INSTITUTIONAL REVIEW BOARD POLICIES
FOR RESEARCH INVOLVING HUMAN PARTICIPANTS
Updated March 29, 2016
Dr. Jennifer Anderson-Meger, Chair IRB
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2/16
INSTITUTIONAL REVIEW BOARD POLICIES AND PROCEDURES
TABLE OF CONTENTS
Background ......................................................................................................................................4
Ethical Principles and Issues Involving Human Participants in Research .......................................4
Research Involving Special Populations ..........................................................................................7
Type of Review ................................................................................................................................7
Student Research ............................................................................................................................11
Cooperative Research With Another Institution ............................................................................13
International Research ...................................................................................................................13
IRB Membership and Meetings .....................................................................................................13
Communication of IRB Decisions .................................................................................................14
Adverse Events ..............................................................................................................................14
Continuing Review ........................................................................................................................16
Modification of a Protocol .............................................................................................................18
Study Closure .................................................................................................................................20
Suspension or Termination of IRB Approval ................................................................................21
Researcher Record Keeping Responsibility...................................................................................24
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Institutional Review Board Policies and Procedures
Viterbo University has established an Institutional Review Board (IRB) to review all research
involving human participants and to implement institutional policies and procedures regarding
such research, The use of human participants in research imposes both ethical and legal
responsibilities upon the university, the project directors, and those conducting the research to
ensure that the rights and welfare of those participants are adequately protected. The primary
function of the IRB is to assist researchers in the protection of the rights and welfare of human
participants. Review and approval by the IRB is meant to aid both the participants and the
researchers by assessing the potential risk and accommodations made to minimize it.
All research involving the human participants that is conducted by Viterbo faculty, staff, or
students, or sponsored, in part or in whole, by Viterbo University must be reviewed and
approved prior to the start of the project and then conducted in full compliance with IRB policies
and procedures.
Research is defined by federal regulations as a systematic investigation including research
development, testing, and evaluation designed to develop or contribute to generalizable
knowledge. It encompasses work which is conducted on or off campus and includes
questionnaires, interviews, surveys, tests, observations, and other experiments, even if the work
is preliminary to a more extensive study. Research includes secondary analyses of data
previously collected. It also includes any systematic collection of data from human participants
that occurs in conjunction with classroom projects, unless the work is done as a learning exercise
for the student and will never be published or presented outside of the course.
It is the responsibility of the researcher to refer his or her project to the IRB whenever humans
are used as participants in research, even if the researcher does not consider the subjects to be at
risk. Current law places the burden of liability for negligence and harm directly on the
researcher and the institution. The IRB policies and procedures are formulated to protect the
university, the researcher, and in the case of the students, the faculty research advisor, from
liability through imposition of minimal standards for research and through procedures for careful
review of projects.
Questions about IRB policies and procedures should be referred to the IRB chairperson.
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A. Background
The Public Health Service Act (Title IV, Part G, Section 491 a) required the Department of
Health and Human Services (DHHS) to issue regulations for the protection of human participants
of research and to implement a program of instruction and guidance in ethical issues associated
with such research. The regulations are codified as Title 45 Part 46 of the Code of Federal
Regulations, Protection of Human Subjects (45 CFR 46), issued on June 18, 1991. These
regulations apply to all research involving human participants that is conducted or supported, in
whole or in part, by DHHS in foreign or domestic settings. The establishment of Viterbo
University’s IRB and its policies and procedures are primarily derived from 45 CFR 46. The
policies and procedures are intended to provide a resource for the preparation and submission of
research applications for IRB reviews. The IRB website contains links to the Federal Office of
OHRP.
B. Ethical Principles and Issues Involving Human Participants in Research
The current regulations in 45 CFR 46 are based on The Belmont Report, which was developed in
the 1970's by the National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research. The report presented three basic ethical principles. These principles of
respect for persons, beneficence, and justice remain as essential requirements for the ethical
conduct of research involving human subjects. Respect for persons recognizes personal dignity
and autonomy of individuals and protection of those that have diminished autonomy.
Beneficence includes an obligation to protect individuals from harm by minimizing risks of harm
and maximizing benefits. Justice requires that benefits and risks are distributed fairly.
In addition to The Belmont Report, Viterbo also is guided by the ethical principles regarding
research involving human subjects as presented in The Nuremberg Code and the World Medical
Association Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical
Research Involving Human Subjects.
In addition to the aforementioned principles, the IRB will be considering the following ethical
issues in determining the nature of the risks and extent to which the benefits of the study justify
exposing the participants to risk:
• Voluntary participation: Participation of human persons must be voluntary, i.e., must
occur as a result of free choice, without compulsion or obligation, based upon
disclosure of relevant information in a clear, concise, and understandable way. The
researcher must take care to avoid coercing their participation.
• Inducement to participate: Participants are frequently offered some form of incentive
or reward for their participation, e.g. earning extra credit points from their professor,
small gifts or prizes, a chance to win money in a lottery. In general, inducements are
allowable as long as they are minimal and are not more attractive to some participants
than to others. The primary ethical issue involves the extent to which an inducement
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might be sufficiently large enough to cloud the person's judgment about whether or
not participation in the study is in their own best interest.
In cases where students may earn extra credit points from their professor, other
options to earn extra credit besides research participation must be available. A
second issue involves the extent to which the participants can reasonably choose not
to participate, especially in a case where participants are approached in a large group
(e.g., class) and asked to participate without standing apart from their peers.
• Informed consent: Obtaining the informed consent of human participants in any
research is a federally mandated safeguard for protecting the rights and welfare of all
individual participants. Whenever possible researchers are required to obtain
informed consent. The IRB will carefully review the method of obtaining consent and
the specific content of informed consent forms. Informed consent should be initiated
in the recruiting process by providing specific information to the participants (as
outlined in the Informed Consent guidelines) and having the participants read and
sign an Informed Consent form before participating in the study. In situations when
informed consent is not possible the researcher must provide the rationale, grounds,
and debriefing processes that will occur with the participants.
For survey research projects, informed consent is obtained by providing the potential
participants with a detailed explanation of the purpose for and the protocol of the
research project. Online surveys should indicate informed consent by providing the
complete informed consent language on the first page of the program. The participant
can then check a box that indicates his or her agreement with the informed consent
and proceed to the survey. For paper surveys there can be a statement that follows
the informed consent that the participant agrees and by completing the survey has
agreed to the process. It also is crucial that researchers ensure to the best of their
ability that the potential subjects understand what is being communicated to them.
Consent must be given freely with the participants understanding the nature and
consequences of what is proposed. Consent also is an ongoing process, not just a
single occurrence. Researchers must inform subjects and/or guardians of any
important new information that might affect their willingness to continue in the study.
Federal law stipulates that a person must be 18 years or older to give legal consent for
his/her own behalf. Subjects under the age of 18 years may participate in research
only with the signature of their parent or legal guardian in addition to their own
signature. This also applies to the completion of anonymous questionnaires, since
persons under 18 are not permitted legally to make the informed choice to participate.
Children should have the information about participation in the research explained to
them in language that they can understand and, if possible, should give their assent to
participate in the study.
• Identification and minimizing of risks: Virtually all research involves some risk, even
though it may be slight (e.g.,embarrassment over a performance on a task). A risk
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may be of a physical, social, and/or psychological nature. The IRB will consider the
extent to which the researchers have attempted to identify the potential risks to the
participant and the extent to which those risks have been minimized as much as
possible without interfering with the validity of the research. In cases where there is
the possibility of more than minimal risk to the subject, approval will depend on the
benefits of the research, the expertise and prior experience of the researcher(s) in
conducting this type of research, the level of inducement to participate, the extent to
which the participant is fully informed of the possible risks, and the availability of
compensatory treatment or follow-up designed to alleviate any negative consequences
from participation.
• Fairness: The research should be designed to treat all individuals fairly. The selection
of participants must be based upon fair procedures and not overburden, overuse, or
unfairly favor or discriminate against any subject pool.
• Deception: In some types of research it may be necessary to withhold some pertinent
information from participants when disclosure of such information would likely
impair the validity of the study. In all such cases, participants should be told that they
are being invited to participate in research in which some features will not be revealed
until the research is concluded.
In any research that involves incomplete disclosure, the following conditions must be
met: 1) there are no undisclosed risks to participants that are more than minimal; 2)
there is an adequate plan for debriefing participants, when appropriate; and 3)
incomplete disclosure is truly necessary to accomplish the goals of the research.
• Confidentiality/Anonymity: In all research involving human participants, it is important
to assure the participants of the confidentiality of their responses. This is especially
important in cases where the study involves asking the participants personal questions
about themselves or obtaining other information that might put the participant
psychologically at risk, if the information was made public. Total anonymity (e.g.,
where the subject’s name or face is never associated with his/her responses, even to
the researcher) is preferable, especially in the case of extremely sensitive or personal
information. This generally means that the participant must be able to provide
information in complete privacy and to submit the information in such a way that it is
mixed in with other participants’ data before it is retrieved by the researcher. Where
it is necessary to have the participants’ names or identification numbers associated
with their responses (e.g., in order to collate several sets of responses by the same
subject), the participants need to be told who will see their data and specifically how
this information will be kept confidential.
• Debriefing: In most cases, it is desirable for participants to be debriefed after their
participation in the study (e.g., given further information about the study and given a
chance to ask questions). There are three cases in which debriefing is required: first,
when the research has involved incomplete disclosure; second, when participants may
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be left with a misleading or potentially harmful perception or inaccurate information;
and third, when compensatory treatment or follow-up is needed. Such debriefing
should not be treated as a substitute for informed consent prior to and during the
individual’s participation in the research.
In some cases, debriefing may not be possible immediately after the study due to
concern about other potential participants finding out about a deceptive aspect of the
study that would preclude further data collection. In these cases, debriefing
statements or descriptions could be offered to the participants. In rare instances,
debriefing may itself pose a social or psychological risk to a participant; in which
case it may be in the best interest of the participant to forego the debriefing
procedure.
• Support and Follow Up: In cases where some physical or psychological distress might
result from the subjects' participation, plans for follow-up support should be provided.
It is up to the researcher to determine that the support be accessible to all participants
without cost or undue hardship.
C. Research Involving Special Populations
Federal regulations require that IRBs give special consideration to protecting the welfare of
particularly vulnerable participants. For example, the DHHS requires additional safeguards for
research involving fetuses, pregnant women, and human in vitro fertilization (45 CFR 46,
Subpart B), prisoners (45 CFR 46, Subpart C), and children (45 CFR 46, Subpart D). If faculty,
staff, or students are associated with research involving fetuses and in vitro fertilization, they
should consult with the IRB chairperson and/or the Dean. Federal regulations, state, and local
laws need to be strictly adhered to concerning these areas. For example, in some instances the
DHHS requires approval by their Ethical Advisory Board prior to conducting a study.
Research involving any of the other special populations must follow all requirements as
indicated in 45 CFR 46. The remainder of this section concentrates on some aspects of research
involving children, incapacity, and AIDS/HIV - related research studies.
D. Type of Review
The type of review required depends upon the nature of the research, the participants, and the
risk imposed upon the participants. Review categories are determined by the Federal
government and can detailed descriptions can be found on the IRB website and the Federal
Office of OHRP.
A.
Research that qualifies for Exempt Status
In general, studies qualify for exempt status if they meet the following conditions:
 Research procedures present virtually no foreseeable risk to participants.
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A vulnerable population (such as children, prisoners, pregnant women, mentally
disabled persons or economically/educationally disadvantaged persons) is not used as
participants.
Information is recorded in such a manner that participants cannot be identified
directly or through identifiers linked to the participants and any disclosure of
participants' responses outside the research could not reasonably place them at risk of
criminal or civil liability or be damaging to their financial standing, employability, or
reputation.
The study does not involve deception of participants.
Federal regulations dictate that only the following types of research are eligible for
exempt status. If a study does not fall into one of these categories, even when the above
conditions are met, the researcher must apply for expedited or full review.
 Research involving the use of survey procedures, interview procedures, observation
of public behavior, or educational tests (such as cognitive, diagnostic, aptitude, or
achievement tests) if either (a) information obtained is recorded in such a manner that
subjects cannot be identified directly or through identifiers linked to the subjects and
any disclosure of the subjects' responses outside the research could not reasonably
place them at risk of criminal or civil liability or be damaging to their financial
standing, employability, or reputation, or (b) the human subjects are elected or
appointed public officials or candidates for public office.
 Research involving the collection or study of existing data, documents, records,
pathological specimens, or diagnostic specimens if these sources are publicly
available or the information is recorded by the investigator in such a manner that
subjects cannot be identified directly or through identifiers linked to the subjects.
 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).
 Taste and food quality evaluation and consumer acceptance studies if wholesome
foods without additives are consumed or a food is consumed that contains an
ingredient at or below the level found to be safe by the Food and Drug
Administration, the Environmental Protection Agency, or the Food Safety and
Inspection Service of the U.S. Department of Agriculture.
 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 public benefit or service programs, procedures for obtaining
benefits or services under those programs, possible changes in or alternatives to those
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programs or procedures, or possible changes in methods or levels of payment for
benefits or services under those programs.
2.
Research that qualifies for EXPEDITED IRB Review
In general, studies qualify for expedited review if they meet the following conditions:
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Research procedures present no more than a minimal risk to participants. Minimal
risk is defined by federal regulations as meaning 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.
A vulnerable population (such as children, prisoners, pregnant women, mentally
disabled persons or economically/educationally disadvantaged persons) is not used as
participants.
Identification of the participants and/or their responses would not reasonably place
them at risk of criminal or civil liability or be damaging to their financial standing,
employability, insurability, reputation, or be stigmatizing.
The study does not involve deception of participants.
Federal regulations dictate that only the following types of research are eligible for
expedited review. If a study does not fall into one of these categories, even when the
above conditions are met, the researcher must apply for full review.
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Research on individual/group characteristics or behavior (such as 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.
Collection of data from voice, video, digital, or image recordings made for research
purposes.
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).
Clinical studies of drugs for which an investigational new drug application is not
required and clinical studies of medical devices for which an investigational device
exemption application is not required or the medical device is approved for marketing
and the medical device is being used in accordance with its approved labeling.
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from
healthy, nonpregnant adults who weigh at least 110 pounds when the amount drawn
may not exceed 550 ml in an 8 week period and collection may not occur more
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frequently than 2 times per week or from other adults and children when 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.
Prospective collection of biological specimens for research purposes by noninvasive
means. Examples include: hair and nail clippings in a nondisfiguring 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; and
sputum collected after saline mist nebulization.
Collection of data through noninvasive procedures (not involving general anesthesia
or sedation) routinely employed in clinical practice, excluding procedures involving
x-rays or microwaves. Examples include: 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 subject’s privacy; weighing
or testing sensory acuity; magnetic resonance imaging; electrocardiography,
electroencephalography, thermography, detection of naturally occurring radioactivity,
electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and
echocardiography; and moderate exercise, muscular strength testing, body
composition assessment, and flexibility testing where appropriate given the age,
weight, and health of the individual.
Research that requires FULL IRB Review
Studies require full review if they meet any of the following conditions:
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Research procedures present more than a minimal risk to subjects. Minimal risk is
defined by federal regulations as meaning 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.
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A vulnerable population (such as children, prisoners, pregnant women, mentally
disabled persons or economically/educationally disadvantaged persons) is used as
participants.
Identification of the participants and/or their responses would reasonably place them
at risk of criminal or civil liability or be damaging to their financial standing,
employability, insurability, reputation, or be stigmatizing.
The study involves deception of participants.
Federal regulations require that the informed consent form contain the following
information:
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An explanation of the purpose of the research and a description of the procedures to
be followed, including the expected duration of the subject's participation
A description of any reasonably foreseeable risks or discomforts to the subject
A description of any benefits to the subject or to others which may reasonably be
expected from the research
A disclosure of appropriate alternative procedures or courses of treatment, if any, that
might be advantageous to the subject
A description of the extent to which confidentiality of records identifying the subject
will be maintained
An explanation of whom to contact for answers to pertinent questions about the
research and research subjects' rights or in the event of a research-related injury to the
subject
A statement that participation is voluntary, refusal to participate will involve no
penalty or loss of benefits to which the subject is otherwise entitled, and the subject
may discontinue participation at any time without penalty or loss of benefits to which
the subject is otherwise entitled.
E. Student Research
If a project is assigned for the purpose of producing generalizable results that may be presented
outside of the class, or published, or may involve risk to the participants, the researcher must
comply with IRB procedures for human subjects research. Submission of an application and
appropriate approval must occur prior to initiating the research (e.g., data collection).
Faculty Using Research Projects in Courses: Do You Need IRB Approval?
Teaching students to conduct ethical research is an important component of the student
learning experience at Viterbo University. The IRB recognizes that student projects
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conducted solely to fulfill a course requirement are generally limited in scope, and are
not designed or intended to create new knowledge or to lead to scholarly publication.
Therefore, an element of the definition of “research” (the intent to develop or contribute
to generalizable knowledge)
is
lacking.
Viterbo
University IRB also
recognizes
some student projects conducted to fulfill course requirements involve activities that, in
a different context, might be viewed as human subjects research. Students conducting
course-related projects that meet all of the Course-Related Student Project Criteria (see
below) are not required to submit an application for IRB review. Provided at the end of
this policy document are examples of course-related student projects that do and do not
require IRB review.
Human subject research activities conducted as part of a course requirement do not
require IRB review and approval if they meet all of the following Course-Related Student
Project criteria:
1. The purpose of the assignment or activity is to teach research methodology.
2. The results of the assignment do not develop or contribute to generalizable knowledge
because either:
a. The activities are course assignments/projects conducted by a student to satisfy the
curriculum requirements of a course, and are typically concluded at the end of the
relevant semester(s) OR
b. The results of the project do not leave the Viterbo University campus OR
c. The project involves gathering data from or about a company, agency, or
organization and the data/results are shared only with that company,
agency, or organization to be used for internal quality assurance or quality
improvement purposes.
3. The project is limited to surveys, questionnaires, interview procedures,
observation of public behavior, or standard educational exercises.
4. The project does not include prisoners, children, or their data.
5. The information is recorded by the researcher without any direct or indirect (code
number or pseudonym) identifier linking anyone to his/her data OR
If direct or indirect identifiers are used when recording the data, the questions
being asked could not reasonably harm a person’s reputation, employability,
financial standing, or place a person at risk of criminal or civil liability.
6. Viterbo University faculty, staff, and students do not receive monetary
compensation or any type of support from an external company, organization, or
agency for collecting, analyzing or reporting the results of the project.
7. The project is not conducted or supported by a federal department or agency that
has adopted the Common Rule (45 CFR 46 subpart A).
If the research activity meets all of the above Course-Related Student Project criteria,
IRB review is not required. If the project does not meet any one of the above criteria, or
if the project extends beyond these limitations, the student or faculty member must submit an
application to the IRB for approval.
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F. Cooperative Research with Another Institution
When cooperative research occurs with another institution, one institution may agree to delegate
responsibility for all or a portion of the research activity to another IRB. This can occur if the
other institution and IRB agree to assume responsibility for the review and if the delegating
institution agrees to abide by the reviewing IRB decisions. The institutions need to determine
who will become the “IRB of record” and assume responsibility for the research. Once this has
been determined the researchers need to provide a copy of the partnering institution’s IRB
Approval Letter to be placed on file with the IRB administrator.
G. International Research
Procedures for reviewing research in foreign countries may differ from those set forth in this
document and in federal regulations. Such international standards as the Nuremberg Code and
Declaration of Helsinki present broad policies, but are not considered sufficient for an institution
having an assurance with a federal agency such as DHHS. Because of the varied policies and
procedures involved with conducting research in foreign countries, it is best that researchers
discuss research projects with the IRB during the planning phase of the project.
H. IRB Membership and Meetings
1. Membership
The Academic Vice-President appoints the IRB Chair and committee members in
consultation with the Deans from the colleges. Membership is designed to represent
programs that carry out human subjects research. Programs with heavier research
participation may have greater representation on the IRB. The Chair will hold expertise
in research methods and human subjects review policies. Appointment arrangements are
at the discretion of the VPAA.
The Chair typically serves for two years but the appointment can be modified by the VPAA.
The IRB Chairperson may request that any board member who frequently does not submit
reviews in a timely manner and/or misses meetings be replaced. Appointment time for
committee members is currently open ended.
2. Meeting Times
IRB meetings should be scheduled as needed to meet student and faculty needs during the
academic year. Regular IRB meetings are scheduled once per month during the academic
year. Full reviews take place during the monthly meetings. study does not fit this
timetable, the investigator should contact the Chairperson of the IRB who will make a
reasonable effort to prevent delay of the research project. IRB may convene during
summer sessions or, in exceptional cases, may conduct business via email or phone
conference.
3. Expedited Review
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Research activities that qualify for expedited review will be reviewed by the IRB
Chairperson and one other IRB member.
I. Communication of IRB Decisions
The Chair of the IRB shall notify the researcher in writing (via software notification) of the
decision of the IRB. The notification shall include:
• That the researcher report any changes in the research protocol and any unanticipated
problems involving risk to the participants promptly to the IRB. Changes in protocol
may not be initiated without IRB approval except when necessary to eliminate
immediate hazards to research participants.
• That the researcher submit updated progress reports of approved research as required
in the original approval and at the termination of the research.
The IRB may disapprove or require modifications, limitations or conditions. In the case of a
disagreement between the researcher(s) and the IRB decisions the researcher can request to meet
with the IRB Chair. If the issue is not resolved the researcher can pursue the issue per the
University’s grievance policies in the Employee Handbook.
J. Adverse Events
Investigators are required to promptly report to the IRB:
(1) Unanticipated problems including adverse events that are unexpected and related.
An event is “unexpected” when its specificity and severity are not accurately reflected in
the protocol-related documents, such as the IRB-approved research protocol, any
applicable investigator brochure, and the current IRB-approved informed consent
package inserts);
(2) Unanticipated adverse device effect. Any serious adverse effect on health or safety or
any life-threatening problem or death caused by, or associated with, a device, if that
effect, problem, or death was not previously identified in nature, severity, or degree of
incidence in the investigational plan or application (including a supplementary plan or
application, or any other unanticipated serious problem associated with a device that
relates to the rights, safety, or welfare of subjects.
(3) In addition to unanticipated problems, the IRB also requires prompt reporting of the
following events: (a) Complaint of a participant when the complaint indicates unexpected
risks or the complaint cannot be resolved by the research team; (b)Violation or deviation
(meaning an accidental or unintentional change to the IRB approved protocol) only when:
one or more participants were placed at increased risk of harm or or the event has the
potential to occur again, or, the event represents serious or continuing noncompliance.
Reporting Process
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In the event that an unanticipated problem or an Adverse Event occurs, the PI must complete the
electronic Report of Adverse Event form, which can be accessed in the Virbatim software
application linked on the IRB webpage. The IRB requires investigators to submit reports within
10 working days (with one exception) of events that meet the definition of an unanticipated
problem involving risks to subjects or others. Exception: If the adverse event involved a death
and indicates that participants or others are at increased risk of harm, investigators are required to
submit a report to the IRB within 3 days.
Unnecessary reporting of events or problems that do not potentially affect the rights, welfare or
safety of subjects in the study may impair the IRB’s ability to review and respond in a timely
manner to actual situations where subject rights, welfare or safety are threatened.
The IRB encourages study teams to communicate this policy to sponsors and should use this
document for verification as necessary.
The IRB staff, when necessary in conjunction with the IRB chair, review reports and decide
whether the event meets the definition of an unanticipated problem increasing risks to subjects or
others.
The IRB considers the following actions:
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Accept report or with no additional requirements.
Approve investigator’s proposed changes.
Administrative hold on the study pending IRB receipt of further information from the PI
in a time period not to exceed 90 days.
Modification of the protocol.
Modification of the information disclosed during the consent process.
Providing additional information to current participant the information may relate to the
participant’s willingness to continue participation.
Making arrangements for clinical care outside the research or additional follow-up for
participants.
Providing additional information to past participants.
Requiring current participants to re-consent to participation.
Alteration of the frequency of continuing review.
Observation of the research or the consent process.
Requiring additional training of the investigator.
Notification of investigators at other sites.
Obtaining additional information.
Termination or suspension of the research. If this action is taken, the IRB Director will
notify the Institutional Official to initiate any reporting actions. If the IRB does not
consider the event to represent an unanticipated problem involving risks to participants
or others, no further action needs to be taken.
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K. IRB Policy Regarding Continuing Review
It is a regulatory requirement that the IRB review research at intervals not greater than one year.
IRB review of human subjects research may be required at more frequent intervals
[45CFR46.109(e); 21CFR 56.109(f)], as appropriate for the degree of risk. This applies whether
a study is reviewed by the full IRB or through an expedited process. It is the investigator’s
responsibility to seek continuing review, and to provide information for the review that is as
complete as possible. Researchers apply for continuing review via the application in the Virbatim
software linked to the IRB website.
A courtesy reminder notification is sent to the research team 30 days before the study’s
expiration date. The continuing review must be submitted no later than 10 days before the study
expires. The IRB will not accept continuing review submissions more than 30 days before the
expiration date.
If the continuing review request is not submitted 10 days before the study expiration date, the
protocol approval will expire. If the project is funded and the IRB approval expires, the funding
may also be withheld. All study-related activities must cease after the expiration date. This
includes recruitment, advertising, screening, enrollment, obtaining research informed consent,
interventions, interactions, and the collection of private identifiable information. A lapse in IRB
approval of research occurs whenever an investigator has failed to provide continuing review
information to the IRB or the IRB has not conducted a continuing review and re-approved the
research by the expiration date.
Periodic review of all human research activities is necessary to determine (1) whether the
risk/benefit ratio has changed, (2) whether there are unanticipated findings involving risks to
subjects, and (3) whether any new information regarding the risks and benefits should be
provided to subjects. Continuing review must occur as long as the research remains active for
long-term follow-up of participants, even if the research is permanently closed to the enrollment
of new participants, and participants have completed research-related interventions. With each
continuing review, the IRB will determine whether approval should be continued or withdrawn,
and will decide on the frequency of continuing review for each study protocol.
IRB approval of a study may be withdrawn if the risks to the subjects are determined to be
unreasonably high, (for example, more than an expected number of adverse events, unexpected
serious adverse events, or evidence that the Investigator is not conducting the investigation in
compliance with IRB or Institutional guidelines). Such findings may result in more frequent
review of the study to determine if approval should be withdrawn or enrollment stopped until
corrective measures can be taken or the study terminated. Continuing review may include, but
may not be limited to review of the following:
• Serious, Unexpected Adverse Events, Unanticipated Events
• Non-Compliance
• Amendments
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• Significant New Findings
• Interim Results
The IRB chair and the IRB members at a convened meeting are responsible for review and
consideration of approval of protocols during continuing review. Continuing review of protocols
originally approved by the full board will continue to be performed by the full board.
Continuing review of protocols originally approved by expedited review will continue to be
reviewed by expedited review. These may be referred to the full committee if it is found that the
research activities no longer meet the expedited criteria for review and approval (e.g. are now
more than minimal risk).
Expiration and Extensions of Approval Period
There is no grace period extending the conduct of the research beyond the expiration date of IRB
approval. Extensions beyond the expiration date will not be granted. If a complete Progress
Report is not received as scheduled, the IRB approval expires and the Investigator must stop all
research procedures, recruitment, enrollment, interventions, data collection, and data analysis.
The termination must be reported to the project sponsor (if applicable). This will be
communicated to the investigator in a letter from the IRB. Once a study has expired, IRB rereview and re-approval must occur before the study can resume. The IRB cannot retrospectively
grant approval to cover a period of lapsed IRB approval.
Criteria for Continuation/Renewal
Continuing review must be substantive and meaningful. When considering whether or not to
renew a study, the IRB revisits the same criteria used to grant initial approval. These include (but
are not limited to):
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The risks to participants continue to be minimized and reasonable in relation to the
anticipated benefits;
The selection of participants continues to be reasonable in relation to the anticipated
benefits;
Informed consent continues to be appropriately obtained and documented;
Significant new findings that have arisen during the study and which might relate to
participants’ willingness to continue to be involved in the study;
Appropriate provisions for monitoring the data and protections to ensure the privacy and
confidentiality of the participants exist;
Safeguards for any vulnerable populations are in place.
In order to determine the status of the study, the following will be revisited at a meeting of the
Full IRB when expedited review cannot be used:
1. A review of the application for continuing review, including a brief summary of the
methods and procedures, the number of participants who have entered and withdrawn
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2.
3.
4.
5.
(including the reason for withdrawal), the gender and minority status of those who have
entered into the protocol, and the number of participants who are considered vulnerable.
A copy of the proposal and all approved amendments.
A copy of the current consent document(s).
Information that may impact on the risk/benefit ratio such as unanticipated problems and
complaints regarding the research.
Research findings to date (if available)
Possible Outcomes of Review for Continuation
As an outcome of continuing review, the IRB may authorize continuation of the research, or
require that the research be modified or halted altogether. The IRB may need to impose special
precautions or relax special requirements it had previously imposed on the research protocol,
such as frequency of monitoring, requirement for interim reports, or duration of approval period.
Appropriate continuing review intervals are addressed with each review conducted by the IRB.
All actions of the IRB, including any changes required to obtain continued renewal approval,
shall be provided in writing to the investigators by the IRB staff.
Site Visits/Audits and Third Party Verifications
The IRB has the authority to observe, or have a third party observe, the consent process of
research it has approved, and to verify that the study is being conducted as required by the IRB
and within the University Policies and Procedures as appropriate. The IRB may identify an IRB
member or member of the IRB staff to perform site visits or to use another party either affiliated
with the institution or not, to verify information in the study application, or in any interim,
continuing review or renewal submissions.
L. Policy on Modification of a Protocol
Per federal regulations, once a human research study has received IRB approval, any subsequent
changes to the study must be reviewed and approved by the IRB prior to implementation (except
when necessary to avoid an immediate, apparent hazard to a subject. See Reporting of Adverse
Events, Unanticipated Problems and Violations).
To request approval of a proposed modification, complete and submit the Request for
Modification of an Approved Protocol electronic form found in the Virbatim IRB software
program linked to the IRB website.
Modifications are categorized into minor changes and significant changes.
Minor modification/change - A proposed change in research related activities that does not
significantly affect an assessment of the risks and benefits of the study and does not substantially
change the specific aims or design of the study.
Significant modification/change - A proposed change in research related activities that
significantly affects an assessment of the risks and benefits of the study or substantially changes
the specific aims or design of the study.
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Examples: Examples of minor changes to a research study include but are not limited to, the
following:
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The addition of research activities that would be considered independent from the main
research protocol;
An increase or decrease in proposed human research subjects' enrollment;
Narrowing the range of the inclusion criteria;
Broadening the range of the exclusion criteria;
Alterations in the dosage form (e.g., tablet to capsule or oral liquid) of an administered
drug, provided the dose and route of administration remains constant;
Decreasing the number or volume of biological samples collections, provided that such a
change does not affect the collection of information related to safety evaluations;
Changes to improve the clarity of statements or to correct typographical errors, provided
that such a change does not alter the content or intent of the statement;
The addition or deletion of qualified investigators;
The addition of study sites or the deletion of study sites;
Examples of significant changes to a study may include, but are not limited to, the following:
 Broadening the range of inclusion criteria;
 Narrowing the range of exclusion criteria;
 Alterations in the dosage or route of administration of an administered drug;
 Extending substantially the duration of exposure to the test material or invention;
 The deletion of laboratory tests, monitoring procedures, or study visits directed at the
collection of information for safety evaluations;
 The addition of serious unexpected adverse events or other significant risks to the
Informed Consent Disclosure; or
 Changes, which, in the opinion of the IRB chairperson or his/her designee, do not meet
the criteria or intent of a minor modification;
 The addition of a qualified investigator with a conflict of interest.
A modification/change to an approved human research study will generally be reviewed at the
same level of review in which the study was first reviewed, either by the Expedited review
process or by the full Committee. Minor changes may undergo Expedited review.
Any additional or revised materials are submitted along with the application for a modification.
Note: Approved modifications do not extend the approval period of the protocol unless requested
by the researcher.
M. Policy on Study Closure
The Viterbo University IRB considers a study to be active until a study closure form (available
on the Viterbo University research web site link to form) is reviewed and approved by the IRB at
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a full-board convened meeting. A study can be considered for closure when all the participants
have fulfilled protocol requirements including follow-up visits and the data analyses are
complete; or if requested by sponsor. It is the continued responsibility of the study team to
maintain confidentiality of the collected and stored data after closure. The Office of Research
Integrity- essentially the IRB must be contacted if stored data is accessed for research purposes
other than the original intent.
Circumstances for Closure:
IRB oversight may end (following a request for closure) under the following circumstances and
conditions:
1. The research must be permanently closed to enrollment with no further
interaction/intervention with subjects (or access to a subject’s personally identifiable
information) for the purpose of research data collection.
AND
2. All data analysis involving the research site(s), under the IRB approval, is complete (with
data and/or samples de-identified and will remain de-identified).
OR
3. Data has been de-identified, with no codes or keys that would allow for the potential of
identifying individuals in the future. NOTE: This typically applies to multi-center
research where de-identified data is provided to the sponsor and the sponsor authorizes
VCU IRB closure.
Requirements for Closure:
In ALL cases for closure, the PI must complete the IRB Study Closure Form and submit it to the
IRB, requesting approval to close the study to further IRB oversight. The closure form is located
in the Virbatim IRB software program linked to the IRB website. If closure is approved by the
IRB, please note the ongoing obligations:

The Viterbo University IRB will retain all pertinent documents in accordance with
federal regulations.
 The Viterbo University IRB strongly recommends that investigators retain all IRB
correspondence and approved documents and raw data for a minimum of 3-5 years
following public presentation or publication of the findings. Note: “Guidance for
Industry E6 Good Clinical Practice Consolidated Guidance” dictates additional unique
records requirements (Section 4.9).
 If the PI closes a study and then later finds that future correspondence or interaction with
human subjects formerly in that protocol is necessary (for the purpose of research data
collection), the PI must immediately inform the IRB of the situation. The PI may request
that the IRB re-open the study by continuing review (if less than 11 months has passed)
or must request a new initial review by the IRB.
IRB Administrative Closure
The IRB has the authority to suspend or terminate approval of research that is not being
conducted in accordance with IRB Policy and Procedures such as but not limited to:
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• late continuing review report,
• failure to complete the study closure form when study is complete,
• investigator has left the institution and did not notify the IRB,
• confirmed documented scientific misconduct,
• unexpected serious harm to participants.
Any suspension or termination of approval shall be documented and include a statement of the
reason for IRB action. It shall be reported promptly to the principal investigator and appropriate
institutional officials.
Responsibility
It is the responsibility of the PI to request study closure. It is the responsibility of the Viterbo
University IRB to review the request and approve of (discontinue IRB oversight) or disapprove
of (require continuing IRB oversight) the study closure.
N. Policy to Suspend or Terminate IRB Approval
Federal regulations give Viterbo University Institutional Review Board (IRB) the authority to
suspend or terminate approval of some or all human participant research activities, according to
criteria based on non-compliance, or serious risk of harm to participants or others. This policy
applies to all human participant research, regardless of funding.
Suspension: A temporary withdrawal of IRB approval for some or all parts or procedures of
approved research. A suspension imposed by any entity other than the IRB or HSD does not
constitute a suspension as described in this document. Examples of non-IRB suspensions include
suspensions imposed by: a sponsor, a Data and Safety Monitoring Board, department chair,
University dean or designee, the Food and Drug Administration, etc. A lapse of IRB approval
due to lack of continuing review (e.g., annual Status Report) is also not considered to be a
suspension.
Full suspension: Suspension of all parts and procedures of a study.
Partial suspension: A suspension of some parts or procedures of an approved study. Examples
of partial suspension: (a) Enrollment of new participants is suspended but the IRB allows the
continuation of all procedures involving already-enrolled participants; (b) The use of one specific
procedure is suspended but all other study activities are allowed to continue; (c) All study
activities involving one group of participants (e.g., children) are suspended while study activities
for other groups (e.g., parents) can continue.
Termination: A permanent withdrawal of IRB approval of some or all parts or procedures of
previously approved research. Termination may apply to an entire study (full termination) or to
only certain parts or procedures of a study (partial termination).
IRB approval expiration date: The date on which IRB approval will expire. Federal regulations
require an IRB to perform a continuing review of a study at least annually. For most research, the
IRB approval expiration date is one year from the date when IRB approval is granted. A
suspension does not change the IRB approval expiration date.
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Parties authorized to suspend or terminate IRB approval: The full convened IRB has the
authority to suspend or terminate IRB approval. This authority is granted by federal regulations
and by the Viterbo University Academic Vice President. Federal regulations do not allow
suspension or termination imposed by the expedited IRB review process (i.e., “Minimal Risk”).
Urgent circumstances: Urgent suspension of IRB approval may be required before the next
meeting of the full convened IRB, if there is an immediate concern about the safety and welfare
of the participants. For such circumstances, the Viterbo University Academic Vice President has
delegated authority to the IRB Chair to suspend IRB approval for some or all parts of a research
study.
Suspension: Authorized parties may suspend IRB approval when there is: (a)An unanticipated
problem involving serious risk of harm to participants or others; (b) Serious or continuing noncompliance with federal or state regulations, Viterbo University, or IRB policies, or IRB
requirements; or (c) Other circumstance of significant concern to the IRB.
Termination: The convened IRB (but no other parties) has the authority to terminate IRB
approval if it determines that the actions required to adequately address the following issues
cannot, or will not, occur: (a) An unanticipated problem involving serious risk of harm to
participants or others; (b) Serious or continuing non-compliance with federal or state regulations,
Viterbo University or IRB policies, or IRB requirements, or (c) Other circumstance of significant
concern to the IRB.
Procedure: IRB’s decision to suspend or terminate.
Voting: The IRB’s decision to suspend or terminate is made following standard IRB procedures
for voting.
Related determinations: For suspensions, the IRB must also determine: (a) what actions and/or
additional information are required (if any) that will address the concerns of the IRB, so that the
IRB can consider lifting the suspension; and (b) the timeline for fulfilling the IRB’s
requirements.
Protection of participants: When a decision has been made to suspend or terminate research,
the IRB identifies and requires any appropriate actions to protect the rights and welfare of past or
currently enrolled participants. These actions may include, but are not limited to: (a) Requiring
some or all participants to be withdrawn from the research, while ensuring that procedures for
withdrawal take into account their safety, rights and welfare; (b) Allowing already-enrolled
participants to continue some or all parts of the research (for example, treatment with an
investigational drug), if the IRB determines it is in the participants’ best interest or is necessary
for their safety; (c) Allowing some or all follow-up research procedures to continue; (d)
Requiring the researcher to carry out other follow-up or monitoring of participants; (e) Requiring
the responsibility for the participants to be transferred to another researcher; (f) Requiring any
appropriate reporting to other parties; or (g) Requiring the researcher to notify the participants of
the suspension/termination; any changes in risks, benefits; or how the research will be
performed.
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Communication with researcher: A suspension or termination of IRB approval is reported
within one business day to the researcher, by email. The suspension or termination may also be
communicated by phone call, particularly when subject safety issues are urgent. The email will
include: (a) The reasons for the suspension or termination; (b) Actions or additional information
required by the IRB, to address the concerns and situation, including steps necessary to protect
participants; and (c) The timeline for the researcher to address the IRB’s requirements.
Researcher responsibilities: The researcher is responsible for: (a) Complying with the IRB’s
decisions and action plan within the specified time frame. This includes documenting the
compliance and actions in writing by email as well as providing any accompanying
documentation required by the IRB; (b) Reporting any follow-up to the situation; (c) Continuing
to report any unanticipated problems (whether or not related to the event that led to suspension or
termination) involving risks to participants or others; (d) Reporting the suspension or termination
to any entities to which the researcher is responsible, such as a collaborator, industry sponsors, or
a coordinating center.
Communication with Federal Agencies: Suspensions (partial or full) or terminations of IRB
approval are determinations that are reported to appropriate federal agencies. Therefore, the
IRB’s determination to impose a termination or a full or partial suspension or the lifting of a full
or partial suspension must be reported by the IRB Administrator to HSD Management within 24
hours of the IRB’s decision.
Federally mandated reporting: Suspension (partial or full) or termination of IRB approval is
reported to appropriate federal agencies as described in document #306, “Federally Mandated
Reporting Procedure”.
Communication with the institution: The IRB letter and/or the federal reporting letter is used
to communicate the suspension or termination to the University as an institution, through the
standard IRB minutes process. The letters are further distributed to the University as described
in document #68, “Distribution of Reporting.”
Continuing review and suspension: The following information applies to studies for which the
IRB approval expiration date occurs during a suspension.
Full suspension: The continuing review should be timed to occur at (or as close as possible to)
the time when it is expected that the IRB will lift the suspension. It is the IRB Chair’s
responsibility to communicate this information to the researcher, and to work with the researcher
so that a Status Report is submitted to the IRB at the appropriate time.
Partial suspension: Continuing review of the non-suspended activities must occur as usual in
order for the non-suspended activities to continue without a lapsed IRB approval. The IRB
review letter should clearly state that the renewal of IRB approval applies only to the nonsuspended study activities. The suspended parts the study undergo continuing review at (or as
close as possible to) the time when it is expected that the IRB will lift the partial suspension even
if this date is not consistent with the timing of routine continuing review. (In this case, the
approval dates for the study do not change.) It is the IRB Administrator’s responsibility to
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communicate this information to the researcher, and to work with the researcher so that a Status
Report is submitted to the IRB at the appropriate time.
Lifting a suspension: To lift a suspension:
The full IRB committee reviews the results of the information and actions required in connection
with the suspension, at a fully convened meeting.
The IRB lifts the suspension if its requirements and concerns have been satisfactorily addressed.
If there are continuing concerns, or confirmation of concerns, the IRB may: (a) Lift some parts of
the suspension but maintain other parts of it; (b) Maintain the suspension as is, and require
further action or information; or (c) Terminate IRB approval.
If the suspension is lifted, all individuals, offices, and institutions that were notified of the
suspension are now notified of the IRB’s decision to lift the suspension.
O. Researcher Record Keeping Responsibility
Keep records, documents, and informed consent forms for at least three years following the
completion of the research project, or for longer if judged necessary. The IRB may request copies
of signed consent forms of all subjects who participated in the research project and/or guardians.
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