affiliated institution holds a
financial interest and/or may derive financial benefit
3. The research involves a drug, device or other invention for which someone who is a colleague of
the Principal Investigator or key personnel is creator and/or holds a financial interest
If a conflict of interest is reported to the IRB prior to its approval of the study, the IRB shall
deliberate upon the conflict and resolve its management as a criterion for approval of the study. If
a conflict of interest is reported to the IRB after approval of a study, the IRB shall deliberate upon
the conflict and resolve its management as a criterion for permitting continuance of the study.
A key to IRB determinations shall be the IRB evaluation as to whether the conflicts could challenge,
or be perceived by others to challenge, the integrity of a reasonable individual or the institution
itself, whether the conflicts could result in decisions that adversely affect the production of valid
scientific results and whether the conflicts might adversely affect the protection of human subjects
or the credibility of the human research protection program. It shall then be the responsibility of
the IRB to determine if the institution is an appropriate site for the research, whether the research
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should be approved and whether (and how) the conflicts shall be managed or eliminated so they
no longer affect the protection of human subjects or the credibility of the human research
protection program.
The IRB will determine whether the conflict is permissible in the context of the protocol or whether
additional actions must be taken. Such actions may include (but are not limited to):
1. Requiring partial or complete financial divestiture
2. Requiring an independent investigator to obtain consent or conduct the researc
3. Requiring an independent data safety monitoring committee or similar monitoring body
4. Requiring additional oversight or monitoring of the research
5. Requiring a second or parallel site for the study
6. Requiring modification of the role(s of particular research staff, changes in location for certain
activities or prohibition of UM as a study site
7. Requiring frequent continuing review
8. Requiring separation of responsibilities for financial decisions and research decisions
9. Requiring that additional information be given to subjects as part of the informed consent
process if, in the IRB's judgment, the information would meaningfully add to protection of the
rights and welfare of subjects ([45 CFR 46.109(b), 21 CFR 56.109(b)
10. Disapproval of the study
Additional Review
The IRB will determine whether a project requires more than annual review and may require an
appropriate monitoring procedure that could include monitoring of the consent process,
observation of the research procedures, formulation of a data and safety monitoring plan, and
review of research related records. In some instances, the IRB may refer review of the research to
an additional committee. However, final authority for additional review lies with the IRB.
STATISTICAL ANAYLYSIS
Responsibilities to Research Subjects (including census or survey respondents and persons and
organizations supplying data from administrative records, as well as subjects of physically or
psychologically invasive research)
1. Know about and adhere to appropriate rules for the protection of human subjects, including
particularly vulnerable or other special populations who may be subject to special risks or who may
not be fully able to protect their own interests. Assure adequate planning to support the practical
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value of the research, the validity of expected results, the ability to provide the protection
promised, and consideration of all other ethical issues involved.
2. Avoid the use of excessive or inadequate numbers of research subjects by making informed
recommendations for study size. These recommendations may be based on prospective power
analysis, the planned precision of the study endpoint(s), or other methods to assure appropriate
scope to either frequentist or Bayesian approaches. Study scope should also take into
consideration the feasibility of obtaining research subjects and the value of the data elements to be
collected.
3. Avoid excessive risk to research subjects and excessive imposition on their time and privacy.
4. Protect the privacy and confidentiality of research subjects and data concerning them, whether
obtained directly from the subjects, from other persons, or from administrative records. Anticipate
secondary and indirect uses of the data when obtaining approvals from research subjects; obtain
approvals appropriate for peer review and for independent replication of analyses.
5. Be aware of legal limitations on privacy and confidentiality assurances. Do not, for example,
imply protection of privacy and confidentiality from legal processes of discovery unless explicitly
authorized to do so.
6. Before participating in a study involving human beings or organizations, analyzing data from
such a study, or accepting resulting manuscripts for review, consider whether appropriate research
subject approvals were obtained. (This safeguard will lower the risk of learning only after the fact
that you have collaborated on an unethical study.) Consider also what assurances of privacy and
confidentiality were given and abide by those assurances.
7. Avoid or minimize the use of deception. Where it is necessary and provides significant
knowledge, as in some psychological, sociological, and other research, assure prior independent
ethical review of the protocol and continued monitoring of the research.
8. Where full disclosure of study parameters to subjects or to other investigators is not advisable,
as in some randomized clinical trials, generally inform them of the nature of the information
withheld and the reason for withholding it. As with deception, assure independent ethical review of
the protocol and continued monitoring of the research.
REVISION OF APPLICATION MATERIALS PRIOR TO IRB APPROVAL
Revisions to new and continuing human subject applications may be required prior to IRB approval.
Correspondence is sent to the investigator detailing requests for revisions, clarification, or
additional information as well as information regarding continuing review. The changes may be
such that the IRB grants conditional approval or the IRB may decide that changes are substantive
enough to require review again at a convened meeting of the IRB.
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An investigator has 60 days to respond to the revisions requested. If the investigator does not
respond in 60 days, the application is deactivated and returned. If the investigator wishes to
conduct a study that has been deactivated, the investigator must submit a new application,
incorporating comments from the prior IRB review.
Under a conditional approval when the IRB requests that specific changes be made to the protocol
and/or consent document(s), investigator responsive materials are reviewed for compliance by the
Chair or designee(s). In those cases where revisions necessitate deferring a protocol as determined
during a full board review, the revised documents are returned to the full board for its review and
approval. The application receives final approval when all required changes have been submitted
and approved by the IRB.
Upon receipt of final approval, the HRPP staff stamps approved informed consent document(s),
HIPAA authorizations and other materials (e.g., letters to subjects, ads) with the IRB approval
stamp, the date of approval, and the date of expiration. These documents are sent to the principal
investigator along with the final approval letter that includes information on the date of human
subject expiration of approval. The letter reminds investigators that changes in research activity
may not be initiated without IRB review and approval except when necessary to eliminate apparent
immediate hazards to subjects.
IRB DECISIONS
The IRB’s review of research whether it be during initial or continuing review or a when reviewing
proposed changes to a previously approved research study can result in one of the following
decisions:
 Approve the research study or proposed changes as submitted without any conditions
 Approve the research study with conditions (when research is approved by the IRB with
conditions at a convened meeting, further review by IRB at a subsequent convened meeting is
not necessary)
 Require modifications to secure approval and defer or table the research study or proposed
changes for further review at a future date after the required modifications are submitted by
the investigator; or
 Disapprove the research study or proposed changes.
Approval of Research with Conditions
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In the course of initial or continuing review of research, or review of proposed changes to
previously approved research, the IRB often requests that investigators make specified changes to
the research protocols or informed consent documents; or submit clarifications or additional
documents. When doing this, depending on the circumstances, the IRB is affording the investigator
an opportunity to respond accordingly to the conditions outlined by the IRB in order to gain
unconditional approval. A research study cannot commence until all conditions specified by the
IRB for approval have been reviewed and verified.
Conditional approval, means that at the time the research study (or proposed changes to a
previously approved research study) is reviewed by the IRB, the IRB determines that certain
conditions must be met in order to approve the research. It may require, as a condition of
approval, specified changes to the research protocol or informed consent document(s); the
investigator’s confirmation about specific assumptions or understandings by the IRB regarding how
the research will be conducted; and/or the submission of additional documents. Based on the
assumption that the conditions are satisfied, the IRB is then able to make all of the determinations
required for approval under the HHS regulations at 45 CFR 46.111 and, if applicable, subparts B, C,
or D of 45 CFR part 46.
Research reviewed and approved with conditions by the IRB at a convened meeting, does not need
to be subsequently reviewed again by the full board. Because the IRB is able to make all the
determinations required for approval, the IRB may designate the IRB chairperson (and/or other
individual(s) with appropriate expertise or qualifications) to review responsive materials from the
investigator and determine that the conditions have been satisfied. Generally speaking, the
primary and secondary reviewers assigned
Circumstances that preclude the IRB from approving research
Any time the IRB reviewing a research project cannot make one or more of the determinations
required for approval by the HHS regulations at 45 CFR 46.111 and, if applicable, subparts B, C, or D
of 45 CFR part 46, the IRB cannot approve the research project. This applies to both initial and
continuing review of research, and review of proposed changes to previously approved research.
For example, the IRB cannot approve a proposed research project undergoing initial review when
the IRB is unable to:
 make the required determinations about research risks and benefits, the adequacy of privacy
and confidentiality protections, or the adequacy of the informed consent process because the
research protocol or documents themselves provide insufficient information related to these
aspects of the research or do not conform to regulatory requirements (for example, if an
informed consent document is not written in a language understandable to the subject, the
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informed consent process is not adequate and therefore criteria for approval under 45 CFR
46.111 cannot be met)
 specify changes to the research protocol that if made would allow the IRB to make these
required determinations.
When an IRB reviewing a research project at a convened meeting is unable to approve research
because it cannot make the determinations required for approval, the IRB can either disapprove
the project, or defer the project for further review at a future date. When deferring the project,
the IRB, under its authority to require modifications in order for an investigator to secure approval,
may require that the investigator make changes to the protocol or informed consent documents, or
submit clarifications or additional documents prior to the next review. If the IRB defers a research
project, the research may not proceed until the IRB reviews the revised research project and
approves it at a subsequent convened meeting.
When an IRB reviewing a research project under an expedited review procedure is unable to
approve the project because the IRB Chair (or designated reviewer(s)) cannot make the
determinations required for approval, the IRB Chair (or designated reviewer(s)) can either refer the
project to the IRB for further review and action at a convened meeting, or defer approval of the
research project and require that the investigator make changes to the protocol or informed
consent documents, or submit clarifications or additional documents prior to further review by the
IRB chairperson (or designated reviewer(s)). Research may not be disapproved under expedited
review.
Examples of required changes or clarifications that generally would preclude the IRB from
approving the research include the following:
1. Providing a justification for enrolling children in the research and an explanation of how the
research would satisfy the requirements of subpart D of 45 CFR part 46 (OHRP notes that in
this example the IRB would need the investigator’s response in order to make the
determinations under subpart D of 45 CFR part 46.
2. Revising the study hypothesis and, accordingly, the study design (OHRP notes that in this
example the IRB would need the investigator’s response in order to make the determinations
under 45 CFR 46.111(a)(1), (2), and (4)).
3. Providing a description of procedures that the control group will undergo (OHRP notes that in
this example the IRB would need the investigator’s response in order to make the
determinations under 45 CFR 46.111(a)(1), (2), and (4)).
4. Providing clarifying information needed to assess the risks to subjects, such as clarifying
whether individuals who have taken aspirin within 14 days prior to enrollment will be
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excluded from the study because of concerns about the risks of bleeding (OHRP notes that in
this example the IRB would need the investigator’s response in order to make the
determinations under 45 CFR 46.111(a)(1) and (2); see example (5) in section D below for an
alternative approach that would allow the IRB to approve the research with conditions);
5. Clarifying the timing and circumstances under which the informed consent of prospective
subjects will be sought (OHRP notes that in this example the IRB would need the investigator’s
response in order to make the determinations under 45 CFR 46.111(a)(4); see example (6) in
section D below for an alternative approach that would allow the IRB to approve the research
with conditions); or
6. Providing a plan to implement additional subject monitoring in order to reduce risks to
subjects, given the number of serious adverse events that have occurred in study subjects
since the prior IRB review (OHRP notes that in this example the IRB would need the
investigator’s response in order to make the determinations under 45 CFR 46.111(a)(1), (2),
and (4)).
Circumstances
Permitting
the
IRB
to
Approve
Research
with
Conditions
The IRB may approve research with conditions if, given the scope and nature of the conditions, the
IRB is able, based on the assumption that the conditions are satisfied, to make all of the
determinations required for approval under the HHS regulations at 45 CFR 46.111 and, if
applicable, subparts B, C, or D of 45 CFR part 46. The authority to approve research with
conditions extends to the IRB’s initial review of research, continuing review of research, and
review of proposed changes to previously approved research. This authority also applies to IRB
review of research at a convened meeting or under an expedited review procedure.
The IRB may require the following as conditions of approval of research:
1. Confirmation of specific assumptions or understandings on the part of the IRB regarding how
the research will be conducted (e.g., confirmation that the research excludes children);
2. Submission of additional documentation (e.g., certificate of ethics training);
3. Precise language changes to protocol or informed consent documents; or
4. Substantive changes to protocol or informed consent documents along with clearly stated
parameters that the changes must satisfy.
When the IRB approves research with conditions, verification procedures must be included as part
of the IRB approval process, under which the IRB Chair (and/or other individual(s) designated by
the IRB) will review responsive materials from the investigator required by the IRB, and determine
whether the conditions of approval have been satisfied (45 CFR 46.102(h)). The IRB’s verification
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that the investigator has satisfied all conditions of approval stipulated by the IRB helps to ensure
that the investigator does not initiate any research that is different from what was approved by
the IRB (45 CFR 46.102(h)).
Note that OHRP does not consider this verification process by the IRB chairperson or any other
individual designated by the IRB to represent the review and approval of minor changes under an
expedited review procedure. As a result, IRBs have significant flexibility regarding who may be
designated to verify that conditions have been satisfied, including designation of someone other
than an IRB member.
Individuals designated by the IRB to review responsive materials from the investigator and
determine whether the IRB’s conditions for approval have been satisfied should have appropriate
expertise or qualifications. Depending upon the nature of the required conditions, the IRB could
designate any of the following individuals or groups of individuals to determine that the conditions
of approval have been satisfied:

The IRB chairperson;

Another IRB member or group of IRB members with particular subject matter expertise or
experience;

A consultant with particular subject matter expertise who is not an IRB member; and/or

An IRB administrator or other qualified IRB administrative staff person, who need not be an IRB
member.
For some conditions, the review of responsive materials from investigators will require medical,
scientific, or other technical expertise. In such cases, the IRB should designate an individual having
the appropriate expertise to review the responsive materials from the investigator; typically, this
would be the IRB chairperson, another IRB member, or an expert consultant. For others
conditions for which the investigator simply needs to make verbatim changes to the protocol or
informed consent document or to submit a specific document, review of the responsive materials
from investigators typically will not require any special expertise. In these cases, the IRB could
designate an IRB administrator or other IRB administrative staff person to review the responsive
materials from the investigator.
The following examples illustrate the types of conditions IRBs could stipulate when approving
research, as well as the type of individual who might be designated by the IRB to determine that
the conditions of approval have been satisfied; these examples are not intended to be allinclusive, nor are they intended to suggest that the type of individual designated in the example is
either appropriate or necessary in all such circumstances:
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1. Requiring submission of documentation of an endorsement letter from a department chair, as
required by institutional policy, and designating an IRB administrator or other qualified IRB staff
member to confirm receipt of the required documentation;
2. Requiring correction of minor grammatical and typographical errors in the informed consent
document, and designating an IRB administrator or other qualified IRB staff member to review the
revised informed consent document and confirm that the required corrections were made;
3. Requiring that a listed investigator provide a copy of his approved clinical privileges/hospital
staff appointment document in order to confirm that he has approval to perform the procedures
(e.g., percutaneous liver biopsies) proposed in the research protocol at the institution where the
research is to be conducted, and designating an IRB administrator or other qualified IRB staff
member to review this document and confirm that the clinical privileges of the listed investigator
include authorization to perform such procedures.
4. Requiring that the investigator re-locate in the informed consent document the statement
“You will receive $500 for participating in this study” from the “Benefits” section of the form to a
separate section under the heading “Compensation,” and designating an IRB administrator or
other qualified IRB staff member to review the revised informed consent document and verify the
re-location;
5. Requiring that the investigator – in order to ensure that risks to subjects are minimized – add
“a history of aspirin use in the past 14 days” to the exclusion criteria for subject enrollment in the
research protocol, and designating an IRB administrator or other qualified IRB staff member to
review the revised protocol and verify that the stipulated language was added to the exclusion
criteria;
6. For a randomized clinical trial comparing two types of surgical procedures, requiring that the
investigator – in order to ensure that informed consent will be obtained under circumstances that
provide prospective subjects with sufficient opportunity to consider whether or not to participate
– revise the protocol to indicate that informed consent of the prospective subjects will be sought
by the investigator during an outpatient clinic visit at least one week before the surgery, and
designating an IRB administrator or other qualified IRB staff member to review the revised
protocol and verify that the requested language regarding the process for soliciting informed
consent of the prospective subjects was added to the protocol.
7. Requiring the investigator to (a) confirm that any standard contrast material used in
radiological procedures dictated by the research protocol will be limited to agents and dose levels
specified in precise detail by the IRB, and (b) submit a revised protocol which includes the precise
agents and dose levels, and designating an IRB administrator or other qualified IRB staff member
to review the revised protocol and verify that the changes made by the investigator match those
specified by the IRB;
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8. Requiring that the investigator modify the informed consent document to include standard
template language used for research involving college psychology students, stating that
comparable non-research alternatives for earning extra credit will be offered to students who
choose not to participate in the research, and designating an IRB administrator or other qualified
IRB staff member to review the revised informed consent document and verify the addition;
9. Requiring the addition to the informed consent document of a description of the risks of a
standard chemotherapy drug, where the risks are well-described in the research protocol, and
designating an IRB member or consultant who is knowledgeable about those risks to review the
revised informed consent document and confirm that the description of the risks is satisfactory;
10. Requiring revision of the research protocol to include a description of the type and amount of
standard contrast material to be used in the radiological procedures dictated by the research
protocol, and designating an IRB member or consultant who is a radiologist to review the revised
protocol and ensure that the use of standard contrast material is medically appropriate;
11. Requiring simplification of the description of the study risks in the informed consent document
to be at an 8th grade comprehension level, and designating the IRB chairperson to review the
revised informed consent document and ensure that risks are accurately described and
understandable at an 8th grade comprehension level;
12. Requiring that the research protocol be revised to include a plan for (a) informing subjects
about the results of standard clinical tests performed as part of the research protocol (e.g., cardiac
function tests), and (b) referring subjects for appropriate clinical follow-up, and designating an IRB
member or a consultant with appropriate clinical expertise (e.g., a cardiologist) to review the
revised protocol and confirm that the plan is medically appropriate.
Changes to Research Proposed after the IRB has Approved the Research with Conditions
After research has been approved with conditions by the IRB, additional changes are sometimes
proposed by the investigator or recommended by designated reviewers before all conditions have
been satisfied and the protocol documents have been finalized. The process for handling such
changes is the same as for any change that is proposed during the period for which IRB approval
has already been given.
Protocol corrections that are only administrative in nature (e.g., correction of typographical and
spelling errors in the protocol) would not need additional IRB review because OHRP does not
consider such corrections to be changes to the research.
Changes to the research that are “minor” may be reviewed by the IRB Chair or by another
experienced reviewer designated by the Chair from among the members of the IRB under an
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expedited review procedure. All members of the IRB must be advised of any such minor changes
that are approved under an expedited review procedure.
Changes to the research that are more than minor would require further review by the IRB at a
convened meeting.
REBUTTAL OR APPEAL OF IRB DECISIONS
Investigators may appeal the IRB’s determination for specific changes to the protocol and/or
consent document(s). At the discretion of the chair, the investigator may make such an appeal in
person and/or in writing to the IRB.
If the IRB decides to disapprove a research activity, it will include in its written notification a
statement of the reasons for its decision, and give the investigator an opportunity to respond in
person and/or in writing. An appeal of a disapproved research project must be reviewed at a full
board meeting. In the case of a decision by the IRB to disapprove, suspend, or terminate a project,
the decision may not be overturned by the Vice Provost for Research or any other officer or agency
of the University of Massachusetts, state government or federal government.
URGENT REVIEW OF APPLICATIONS
Urgent review procedures may be invoked only under unusual circumstances. This does not
include urgency that is a result of negligence or delay on the part of the investigator or his/her staff
to submit human subject applications in a timely fashion.
On occasion, however, an investigator is faced with an immediate deadline beyond his or her
control. If the Chair permits urgent review of a protocol, the materials are distributed as soon as
possible to IRB members to allow sufficient time for review prior to the meeting. The investigator
may be required to attend the meeting to answer any questions that arise. In the event the Chair
has a conflict of interest, the Vice Chair may give approval for the urgent review of a protocol.
SUSPENSION OR TERMINATION OF IRB APPROVAL
The IRB has the authority to suspend or terminate approval of human subject research that is not
being conducted in accordance with federal regulations, the IRB’s requirements, or when an
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unanticipated problem involving risks to subjects or others occurs. In general, these may include
any incident, experience, or outcome, which has been associated with an unexpected event(s),
related or possibly related to participation in the research, and suggests that the research places
subjects or others at a greater risk of harm than was previously known or suspected. Unanticipated
events may or may not require suspension of the research. Each incident is evaluated on a case by
case basis to make this determination.
Any suspension or termination of approval includes a statement of the reasons for the IRB’s action
and is reported promptly to the investigator, the investigator’s department chair, the Office of
Research and Sponsored Programs. The IRB may require remedial action or education as deemed
necessary for the investigator or any other key personnel. Federal regulatory agencies are notified
as required by federal regulation.
Suspension involves temporarily discontinuing an investigator’s privilege to conduct human subject
research. The suspension may be partial in that certain activities may continue while others may
stop or it may be complete in that no activity related to the research may proceed. The IRB will
make this determination.
Termination is the ending of all activities related to a specific human research project or may
involve revocation of an investigator’s privilege to conduct human subject research at Suffolk
University except for the continuation of follow-up activities necessary to protect subject safety.
PROTOCOL REVIEW TIMELINE
The time it takes to process an application depends on the complexity of the research study, the
quality and completeness of the application, and the number of protocols being processed at any
given time. Other variables include whether the application can be reviewed under an expedited
procedure or meets the threshold for full board review.
The most common problem with applications (new project applications in particular) is that not
enough detail is provided for reviewers to evaluate the study's purpose and/or procedures. The
more complete the initial description is, the less likely it is that the application will be routed back
and forth between the investigator and compliance staff or IRB Chair to fill in necessary details. Each
question in the application should be read carefully and answered thoroughly. A complete and
accurate answer to each question should be provided and details throughout the application must
be consistent.
Applications that meet exemption criteria will be processed immediately and normally reviewed by
research compliance staff within 1-2 days following receipt.
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Applications meeting one or more expedited review categories are processed on a rolling basis – no
“submission deadlines” are associated with expedited reviews; they are processed immediately and
normally reviewed within a week following receipt. IRB members conducting expedited reviews
are asked to upload review comments within five working days following their assignment as an
expedited reviewer.
Important Note to Investigators: Expedited review does not mean that the review process is
faster than a full board review; it is merely a different process.
Applications that require review by the convened IRB must be received at least 30 working days
prior to the scheduled meeting date posted on the Research Compliance website.
CASE STUDIES
A Case Study is understood to mean the collection and presentation of detailed information about
a particular participant or small group, frequently including the accounts of subjects themselves. A
form of qualitative descriptive research, the case study looks intensely at an individual or small
participant pool, drawing conclusions only about that participant or group and only in that specific
context. It may involve collecting data about participants using participant and direct observations,
interviews, protocols, tests, examinations of records, and collections of writing samples. Case
studies may also involve either retrospective or prospective study. A retrospective case study looks
backwards and examines the incidence of certain factors in relation to an established outcome. A
prospective case study looks forward and examines a particular individual or case for a particular
outcome that may be associated with the presence/absence of relevant factors.
IRB Review of Case Studies: Case studies generally fail to meet the federal definition of research
because there is no intent to test a hypothesis via systematic analysis. As a result, case studies
generally qualify for exempt review by the IRB provided that the study (a) does not involve a
sensitive topic, (b) is conducted in a manner that protects subjects’ identity, and (c) does not
involve at-risk or special populations. A listing of privacy issues and special populations are
provided below.
Subject private and/or medical identifiers: Exempt studies may not include any of the following
identifiers:
 Names
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
All elements of dates (except year ) for dates related to an individual, including birth date,
admission date, discharge date, or date of death
 All geographic subdivisions smaller than a State, including street address, city, county,
precinct, zip code, and their equivalent geocodes
 Telephone numbers
 Fax Numbers
 Electronic mail addresses
 Social security number
 Medical record numbers
 Health plan beneficiary numbers
 Account numbers
 Certificate/license numbers
 Vehicle identifiers and serial numbers, including license plate number
 Device identifiers and serial numbers
 Web Universal Resource Locators (URLs) Internet Protocol (IP) address numbers
 Biometric identifiers, including finger and voice prints
 Full face photographic images and any comparable images
 Any other unique identifying number, characteristic or code
IRB Review of “N of one” Studies and Case Series with Data Manipulation: It is noted,
however, that an “N of one” trial that uses an experimental treatment on a single subject, or a case
series that incorporates levels of data manipulation (statistics) to allow possible extrapolation of
the results to a larger population, would satisfy the federal definition of research. As such, these
studies must be submitted to the IRB for expedited for full board review.
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5 Continuing Review of Research
While a research project is ongoing, the IRB must review and consider proposed changes to the
research as they are received, including protocol and consent form modifications. The IRB also
periodically receives and reviews reports of unanticipated problems involving risks to subjects or
others and other information about the research.
In general, IRB review of a proposed change to a research project or a report of unanticipated
problems during the period for which approval is authorized does not constitute continuing review
of the project as a whole. Although an IRB may become familiar with various individual aspects of
the research project’s conduct, such familiarity does not relieve the IRB of the responsibility to
conduct continuing review at least annually, which provides an opportunity to reassess the totality
of the project and assure that, among other things, risks to subjects are being minimized and are
still reasonable in relation to anticipated benefits, if any, to the subjects and the knowledge that is
expected to result.
Regulatory Requirements Guiding the Conduct of Continuing Reviews
The IRB will conduct the continuing review of research in accordance with the provisions of
45CFR46.109(e) and report its findings and actions to the investigator and the institution. The IRB
will conduct continuing review of research at intervals appropriate to the degree of risk, but not
less than once per year. Generally speaking, annual review will be adequate for most Suffolk
University research protocols. An IRB member may not participate in the continuing review of any
project in which the member has a conflicting interest, except to provide information requested by
the IRB.
Except when an expedited review procedure is used, continuing review of research must occur at
convened meetings of the IRB at which a majority of the members are present, including at least
one member whose primary concerns are in nonscientific areas. In order for research undergoing
continuing review to be approved, it must receive the approval of a majority of those members
present at the meeting (45 CFR 46.108(b)).
In carrying out its responsibilities with respect to the continuing review of research the IRB must:
 Determine which projects require review more often than annually
 Determine which projects need verification from sources other than the investigators that no
material changes in the research have occurred since the previous IRB review and
 Ensure prompt reporting to the IRB of proposed changes in a research activity
 Ensure that changes in approved research, during the period for which IRB approval has
already been given, is not initiated without IRB review and approval except when necessary
to eliminate apparent immediate hazards to the human subjects.
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The IRB may use an expedited review procedure to conduct continuing review of research for some
or all of the research appearing on OHRP’s list of research eligible for expedited review (see
http://www.hhs.gov/ohrp/policy/expedited98.html) and found by the reviewer(s) to involve no
more than minimal risk.
Under an expedited review procedure, the review may be carried out by the IRB Chair or by one or
more experienced reviewers designated by the IRB Chair from among the members of the IRB.
In reviewing the research, designated reviewers may exercise all of the authorities of the IRB except
disapproval of the research. For any research approved under an expedited review procedure at
the time of continuing review, all IRB members must be advised of such approvals.
IRB Documentation Requirements
The IRB must prepare and maintain adequate documentation of IRB activities during continuing
review of research to include:
 Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the
proposals, approved sample consent documents, progress reports submitted by investigators,
and reports of injuries to subjects
 Minutes of IRB meetings that provide sufficient detail to show attendance at the meetings;
actions taken by the IRB; the vote on these actions including the number of members voting for,
against, and abstaining; the basis for requiring changes in or disapproving research; and a
written summary of the discussion of any controverted issues and their resolution
 Records of continuing review activities
 Copies of all correspondence between the IRB and the investigators
 Statements of significant new findings provided to subjects
Key IRB Considerations When Evaluating Research Undergoing Continuing Review
1. Criteria for IRB Approval of Research Undergoing Continuing Review
HHS regulations set forth the criteria for IRB approval of research. These criteria apply to both
initial review and continuing review of research and provide the framework for the IRB’s evaluation
of research. In order to re-approve research at the time of continuing review, the IRB must
determine that all of following requirements are satisfied:

Risks to subjects are minimized by using procedures that are consistent with sound research
design and which do not unnecessarily expose subjects to risk; and if applicable and
whenever appropriate, by using procedures already being performed on the subjects for
diagnostic or treatment purposes.

Risks to subjects are reasonable in relation to anticipated benefits, if any, to the subjects
and the importance of the knowledge that may reasonably be expected to result.

Selection of subjects is equitable.
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
Informed consent continues to be sought from each prospective subject or the subject’s
legally authorized representative, and appropriately documented in accordance with, and to
the extent required by HHS regulations.

When appropriate, the research plan makes adequate provision for monitoring the data
collected to ensure the safety of subjects.

When appropriate, there are adequate provisions to protect the privacy of subjects and to
maintain the confidentiality of data collected.

Appropriate safeguards are included to protect subjects likely to be vulnerable to coercion
or undue influence.

When the research involves pregnant women, fetuses, or neonates, prisoners, or children,
the research satisfies the additional requirements for IRB approval under HHS regulations at
subpart B, C, or D, respectively, of 45 CFR part 46.
When conducting continuing review, the IRB should start with the working presumption that the
research, as previously approved, does satisfy all of the above criteria. The IRB should focus on
whether there is any new information provided by the investigator, or otherwise available to the
IRB, that would alter the IRB’s prior determinations, particularly with respect to the IRB’s prior
evaluation of the potential benefits or risks to subjects.
The IRB also should assess whether there is any new information that would necessitate revision of
the protocol and/or the informed consent document. The IRB has the authority to disapprove or
require modifications in (to secure re-approval of) a research activity that does not meet the above
criteria. If research does not satisfy all of the above criteria, the IRB must require changes that
would result in research satisfying these criteria, defer taking action, or disapprove the research.
When conducting continuing review and evaluating whether research continues to satisfy the
criteria for IRB approval of research, IRBs should pay particular attention to the following four
aspects of the research:

Risk assessment and monitoring;

Adequacy of the process for obtaining informed consent;

Investigator and institutional issues; and

Research progress
2. Risk Assessment and Monitoring
One of the most important considerations for the IRB at the time of continuing review is whether
any new information is provided by the investigator, or otherwise available to the IRB, that would
alter the IRB’s previous conclusion that the risks to subjects are minimized and the risks to subjects
are reasonable in relation to anticipated benefits, if any, to the subjects and the importance of the
knowledge that may reasonably be expected to result.
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The IRB will consider relevant information received since the date of the last IRB review and
approval of the research project received from the investigator, any monitoring entity (e.g., the
research sponsor, a coordinating or statistical center) or any other source.
Information regarding any unanticipated problems that have occurred since the previous IRB
review in most cases will be pertinent to the IRB’s determinations at the time of continuing review
regarding the risk/benefit relationship of the research.
It also may be appropriate for the IRB at the time of continuing review to confirm that any
provisions under the previously approved protocol for monitoring the research data to ensure
safety of subjects have been implemented and are working as intended.
3. Evaluating the Adequacy of the Informed Consent Process
At the time of continuing review, the IRB should review a copy of the sample informed consent
document submitted by the investigator to verify that the investigator is using the most recently
approved version and that the document contains the most accurate, up-to-date information about
the research. The IRB must be able to readily recognize the most current version of the IRBapproved informed consent document, for example, using date stamps, version numbers, or
initialing and dating documents to indicate when a version was approved.
Likewise, if the IRB waived the requirement for the investigator to obtain a signed consent form for
some or all subjects, the IRB should assess the accuracy of the content of the information being
provided to subjects orally and of any written statement regarding the research that is being
provided to subjects.
When reviewing an informed consent document, the IRB must ensure that the currently approved
or proposed consent document adequately addresses the elements of informed consent required
under 45 CFR 46.116(a) and (b). The IRB should be particularly attentive to whether the informed
consent document provides an accurate and up-to-date description of the reasonably foreseeable
risks and discomforts of the research to the subjects and any appropriate alternative procedures
that might be advantageous to the subject.
The IRB also should assess whether there is any new information presented by the investigator or
others (for example, subjects or other individuals who have observed the investigator obtaining
subjects’ informed consent) that raises concerns about the circumstances under which informed
consent is being obtained. For example, the IRB should assess whether there is any new
information indicating that the investigator may not be obtaining informed consent under
circumstances that provide subjects with sufficient opportunity to consider whether or not to
participate or that minimize the possibility of coercion or undue influence.
As part of the process for obtaining informed consent, subjects must be provided, when
appropriate, with a statement that significant new findings developed during the course of the
research which may relate to the subjects’ willingness to continue participation will be provided to
the subjects.
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Continuing review provides the IRB with an opportunity to determine whether there is any new
information that should be considered to represent such a significant new finding and therefore be
communicated to subjects who have already enrolled in the research.
4. Evaluating Investigator and Institutional Issues
When appropriate, the reviewing IRB should consider issues regarding the investigator and the
institution(s) where the research is being conducted during its continuing review, such as the
following:

Changes in the investigator’s situation or qualifications (e.g., suspension of research
privileges, change in status, or increase in number of research studies conducted by the
investigator)

Evaluation, investigation, and resolution of any complaints related to the investigator’s
conduct of the research

Changes in the acceptability of the proposed research in terms of institutional commitments
(e.g., personnel and financial resources, adequacy of facilities) and applicable regulations,
State and local law, or standards of professional conduct or practice and

Reports from any third party observations of the research carried out under 45 CFR
46.109(e).
5. Evaluating Research Progress
This section discusses three considerations for when the IRB evaluates the progress of a research
study.
Confirmation that Continuing Review Information is Consistent with the IRB-approved Protocol
The IRB should confirm that the information provided by the investigator at the time of continuing
review is consistent with the research protocol previously approved by the IRB. If this information
suggests that the investigator is not conducting the research in accordance with either the IRBapproved protocol or the requirements or determinations of the IRB, the IRB should either defer reapproving the research or re-approve the research for a limited period of time (e.g., one month)
and seek an explanation from the investigator regarding the apparent discrepancies.
Total Subject Enrollment
As part of its initial review of a research project, the IRB typically will have approved a protocol that
includes the expected total number of subjects to be enrolled by the investigator and the expected
rate of enrollment. Evaluating information about the number of subjects enrolled in the research at
the time of continuing review may allow the IRB to ascertain whether enrollment is consistent with
the planned number of subjects described in the IRB-approved protocol. A marked difference
between the actual and expected rates of enrollment may indicate a problem with the research
project that requires further evaluation, including whether the research project is likely to provide
sufficient data to answer the scientific question(s) being posed.
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Subject Withdrawals
Subjects may discontinue their participation in research at any point for various reasons (e.g.,
serious adverse events, conflicts with the investigators, transportation problems, etc.).
The IRB’s continuing review procedures in general should provide for review of:

The number of subjects who discontinued their participation; and

A summary of the reasons for the withdrawals, if known.
IRB review of this information may shed light on problems related to the conduct of the research.
For example, a high rate of subject withdrawal secondary to serious adverse events may indicate
that the risks of the research are greater than expected and may lead the IRB to conclude that the
research should not be approved for continuation because the risks to subjects are not being
minimized or are not reasonable in relation to the anticipated benefits to the subjects and the
importance of the knowledge that may reasonably be expected to result.
Process for Conducting Continuing Review
Appropriately trained compliance staff members, regardless of whether they are members of the
IRB, may perform preliminary reviews of continuing review documents and complete IRB files in
order to facilitate the continuing review of research by the IRB. As part of this preliminary review,
compliance staff may perform the following functions, among others:

Confirm that all documents required by the IRB have been submitted by the investigator;

Assess whether the information and documents submitted by the investigator are consistent
with the research protocol previously approved by the IRB;

Confirm that the informed consent document submitted by the investigator matches the
current IRB-approved informed consent document;

Aid the IRB in identifying important issues and concerns that the IRB may wish to consider;
and

Provide technical assistance and guidance to the IRB at convened meetings and to the IRB
Chair or designated IRB members during an expedited review process
IRB staff members who are not IRB members may not be delegated responsibility for making the
determinations that must be made by the IRB at the time of continuing review.
Key Procedural Requirements for Continuing Review Conducted by the IRB at a
Convened Meeting
Continuing review must take place at a convened meeting at which a majority of the IRB members
are present, including at least one member whose primary concerns are in nonscientific areas,
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unless the research qualifies for review under an expedited review procedure. In order for research
undergoing continuing review to be approved by the IRB at a convened meeting, it must receive the
approval of a majority of those members present at the meeting.
Should the quorum fail during a meeting (e.g., loss of a majority through exclusion (i.e., recusal) of
members with conflicting interests or early departures of members, or absence of a nonscientist
member), the IRB may not take further actions or votes for research projects undergoing continuing
review unless the quorum can be restored.
The IRB must ensure that no member participates in the IRB’s continuing review of any research
project in which the member has a conflicting interest, except to provide information requested by
the IRB.
For each research project undergoing continuing review, the minutes of IRB meetings must be in
sufficient detail to show actions taken by the IRB; the vote on these actions, including the number
of members voting for, against, and abstaining; the basis for requiring changes in or disapproving
the research; and a summary of the discussion of controverted issues and their resolution. The
recusal of IRB members that occurs as a result of a conflicting interest is to also be documented
when recording votes on IRB actions.
Submission of Documents to the IRB
Investigators are responsible for fulfilling requirements associated with continuing review in time
for the IRB to carry out continuing review prior to the expiration date of the current IRB approval.
In particular, investigators are responsible for submitting sufficient materials and information for
the IRB to meet its regulatory obligations and should follow the institutional policies and
procedures for continuing IRB review of research that are required by 45 CFR 46.103(b)(4) and
referenced in Suffolk University’s OHRP-approved Federalwide Assurance (FWA).
As a minimum, the following documents must be submitted by the investigator along with the
application for continuing review if not already available to the IRB as part of the existing IRB
records for the research:

A brief project summary (this could be included as part of a progress report described in the
next bullet, provided as a separate document, or be addressed by referencing other
documents made available to the IRB, including the informed consent document(s))

A progress report that includes the following:

The number of subjects accrued (for multicenter research studies, the number of subjects
accrued at the local institution and the number accrued study-wide, if available, should be
provided)

A brief summary of any amendments to the research approved by the IRB since the IRB’s
initial review or the last continuing review

Any new and relevant information, published or unpublished, since the last IRB review,
especially information about risks associated with the research (note that OHRP does not
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expect the IRB to perform an independent review of the relevant scientific literature
related to a particular research project undergoing continuing review; this responsibility
rests with the investigators and any monitoring entity for the research)

A summary of both any unanticipated problems and available information regarding
adverse events (the amount of detail provided in such a summary will vary depending on
the type of research being conducted; in many cases, such a summary could be a brief
statement that there have been no unanticipated problems and that adverse events have
occurred at the expected frequency and level of severity as documented in the research
protocol, and the informed consent document

A summary of any withdrawal of subjects from the research since the last IRB review, and
the reasons for withdrawal, if known; and

A summary of any complaints about the research from subjects or others since the last IRB
review

The latest version of the IRB-approved protocol and sample informed consent document(s)

Any proposed modifications to the informed consent document or protocol

Any other significant information related to subject risk
Continuing reviews will be done by the full board when deemed appropriate or using expedited
review when criteria for expedited review can be met.
Distribution and Availability of Documents for Review by IRB Members
When conducting continuing review of research the IRB should be familiar with, and have access to,
all IRB records related the research, including those associated with the initial review and approval
and any other previous reviews, including ad hoc and scheduled continuing reviews and any
reviews of amendments to the research or unanticipated problems.
For continuing review of research at a convened meeting, IRB members will receive appropriate
materials 14 days in advance of the meeting to allow adequate time for review.
For continuing review of a research study not eligible for expedited review all IRB members will
receive and review copies of the progress report described in the preceding section and the current
IRB-approved informed consent document or any newly proposed consent document. The primary
reviewer should have available, for review as needed, the complete IRB file. Prior to March 2013
are retained in hard copy format in ORSP. Protocols initially submitted through IRBNet are retained
indefinitely in IRBNet. A complete protocol file includes:
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 the complete protocol
 relevant IRB meeting minutes and
 any additional documents submitted by the investigator with the continuing review progress
report.
The complete IRB file will be made available upon request to any IRB member prior to the meeting
at which the research is to be reviewed and should be accessible during the meeting to allow
members to resolve any questions that may arise during the IRB’s deliberations.
When conducting continuing review of research under an expedited review procedure, the IRB
chairperson (or designated IRB member(s)) should receive and review copies of the progress report
described in the preceding section, the current IRB-approved informed consent document, and any
newly proposed consent document, and have available, for review as needed, all of the abovereferenced documentation, including the complete IRB protocol file.
Primary Reviewers
Suffolk University will use a primary and secondary reviewer system for continuing review of
research similar to that used for initial review of research protocols at convened IRB meetings.
The primary reviewer’s summary should highlight any critical issues for consideration by the IRB,
identify any key changes being proposed by the investigator, and include recommendations for
action by the IRB.
A typical primary reviewer’s summary might note that no issues of concern have arisen since the
prior IRB review, no changes are being proposed by the investigator, adverse events are of the type
and frequency expected, the research appears to satisfy all criteria required for approval under 45
CFR 46.111 (and subparts B, C, and D when applicable), and the primary reviewer recommends
approval without any stipulated changes.
Procedures for Continuing Review Deliberations During IRB Meetings
No IRB member may participate in the review of research in which the member has a conflicting
interest, except to provide information requested by the IRB.
Research studies undergoing continuing review by the IRB at convened meetings should be
considered and discussed individually. Furthermore, OHRP recommends that the IRB act and vote
on research studies individually. Individual consideration of, and voting on actions related to,
research projects during continuing review will help to ensure that members with a conflicting
interest related to a particular study do not participate in the IRB’s continuing review of that study,
except to provide information requested by the IRB.
The amount of time the IRB spends on the continuing review of a particular research project at a
convened meeting will vary depending on the nature and complexity of the research, the amount
and type of new information presented to the IRB by the investigator, and whether the investigator
is seeking approval of substantive changes to the research protocol or informed consent document.
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In the absence of any concern about the research being raised by the IRB member assigned to be
the primary reviewer or by any other IRB member present at the IRB meeting, the IRB should be
able to complete its continuing review deliberations for such a research project within a brief
period of time.

The primary reviewer provides a brief synopsis of the research and using the completed
review checklist as a guide, should state that:

No concerning issues have arisen since the prior IRB review and approval

No changes to the project are being proposed by the investigator

Adverse events in subjects have been of the type and frequency expected

The research appears to continue to satisfy all criteria for approval under the regulations
at 45 CFR 46.111 (and subparts B, C, and D, when applicable); and

The reviewer recommends approval without any conditions.

The IRB chairperson calls for a motion on the project

The primary reviewer makes a motion to approve the research without conditions and
another member seconds the motion

The IRB chairperson makes a request for discussion by the IRB members; and

Following any discussion, the IRB chairperson calls for a vote on the motion to approve the
project without conditions.

Documentation of approval should include the following statement: This protocol was
evaluated to ensure risks to subjects continue to be minimized and remain reasonable in
relation to any anticipated benefits and the knowledge expected to result. The
information provided by the investigator is consistent with the research protocol.
Approving Research with Conditions at the Time of Continuing Review
Given the authorities that IRBs have under HHS regulations at 45 CFR 46.109(a), when conducting
either initial or continuing review of a research study, an IRB can take any of the following actions:

Approve the research study either as submitted without any conditions, or with conditions;

Require modifications to secure approval and defer or table the research study for further
review at a future date after the required modifications are submitted by the or

Disapprove the research study.
When approving research with conditions at the time of continuing review, the IRB should be
careful to specify whether any conditions need to be satisfied before an investigator can continue
particular research activities related to those conditions. For example, if at the time of continuing
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review, the IRB requires the investigator to change the research protocol to include a specific new
procedure for screening prospective subjects, the IRB could approve the research with the
following condition: research activities involving currently enrolled subjects may continue, but no
new subjects may be enrolled until a designated IRB member reviews a revised protocol and
verifies that the protocol includes the new screening procedure.
Additional Considerations Regarding Continuing Review Using an Expedited Review Procedure
When conducting continuing review under an expedited review procedure, the IRB Chair or other
member(s) designated by the Chair, at their discretion, may invite individuals with competence in
special areas to assist in the review of issues which require expertise beyond or in addition to that
available to the IRB. In such cases the IRB records must document the involvement of such expert
consultants in the expedited review. However, only the IRB Chair or experienced IRB members
designated by the Chair may carry out continuing review and approve research under the expedited
review procedure.
A compliance staff member from ORSP who is also an experienced member of the IRB may be
designated by the IRB Chair to conduct continuing review of research under an expedited review
procedure.
Documentation for continuing reviews conducted under an expedited review procedure include:

The specific categories permitting the expedited review; and

Documentation of the review and action taken by the IRB Chair or designated reviewer
Expedited review category (8)(c) and data analysis
OHRP considers a research study to continue to involve human subjects as long as the investigators
conducting the research continue to obtain: (1) data about the subjects of the research through
intervention or interaction with them; or (2) identifiable private information about the subjects of
the research (45 CFR 46.102(f)). OHRP interprets obtaining identifiable private information to
include an investigator’s use, study, or analysis of identifiable private information. Therefore, as
long as a non-exempt human subjects research study continues to involve use, study, or analysis of
identifiable private information by the investigators, the research continues to involve human
subjects and must undergo continuing review by an IRB at least annually (45 CFR 46.109(e)), even if
the participation of all subjects in a research project has been completed or discontinued. OHRP
notes that simply maintaining individually identifiable private information without using, studying,
or analyzing such information is not human subjects research and thus does not require continuing
review.
Under expedited review category 8(c), an IRB may use an expedited review procedure to conduct
continuing review when the only remaining human subjects research activity is the analysis of data
that includes identifiable private information and the IRB chairperson (or another experienced IRB
member designated by the chairperson) determines that this activity involves no more than
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minimal risk. OHRP expects that in nearly all cases such research activities will involve no more than
minimal risk and therefore be eligible for IRB review under an expedited review procedure.
OHRP notes that the process for conducting continuing review of research under expedited review
category (8)(c) can be accomplished through a simple, abbreviated process. For example, the
investigator, as part of the continuing review process, could provide to the IRB the following
statement regarding the research: “the study only involves data analysis, which is proceeding in
accordance with the IRB-approved research protocol, and there are no problems to report.” This
statement could be provided by email or as part of a standard continuing review application form.
Upon receipt of such a statement from the investigator, the IRB chairperson, or other member(s)
designated by the chairperson, under the expedited review procedure may approve the
continuation of the research project for another year without further deliberation or review.
3. Expedited Review Category (9)
Under category (9), an expedited review procedure may be used for the continuing review of
research previously approved by the IRB at a convened meeting that meets the following
conditions:

The research is not conducted under an investigational new drug application (IND) or an
investigational device exemption (IDE)

Expedited review categories (2) through (8) do not apply to the research

The IRB has determined and documented at a convened meeting that the research involves
no greater than minimal risk to the subjects and

No additional risks of the research have been identified
With regard to the third condition, the IRB at a convened meeting must have determined that
either (a) the research project as a whole involved no more than minimal risk, or (b) the remaining
research activities involving human subjects present no more than minimal risk to the subjects. This
determination, particularly with respect to (a), could occur as early as the convened IRB meeting at
which the IRB conducted its initial review.
With regard to multicenter research projects, the fourth condition that “no additional risks have
been identified” is interpreted by OHRP to mean that neither the investigator nor the IRB at a
particular institution has identified any additional risks from any institution engaged in the research
project or from any other relevant source since the IRB’s most recent prior review.
Determining the Frequency of Continuing Review
The IRB must conduct continuing review of research at intervals appropriate to the degree of risk,
but not less often than once a year (45 CFR 46.109(e)). In addition, the IRB must have and follow
written procedures for conducting continuing review and for determining which projects require
review more often than annually (45 CFR 46.103(b)(4) and 46.108(a)).
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The IRB should decide the frequency of continuing review for each research project necessary to
ensure the continued protection of the rights and welfare of research subjects. More frequent
review (i.e., more frequently than once per year) may be appropriate, for example, when the risks
to subjects warrants more frequent reassessment. OHRP recommends that the IRB consider factors
such as the following when deciding on an appropriate interval for continuing review and that
these factors be outlined in the IRB’s written procedures for deciding the frequency of continuing
review:

The nature of any risks posed by the research project;

The degree of uncertainty regarding the risks involved;

The vulnerability of the subject population;

The experience of the investigators in conducting research;

The IRB’s previous experience with the investigators (e.g., compliance history, previous
problems with the investigator obtaining informed consent, or prior complaints from
subjects about the investigator);

The projected rate of enrollment; and

Whether the research project involve novel interventions.
At the time of initial approval of a research project, the IRB should specify the duration of the
approval period and the interval by which continuing review must occur (e.g., 4 months, 6 months,
or 1 year) in order for the research to continue. OHRP notes that in addition to specifying a time
interval, the IRB also may specify a subject enrollment number as a threshold for determining when
continuing review is to occur. For example, at the time of initial review and approval of a high-risk
clinical trial, the IRB might require that continuing review occur either in 6 months or after 5
subjects have been enrolled, whichever occurs first. OHRP also recommends that the minutes of
IRB meetings clearly document the approval period (continuing review interval).
Similarly, OHRP recommends that at the time of continuing review the IRB consider whether the
current frequency of continuing review for the research study is adequate or should be adjusted.
For example, if the IRB initially approved a research study for a period of a year and at the first
annual continuing review determined that the risks posed to the subjects have increased
significantly, the IRB might re-approve the project after determining that the criteria for approval
under 45 CFR 46.111 remain satisfied, but require that the next continuing review occur in 6
months.
The IRB’s determinations regarding the approval of research and the required interval for
continuing review must be communicated to the investigator in writing (45 CFR 46.103(b)(4) and
46.109(d)).
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Lapses in IRB Approval
As previously noted, continuing review of research must occur at intervals appropriate to the
degree of risk, but not less frequently than once per year.
It is the responsibility of investigators to provide in a timely manner the information needed by the
IRB to perform its continuing review functions, and any reminder notices regarding the need to do
so from the IRB to investigators are a courtesy.
Regulations at 45 CFR part 46 make no provision for any grace period extending the conduct of
research beyond the expiration date of IRB approval. A lapse in IRB approval of research occurs
whenever an investigator fails to provide continuing review information to the IRB or the IRB has
not conducted continuing review and re-approved the research – with or without conditions – by
the expiration date of IRB approval. In such circumstances, all research activities involving human
subjects must stop after IRB approval expires, unless it is determined to be in the best interests of
already enrolled subjects to continue participating in the research.
Enrollment of new subjects cannot occur after the expiration of IRB approval. Continuing
participation of already enrolled subjects in a research project during the period when IRB approval
has lapsed may be appropriate, for example, when the research interventions hold out the
prospect of direct benefit to the subjects or when withholding those interventions poses increased
risk to the subjects.
When continuing review of a research project does not occur prior to the end of the approval
period specified by the IRB, IRB approval expires automatically. It is therefore the policy of Suffolk
University, to administratively close any protocol that does not pose a risk to subjects by this
action, on the date that IRB approval expires.
Suspension or Termination of IRB Approval of Research or Disapproval at the Time of
Continuing Review
The IRB has the authority to suspend or terminate approval of research that is not being conducted
in accordance with the IRB’s requirements or that is associated with unexpected serious harm to
subjects. A suspension or termination of IRB approval of research may occur at any time during the
period covered by the IRB approval.
Suspension of IRB approval may be appropriate when a significant issue is first identified and while
the IRB investigates the matter. For example, if there is an allegation of serious noncompliance by
an investigator or a human subject safety issue that needs further investigation and evaluation, the
IRB may decide to suspend its approval of the research project while the allegation or issue is
undergoing evaluation. The IRB may consider whether it is appropriate to notify subjects about the
suspension and the reasons for it, and if so, when the subjects should be notified, given that
complete information may not be available.
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Any suspension or termination of IRB approval must be promptly reported to the investigator,
appropriate institutional officials, any HHS agency that supports the research, and OHRP. Reports
of suspension of an IRB protocol must include the reasons for the IRB’s action (45 CFR 46.113).
Identifying the Point When Continuing Review is no Longer Necessary
Continuing review and re-approval of a research project at least annually is required so long as the
project continues to involve human subjects. A research project continues to involve human
subjects as long as the investigators conducting the research continue to obtain:

Data about the subjects of the research through intervention or interaction with them; or

Identifiable private information about the subjects of the research
With respect to obtaining identifiable private information, OHRP considers this to include obtaining
identifiable biological specimens originating from living individuals. Furthermore, OHRP considers
obtaining identifiable private information to include:

Collecting or receiving identifiable private information from any source not already in the
possession of the investigator

Collecting identifiable private information by observing or recording private behavior without
interacting or intervening with the human subjects; and

Using, studying, or analyzing identifiable private information, even if the information was
already in the possession of the investigator before the research begins. This includes using,
studying, or analyzing any of the following:

Identifiable private information obtained by interacting or intervening with the
human subjects;
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Identifiable private information stored in documents, records, photographs, images,
video recordings, or audio recordings provided to the investigators from any source;

Identifiable private information stored in documents, records, photographs, images,
video recordings, or audio recordings already in the possession of the investigator
before the research begins;
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Identifiable private information obtained about an individual by interviewing other
people (e.g., an individual’s healthcare provider or teacher);
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Identifiable biological specimens provided to the investigators from any source; or
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Identifiable biological specimens already in the possession of the investigator before
the research begins.
A research project no longer involves human subjects once the investigators have finished
obtaining data through interaction or intervention with subjects or obtaining identifiable private
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information about the subjects, which includes the using, studying, or analyzing identifiable private
information. Once all such activities described in the IRB-approved protocol are finished, the
research project no longer needs to undergo continuing review. For example, when the only
remaining activity of a research project involves the analysis of aggregate data sets without
individual subject identifiers, no further continuing review is necessary. At that point the IRB can
formally close the IRB file for that project and advise the investigator of that action.
Similarly, simply maintaining individually identifiable private information without using, studying, or
analyzing such information is not human subject research and thus does not require continuing
review.
Continuing Review and Exempt Research
Human subjects research studies that qualify for exemption under 45 CFR 46.101(b) are exempt from
all requirements of 45 CFR part 46, including the requirements related to continuing review.
However, if an investigator decides to modify an exempt human subjects research project in such a
way that it would no longer qualify for exemption, the investigator must submit the modified research
protocol to the IRB for review prior to implementation of the modified research project.
Use of Expedited Review Procedures for Continuing Review
Generally, if research did not qualify for expedited review at the time of initial review, it does not
qualify for expedited review at the time of continuing review, except in limited circumstances
described by expedited review categories (8) and (9). It is also possible that research activities that
previously qualified for expedited review have changed or will change, such that expedited IRB
review would no longer be permitted for continuing review, for example, a modification to the
protocol in which the previous risk to subjects was minimal but as a result of the modification, now
places them at more than minimal risk.
Expedited Review Category (8):
Under Category (8), an expedited review procedure may be used for the continuing review of research
previously approved by the convened IRB as follows:
 Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects
have completed all research-related interventions; and (iii) the research remains active only for
long-term follow-up of subjects; or
 Where no subjects have been enrolled and no additional risks have been identified;
 Where the remaining research activities are limited to data analysis.
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Expedited Review Category (9):
Under Category (9), an expedited review procedure may be used for continuing review of research
not conducted under an investigational new drug application or investigational device exemption
where categories (2) through (8) do not apply but the IRB has determined and documented at a
convened meeting that the research involves no greater than minimal risk and no additional risks
have been identified.
The determination that "no additional risks have been identified" does not need to be made by the
convened IRB.
Key Procedural Requirements for Continuing Review Conducted under an Expedited
Review Procedure
When continuing review of research is conducted under an expedited review procedure, the review
must be conducted by the IRB chairperson or one or more experienced reviewers designated by the
IRB chairperson from among the IRB members. The IRB must have procedures in place to ensure
that no IRB member participates in the expedited review of research in which the member has a
conflicting interest, except to provide information requested by the chairperson or his/her
designee(s) (46 CFR 46.107(e)). The IRB chairperson or IRB members designated by the chairperson
only can approve or require modification in (to secure approval of) research, but may not
disapprove research using the expedited procedures (45 CFR 46.110(b)). Disapproval of a research
project at the time of continuing review can only occur after review by the IRB at a convened
meeting, not by the expedited review process. All IRB members must be advised of research that
has been approved under an expedited review procedure (45 CFR 46.110(c)).
See section E below for additional guidance regarding when an expedited review procedure may be
used to conduct continuing review.
Determination of the Date for Continuing Review of a Protocol
The IRB must conduct continuing review of research at intervals appropriate to the degree of risk,
but not less frequently than once per year. The IRB should decide the frequency of continuing
review for each study protocol necessary to ensure the continued protection of the rights and
welfare of research subjects.
Continuing reviews should be completed at a minimum, no later than 12 months from the initial
date the protocol was approved by the IRB.
Applications for continuation review must be submitted to allow enough time for processing and
review of the protocol prior to the protocol expiration date. Generally speaking, six weeks allows
sufficient time for processing and review of the protocol.
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Applications for continuing review received after the continuation review date will not be
considered and the protocol will expire on the continuation review date. An expired protocol
means that the project has terminated and any additional work or use of existing data requires the
submission of a new protocol application for IRB review.
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6 Modifications to Approved Research
SUBMISSION OF MODIFICATIONS TO CURRENTLY APPROVED RESEARCH
All modifications to currently approved research are required to have IRB review and approval prior
to implementation except when necessary to eliminate apparent immediate hazards to the subject.
The IRB may only approve modifications through the current approval expiration period. Minimal
risk changes may receive an expedited review. Modifications to approved protocols that may affect
the risk to subjects are forwarded to the convened IRB for review, even if they were originally
reviewed and approved through the expedited process.
The following items must be submitted to modify currently approved research activities
1. Completed Study Amendment Request form with a summary of changes either on the form or
attached on a separate sheet
2. All applicable documents (e.g., copy of sponsor’s amended protocol, letter of explanation giving
rationale for change, study instruments, recruitment tools etc). The amendment may require
convened IRB review if the modification is significant and impacts the risks or benefits to subjects in
the research. Changes in the risks or benefits to subjects may require modifications to the consent
form and the re-consenting of subjects. Investigators will report proposed changes in previously
approved human subject research activities to the IRB. If approved research is changed to eliminate
an apparent immediate hazard(s) to the subject, the investigator is required to notify the IRB of the
change(s) promptly (within five (5) business days). The IRB will review at the next convened
meeting to determine if the change(s) instituted were consistent with the subject’s continued
welfare.
Modifications (Amendments/Revisions) to Currently Approved Research
The terminology used to describe a change to a protocol may vary, including terms such as
modification, amendment or revision. Typically outside sponsors may call any change to the
protocol an amendment. For purposes of this document the term modification will be used to
designate a change.
All modifications to currently approved research are required to have IRB review and approval prior
to implementation except when necessary to eliminate apparent immediate hazards to the subject.
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The modification application should include any required changes to the protocol, consent or other
study documentation. The modification reviewer has access to the same documentation as the
initial or continuing reviewer and is expected to conduct the review with the same diligence as an
original or continuing review regardless of whether or not the review is expedited or full board
review.
Regulations permit the use of expedited procedures for review of minor changes to previously
approved research during the period for which the approval is authorized. Modifications that alter
the risk/benefit ratio are assigned to a primary reviewer and presented to the full board at a
convened meeting.
The essence of the study should be summarized by the reviewer for IRB members and the reviewer
should state what the proposed modification is and how it will affect the conduct of the study, the
risk/benefit ratio, and whether or not the modification should be approved as written. If the
modification requires a change in the informed consent document, then the reviewer must review
that change and recommend appropriate board action. Modifications submitted to the IRB, along
with supporting correspondence, are entered into the IRB database, and placed in the study file.
Investigators are notified in writing of the decision of the IRB and of any changes required.
Modification approval is not granted until all required changes have been made and submitted for
review and approval. Once approved, the investigator is sent a modification approval form. The IRB
may only approve modifications through the current approval expiration period, unless considered
at the time of continuation review. Upon receipt of the approval for the modification, the
investigator may initiate the modification.
If approved research is changed to eliminate an apparent immediate hazard(s) to the subject, the
investigator is required to notify the IRB of the change(s) promptly (within five (5) business days).
The IRB will review at the next convened meeting to determine if the change(s) instituted were
consistent with the subject's continued welfare.
Definitions and Examples of Minor versus Major Modifications
The following definitions may be helpful to determine the level of approval to pursue; investigators
are encouraged to contact the HSPP staff with any questions prior to submitting the request if
uncertain about the review type required.
Minor Modifications
Level of Approval: Expedited
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Definition: Minor changes have no substantive effect upon an approved protocol or reduce the risk
to the subject
Examples of minor changes are:

Changes in research personnel that do not alter the competence of the research team to
conduct the research
 Scientific and/or therapeutic changes that leave the research population at the same or lower
risk than risk(s) already approved
 A minor increase or decrease in the number of participants (<25% change) or a >25% increase
in the # of participants to be enrolled, but the # of participants to be "treated" remains the
same. (e.g. - increase in # consented due to a higher than expected rate of screen failures) or
a larger % increase in # of subjects which does not affect the statistical plan.
 Changes in research procedures that have a minor impact on risks of harm, such as changes in
the amount and frequency of blood draws ( which remain within the expedited criteria),
addition of a clinic visit that involves no new procedures, or addition of a questionnaire that
does not introduce new subject matter.
 An increase in the number of study visits for the purpose of increased safety monitoring
 Minimal changes in remuneration
 Changes to improve the clarity of statements, enhance comprehension or to correct
typographical errors, updating to current template, without altering the content or intent of
the statement
 Clarification of discrepancies within the IRB review materials (protocol cover sheet, protocol,
consent) such as numbers of subjects, number and identity of research sites, timing, nature,
and duration of research procedures.
Major Modifications
A major modification is defined as a change that materially affects an assessment of the risks and
benefits of the study. For example a change that increases risks to subjects, alters the informed
consent process whereby a waiver is requested, requests a change in inclusion criteria whereby a
vulnerable population is added, or substantially changes the specific aims or design of the study.
Level of Approval: Full Board
Examples of major changes that are considered to increase the risk to the subject:
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Knowledge of a new risk which might affect the risk/ benefit ratio (For example, if a risk that
is serious, life-threatening, or could potentially result in permanent disability). The addition of
these sorts of risk might affect the IRB's view of the risk/benefit ratio and should therefore be
reviewed by the full board.
Increasing the length of time a subject is exposed to experimental aspects of the study.
Increasing the dose/strength of an investigational drug.
Changing the originally targeted population to include a more at-risk population (example:
previous exclusion for those with renal failure are now allowed to enroll, or adding children or
pregnant women to the study.)
Adding additional procedures where the risk of the additional procedure is greater than
minimal risk.
Adding an element that may breech the confidentiality of the subject such as tissue banking
or genetic testing.
An increase >25% in the # of participants to be "treated” which affects the statistical plan for
the study.
Requesting surrogate assent for a full board study.
Submission of Materials and Feedback Time Frame
Approval of a modification does not extend or otherwise change the project's expiration date.
Deadlines for submissions only apply to full board reviews. Refer to the meeting dates and
submission deadlines on the Research Compliance website. Full board reviews must be submitted
by a deadline that is approximately 30 days prior to the convened meeting.
Expedited modifications can be reviewed at anytime and will be, typically, reviewed within 5
business days after which the investigator will receive feedback from the review.
Changing Principal Investigators
When changing principal investigators, a protocol modification must be submitted to show who
was the PI and who is now being appointed PI. The old PI signs off on the modification attestations.
Changes in principal investigators qualify for expedited review of the modification.
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7 Final Reports and Closure of Protocols
SUBMISSION OF FINAL REPORTS
A process for review of study closures and final reports is required because of the potential risks to
human subjects that may arise if study activities are terminated without review. Such risks may
include ethically indicated follow-up procedures that may otherwise not be made available. Such
review is also required because regulations require prompt reporting to the IRB of changes in a
research activity and the completion of a study is considered a change in activity.
Studies may be recommended for closure by the Principal Investigator if all of the following
conditions are met:
1) All subject enrollment is complete;
2) All data (including study follow-up data) pertaining to human subjects have been collected;
3) No further human subject interaction is planned for the purpose of research;
4) No further analysis of identifiable private information is to be conducted.
Industry sponsored studies may be closed upon recommendation of the Principal Investigator if
either of the following apply:
 The Suffolk University study site is closed by the sponsor. In this case, the final report must
include a notification (letter or email) from the sponsor or sponsor's representative indicating
that the Suffolk University study site is closed and that individually identifiable data are no
longer being collected on subjects at this site [NOTE - Data analysis may be ongoing by the
sponsor at another site, but data analysis may not be ongoing by the UMass Boston Principal
Investigator]; or
 The Principal Investigator has withdrawn his/her participation in the sponsor's protocol. In
this case, the Principal Investigator must include a copy of the notification to the sponsor
(letter or email) with the final report.
To formally complete ('close') a study, Principal Investigators must submit a final report specific to that
study. Because there is no provision for any grace period beyond the expiration date for the study
defined by the IRB, the final report should be submitted prior to this expiration date. If a final report is
not received and approved prior to this date, the study will be suspended.
Final reports submitted for a study currently under suspension for lapse in IRB approval must include a
description of activities that have occurred in the study since approval of the prior continuing review.
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Final reports may be reviewed and approved by an “expedited” process. This expedited review
may be conducted by an IRB chair, an IRB-designee or an administrative-designee. In this
circumstance, the reviewer may approve the final report and close the study or, if appropriate,
he/she may defer a decision and refer the final report to the convened IRB.
Final reports may be reviewed and approved by an administrative-designee only if all of the
following conditions have been met:
 All subjects have finished their final research visits and enrollment is permanently closed with
no prospect for further data collection or any continuing human subject interactions or
interventions for the purpose of research;
 If the study has a sponsor, either the sponsor or the sponsor representative has indicated in
writing that the study is completed at the University and that study closure is requested or
the Principal Investigator has withdrawn his/her participation in the sponsor's protocol and
has given written notification of this withdrawal to the sponsor;
 All data (including study follow-up data) pertaining to human subjects has been collected;
 Data analysis of identifiable private information at the University is complete;
 All study documents (e.g. adverse event reports, study deviations etc) have been reviewed. If
any of these above conditions do not apply and/or if there is any new information about risk
or subject safety included in the final report that was not previously reported and/or for any
other reason the administrative designee believes appropriate, the final report shall be
referred to the IRB chair or IRB designee for approval or deferral to the convened IRB.
If the final report is referred to the convened IRB, the Board shall decide what actions must be
taken to resolve any issues that may be made known in the final report.
If a study is not closed by the Principal Investigator but rather is allowed to expire, the ORSP Staff
Assistant or Research Compliance Manager will send an administrative closure letter to the
Principal Investigator. This letter will be part of the IRB’s permanent record for the research and is
undesirable as a last action status.
If a Principal Investigator terminates employment or other association with the University, he/she
is obligated to submit a final report to the IRB or transfer the protocol to another Principal
Investigator via an amendment which requires approval by the department chair and IRB. If the
departing Principal Investigator is unwilling or unable to provide such an amendment, the
department chair may take such action or the Research Compliance Manager may seek to
administratively close the study in the manner defined in the paragraph above.
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A study may also be administratively closed by an IRB Chair, an IRB-designee or an administrativedesignee without a final report from the Principal Investigator if the Principal Investigator (or the
department chair in the case where a principal investigator is unavailable) provides a written memo
to the IRB affirming that the study was never initiated after IRB approval and that no subjects were
ever enrolled in the study. If the study was sponsored, the Principal Investigator must also submit
written documentation (letter or email) to the IRB Administrator that:
 The sponsor has notified the Principal Investigator that the study is being discontinued or
closed; or
 The Principal Investigator has notified the sponsor that he/she no longer wishes to participate
in the study and the study is being discontinued or closed. A copy of this notification should
be provided by the Principal Investigator to the IRB Administrator.
Change in Primary Institutional Affiliation of an Investigator
When a faculty PI changes primary institutional affiliation but wishes to continue with an IRBapproved research study, the PI must provide IRB contact information for the new institution to
effect a transfer of such approval to the new FWA assured institution.
New faculty joining Suffolk University must provide verification of IRB approval for any human
subject research project for which activity is desired to be continued as a Suffolk University faculty
member. All studies will need to be converted to a Suffolk University research application upon
continuing review.
ADMINISTRATIVE CLOSURE OF PROTOCOLS
 Protocols submitted for initial approval which require information or modification by the
investigator and for which no activity has occurred within a period of 60 days.
 Lapses in IRB approval of a protocol for failing to submit a timely request for continuing review or
respond to reviewer concerns
 Departure of the principal investigator when no arrangement has been made prior to departure
for transferring protocol oversight to another qualified faculty or staff member
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8 Investigator and IRB Reporting Requirements
REPORTING ADVERSE EVENTS AND UNANTICIPATED PROBLEMS INVOLVING RISKS TO
SUBJECTS AND OTHERS
The IRB has the authority to suspend or terminate approval of research conducted or supported by
HHS that is not being conducted in accordance with the IRB’s requirements or that has been associated
with unexpected serious harm to subjects. Any suspension or termination of approval must include a
statement of the reasons for the IRB’s action and must be reported promptly to the investigator,
appropriate institutional officials, and any supporting department or agency head in accordance with
45 CFR 46.113.
Federal regulations [45CFR46.103(b)(5) and 21CFR56.108(b)(1)] require the prompt reporting by
investigators “any adverse event or unanticipated problems involving risk to subjects or others
(UPIRTSO).” The IRB defines unanticipated problems or risks to others as any problem or event which
in the opinion of the local investigator was unanticipated, serious and at least possibly related to the
research procedures.
An Unanticipated Problem Involving Risks to Subjects and Others is defined as any incident,
experience, or outcome that meets all 3 of the following criteria:
1. Unexpected (nature, severity or frequency) given: (a) the research procedures that are
described in the protocol-related documents, such as the IRB-approved research protocol
and informed consent document; and
(b) the characteristics of the subject population being studied; and
2. Related or Possibly Related (to participation) , and
3. Suggests that the research places subjects or others at a greater risk of harm (including
physical, psychological, economic, or social harm) than was previously known or recognized.
Such events must be reported to the IRB within 48 hours utilizing the appropriate form. The form can
be found in IRBNet Library Manager or in the Investigator Toolbox on Suffolk University’s Research
Compliance website.
An incident, experience, or outcome that meets the three criteria above generally will warrant
consideration of substantive changes in the research protocol or informed consent
process/document or other corrective actions in order to protect the safety, welfare, or rights of
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subjects or others. Examples of corrective actions or substantive changes that might need to be
considered in response to an unanticipated problem include:

changes to the research protocol initiated by the investigator prior to obtaining IRB
approval to eliminate apparent immediate hazards to subjects;

modification of inclusion or exclusion criteria to mitigate the newly identified risks;

implementation of additional procedures for monitoring subjects;
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suspension of enrollment of new subjects;

suspension of research procedures in currently enrolled subjects;

modification of informed consent documents to include a description of newly recognized
risks; and

provision of additional information about newly recognized risks to previously enrolled
subjects.
UPIRTSOs may include:
 Any serious event (including on-site and off-site adverse events, injuries, side effects, deaths or
other problems) which in the opinion of the local investigator was unanticipated, involved risk
to subjects or others, and was possibly related to the research procedures;
 Any serious accidental or unintentional change to the IRB-approved protocol that involves risk
or has the potential to recur;
 Any deviation from the protocol taken without prior IRB review to eliminate apparent
immediate hazard to a research subject;
 Any publication in the literature, safety monitoring report (including Data and Safety
Monitoring Reports), interim result or other finding that indicates an unexpected change to
the risk/benefit ratio of the research;
 Any breach in confidentiality that may involve risk to the subject or others;
 Any complaint of a subject that indicates an unanticipated risk or that cannot be resolved by
the research staff; or
 Any other serious and possibly related event which in the opinion of the investigator
constitutes an unanticipated risk.
Adverse events encompass both physical and psychological harms. They occur most commonly in
the context of biomedical research, although on occasion, they can occur in the context of social
and behavioral research.
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How to determine which adverse events are unanticipated problems
According to OHRP, most IRB members, investigators, and institutional officials understand the
scope and meaning of the term adverse event in the research context, but lack a clear
understanding of OHRP’s expectations for what, when, and to whom adverse events need to be
reported as unanticipated problems, given the requirements of the HHS regulations at 45 CFR part
46.
The following Venn diagram summarizes the general relationship between adverse events and
unanticipated problems:
The diagram illustrates three key points:
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The vast majority of adverse events occurring in human subjects are not unanticipated
problems (area A).
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A small proportion of adverse events are unanticipated problems (area B).
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Unanticipated problems include other incidents, experiences, and outcomes that are not
adverse events (area C).
The key question regarding a particular adverse event is whether it meets the three criteria
described and therefore represents an unanticipated problem. To determine whether an adverse
event is an unanticipated problem, the following questions should be asked:
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Is the adverse event unexpected?
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Is the adverse event related or possibly related to participation in the research?
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Does the adverse event suggest that the research places subjects or others at a greater
risk of harm than was previously known or recognized?
If the answer to all three questions is yes, then the adverse event is an unanticipated problem and
must be reported to appropriate entities under the HHS regulations at 45 CFR 46.103(a) and
46.103(b)(5). The next three sub-sections discuss the assessment of these three questions.
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Assessing whether an adverse event is unexpected
In its guidance document, OHRP defines unexpected adverse event as follows:
Any adverse event occurring in one or more subjects participating in a research protocol, the
nature, severity, or frequency of which is not consistent with either:
1. The known or foreseeable risk of adverse events associated with the procedures involved in
the research that are described in (a) the protocol-related documents, such as the IRB-approved
research protocol, any applicable investigator brochure, and the current IRB-approved informed
consent document, and (b) other relevant sources of information, such as product labeling and
package inserts; or
2. The expected natural progression of any underlying disease, disorder, or condition of the
subject(s) experiencing the adverse event and the subject’s predisposing risk factor profile for the
adverse event.
It may be difficult to determine whether a particular adverse event is unexpected and for many
studies, determining whether a particular adverse event is unexpected by virtue of an unexpectedly
higher frequency can only be done through an analysis of appropriate data on all subjects enrolled
in the research.
The vast majority of adverse events occurring in the context of research are expected in light of (1)
the known toxicities and side effects of the research procedures; (2) the expected natural
progression of subjects’ underlying diseases, disorders, and conditions; and (3) subjects’
predisposing risk factor profiles for the adverse events. Thus, most individual adverse events do
not meet the first criterion for an unanticipated problem and do not need to be reported under the
HHS regulations 45 CFR part 46.103(a) and 46.103(b)(5)
Assessing whether an adverse event is related or possibly related to participation in research
Adverse events may be caused by one or more of the following:
1. The procedures involved in the research;
2. An underlying disease, disorder, or condition of the subject; or
3. Other circumstances unrelated to either the research or any underlying disease, disorder, or
condition of the subject.
In general, adverse events that are determined to be at least partially caused by (1) would be
considered related to participation in the research, whereas adverse events determined to be
solely caused by (2) or (3) would be considered unrelated to participation in the research.
Determinations about the relatedness of adverse events to participation in research commonly
result in probability statements that fall along a continuum between definitely related to the
research and definitely unrelated to participation in the research. OHRP considers possibly related
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to participation in the research to be an important threshold for determining whether a particular
adverse event represents an unanticipated problem. OHRP defines possibly related as follows:
There is a reasonable possibility that the adverse event may have been caused by the procedures
involved in the research.
It may also be difficult to determine whether a particular adverse event is related or possibly
related to participation in the research.
Many individual adverse events occurring in the context of research are not related to participation
in the research and, therefore, do not meet the second criterion for an unanticipated problem and
do not need to be reported under the HHS regulations 45 CFR part 46.103(a) and 46.103(b)(5).
Assessing whether an adverse event suggests that the research places subjects or others at a
greater risk of harm than was previously known or recognized
The first step in assessing whether an adverse event meets the third criterion for an unanticipated
problem is to determine whether the adverse event is serious.
A serious adverse event is defined as any adverse event that:
1. Results in death
2. Is life-threatening (places the subject at immediate risk of death from the event as it
occurred)
3. Results in inpatient hospitalization or prolongation of existing hospitalization
4. Results in a persistent or significant disability/incapacity
5. Results in a congenital anomaly/birth defect or
6. Based upon appropriate medical judgment, may jeopardize the subject’s health and may
require medical or surgical intervention to prevent one of the other outcomes listed in this
definition (examples of such events include allergic bronchospasm requiring intensive
treatment in the emergency room or at home, blood dyscrasias or convulsions that do not
result in inpatient hospitalization, or the development of drug dependency or drug abuse).
Adverse events that are unexpected, related or possibly related to participation in research, and
serious are the most important subset of adverse events representing unanticipated problems
because such events always suggest that the research places subjects or others at a greater risk of
physical or psychological harm than was previously known or recognized and routinely warrant
consideration of substantive changes in the research protocol or informed consent
process/document or other corrective actions in order to protect the safety, welfare, or rights of
subjects.
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The IRB has the authority to suspend or terminate approval of research that, among other things,
has been associated with unexpected serious harm to subjects (45 CFR 46.113). In order for the
IRB to exercise this important authority in a timely manner, it must be informed promptly of those
adverse events that are unexpected, related or possibly related to participation in the research,
and serious.
However, other adverse events that are unexpected and related or possibly related to participation
in the research, but not serious, would also be unanticipated problems if they suggest that the
research places subjects or others at a greater risk of physical or psychological harm than was
previously known or recognized. Again, such events routinely warrant consideration of substantive
changes in the research protocol or informed consent process/document or other corrective
actions in order to protect the safety, welfare, or rights of subjects or others.
The flow chart below provides an algorithm for determining whether an adverse event represents
an unanticipated problem that needs to be reported under HHS regulations at 45 CFR part 46.
Reporting of other unanticipated problems (not related to adverse events) by investigators to the
IRB
Upon becoming aware of any other incident, experience, or outcome that may represent an
unanticipated problem, the investigator should assess whether the incident, experience, or
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outcome represents an unanticipated problem by applying the criteria described earlier. If the
investigator determines that the incident, experience, or outcome represents an unanticipated
problem, the investigator must report it promptly to the IRB.
Content of reports of unanticipated problems submitted to the IRB
Investigators should include the following information when reporting an adverse event, or any
other incident, experience, or outcome as an unanticipated problem to the IRB:
1. Appropriate identifying information for the research protocol, such as the title,
investigator’s name, and the IRB project number;
2. A detailed description of the adverse event, incident, experience, or outcome;
3. An explanation of the basis for determining that the adverse event, incident, experience, or
outcome represents an unanticipated problem; and
4. A description of any changes to the protocol or other corrective actions that have been
taken or are proposed in response to the unanticipated problem.
Changes to a multicenter research protocol that are proposed by an investigator at one
institution in response to an unanticipated problem
For multicenter research protocols, if a local investigator at one institution engaged in the research
independently proposes changes to the protocol or informed consent document in response to an
unanticipated problem, the investigator should consult with the study sponsor or coordinating
center regarding the proposed changes because changes at one site could have significant
implications for the entire research study.
IRB review and further reporting of unanticipated problems
Once reported to the IRB, further review and reporting of any unanticipated problems will proceed
as follows:

Review by the Research Compliance Manager and IRB Chair to determine necessary
disposition

Or review by the convened IRB if determined to be warranted by the RCM and IRB Chair
When reviewing a report of an unanticipated problem, the IRB should consider whether the
affected research protocol still satisfies the requirements for IRB approval under HHS regulations at
45 CFR 46.111. In particular, the IRB should consider whether risks to subjects are still minimized
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and reasonable in relation to the anticipated benefits, if any, to the subjects and the importance of
the knowledge that may reasonably be expected to result.
When reviewing a particular incident, experience, or outcome reported as an unanticipated
problem by the investigator, the IRB may determine that the incident, experience, or outcome does
not meet all three criteria for an unanticipated problem. In such cases, further reporting to
appropriate institutional officials, the department or agency head (or designee), and OHRP would
not be required under HHS regulations.
The IRB has authority, under HHS regulations to require, as a condition of continued approval by
the IRB, submission of more detailed information by the investigator(s), the sponsor or the study
coordinating center about any adverse event or unanticipated problem occurring in a research
protocol.
Any proposed changes to a research study in response to an unanticipated problem must be
reviewed and approved by the IRB before being implemented, except when necessary to eliminate
apparent immediate hazards to subjects. If the changes are more than minor, the changes must be
reviewed and approved by the convened IRB.
Reporting Unanticipated problems to OHRP and supporting agency heads (or designees)
Unanticipated problems occurring in research covered by an OHRP-approved assurance also must
be reported by the institution to the supporting HHS agency head (or designee) and OHRP (45 CFR
46.103(a)). The IRB Chair or administrator or RCM is responsible for reporting unanticipated
problems to the supporting HHS agency head (or designee) and OHRP. For further information on
reporting to OHRP, see the Guidance on Reporting Incidents to OHRP.
Time frame for reporting unanticipated problems to the IRB, appropriate institutional officials,
the department or agency head (or designee), and OHRP
The HHS regulations require prompt reporting of unanticipated problems to the IRB, appropriate
institutional officials, any supporting department or agency head (or designee), and OHRP. The
purpose of prompt reporting is to ensure that appropriate steps are taken in a timely manner to
protect other subjects from avoidable harm. If the RCM in consultation with the IRB Chair or IO, or
following review by the full IRB if determined to be appropriate, any reports to OHRP or other
federal agencies will be made within 20 days of being made aware of the unanticipated problem.
The requirements for prompt reporting may be met by submitting a preliminary report to the IRB,
appropriate institutional officials, the supporting HHS agency head (or designee), and OHRP, with a
follow-up report submitted at a later date when more information is available. Determining the
appropriate time frame for reporting a particular unanticipated problem requires careful judgment
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by persons knowledgeable about human subject protections. The primary consideration in making
these judgments is the need to take timely action to prevent avoidable harms to other subjects.
What the IRB should consider at the time of initial review with respect to adverse events
Before research is approved and the first subject enrolled, the investigator(s) and the IRB should
give appropriate consideration to the spectrum of adverse events that might occur in subjects. In
particular, in order to make the determinations required for approval of research under HHS
regulations at 45 CFR 46.111(a)(1), (2), and (6), the IRB needs to receive and review sufficient
information regarding the risk profile of the proposed research study, including the type,
probability, and expected level of severity of the adverse events that may be caused by the
procedures involved in the research. The investigator also should describe how the risks of the
research will be minimized.
In addition, depending upon the risks of the research and the likelihood that the research could
involve risks to subjects that are unforeseeable, the IRB must ensure, if appropriate, that the
research includes adequate provisions for monitoring the data collected to ensure the safety of
subjects (45 CFR 46.111(a)(6)). Such provisions typically would include monitoring, among other
things, adverse events and unanticipated problems that may occur in subjects enrolled in the
research. The HHS regulations at 45 CFR part 46 do not require that the IRB conduct such
monitoring, and OHRP believes that, in general, the IRB is not the appropriate entity to monitor
research.
OHRP notes that adequate monitoring provisions for research, if deemed appropriate by the IRB,
might include one or more of the following elements, among others:
1.
The type of data or events that are to be captured under the monitoring provisions.
2.
The entity responsible for monitoring the data collected, including data related to
unanticipated problems and adverse events, and their respective roles (e.g., the
investigators, the research sponsor, a coordinating or statistical center, an independent
medical monitor, a DSMB/DMC, and/or some other entity). (OHRP notes that the IRB has
authority to observe or have a third party observe the research (45 CFR 46.109(e).)
3.
The time frames for reporting adverse events and unanticipated problems to the
monitoring entity.
4.
5.
The frequency of assessments of data or events captured by the monitoring provisions.
Definition of specific triggers or stopping rules that will dictate when some action is
required.
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As appropriate, procedures for communicating to the IRB(s), the study sponsor, the
investigator(s), and other appropriate officials the outcome of the reviews by the monitoring
entity.
The monitoring provisions should be tailored to the expected risks of the research; the type of
subject population being studied; and the nature, size (in terms of projected subject enrollment
and the number of institutions enrolling subjects), and complexity of the research protocol.
For example, for a multicenter clinical trial involving a high level of risk to subjects, frequent
monitoring by a DSMB/DMC may be appropriate, whereas for research involving no more than
minimal risk to subjects, it may be appropriate to not include any monitoring provisions.
What the IRB should consider at the time of continuing review with respect to unanticipated
problems and adverse events
For non-exempt research conducted or supported by HHS, the IRB must conduct continuing review
of research at intervals appropriate to the degree of risk, but not less than once per year (45 CFR
46.109(e)). At the time of continuing review, the IRB should ensure that the criteria for IRB
approval under HHS regulations at 45 CFR 46.111 continue to be satisfied. In particular, the IRB
needs to determine whether any new information has emerged – either from the research itself or
from other sources – that could alter the IRB’s previous determinations, particularly with respect to
risk to subjects. Information regarding any unanticipated problems that have occurred since the
previous IRB review in most cases will be pertinent to the IRB’s determinations at the time of
continuing review.
It may also be appropriate for the IRB at the time of continuing review to confirm that any
provisions under the previously approved protocol for monitoring study data to ensure safety of
subjects have been implemented and are working as intended (e.g., the IRB could require that the
investigator provide a report from the monitoring entity described in the IRB-approved protocol).
Among other things, a summary of any unanticipated problems and available information regarding
adverse events and any recent literature that may be relevant to the research is to be included in
continuing review reports submitted to the IRB by investigators. The summary could be a simple
brief statement that there have been no unanticipated problems and that adverse events have
occurred at the expected frequency and level of severity as documented in the research protocol,
and the informed consent document.
For
additional
details
about
OHRP’s
guidance
http://www.hhs.gov/ohrp/policy/contrev0107.html.
on
continuing
review,
see
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Unanticipated problem involving risks to subjects or others: Any incident, experience, or outcome
that meets all of the following criteria:
1.
2.
3.
unexpected (in terms of nature, severity, or frequency) given (a) the research procedures
that are described in the protocol-related documents, such as the IRB-approved research
protocol and informed consent document; and (b) the characteristics of the subject
population being studied;
related or possibly related to a subject’s participation in the research; and
suggests that the research places subjects or others at a greater risk of harm (including
physical, psychological, economic, or social harm) related to the research than was
previously known or recognized.
Unexpected adverse event: Any adverse event occurring in one or more subjects in a research
protocol, the nature, severity, or frequency of which is not consistent with either:
1.
the known or foreseeable risk of adverse events associated with the procedures involved
in the research that are described in (a) the protocol–related documents, such as the IRBapproved research protocol, any applicable investigator brochure, and the current IRBapproved informed consent document, and (b) other relevant sources of information, such
as product labeling and package inserts; or
2.
the expected natural progression of any underlying disease, disorder, or condition of the
subject(s) experiencing the adverse event and the subject’s predisposing risk factor profile
for the adverse event.
Examples of Unanticipated Problems that Do Not Involve Adverse Events and Need to be
Reported Under the HHS Regulations at 45 CFR Part 46
1.
An investigator conducting behavioral research collects individually identifiable sensitive
information about illicit drug use and other illegal behaviors by surveying college students.
The data are stored on a laptop computer without encryption, and the laptop computer is
stolen from the investigator’s car on the way home from work. This is an unanticipated
problem that must be reported because the incident was (a) unexpected (i.e., the
investigators did not anticipate the theft); (b) related to participation in the research; and (c)
placed the subjects at a greater risk of psychological and social harm from the breach in
confidentiality of the study data than was previously known or recognized.
The event described in the above example was unexpected in nature, related to participation in the
research, and resulted in new circumstances that increased the risk of harm to subjects. In the
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example, the unanticipated problem warranted consideration of substantive changes in the
research protocol or informed consent process/document or other corrective actions in order to
protect the safety, welfare, or rights of subjects. In addition, the third example may have
presented unanticipated risks to others (e.g., the sexual partners of the subjects) in addition to the
subjects. In each of these examples, while these events may not have caused any detectable harm
or adverse effect to subjects or others, they nevertheless represent unanticipated problems and
should be promptly reported to the IRB, appropriate institutional officials, the supporting agency
head and OHRP in accordance with HHS regulations at 45 CFR 46.103(a) and 46.103(b)(5).
Example of Adverse Events that Do Not Represent Unanticipated Problems and Do Not Need to
be Reported under the HHS Regulations at 45 CFR Part 46
1.
An investigator is conducting a psychology study evaluating the factors that affect reaction
times in response to auditory stimuli. In order to perform the reaction time measurements,
subjects are placed in a small, windowless soundproof booth and asked to wear
headphones. The IRB-approved protocol and informed consent document describe
claustrophobic reactions as one of the risks of the research. The twentieth subject enrolled
in the research experiences significant claustrophobia, resulting in the subject withdrawing
from the research. This example is not an unanticipated problem because the occurrence of
the claustrophobic reactions – in terms of nature, severity, and frequency – was expected.
2.
An investigator performs prospective medical chart reviews to collect medical data on
premature infants in a neonatal intensive care unit (NICU) for a research registry. An infant,
about whom the investigator is collecting medical data for the registry, dies as the result of
an infection that commonly occurs in the NICU setting. This example is not an unanticipated
problem because the death of the subject is not related to participation in the research, but
is most likely related to the infant’s underlying medical condition.
NOTE: For purposes of illustration, the case examples provided above represent generally
unambiguous examples of adverse events that are not unanticipated problems. OHRP recognizes
that it may be difficult to determine whether a particular adverse event is unexpected and whether
it is related or possibly related to participation in the research. In addition, the assessment of the
relationship between the expected and actual frequency of a particular adverse event must take
into account a number of factors including the uncertainty of the expected frequency estimates,
the number and type of individuals enrolled in the study, and the number of subjects who have
experienced the adverse event.
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Example of Adverse Events that Represent Unanticipated Problems and Need to be Reported
Under the HHS Regulations at 45 CFR Part 46
1.
A behavioral researcher conducts a study in college students that involves completion of a
detailed survey asking questions about early childhood experiences. The research was
judged to involve no more than minimal risk and was approved by the IRB chairperson under
an expedited review procedure. During the completion of the survey, one student subject
has a transient psychological reaction manifested by intense sadness and depressed mood
that resolved without intervention after a few hours. The protocol and informed consent
document for the research did not describe any risk of such negative psychological
reactions. Upon further evaluation, the investigator determines that the subject’s negative
psychological reaction resulted from certain survey questions that triggered repressed
memories of physical abuse as a child. The investigator had not expected that such
reactions would be triggered by the survey questions. This is an example of an
unanticipated problem that must be reported in the context of social and behavioral
research because, although not serious, the adverse event was (a) unexpected; (b) related
to participation in the research; and (c) suggested that the research places subjects at a
greater risk of psychological harm than was previously known or recognized.
Problems/events that are unanticipated and serious should be reported to the IRB within 48 hours only
if in the opinion of the local investigator they are possibly, probably or definitely related to the
research procedures. Those serious, unanticipated problems/events that the local investigator deems
unlikely or not related do NOT meet the IRB’s definition of UPIRTSO and should be reported in
summary form only at the time of IRB continuing review.
All problems/events that do NOT meet the IRB’s definition of UPIRTSO should be reported to the IRB
in summary form at the time of annual continuing review. Accompanying documentation (sponsor
report forms, etc.) should NOT be included with this summary.
REPORTING NON-COMPLIANCE PROTOCOL AND DEVIATIONS
Federal regulations require the reporting of serious and continuing noncompliance to the IRB,
institutional
officials
and
certain
federal
agencies
and
department
heads.
Noncompliance as “any failure to follow federal regulations, state laws or institutional policies
relevant to human subject research, or the requirements and determinations of the reviewing IRB.
When noncompliance has occurred, federal regulations require IRBs to determine whether the
incident is serious, continuing, or both. Suffolk University defines serious noncompliance as noncompliance that affects the rights and welfare of participants or that may put participants at risk of
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harm. Continuing noncompliance is defined as multiple or repeated instances of noncompliance,
particularly after written notice from the IRB that the investigator must take action to correct
noncompliance. The multiple or repeated instances of noncompliance may occur on one protocol
or on more than one protocol and may occur simultaneously or over a period of time.
Examples of noncompliance may include:











failure to obtain informed consent or inadequate procedures for obtaining informed
consent from subjects
conducting human subjects research without a Suffolk University IRB approved protocol,
IRB authorization agreement, or exemption
inadequate supervision of research that involves potential risks to subjects and others
conducting research, including enrollment of subjects, when IRB approval has expired or has
been suspended or terminated
initiating changes to the research protocol without prior IRB approval unless the change is
necessary to eliminate apparent immediate hazards to the subject
failing to adhere to the conditions of approval of a protocol as specified by the IRB
starting research under a protocol before meeting the conditions required by the IRB and
receiving IRB notification of approval
failing to take IRB or institutionally required human subjects protection training
enrolling more subjects than approved by the IRB
failing to have research participants sign a new consent form when new and relevant risks
are discovered or failing to provide this new information to participants
altering an IRB-approved consent process or an IRB-approved recruitment process without
prior IRB approval
Examples of serious noncompliance include:





one or more instances of conduct defined above as noncompliance that exposes subjects or
others to risks of harm that are not an inherent part of the approved research protocol
conduct defined as noncompliance above, even though subjects or others have not been
exposed to risks of harm not inherent in the approved protocol, where the IRB finds no
mitigating circumstances
misrepresentation of information related to the human subjects research protocol or
performance of the research
conducting non-exempt research without IRB approval
making substantive changes to a previously approved protocol without IRB approval
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conduct that adversely affected the integrity or effectiveness of human subjects protections
or subjects rights or welfare
Whether the conduct was inadvertent, careless or reckless, or intentional may be taken into
consideration by the IRB in a determination of seriousness.
IRB Determinations related Noncompliance
If the IRB makes an initial assessment of the noncompliance report as representing potentially
serious or continuing noncompliance as defined above, the committee renders a preliminary
determination. The investigator is then provided with an opportunity to respond to this
preliminary finding and provide additional relevant information or detail any potential mitigating
circumstances that might not have previously been considered. The IRB will review this response
and make a final determination regarding the noncompliance. If the IRB makes a final
determination that a report constitutes serious and/or continuing noncompliance, it must also
make recommendations regarding whether the Institutional Official will report the noncompliance
to the OHRP or any other federal department or agency that funds or supports the research in
which the noncompliance occurred.
In addition to making a determination of serious and/or continuing noncompliance, the Board must
also decide what further action is required.
Actions related to the protocol can include:











Requesting the investigator make modifications to the protocol
Requiring more frequent review of the protocol (e.g., more often that the minimal of annual
review)
Requesting the investigator modify the consent process or consent documents
Requiring the investigator to provide additional information to current and/or past
participants or re-consenting to participation
Requesting further corrective actions by the study team
Reconsideration of IRB approval
Implementation of monitoring of the research
Implementation of monitoring of the consent process
Suspension of the research
Termination of the research
Referral of the matter to the Institutional Official via the Human Research Protection
Program Advisory Committee for further consideration.
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The IRB may require additional action, such as protocol or consent form revisions, even without a
finding of serious or continuing noncompliance.
NOTE: Although the IRB can suspend the research study, only the Institutional Official has the
authority to suspend an individual’s privileges to conduct research.
IRB Review of Corrective Action Plans:
As part of the noncompliance report to the IRB, investigators are required to outline a corrective
action plan to prevent similar errors from occurring in the future. The IRB reviews this for
adequacy and may require revision if not found to be sufficiently robust. Corrective action plans
may include:



Additional education of the investigator and/or the research staff
Additional monitoring of support staff by the investigator, including more frequent staff
meetings or review of work by an auditor
Revisions to internal documents for processes
INVESTIGATING ALLEGATIONS OF NON-COMPLIANCE
The 45 CFR 46, 103 (b)(5) requires that any serious or continuing non-compliance with DHHS human
subjects regulations or the determinations of the IRB must be promptly reported to the Office of
Human Research Protections (OHRP).
Suffolk University adopts following policies procedures for evaluating and reporting non-compliance.
Definitions of Non-compliance
Serious Noncompliance
 Approval of a protocol by the IRB determined not to be in compliance with federal regulations.
 Human subject research being carried out without IRB review and approval by the IRB.
 Serious noncompliance also includes substantive modifications to IRB-approved research without IRB
approval.
Continuous Noncompliance
This involves the IRB or a principal investigator making the same mistake several times repeatedly,
particularly after an IRB has informed him or her and his/her team member(s) of the problem.
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Continuous noncompliance also consists of a principal investigator having multiple problems with noncompliance over a long period of time or has a problem with multiple projects.
IRB Review of Non-compliance
The IRB shall have the authority conduct for cause site visit or to request any information it desires
necessary from any source, including the PI, other investigators on the research protocol, the sponsor
and the FDA in order to determine whether more frequent review is necessary. When IRB obtains
evidence that an investigator or his team member(s) is noncompliant, the IRB Chair or IO may appoint
an ad-hoc committee to investigate the matter and report back to the board for its action. The ad hoc
committee will consist of a minimum of three voting IRB members: one scientific member, one nonscientific member and a community member.
In some circumstances, the Institutional Official (IO), IRB Chair, or Research Compliance Manager may
directly receive information suggesting the investigator is noncompliant or the research protocol is not
conducted in accordance with federal regulations or the IRB approved protocol. In such circumstances,
the Research Compliance Manager will promptly report to the IRB which initially approved the subject
protocol. The Chair or IO may then appoint an ad-hoc committee to investigate the matter and report
back to the committee for its action.
In cases where the Research Compliance Manager makes a preliminary inquiry into the matter and the
PI admits to engaging in an action that is noncompliant, the IO will forgo appointing a subcommittee
and the report will be made directly to OHRP by the IO.
Basis for Action
The IRB shall suspend or terminate any research protocol when it determines that:
1. Any of the requirements for initial review, amendments and/or continuing review approval set
forth herein are not being complied with, or
2. The research is not being conducted in accordance with representations made in research
protocol submitted to the IRB and approved by the IRB
Suspension or Termination
The IRB and the Institutional Official have the authority to suspend or terminate approval of human
subject research that is not being conducted in accordance with the IRB’s requirements or that has
been associated with unexpected serious harm to subjects. The Institutional Official and the IRB, has
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the authority to suspend or terminate human subjects research if the research is disruptive to
institution’s operations or potentially injurious to the Institution, its staff, personnel or participants.
Reporting
Any suspension or termination of approval includes a statement of the reasons for the IRB’s action and
is reported promptly to the IO, the investigator’s department chair, and the Office of Research and
Sponsored Programs, and the sponsor (if applicable The report will include the name of the principal
investigator and his team members (if they are involved), the title of the research project and/or grant
proposal in which the noncompliance occurred (there could be more than one project, if multiple
projects are involved), the nature of noncompliance and the actions the IRB is taking to address
noncompliance. In certain circumstances (e.g., clinical trials), the IRB may decide that participants in
the noncompliant study should be informed of the breach of conduct and solicit permission from
participants to publish the information.
Corrective Actions
The IRB may take several courses of action including suspending the protocol or the investigator,
conduct random audits of the investigator including his team members or collaborators and
disallowing the principal investigator for a period of time. The IRB may require remedial action or
education as deemed necessary for the investigator or any other key personnel.
CLASSIFYING, CORRECTING AND REPORTING NON-COMPLIANCE
The IRB is responsible for determining the validity of all allegations of non-compliance with respect to
human subjects research activities conducted under the auspices of Suffolk University and, if found to
be non-compliant, determining whether it constitutes non-compliance that is serious and/or
continuing in nature.
When the IRB determines that a research protocol is not in compliance with regulations, regardless of
whether it received prior review and approval by the IRB, it may direct one or more corrective actions
be taken.
An allegation of non-compliance that is potentially serious or continuing will be referred to an ad hoc
Compliance Review Committee comprised of regular voting members of the IRB for further evaluation
and fact finding. The protocol and all other documentation or information related to the allegation of
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non-compliance is to be reviewed by the subcommittee within 14 working days of receipt of the
allegation. The subcommittee recommendation is then forwarded to the IRB. Before making any
determination of serious or continuing non-compliance, the IRB will review the subcommittee
recommendation at the next regularly convened board meeting to which the investigator will have the
opportunity to attend. The failure of an investigator to make him or her-self available for the
convened board meeting will not delay IRB review, deliberation and action on the protocol.
When the IRB finds non-compliance that is determined to be serious or continuing, the IRB reports its
findings to the Institutional Official (IO). The IO then reports the finding to other appropriate
institutional officials and/or external agencies, including the sponsor, in accordance with UMass Boston
policy. All such IRB determinations and requested corrective actions are communicated in writing to
the principal investigator within 30 days of receipt of the initial allegation of non-compliance.
Any review resulting in the suspension or termination of IRB approval for any reason must be
reported to OHRP in accordance with federal regulations.
Timeline for Reporting
Regulations state that violations should be reported promptly. The IRB will determine the nature of the
incident and report the incident within 30 days of receiving notification of alleged noncompliance or
learning of potential noncompliance. The IRB may or may not complete an investigation prior to
notifying the authorities.
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9 Compliance Monitoring
AUDITING ACTIVITIES
Professional staff in the Office of Research and Sponsored Programs (ORSP), acting on behalf of the
IRB, may conduct a monitoring visit. The reason(s) for on-site review may include, for example, (1)
random selections, (2) complex projects involving unusual levels or types of risks to subjects, (3)
projects conducted by an investigator who previously failed to comply with IRB determinations, or (4)
projects where continuing review or reports from other sources have indicated that changes without
IRB approval may have occurred or subjects were consented inappropriately, (5) HIPAA noncompliance, (6) subject or whistleblower complaints, or (7) a request by an IRB member and with
approval by the IRB.
COMPLIANCE MONITORING & AUDITING OF INVESTIGATOR ACTIVITIES
All protocols reviewed and approved by the IRB are subject to regulatory monitoring by the IRB and/or
ORSP compliance personnel. Studies are selected at random as well as according to criteria listed
below or in accordance with IRB requirements or determinations. Investigators and other study
personnel involved in human subject research are required to comply with all laws and regulations
governing their research activities, as well as with requirements and determinations of the IRB. Study
personnel includes the principal investigator and any staff members directly involved with
participants or the informed consent process.
Specifically, principal investigators are required to:
• Notify the IRB when a protocol is changed to eliminate an apparent immediate hazard to one or
more human subjects—as soon as possible and not later than 48 hours after the change.
• Notify the IRB of any information related to non-compliance with federal regulations, state laws,
institutional policies, or IRB requirements and determinations—as soon as possible and not later than 5
working days from the date of learning the information.
• Respond in a timely manner to all IRB requests regarding compliance. In cases where serious or
continuing non-compliance has occurred, the IRB may exercise its authority to monitor, suspend, or
terminate the research.
Monitoring IRB Protocols
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After a protocol has been selected for auditing and usually 2 to 4 days before the planned visit, the
Research Compliance Manager or designee contacts the investigator, and study coordinator if
applicable, to schedule the visit. A written follow-up message from the ORSP confirms the
appointment and lists materials that should be available for the reviewer, as well as any issues that
need to be specifically addressed. The auditor inspects the general maintenance of study records,
including the following specific documents as applicable:
• Original IRB Protocol approval
• Amendments
• Consent Forms
• IRB Continuing Review materials (this would include Final Report)
• Final Report
• Adverse Events or Unanticipated Problems
• Sponsor Correspondence
• Participant Screening and Enrollment Logs
• Monitoring Reports (if applicable)
Within 2 weeks of completing the visit, the ORSP Research Compliance Manager completes the
monitoring report and provides a copy to the IRB Chair and to the principal investigator. A copy of
the report is placed in the protocol file and the report is made available for review by the convened
IRB.
Sources of Information and Disposition of Reports
Investigators may report to the IRB themselves about non-IRB approved human subject research in
which they are involved. Other reports may be received from faculty, staff, subjects, or reported
anonymously via the research compliance hotline. Reports may be oral or in writing and should
include as much pertinent factual data as possible. Reports are to be transmitted immediately to
the IRB Chair or Research Compliance Manager.
Determination of Alleged Infractions of Institutional Policy
The Research Compliance Manager interviews the investigator to seek additional information to
help determine whether or not an infraction of institutional rules has occurred. Emphasis in the
interview is placed on fact finding.
If it is determined by the Research Compliance Manager that no infraction has occurred, no further
action is taken.
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If it is determined that an infraction has occurred, the investigator is notified in writing of the
procedures he or she must follow to comply with institutional policy regarding the review of human
subject research. The procedures are outlined below.
Documentation and Review of Non-approved Research

Exempt Research
The investigator is required to suspend the exempt research and, if the investigator plans to
continue the research to submit a protocol to the IRB within 7 days. If the research has been
completed, or if the investigator does not plan to continue the research, the investigator is
required to document as fully as possible the research that was conducted without IRB
review. This documentation should include a description of the procedures that were
followed, the number of subjects studied, and results of the study.
The department chair or the next higher level of administrative authority is notified of actions
taken.
When an investigator wishes to continue the non-approved research, and a protocol has been
received by the IRB, it is processed in the usual manner for exempt research.
Data collected prior to IRB approval will not be approved for publication or presentation purposes.
If the investigator fails to submit a protocol within the designated time, the IRB sends a written
report, including a description of IRB actions, to the department chair or next higher level of
administrative authority for appropriate action within 3 days. Failure of the department chair to act
or comply, is reported to the President with a recommendation for appropriate actions.
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Non-exempt Research
The investigator is required to suspend the research at once. If the investigator plans to continue
the research, he or she must submit a complete protocol to the IRB within 7 days. If the research
has been completed, or if the investigator does not plan to continue the research, the investigator
is required to document as fully as possible the research that was conducted without IRB review.
This documentation should include a description of the procedures that were followed, the number
of subjects studied, and results of the study and submitted to the IRB within seven days.
If there is a question, because of increased risk to subjects, as to whether the research should be
suspended pending completion of protocol submission and approval, the Research Compliance
Manager counsels with the Chair of the IRB, department chair and/or relevant experts. In case of
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failure to agree on suspension of the research, the determination of the Institutional Official will be
final.
The department chair or the next higher level of administrative authority is notified of the above
actions.
When an investigator wishes to continue the non-approved research and a protocol has been
received by the IRB, it is processed in the usual manner for non-exempt research. The minutes of
the appropriate meeting of the IRB will indicate that the protocol was submitted as a result of
determination by the IRB that the investigator had been conducting human subject research
without IRB approval.
If the investigator fails to submit a protocol within the designated time, the IRB sends a written
report, including a description of IRB actions, to the department chair or next higher level of
administrative authority for appropriate action within 3 days. Failure of the department chair to act
or comply, is reported to the Provost with a recommendation for appropriate actions.
Data collected prior to IRB approval will not be approved for publication or presentation
purposes.
Noncompliance and Protocol Deviations
Federal regulations require the reporting of serious and continuing noncompliance to the IRB,
institutional officials and certain federal agencies and department heads.
When noncompliance occurs, federal regulations require that the institution determine whether
the incident is serious, continuing, or both. Serious noncompliance is defined as non-compliance
that affects the rights and welfare of participants or that may put participants at risk of harm.
Continuing noncompliance is defined as multiple or repeated instances of noncompliance,
particularly after written notice from the IRB that the investigator must take action to correct
noncompliance. The multiple or repeated instances of noncompliance may occur on one protocol
or on more than one protocol and may occur simultaneously or over a period of time.
Noncompliance with federal regulations may include:
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failure to obtain informed consent or inadequate procedures for obtaining informed
consent from subjects
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conducting human subjects research without an IRB approved protocol or exemption
inadequate supervision of research that involves potential risks to subjects and others
conducting research, including enrollment of subjects, when IRB approval has expired
or has been suspended or terminated
initiating changes to the research protocol without prior IRB approval unless the change
is necessary to eliminate apparent immediate hazards to the subject
failing to adhere to the conditions of approval of a protocol as specified by the
responsible IRB
starting research under a protocol before meeting the conditions required by an IRB
and receiving an IRB notification of approval
failing to take IRB or institutionally required human subjects protection training
enrolling more subjects than approved by an IRB
failing to have research participants sign a new consent form when new and relevant
risks are discovered or failing to provide this new information to participants
altering an IRB-approved consent process or an IRB-approved recruitment process
without prior IRB approval
Serious noncompliance includes:
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one or more instances of conduct defined above as noncompliance that exposes
subjects or others to risks of harm that are not an inherent part of the approved
research protocol
conduct defined as noncompliance above, even though subjects or others have not
been exposed to risks of harm not inherent in the approved protocol, where the IRB
finds no mitigating circumstances
misrepresentation of information related to the human subjects research protocol or
performance of the research
conducting non-exempt research without IRB approval
making substantive changes to a previously approved protocol without IRB approval
conduct that adversely affects the integrity or effectiveness of human subjects
protections or subjects rights or welfare
IRB Determinations Involving Noncompliance
If the IRB makes an initial assessment of the noncompliance report as representing
potentially serious or continuing noncompliance as defined above, the committee renders a
preliminary determination. The investigator is then provided with an opportunity to
respond to this preliminary finding and provide additional relevant information or detail any
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potential mitigating circumstances that might not have previously been considered. The IRB
will review this response and make a final determination regarding the noncompliance. If the
IRB makes a final determination that a report constitutes serious and/or continuing
noncompliance, the Institutional Official will report the noncompliance to the OHRP and any
other federal department or agency that funds or supports the research in which the
noncompliance occurred.
In addition to making a determination of serious and/or continuing noncompliance, the
committee also must decide what further action is required such as suspension or
termination of the research or suspension of the investigator’s privilege to conduct research.
Actions related to the protocol can include:
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Requesting the investigator make modifications to the protocol
Requiring more frequent review of the protocol (e.g., more often that the minimal of
annual review)
Requesting the investigator modify the consent process or consent documents
Requiring the investigator to provide additional information to current and/or past
participants or re-consenting to participation
Requesting further corrective actions by the study team
Reconsideration of IRB approval
Implementation of monitoring of the research
Implementation of monitoring of the consent process
Suspension of the research
Termination of the research
Referral of the matter to the Institutional Official
The IRB may require additional action, such as protocol or consent form revisions, even
without a finding of serious or continuing noncompliance.
NOTE: Although the IRB can suspend the research study, only the Institutional Official has
the authority to suspend an individual’s privileges to conduct research.
IRB Review of Corrective Action Plans
As part of the noncompliance report to the IRB, investigators are required to outline a
corrective action plan to prevent similar errors from occurring in the future. The IRB reviews
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this for adequacy and may require revision if not found to be sufficiently robust. Corrective
action plans may include:
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Additional education of the investigator and/or the research staff
Additional monitoring of support staff by the investigator, including more frequent staff
meetings or review of work by an auditor
Revisions to internal documents for processes
Determination of an Alleged Repeated Infraction of Institutional Policy
The procedures outlined in "Determination of Alleged Infractions" above will apply for a repeated
alleged infraction. If it is determined by the Research Compliance Manager that a second or
additional infraction has occurred, the IRB promptly notifies the Institutional Official, Provost, and
the department chair or next higher administrative authority in writing, with the recommendation
that the investigator's privilege to do research be suspended at once, that the funding agency (if
applicable) be notified of the suspension, and that unused funds be returned.
Reporting Protocol Deviations and Noncompliance
When and Where Reports are to be Made
Initial reports of noncompliance should be made to the IRB that has been involved in the review
and approval of the research. Reports can be made to the Chair or the Research Compliance
Manager. When no application has been submitted to an IRB, the report should go to the IRB that
normally would have jurisdiction over the protocol or exemption. Reports should be made
promptly after discovery of the alleged noncompliance.
Reports of noncompliance should be made within 48 hours of receiving notice of the alleged
noncompliance, if the alleged noncompliance requires immediate intervention to prevent serious
harm to participants or others. In all other cases, reports of noncompliance should be made within
seven (7) days after discovery of the alleged noncompliance.
Self-reporting Obligations of Investigators and Research Study Staff
Investigators or study staff must report noncompliance to the IRB in accordance with the
procedures outlined above. The report should be in writing and contain the following:
1. Detailed information about the noncompliance, including relevant dates.
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2. Any corrective action, planned or already taken, to ensure that the noncompliance is
corrected and will not occur again.
3. An assessment of whether any subjects or others were placed at risk as a result of the
noncompliance or suffered any physical, social, or psychological harm.
4. Any other relevant information.
Others Reporting Noncompliance
Any individual may report instances of noncompliance. Noncompliance is sometimes discovered
during a protocol review or investigation of a participant complaint; HRPP compliance monitors;
research compliance staff; participants, potential participants or others, such as family members;
members or staff of another IRB; sponsors and other auditors; and others not involved with the
research project but having information about possible noncompliance.
The written reports filed by individuals other than investigators or study staff should include:
1.
2.
3.
4.
5.
Detailed information about the alleged noncompliance, including relevant dates.
How the person reporting obtained the information provided in the report.
Information about any injury, potential harm, or risk to the subject or others.
How the reporter may be contacted for further information, if needed.
Any other relevant information.
IRB Procedures for Handling Allegations and Reports of Noncompliance
Review by Research Compliance Manager. The Research Compliance Manager generally conducts
the first review of reports of noncompliance.
1. The RCM reviews each report of noncompliance and, if necessary, conducts an investigation
of the report. If the report did not come from the investigator, the RCM will obtain the
investigator's response to the report if it appears there is a basis in fact for the allegation.
2. If the RCM, in consultation with the IRB Chair determines that there is no basis for finding
that noncompliance, as defined in this policy, has occurred, no action is required and the
case is closed.
3. If the RCM determines that the report constitutes noncompliance, as defined in this policy,
the RCM will either resolve the noncompliance issue by contacting the investigator without
further consultation with the IRB Chair or IRB or will send the report with his or her
determination to the IRB for review.
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4. If the RCM determines that the report may constitute serious or continuing noncompliance,
as defined in this policy, the RCM, will notify the IRB Chair and/or IO and the issue will be
referred to the fully convened IRB for review. If there is any doubt on the part of the RCM
whether the report involves serious or continuing noncompliance, the report may be
discussed with the IRB Chair, IO, or be referred to the IRB for consideration at the next
convened meeting.
5. If the RCM believes that the report may require immediate action to protect participants,
the RCM will immediately refer the report to the IRB Chair or IO.
6. If ay report of noncompliance involves the IRB Chair as the Principal Investigator or Coinvestigator, the RCM will consult with the IO and refer the matter to the IRB. The IRB Chair
will recuse him or herself from determinations of whether the report involves
noncompliance or serious non-compliance and IRB recommended remedial actions.
Review by IRB Chair
1. The IRB Chair (unless non-compliance involves the Chair), will review a report referred by
the RCM to determine whether the report requires additional action, including any
immediate action to protect participants if the report suggests a potential adverse effect on
the safety or welfare of subjects or others.
2. If a report suggests that the safety or welfare of subjects or others is risk, the IRB Chair may
immediately suspend the research, pursuant to policy contained herein.
3. Any suspension of research by the IRB Chair must be promptly reported to the IRB and the
Institutional Official (IO).
4. If the IRB chair immediately suspends research to protect participant safety, the Chair will
promptly notify the investigator of the suspension.
5. If the IRB Chair immediately suspends research to protect participant safety, the IRB Chair's
decision and the reasons for the decision will be scheduled for discussion at the next
meeting of the IRB. The IRB will determine whether to lift or continue the suspension. The
IRB will promptly notify the investigator and the IO of its decision. IRB discussion and
resolution of issues of noncompliance relating to the suspension may be scheduled for a
subsequent IRB meeting.
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Review by the IRB
The noncompliance report, copies of all related documents, the RCM’s summary along with
written assessments will be made available to the full IRB. The full IRB assesses (a) whether the
noncompliance described in the report is serious, (b) whether the noncompliance is continuing,
(c) what are the appropriate remedies, and (d) whether reporting to federal agencies is required.
As part of their assessment, the IRB may request additional information or review by someone
with a specific expertise.
1.
Before making a determination of serious or continuing noncompliance or suspension or
termination of research, the IRB may invite the investigator to present additional materials
and to appear in person. The IRB members may ask questions of the investigator.
2. After reviewing a report, the IRB will make determinations on the following issues:
 Whether the report constitutes serious or continuing noncompliance;
 Appropriate remediation measures, such as:
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Requiring modifications to the protocol
Revising the continuing review timetable
Modifying the consent process
Modifying the consent document
Providing additional information to current participants (e.g. whenever the
information may relate to the participant's willingness to continue participation)
Providing additional information to past participants
Requiring additional training of an investigator and/or study staff
Reconsidering approval
Requirement that current participants re-consent to participation
Monitoring of the research
Monitoring of the consent
Referral to other organizational entities (e.g., legal counsel, risk management,
institutional official)
Other actions appropriate for the local context
- Whether suspension or termination of research is warranted
- Whether further reporting to federal agencies and department heads is required
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The IRB can recommend suspension of an investigator's privileges to conduct human subject
research. The IRB must bring any recommendation to suspend research privileges to the IO.
After making its determinations, the IRB will notify the investigator in writing of the IRB's decisions,
with copies to the chair of the investigator’s department and/or research unit, and the
investigator’s dean or director, and if further reporting is required, report its decisions to the IO for
further reporting pursuant to Suffolk University’s policy with respect to reporting to federal
authorities Reports of Serious or Continuing Noncompliance and/or Suspension or Termination of
Research.
1. Conflict of interest. Any IRB or Advisory Committee member who has a conflict of interest
relating to the matter under review will excuse him or herself from the proceedings as required by
Suffolk University IRB Conflict of Interest Policy.
2. Confidentiality for complainants and witnesses. Generally, the individual under review should
have access to the identity of the person who made the allegations and others who provide
information. However, if such persons wish to maintain their anonymity, the IRB will make every
effort to protect their identities, while at the same time affording the individual under review
access to the substance of the allegations and information presented against him or her. The IRB
cannot guarantee anonymity.
3. Nonretaliation. The IRB must have the ability to protect human subjects and, therefore, must
be able to secure all the factual information necessary to make fair and objective determinations.
Retaliation against those who make allegations in good faith and who have relevant information is
illegal and will not be tolerated at Suffolk University.
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10 Meeting Minutes
Federal regulations outlined in 45 CFR 46.115(2) and 21 CFR 56.115(2) require that, "Minutes of IRB
meetings . . . shall be in sufficient detail to show attendance at the meeting; actions taken by the
IRB; the vote on these actions including the number of members voting for, against, and abstaining;
the basis for requiring changes in or disapproving research; and a written summary of the discussion
of controverted issues and their resolution." These reflect minimum requirements.
However, it cannot be assumed that all regulatory requirements for review of research have taken
place at an IRB meeting unless the IRB minutes record that they were considered and discussed.
Good minutes should enable a reader who was not present at the meeting to determine exactly how,
and with what justification, the IRB arrived at its decisions. Comprehensive minutes demonstrate
respect for the human subjects of research. They should also provide the IRB itself with sufficient
detail to help it reconstruct its discussions at a later date if necessary, and thus ensure compliance
not only the IRB, but investigators and ISU as a whole.
IRB minutes must uniformly document that the IRB considered all the regulatory review
requirements. That is, meeting minutes should reflect IRB determinations that:
• risks are minimized and reasonable in relation to anticipated benefits
• the selection of subjects is equitable
• informed consent is obtained and documented unless a waiver is granted
• measures to protect the privacy and confidentiality of data are adequate
• adequate provisions for monitoring data to ensure safety are made
• appropriate safeguards for vulnerable populations are in place
The level of risk determined by the IRB for each protocol must also be documented, with studyspecific justification for the determination.
If IRB members participate by telephone, minutes must document that each member received all
pertinent material prior to the meeting and can equally and actively participate in the discussion.
Where members have a conflict of interest, IRB minutes should document that the person left the
room during the deliberation and vote. If the member was asked to provide information to the IRB,
minutes should note that the member remained in the room to provide information but was recused
prior to the discussion and vote.
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IRB minutes are subject to the Freedom of Information Act (FOIA); therefore they should be written
impersonally, and opinions expressed by members should not be attributed to them. Members
should only be identified by name when they are recused from a particular review or leave the
meeting for any reason, or when the committee bases a decision based on a member’s specific
expertise (e.g. a physician member indicates that a medical procedure is consistent with standard
practices, etc.). Further, minutes must be written professionally, with attention to correct word
usage, grammar, punctuation, complete sentences, consistency in headings and titles, etc.
The recorder, at his/her discretion, may cut and paste into the meeting minutes template from the
protocol or from reviews received from the primary reviewers for the meeting. However, the writer
is responsible for ensuring that information copied is grammatically correct, makes sense in the new
context, is free of typos, is in the correct tense, etc. Because minutes are subject to FOIA, they
reflect upon the professional image or reputation of the writer and ISU.
The following is guidance regarding information to include in IRB minutes for different types of
review. Basic meeting information, such as documentation of quorum, presence of members and
visitors, application information, recusals, documentation of the approval period, etc., should be
included for all meeting minutes, regardless of the type of review.
New Studies
Purpose and Procedures: A brief description of the purpose and overview of procedures. Specific
details about procedures are not necessary, but readers should be able to get a general idea of what
participants are being asked to do.
For previously tabled studies, include a summary of committee requests and a description of the
investigator’s response.
Discussion: A summary of the discussion of issues identified by the committee, particularly
controverted issues and their resolution. In general, any discussion with the investigators should be
recorded as a summary and not as a transcription of the conversation; in instances where the PI is
providing information that must be documented for the review or in compliance cases, more specific
statements may be
required. If no controverted issues are discussed, a statement to this effect should be included.
Subject Selection and Recruitment: A summary of the types of subjects to be included and
recruitment plans, justification for the inclusion or exclusion of specific populations, and
documentation of the committee’s determination of whether subject selection is equitable and
recruitment plans are non- coercive.
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Risks: A summary of the foreseeable risk(s) and procedures for minimizing risks identified by the
investigator, followed by the committee’s assessment of the risk(s) (e.g., whether additional risks
exist, etc.). The minutes should document the committee’s determination that risks have been
minimized appropriately or specify the additional procedures that the IRB deems appropriate to
minimize the risks.
Level of Risk: Documentation of the committee’s assessment of the level of risk (minimal, slightly
greater than minimal, or greater than minimal) along with a study-specific justification for the
determination and a comparison to the subject’s everyday life (e.g., blood draw procedures in the
research present no more risk than blood drawn for screening purposes at the doctor’s office;
questions asked in a survey are similar to questions one might be asked during an aptitude exam at
school).
Potential Benefits: A summary of the benefit(s) identified by the investigator, followed by the
committee’s assessment of the anticipated benefit(s).
Risk/Benefit Ratio: Documentation of the committee’s determination of whether risks are
reasonable in relation to the anticipated benefits of the research.
Data and Safety Monitoring: Where applicable, include a description of the data and safety
monitoring plan proposed by the investigator followed by the committee’s assessment of whether or
not the plan is adequate to ensure the safety of participants. Data and safety monitoring is required
when analysis of data would help determine if changes in the research protocol may be necessary
based on study results. Otherwise, a statement that data and safety monitoring is not required for
the study is sufficient.
Confidentiality: A summary of the plans to maintain confidentiality of the data and protect the
privacy of participants, followed by the committee’s determination of whether or not these plans
are adequate and why the plans are adequate or not.
Informed Consent: A description of the informed consent process, including whether
• documented consent will be obtained;
• all elements of consent are included in the form; (if not, describe those that are missing);
• there are any special provisions for special or vulnerable populations, such as parental
consent, consent of a legal guardian, translation of consent materials, the use of a short form,
etc.;
• special requirements for studies regulated by the FDA, those involving genetic information,
HIPAA authorization, etc., have been met.
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The committee’s determination that the informed consent process is appropriate should also be
included. Waivers: A description of the waiver (i.e., waiver of consent, elements of consent, or
documentation of
consent), including identification of specific elements to be waived. The committee’s determinations
of
each of the waiver criteria, with study-specific justification must also be included.
Waivers of the requirement for signed authorization under HIPAA would also be discussed here.
Safeguards for Vulnerable Populations: When applicable, a description of safeguards for participants
from vulnerable populations, including the committee’s determination of whether safeguards are
adequate.
Special Determinations: The committee’s determinations, including study-specific justification,
required for research involving minors, prisoners, or pregnant women, fetuses, or neonates.
Information/Revisions Needed to Grant Approval: A description of the information and/or revisions
required by the committee, including the basis for each.
Recommendations: Documentation of the committee’s decision to approve, approve with
contingencies, table, or disapprove the application, and who has the authority to grant final approval
(i.e., the Chair(s), the IRB).
Continuing Reviews and Modifications
Purpose and Procedures: A brief description of the purpose and overview of procedures. Specific
details about procedures are not necessary, but readers should be able to get a general idea of what
participants are being asked to do.
A brief overview of past IRB review decisions is also helpful, particularly concerning the level of risk,
any waivers that were granted, and any specific findings related to vulnerable populations.
For previously tabled studies, include a summary of committee requests and a description of the
investigator’s response.
Modifications: A brief description of the modifications proposed by the investigator or any that were
identified during continuing review.
Accrual/Withdrawals: A description of the number of participants who enrolled in the study in
comparison to the number approved. Any participant withdrawals should be documented here,
along with a discussion about whether or not the withdrawals were due to problems with the study.
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Unanticipated Problems/Adverse Events or Subject Complaints: A summary of unanticipated
problems, adverse events, or complaints from subjects that were reported. If an adverse event was
reported to the IRB during the approval period, a summary of the event and findings of the
committee should be included. If the PI has indicated that no problems have occurred, this should be
stated.
New Information: A summary of any new information that suggests previously unknown or
additional risks to participants or that may impact future participants’ willingness to enroll in the
study. If the committee determined that no new information is presented that would impact
willingness to participate, this should be stated.
Discussion: A summary of the discussion of issues identified by the committee, particularly
controverted issues and their resolution. Any discussion with the investigators should be recorded as
a summary and
not as a transcription of the conversation. If no controverted issues are discussed, a statement to
this effect should be included.
Review of Approval Criteria: Minutes should reflect if the IRB determined that risks to participants
continue to be minimized and reasonable in relation to benefits, that subject selection continues to
be equitable, that privacy and confidentiality protections are still adequate, as are data safety and
monitoring plans and safeguards for vulnerable participants, and that the informed consent process
continues to be appropriate. A statement such as “the IRB determined that because study
procedures have not changed and no problems or adverse events occurred, the study continues to
present only minimal risk to participants and may continue as previously approved” is appropriate if
no modifications are proposed. If the committee does not make this finding, the reasons why should
be stated.
Information/Revisions Needed to Grant Approval: A description of the information and/or revisions
required by the committee, including the basis for each.
Recommendations: Documentation of the committee’s decision to approve, approve with
contingencies, table, or disapprove the application, and who has the authority to grant final approval
(i.e., the Chair(s), the IRB).
Modifications
Purpose and Procedures: A brief description of the purpose and overview of procedures. Specific
details about procedures are not necessary, but readers should be able to get a general idea of what
participants are being asked to do.
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A brief overview of past IRB review decisions is also helpful, particularly concerning the level of risk,
any waivers that were granted, a history of adverse events, and any specific findings related to
vulnerable populations.
For previously tabled studies, include a summary of committee requests and a description of the
investigator’s response.
Modifications: A brief description of the modifications proposed by the investigator.
Discussion: A summary of the discussion of issues identified by the committee, particularly
controverted issues and their resolution. Any discussion with the investigators should be recorded as
a summary and
not as a transcription of the conversation. If no controverted issues are discussed, a statement to
this effect should be included.
Review of Approval Criteria: Minutes should reflect the IRB determination of whether or not the
modification changes the level of risk or any previous determinations related to approval. Studyspecific justification should be included when the modification directly affects one or more approval
criteria (e.g., if a new type of participant is added, justification for why subject selection continues to
be equitable should be documented).
Information/Revisions Needed to Grant Approval: A description of the information and/or revisions
required by the committee, including the basis for each.
Recommendations: Documentation of the committee’s decision to approve, approve with
contingencies, table, or disapprove the application, and who has the authority to grant final approval
(i.e., the Chair(s), the IRB).
Adverse Events
Description: A summary of the event, the investigator’s response, and any other pertinent details.
Discussion: A summary of the committee’s discussion of the event.
Determinations: Documentation of the IRB’s determinations of whether or not
• the event is serious or related to the study,
• the study should proceed,
• any information about the event should be shared with current participants,
• the consent form should be revised to inform participants of new risks.
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Potential Noncompliance
Description: A summary of the potential noncompliance.
Discussion: A summary of the committee’s discussion surrounding the issue. Determinations:
Documentation of the IRB’s determinations of
• whether or not the situation constitutes noncompliance,
• the level of noncompliance (minor, serious, continuing), including justification (e.g., the reason
why the noncompliance was not considered serious),
• corrective actions to be employed.
New Business/Education
The following items should also be documented in the minutes:
• A brief description of the topic of any educational or training information provided during
meetings
• A brief description of any policies under review and IRB decisions to adopt or revise policies
• Other miscellaneous discussions as applicable
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11 Record Retention and Access to Research Data
RETENTION OF RESEARCH DATA AND IRB RECORDS
Accurate and appropriate research records are an essential component of any research project.
Both the University and the PI have responsibilities and rights concerning access to, use of, and
maintenance of original research data.
Except where precluded by the specific terms of sponsorship or other agreement, tangible research
property, including the scientific data and other records of research conducted under the auspices
of Suffolk University, belongs to Suffolk. Where research is funded by a contract with Suffolk
University that includes specific provisions regarding ownership, retention of and access to
technical data, the provisions of that agreement will supersede this policy. The PI is responsible for
the maintenance and retention of research data in accordance with this policy.
Research data include laboratory notebooks as well as any other records that are necessary for the
reconstruction and evaluation of reported results of research and the events and processes leading
to those results, regardless of the form or the media on which they may be recorded. Suffolk must
retain research data in sufficient detail and for an adequate period of time to enable appropriate
responses to questions about accuracy, authenticity, primacy, and compliance with laws and
regulations governing the conduct of the research. It is the responsibility of the PI to determine
what needs to be retained under this policy.
All IRB files and documents that relate to the protection of human research participants must be
retained for a minimum period of three years following completion of the study (i.e. submission of a
final report). If a protocol is cancelled without participant enrollment, IRB records are maintained
for at least three years after cancellation. Such files and documents include, but are not limited to:
• IRB submission documents
• Research protocols
• Scientific evaluations
• Audio and video recordings
• Certificates of Confidentiality issues by NIH or other federal agencies
• Progress reports submitted by investigators
 Reports of protocol deviations
• Reports of injuries to participants
• Records of continuing review activities
• Correspondence between the IRB and the investigator
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• Statements of significant new findings provided to participants
• For initial and continuing review of research using the expedited procedure:
-The specific permissible category
-Description of action taken by the reviewer
-Any findings required under the regulations
• For exemption determinations the specific category of exemption
• Unless documented in the IRB minutes, determinations required by the
regulations and protocol-specific findings supporting those determinations for:
-Waiver or alteration of the consent process
-Research involving pregnant women, fetuses, and neonates
-Research involving prisoners
-Research involving children
• For each protocol’s initial and continuing review, the frequency for the next
continuing review
• Membership rosters
• Minutes
• Other correspondence not related to a specific research study.
Paper records on site are maintained in a locked file room or locked offices within the main IRB
Office and are available only to IRB staff. All records are accessible for inspection by authorized
representatives of the OHRP, FDA, sponsors, and other authorized entities at reasonable times and
in a reasonable manner.
When the retention period for a paper record expires, and a decision is made by the Research
Compliance Manager or designee in conjunction with the Institutional Official to no longer retain
the record, the record will be shredded or otherwise destroyed. In such an instance the Research
Compliance Manager will advise the Principal Investigator to inform the sponsor that study records
will be destroyed on a specific date so that the sponsor may discuss any concerns with the IRB
before the action is taken. The IRB anticipates maintaining its electronic records indefinitely. For
studies for which a waiver of informed consent or documentation of informed consent has not been
approved, a signed and dated consent form (on paper with original signature) must be maintained
by the investigator for as long as the research records are retained.
IRB RECORD RETENTION STANDARDS
The HHS protection of human subjects regulations require institutions to retain records of IRB
activities and certain other records frequently held by investigators for at least three years after
completion of the research (45 CFR 46.115(b)). In addition, other regulations may apply and require
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retention of these records for a longer period of time. Documentation of the informed consent of
the subjects - either the signed informed consent form or the short form and the written research
summary - are records related to conducted research that are typically held by investigators and
must be retained for at least three years after completion of the research, unless the IRB waived the
requirement for informed consent or the requirement for documentation of informed consent (45
CFR 46.117).
If investigators have been designated to retain certain records (e.g., informed consent documents
signed by subjects) on behalf of the institution as required by the HHS regulations at 45 CFR
46.115(b), they must retain the records in some form. Such records may be preserved in hardcopy,
electronic or other media form and must be accessible for inspection and copying by authorized
representatives of HHS at reasonable times and in a reasonable manner (45 CFR 46.115(b)).
Retention of multiple copies of each record is not required. If investigators who have been
designated to retain records on behalf of the institution leave that institution, the investigators and
the institution should identify the successor responsible for maintaining those institutional records,
either at the original institution or wherever the records are relocated, for the period of time
required under HHS regulations at 45 CFR 46.115(b).
Other regulations, policies or professional standards may apply to the retention of records,
including study data.
The University claims rights of access to data derived from any research or other scholarly activity
which is performed by its faculty, staff, students or other individuals and is undertaken in
connection with a sponsored project or is directly and immediately related to duties or
responsibilities for which a person is compensated by the University or one of its units, or is
conducted with more than insignificant use of facilities or equipment provided by the University
or one of its units (hereinafter, “research”). These rights will be exercised only for University
purposes, which include, but are not restricted to:
1. securing intellectual property rights;
2. protecting the rights, including those of access to the data, of graduate and other students,
post doctoral researchers, and other members of the University community;
3. facilitating the investigation of charges, such as misconduct or conflict of interest;
4. carrying out its responsibilities with regard to the use of animals, human subjects,
recombinant DNA, etiologic agents, radioactive materials, and the like;
5. carrying out the terms of sponsored project agreements; and
6. meeting the requirements of law.
The meaning of the term “data” varies from field to field and, in case of doubt or ambiguity, the
University will look to the custom of the relevant field. At a minimum, however, the term includes
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information recorded or customarily recorded in the relevant field, as a result of research. Data
include notes, records, slides, photographs, drawings, information stored in electronic and/or
computer readable form, reports, publications, correspondence, and summaries, compilations, or
derivatives of other data.
Since research at Suffolk University is ordinarily performed under the responsible charge of its
faculty, the usual custodian of the data will be the faculty member in charge of the research. The
data must be retained by the faculty member for a period which is reasonable under the
circumstances. For sponsored projects, for example, data should be retained for the period
required by the sponsor; in the absence of other information, seven years after the submission of
final fiscal and technical reports may be considered sufficient.
If there are questions about the research or its performance, the data must be retained until the
questions are resolved. If a student is involved, the data must be retained at least until the degree
is awarded or it is absolutely clear that the student has abandoned the work. If the work is
published, the data should be retained until a reasonable period has elapsed so that any questions
concerning the publication may be answered. Applicable records retention policies of the unit
must also be followed.
Where necessary to effect its rights of access, the University has the option to take custody of the
data in a manner to be specified by the Associate Vice Provost for the Office of Research and
Sponsored Programs..
In those circumstances in which a University faculty member is not in responsible charge of the
research, the non-faculty principal investigator or other person designated by the relevant
department chair or center director must retain the data. If a faculty member or other designated
person is no longer capable of retaining the data, it must be deposited with the department chair
or center director for retention.
If a faculty member or other custodian of the data wishes to remove the data from the University,
for example to take with him or her to a new position at another university, approval of the
department chair or center director is required. The Associate Vice Provost of the Office of
Research and Sponsored Programs or designee must also approve the removal of the data if a
sponsored project, a patent or other intellectual property, an unresolved dispute involving the
data, an apparent injustice or unfairness to another individual if the data were to be removed, or
any other question concerning the data, the research, or its performance, is involved. The ability
of a student to maintain progress toward a Suffolk University degree shall be a major
consideration in any decision as will the ability of other members of the University community to
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continue their research at Suffolk University. The removing custodian shall have the same
obligation of providing access to the University as he or she had while the data were at Suffolk
University and must agree to provide that access whenever requested by the University. As a
memorial of that obligation, the department chair shall retain for at least a three-year period a
copy of this policy signed and dated by the removing custodian, along with a list of the data that
was removed.
This policy does not deal with the legal “ownership” of data. That is rarely at issue and in those
cases in which ownership might be of practical significance the matter would be determined by
applicable law, by the University’s Intellectual Property Policy and, in the case of a sponsored
project, by the sponsored project agreement. The Intellectual Property Policy requires that faculty
and others to whom it applies execute formal assignments to the University of the invention and
any resulting patents.
The University, as a matter of operating policy, rarely exercises exclusive ownership rights and
then only when it is furtherance of the University’s mission to do so. Even in cases in which the
assertion of an exclusive ownership right might be appropriate, the University would normally
permit custody by the faculty member or other project principal investigator as described above.
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Human Subject Protections Program Policy Manual
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Human Subject Protections Program Policy Manual
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