Institutional Review Board Procedure Manual

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Institutional Review Board
Procedure Manual
A substantial portion of information in this manual is directly taken from the federal regulations
45 CFR 46 and 21 CFR 56.
The information within these guidelines was current and accurate at the time of printing.
Recognizing the conditions change, the Institutional Review Board reserves the right to change
or amend the policies, procedures, and content contained in the guidelines.
Updated: September 2014
One of the 14 universities in Pennsylvania’s State System of Higher Education, Edinboro University is committed to affirmative
action for all persons in its educational programs, activities, and employment practices.
IRB Guidance and Procedures
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Table of Contents
I.
Purpose, Scope, Principles, and Authority...................................................................4
II.
Human Subjects Administration...................................................................................6
III.
Protocol and Submission..............................................................................................10
IV.
Initial Review of Research............................................................................................11
V.
Continuing review of Research....................................................................................14
VI.
Criteria for IRB approval of research........................................................................15
VII.
Reviewing the Informed Consent................................................................................25
VIII. Reporting Decisions......................................................................................................28
IX.
Determining which projects require more than annual review................................29
X.
Determining which projects require additional verification....................................30
XI.
Reporting changes ........................................................................................................30
XII.
Non-compliance and Unanticipated Problem Reporting..........................................31
XIII. Internal audits...............................................................................................................32
XIV. Research involving multiple sites or collaborating agencies or institutions............33
XV.
Appendices
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
K.
L.
M.
US DHHS OHRP Human Subject Regulations Decision Charts.................45
Glossary.............................................................................................................46
IRB Protocol form.............................................................................................53
IRB Research Description Guidance..............................................................55
IRB Approved Project Renewal Form............................................................64
EU IRB Second Review Form..........................................................................65
OHRP – when to report....................................................................................66
Unanticipated Problems Report......................................................................67
Consent template...............................................................................................68
Group consent template...................................................................................70
Assent sample 3-10 year olds template............................................................73
Assent sample 11-18 year olds template..........................................................74
Online survey consent template.......................................................................75
IRB Guidance and Procedures
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I.
Purpose, Scope, Principles, and Authority
Institutional Review Board (IRB)
IRB refers to its members acting collectively. They function under the auspices of the Dean of
the School of Graduate Studies and Research at Edinboro University of Pennsylvania
(University) and are responsible for reviewing all research involving human subjects conducted
by faculty, students, or staff of the university.
The IRB must function in compliance with Department of Health and Human Services (DHHS)
regulations, federal and state laws, rules, regulations, and standards, including regulations of
appropriate private and governmental accrediting and regulatory agencies having jurisdiction
over such matters.
Purpose
The purpose of the University’s Institutional Review Board (IRB) is to ensure that the
appropriate steps are taken to protect the rights and welfare of humans who choose to participate
as subjects of research. The IRB maintains guiding principles and operating policies (as
contained in this book) demanding the highest professional standards in dealing with human
subjects; and reviews all research projects involving human subjects to ensure that appropriate
standards are met and the research procedures do not infringe upon the safety, health, welfare or
life of the subjects.
Scope
All projects using humans as subjects, directly or indirectly must be approved in advance by
University’s IRB. This means that whether one is conducting a survey or interview, taking
samples or observing data, the project requires institutional review and approval. The IRB is
solely responsible at EUP for the approval of all human subject research in addition to
determining level of informed consent a project requires. The IRB Chair has the responsibility
and authority to determine whether a project requires IRB approval and what level of review that
project requires.
Specifically exempted from IRB review are activities of academic units and administrative
departments designed to assess student performance and evaluate academic programs. These
activities include student course evaluations, student surveys assessing perceptions of an
academic program or sequence, and student exit interviews that address only curriculum and
program concerns. Such activities do not meet the federal guidelines to qualify as research since
they do not contribute to the “generalizable knowledge”; as long as those activities do not rise to
the level of being deemed research by federal regulations, they do not need reviewed by the IRB.
Principles
The University IRB is guided by the ethical principles embodied in the Belmont Report, which
provides the foundation for the protection of human subjects. Additionally, the University IRB
will abide by the applicable federal regulations and provide training for anyone who will be
involved with human subjects.
IRB Guidance and Procedures
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On September 30, 1978, the National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research submitted its report entitled "The Belmont Report: Ethical
Principles and Guidelines for the Protection of Human Subjects of Research." The Report,
named after the Belmont Conference Center at the Smithsonian Institution where the discussions,
which resulted in its formulation, were begun, sets forth the basic ethical principles underlying
the acceptable conduct of research involving human subjects. Those principles, respect for
persons, beneficence, and justice, are now accepted as the three requirements for the ethical
conduct of research involving human subjects.
Respect for persons involves recognition of the personal dignity and autonomy of
individuals, and special protection of those persons with diminished autonomy (informed
consent)
Beneficence entails an obligation to protect persons from harm by maximizing
anticipated benefits and minimizing possible risks of harm (risk/benefit analysis;
minimize risks)
Justice requires that the benefits and burdens of research be distributed fairly (equality of
selection of subjects
Authority of the IRB
The IRB has the authority and responsibility to evaluate all research involving human subjects
conducted by faculty, students, or staff at Edinboro University of Pennsylvania, to monitor for
compliance with sound ethical principles and applicable regulations, and conduct continuing
review of approved projects until their completion.
The IRB will evaluate each proposal to determine that:
 Risks to subjects are minimized
 Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and
the importance of the knowledge that may reasonably be expected to result
 Selection of subjects is equitable
 Informed consent will be sought from each prospective subject or the subject's legally
authorized representative, in accordance with, and to the extent required by §46.116
 Informed consent will be appropriately documented, in accordance with, and to the extent
required by §46.117
 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
Note: In addition, at the University, the IRB determines that:
o The researcher possesses the qualifications required for conducting the research
o Research utilizes methods that are adequate and appropriate
o Rights and welfare of the subjects are adequately protected
The IRB may take one of the following three actions in regard to the proposed research project:
Approved, Approved Subject to Restrictions, or Disapproved.
IRB Guidance and Procedures
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At the University, an approval by the IRB signifies only that the proposal adequately satisfies
requirements for the protection of research participants. It does not imply, directly or indirectly,
institutional support or permission to conduct the study.
The IRB does not have the authority to grant retroactive approval once human subjects have
already been enrolled.
The IRB has the authority to suspend or terminate approval of research that is not being
conducted in accordance with the IRB requirements.
Compliance
The IRB will ensure institutional compliance with the ethical considerations, such as the DHHS
regulations that are in the Code of Federal Regulations, Title 45 Public Welfare, Part 46
Protection of Human Subjects (45 CFR 46). Those basic regulations were revised and effective
June 23, 2005. Additional protections for various vulnerable populations have been adopted by
DHHS, are as follows:
 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."
 Subpart D, "Additional Protections for Children Involved as Subjects in Research."
FDA regulations on the protection of human subjects are codified in Title 21 Parts 50 and 56 of
the Code of Federal Regulations. Part 50 sets the requirements for informed consent and Part 56
sets forth the provisions for institutional review boards.
Note: DHHS regulations require institutions to assure their compliance with 45 CFR 46 before
initiating participation in DHHS-conducted or -supported research involving human subjects.
The terms of these written institutional assurances are negotiated with Office for Human
Research Protections (OHRP) and constitute binding commitments to comply with the
provisions of 45 CFR 46. Each negotiated commitment is called an Assurance document and is
entered into by the institution and OHRP, representing DHHS.
Authority
The federal regulations Title 45 Section 46 of the Code of Federal Regulations (CFR) and Title
21 CFR 56 define the authority of the IRB. The University holds a Federal Wide Assurance
(FWA) with the Department of Health and Human Services (DHHS) which describes the
principles and guidelines under which University will conduct research involving human
subjects.
II.
Human Subjects Administration
The IRB is designed to review, approve initiation of, and conduct periodic review of all research
projects involving human subjects conducted by the University’s faculty, students, or staff
(including collaborative projects with other institutions and agencies). It is expected that all
University faculty, staff, and students will understand and adhere to the ethical principles and the
IRB Guidance and Procedures
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federal regulations concerning human subjects research. In order to certify that investigators
understand, the University will provide approved training for appropriate administration, IRB
members, University investigators, and students. Should any University employee have a
question concerning the regulations and/or principles, he/she should direct it to the Chair of the
EU IRB.
Responsibilities
The President appoints the members to the committee upon the recommendations of the Provost
and the Dean for Graduate Studies and Research, with the exception of the chair of the Senate
Research committee who serves on the IRB as a condition of their position. The Institutional
Review Board will consist of seven members, including one member who is not an employee of
the University and one member currently serving as chair on the Senate Research Committee.
The committee will have at least five members, with varying backgrounds to promote complete
and adequate review of research activities commonly conducted by the institution1.
It is expected that the recommended members are sufficiently qualified through the experience
and expertise and that there is a 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. The appointments will take the following information into consideration:
 the person is able to determine that the proposed research in terms of institutional
commitments and regulations, applicable law, and standards of professional conduct and
practice
 the person is able knowledgeable about vulnerable populations
 have at least one member whose primary concerns are in scientific areas
 have at least one member whose primary concerns are in nonscientific areas
 have 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 the institution
 will not be solely comprised of males or females
All members except the representative from the Senate Research Committee shall serve for a
term of three years and may be re-appointed by the President of the University upon
recommendation by the Provost and Vice President for Academic Affairs or the Dean for
Graduate Studies and Research. The representative from the Senate Research Committee will
serve only for the time period during which he/she is chair of the Senate Research Committee
The Provost and Vice President for Academic Affairs of University has designated the Dean for
Graduate Studies and Research as the Authorized Institutional Official for oversight and research
and its compliance functions. The compliance functions include the IRB.
University’s School of Graduate Studies and Research (SGSR) will provide administrative
support for the Institutional Review Board (IRB).
Records
According to 46.115, “an IRB shall prepare and maintain adequate documentation of IRB
1
45 CFR 46.107
IRB Guidance and Procedures
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activities, including the following:
 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 which shall be in 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 controverted issues
and their resolution.
 Records of continuing review activities.”
 Copies of all written correspondence between the IRB and the investigators.
 A list of members
 Written procedures
 Statements of significant new findings provided to subjects
The records required by this policy shall be retained for at least 3 years, and records relating to
research that is conducted shall be retained for at least 3 years after completion of the research.
The federal law 45 CFR §46.115(b) requires that these records shall be retained for at least 3
years, and records relating to research that is conducted shall be retained for at least 3 years after
completion of the research.
Participant information, including informed consents, data, and electronic records, must be kept
for a minimum of 3 years pursuant to federal law; at that time research materials may be
destroyed, in a secure manner. Secure methods of records destruction for paper records include
shredding or incineration and for electronic data deleting data beyond deleting the file (i.e., using
software that provides a secure wipe of the data). Any media that contain data (i.e., CD/DVD,
usb, or external hard drives) will need to be wiped or destroyed in a secure fashion.
Participant records, including informed consent and data, may be kept until such time as they are
no-longer needed by the researcher. It is the responsibility of all researchers involved in the
project to make sure that participant materials, including data and informed consent, are kept
secure and if destroyed done so in a secure manner.
Chair and Members of the IRB
The chair is appointed by the President of University. His/her responsibilities are:
 chairs all regular meetings or special sessions of the IRB;
 performs all functions of a voting IRB member;
 has the authority to temporarily suspend research that is not in compliance with
governing laws, regulations, and guidelines;
 represents the IRB when attendance of the total membership is not required;
 participates in or designates others to participate in sessions designed to inform and
educate others concerning the aims and functions of IRB;
IRB Guidance and Procedures
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remains informed of the latest changes in federal, state and local regulations concerning
ethical considerations involved in research using human subjects and assists IRB
members in similar efforts;
informs the investigator of the decision;
apprises the Dean of Graduate Studies and Research of the membership of the Board.
When a member's term expires, the chairperson will inform the Dean of Graduate Studies
and Research of the expiration, including whether or not the member wishes to be
considered for an additional term;
submits a yearly summary of research activities;
informs the principal investigator of the restrictions in writing when the protocol is
Approved Subject to Restrictions. The principal investigator must submit documentation
of the incorporation of the restrictions to the chair prior to final approval. The application
will then be processed as an approved application. Should the principal investigator be
unwilling to accept the restrictions, the chair will note such and the application will be
processed as though it had been disapproved.
informs the principal investigator in writing of the reasons for the disapproval if the
application is Disapproved. Every effort shall be made by the chair and the principal
investigator to meet and discuss those elements of the application, which make it
unacceptable in order to arrive at a solution. In those cases in which agreement on an
alternative approach cannot be researched, the chair will prepare a letter of disapproval
and will distribute it with the disapproved application as follows :
 principal investigator (PI);
 members of the IRB;
 appropriate department chairperson;
 appropriate dean;
 Dean of Graduate Studies and Research
 Provost and Vice-President for Academic Affairs; and
 IRB's files.
IRB Chair responsibilities:
The IRB chair is responsible for instituting and managing a procedure to determine which
projects require review in accordance with governing regulations. The IRB Chair may designate
other university personnel to review individual proposals and make the determination as to the
level of IRB review required. Additionally, the IRB Chair sets the meeting schedule and agenda,
and conducts all meetings of the IRB. The IRB Chair will be granted one course (3 credit hours)
release time per semester (Fall and Spring) each academic year.
The IRB members’ responsibilities:
 ensuring that the projects are in compliance with governing regulations;
 expected to complete their expanded training;
 become familiar with standards of research conduct and practice, the appropriate CFR,
other regulatory agencies, IRB Guidelines, and the University’s research policies;
 attend scheduled meetings or inform the chair if unable to attend a meeting;
 review and evaluate all protocols requiring a quorum vote;
 act as reviewers for research eligible for expedited review;
IRB Guidance and Procedures
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participate in periodic revisions of the IRB guidelines;
excuse themselves and not be involved in review of any activity in which they have
conflicting interests;
maintain confidentiality of IRB activities and information;
inform the IRB Chair of noncompliance issues;
review the applications and make recommendations to the Dean of Graduate Studies and
Research when vacancies on the Board exist
Meetings
Meetings may be conducted via the internet or in person. The IRB shall meet as often as
necessary to provide review and advisement, but at least twice per semester.
Voting
Four members of the Board shall constitute a voting quorum. Acceptance of a proposal shall
require a minimum of four supporting votes
III.
Protocol and Submission
There are three types of IRB review that are further explained in Section III. Initial Review:
1. Exempt Review (protocol approval is determined by the IRB Chair or designee).
Exemption is not the same as exclusion from IRB review.
2. Expedited Review (protocol approval is determined by the chair of the IRB or designee).
3. Full Review (protocol approval is determined by every member of the IRB).
A complete protocol will only be considered by the IRB. A complete IRB protocol will include
the following information:
 Required. A completed original IRB Application with collaborator(s), co-investigator(s),
and
 Required. A research proposal describing the rationale for the study, research questions
to be answered, methods, procedures, data analysis plan, and other required information.
This may be completed as part of the IRB application as long as all the topics are
addressed as found in the IRB Research Project Description Guidelines;
 Required. An informed consent form or justification for Waiver of Informed Consent or
Waiver of Documentation of Consent;
 If applicable, the following must be included:
o the study involves the use of questionnaires, surveys or similar instruments
o site permission letters for extramural research
o additional approval documentation (IACUC, IBC, etc).
o one complete copy of the grant application
o recruitment materials (flyers, posters, web-pages, email messages, etc.,);
o sponsor protocol
o assent form
IRB Guidance and Procedures
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Protocols must be submitted and approved prior to data collection or recruitment of human
subjects. The stated timelines and dates in the protocol must allow enough time for IRB
approval. The IRB cannot retroactively approve data collection and protocols with unrealistic
timelines will be withdrawn from consideration. Data collected without IRB approval cannot be
used in publication or dissemination. The general procedure for submission is:
1.
2.
3.
4.
5.
6.
7.
IV.
Obtain current forms from the EU IRB website (www.edinboro.edu - Keyword IRB).
Complete the form and provide the necessary materials
Complete the required Human Subjects training (must be completed once every 3 years)
Submit the completed protocol to IRB Chair at [email protected]
The IRB Chair will review for completeness and determination
The Principal Investigator (PI) will be informed by the IRB of the determination
If necessary, IRB Chair will remind the PI 30 days prior to the impending expiration of
the IRB approval.
Initial Review of Research
The IRB Chair, or designee, will evaluate completed proposals to determine the review type the
project will receive. The types are defined by 45 CFR 46 and clarified through the Office of
Human Research Protections (OHRP) as follows:

Exempt Review involves research where the only involvement of human subjects will be
in one or more of the following categories:
1. Research conducted in established or commonly accepted educational settings,
involving normal educational practices, such as:
a. research on regular and special education instructional strategies, or
b. research on the effectiveness of or the comparison among instructional
techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public
behavior, unless:
a. information obtained is recorded in such a manner that human subjects can
be identified, directly or through identifiers linked to the subjects; and
b. 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 (I)(B) of this policy, if:
a. the human subjects are elected or appointed public officials or candidates
for public office; or
b. Federal statute(s) require(s) without exception that the confidentiality of
the personally identifiable information will be maintained throughout the
research and thereafter.
IRB Guidance and Procedures
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
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.
a. public benefit or service programs;
b. procedures for obtaining benefits or services under those programs
c. possible changes in or alternatives to those programs or procedures; or
d. possible changes I methods or levels of payment for benefits or services
under those programs
5. Taste and food quality evaluation and consumer acceptance studies,
 if wholesome foods without additives are consumed or
 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
Agriculture2,3.
6. Emergency use of a test article, provided that such emergency use is reported to
the IRB within 5 working days. Any subsequent use of the test article at the
institution is subject to IRB review4.
7. Certain changes may disqualify the research from exempt status. Therefore, any
proposed changes to an exempt study must be submitted to the IRB for review
and approval prior to implementation.
8. Exempt research activities are subject to the same subject protections and ethical
standards as outlined in The Belmont Report.
9. These exemptions do not apply to research involving prisoners5.
10. Research Involving Children
a. The exemptions specified above, in Section 1, 3, 4, 5 and 6 all apply to
research involving children.
b. The exemption specified above in Section 2 only applies for research
involving observation of public behavior when the Investigator does not
participate in the activities being observed. The exemption does not apply
where the research involves survey or interview procedures or any direct
interaction with the participants being observed6.
Expedited Review involves 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.
 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
2
45 CFR 46.101(b)
21 CFR 56.104(d)
4
21 CFR 56.104(c)
5
45 CFR 46.101, footnote 1
6
45 CFR 46.101, footnote 1; 45 CFR 46.401(b)
3
IRB Guidance and Procedures
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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.
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
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.
Prospective collection of biological specimens for research purposes by noninvasive
means. Examples: (a) hair and nail clippings in a nondisfiguring manner; (b)
deciduous teeth at time of exfoliation or if routine patient care indicates a need for
extraction; (c) permanent teeth if routine patient care indicates a need for extraction;
(d) excreta and external secretions (including sweat); (e) 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; (f) placenta removed at delivery;
(g) amniotic fluid obtained at the time of rupture of the membrane prior to or during
labor.
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.)
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 DHHS regulations for the protection of human subjects. 45 CFR 46.101(b) (4).
This listing refers only to research that is not exempt.)
Collection of data from voice, video, digital, or image recordings made for research
purposes.
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 DHHS 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.)
Continuing review of research previously approved by the convened IRB as follows:
IRB Guidance and Procedures
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V.
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.
 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.
Full Board Review involves research activities that do not qualify to be reviewed as
exempt or expedited.
Continuing Review of Research
Approved expedited or full review studies minimally require an annual review and approval by
the IRB. The Review Report/Renewal Request must be completed and returned to IRB Chair
two weeks prior to the IRB approval expiration date. Timely completion of the review report will
ensure that researchers are able to continue the research since, at the expiration date of the
project; the research must stop until the determination from the IRB is received.
Continuing review is no longer required for expedited or full studies when:
 The research is permanently closed to the enrollment of new participants;
 All participants have completed all research-related interventions; and
 Collection and analysis of private identifiable information has completed.
Full board and expedited studies require the following be submitted for continuing review:
 a current count of participants
 if any participants have withdrawn from the study, and the reasons
 if there have been any unanticipated adverse effects reported by subjects
 a current copy of the consent/assent form,
 a current copy of the research protocol,
 expected date of completion,
 summary of project to date,
 if there will be any changes to the previously approved protocol, and
 all other additional documents and materials, including questionnaires, payments
schedules, recruitment materials, and scripts
Any revisions to the previously approved consent process, the protocol, recruitment, enrollment,
or other study related activity are to be submitted as an amendment
Continuing reviews ensure that current informed consent documents are accurate and complete.
Reviewers are required to ensure that the submitted informed consent documents and protocols
IRB Guidance and Procedures
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are accurate and complete. When adverse events occur or changes are desired, a revised project
protocol along with updated forms should be submitted to the IRB Chair with changes
highlighted. Then the IRB will provided the following determination “Approve” for
continuation, if explicit clarifications are required, “Approved with explicit conditions,” if
general clarifications and issues are required, “Table,” or “Disapprove” if the IRB can no longer
approve the research.
All continuing reviews must be received and reviewed prior to the expiration data of the
approval. Continuation submitted but with insufficient time for review and approval by the
expiration date is considered expired and all research and research related activity must cease
until IRB approval of continuation. While the IRB Chair will notify the investigator when a
study is due for renewal, the investigator is still responsible for ensuring that the study is not
conducted after IRB approval has expired.
Only those projects which received an initial approval via expedited review may be granted a
continuation via expedited review or that meet the criteria for expedited review of continuation
outlined in 45 CFR 46.110(F)(9). The IRB will notify the investigator in writing of the IRB’s
decision.
The IRB has the authority to observe or appoint a third-party to observe research conduct,
including consent procedures. It may also consider whether a study requires independent
verification from sources other than the PI to ensure that no material changes have occurred
since the last IRB approval. The IRB will require verification of the information provided for
continuing review when:
1. continuing review materials appear inconsistent or inaccurate compared to prior
applications or records and discrepancies cannot be resolved via communication with the
PI, or
2. the IRB determines that such actions are useful as part of a corrective action plan for any
unanticipated problem or event.
If the findings of such investigations during the continuing review process warrant corrective
actions, the IRB may suspend or terminate a research project to ensure the quality of research.
Continuing review materials (reviewer checklists, research determinations, and specific protocol
findings) are stored in the IRB files.
Frequency of Reviews
The frequency of continuing review is determined at the time of initial review and must occur at
least once a year. The factors considered in setting the frequency of review include: the nature of
the study; the degree of risk involved, the vulnerability of the study subject population, or
investigator’s previous history. The frequency of continuing review may be modified at any time
as declared necessary by the IRB.
VI.
Criteria for IRB approval of research.
IRB Guidance and Procedures
15
The IRB will have to determine if all of the following requirements are satisfied in order to
approve a submitted protocol.
1. Risks to subjects are minimized:
a. by using procedures which are consistent with sound research design and which
do not unnecessarily expose subjects to risk, and
b. whenever appropriate, by using procedures already being performed on the
subjects for diagnostic or treatment purposes.
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects,
and the importance of the knowledge that may reasonably be expected to result.
a. In evaluating risks and benefits, the IRB should 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).
b. The IRB should not consider possible long-range effects of applying knowledge
gained in the research (for example, the possible effects of the research on public
policy) as among those research risks that fall within the purview of its
responsibility.
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 and should be particularly cognizant of the 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, in accordance with, and to the extent required by §46.116.
5. Informed consent will be appropriately documented, in accordance with, and to the
extent required by §46.117.
6. When appropriate, the research plan makes adequate provision for monitoring the
data collected to ensure the safety of subjects.
7. When appropriate, there are adequate provisions to protect the privacy of subjects and
to maintain the confidentiality of data.
8. Recruitment and selection of subjects must be equitable within the confines of the
study. Subjects must not be arbitrarily excluded on the basis of sex, race, national
origin, religion, creed, education, age, color, ancestry, handicap, disability, or
socioeconomic status.
9. Media Advertising:
IRB Guidance and Procedures
16
A. Inclusions: 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, flyers, and internet that are intended for prospective subjects.
B. Exclusions: 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), news stories, and publicity intended for
other audiences, such as financial page advertisements directed toward
prospective investors (21CFR56).
C. IRB approval:
i.
FDA considers direct advertising for study subjects to be the start of the
informed consent and subject selection process. Advertisements should be
reviewed and approved by the IRB as part of the package for initial
review. However, when the clinical investigator decides at a later date to
advertise for subjects, the advertising may be considered an amendment
to the ongoing study. When such advertisements are easily compared to
the approved consent document, the IRB chair, or other designated IRB
member, may review and approve by expedited means, as provided by 21
CFR 56.110(b)(2). When the IRB reviewer has doubts or other
complicating issues are involved, the advertising should be reviewed at a
convened meeting of the IRB.
ii. FDA expects IRBs to review the advertising to assure that it is not unduly
coercive and does not promise a certainty of cure beyond what is outlined
in the consent and the protocol. This is especially critical when a study
may involve subjects who are likely to be vulnerable to undue influence.
[21 CFR 50.20, 50.25, 56.111(a)(3), 56.111(b), and 812.20(b)(11).]
iii. 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 retaping because of inappropriate wording.
iv. No claims should be made, either explicitly or implicitly, that the drug,
biologic or device is safe or effective for the purposes under investigation,
or that the test article is known to be equivalent or superior to any other
drug, biologic or device. Such representation would not only be
IRB Guidance and Procedures
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misleading to subjects but would also be a violation of the Agency's
regulations concerning the promotion of investigational drugs [21 CFR
312.7(a)] and of investigational devices [21 CFR 812.7(d)].
v.
Advertising for recruitment into investigational drug, biologic or device
studies should not use terms such as "new treatment," "new medication"
or "new drug" without explaining that the test article is investigational. A
phrase such as "receive new treatments" leads study subjects to believe
they will be receiving newly improved products of proven worth.
vi. Advertisements should not promise "free medical treatment," when the
intent is only to say subjects will not be charged for taking part in the
investigation. Advertisements may state that subjects will be paid, but
should not emphasize the payment or the amount to be paid, by such
means as larger or bold type.
vii. Generally, FDA believes that 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. It should be noted, however,
that FDA does not require inclusion of all of the listed items.
 the name and address of the clinical 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., a no-cost
health examination);
 the time or other commitment required of the subjects;
 the location of the research, and
 the person or office to contact for further information.
10. Internet: One method of recruiting subjects is through advertisements (e.g.,
websites). OHRP consistently has interpreted HHS regulations to provide IRB
authority and responsibility for review of study recruitment material, including
advertisements. Although websites use a different medium than traditional print or
broadcast advertisements, the requirements are the same.
11. Vulnerable Populations:
Whenever subjects in a study may be vulnerable to injury, coercion, or undue
influence, the study must include additional safeguards to protect their rights and
welfare. Vulnerable populations requiring additional safeguards are pregnant
women and fetuses, prisoners, children, persons who are intellectually or
emotionally impaired, students, associates, or subordinates, economically
disadvantaged subjects, and aged/elderly.
IRB Guidance and Procedures
18
45CFR46 specifically addresses three categories of vulnerable research subjects.
These include:



Subpart B, "Additional Protections Pertaining to Research, Development, and
Related Activities Involving Fetuses, Pregnant Women, and Human in Vitro
Fertilization."
Subpart C, "Additional Protections Pertaining to Biomedical and Behavioral
Research Involving Prisoners as Subjects."
Subpart D, "Additional Protections for Children Involved as Subjects in
Research."
Considerations
A. According to 46.204, “pregnant women or fetuses may be involved in
research if all of the following conditions are met:
 Where scientifically appropriate, preclinical studies, including studies
on pregnant animals, and clinical studies, including studies on
nonpregnant women, have been conducted and provide data for
assessing potential risks to pregnant women and fetuses;
 The risk to the fetus is caused solely by interventions or procedures
that hold out the prospect of direct benefit for the woman or the fetus;
or, if there is no such prospect of benefit, the risk to the fetus is not
greater than minimal and the purpose of the research is the
development of important biomedical knowledge which cannot be
obtained by any other means;
 Any risk is the least possible for achieving the objectives of the
research;
 If the research holds out the prospect of direct benefit to the pregnant
woman, the prospect of a direct benefit both to the pregnant woman
and the fetus, or no prospect of benefit for the woman nor the fetus
when risk to the fetus is not greater than minimal and the purpose of
the research is the development of important biomedical knowledge
that cannot be obtained by any other means, her consent is obtained in
accord with the informed consent provisions of subpart A of this part;
 If the research holds out the prospect of direct benefit solely to the
fetus then the consent of the pregnant woman and the father is
obtained in accord with the informed consent provisions of subpart A
of this part, except that the father's consent need not be obtained if he
is unable to consent because of unavailability, incompetence, or
temporary incapacity or the pregnancy resulted from rape or incest.
 Each individual providing consent under paragraph (4) or (5) of this
section is fully informed regarding the reasonably foreseeable impact
of the research on the fetus or neonate;
 For children as defined in §46.402(a) who are pregnant, assent and
permission are obtained in accord with the provisions of subpart D of
this part;
IRB Guidance and Procedures
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


No inducements, monetary or otherwise, will be offered to terminate a
pregnancy;
Individuals engaged in the research will have no part in any decisions
as to the timing, method, or procedures used to terminate a pregnancy;
and
Individuals engaged in the research will have no part in determining
the viability of a neonate.”
B. Prisoners
According to 46.303, “prisoner means any individual involuntarily
confined or detained in a penal institution. The term is intended to
encompass individuals sentenced to such an institution under a criminal or
civil statute, individuals detained in other facilities by virtue of statutes or
commitment procedures which provide alternatives to criminal
prosecution or incarceration in a penal institution, and individuals detained
pending arraignment, trial, or sentencing.”
According to 46.302, “inasmuch as prisoners may be under
constraints because of their incarceration which could affect their ability to
make a truly voluntary and uncoerced decision whether or not to
participate as subjects in research, it is the purpose to provide additional
safeguards for the protection of prisoners involved in research activities to
which this subpart is applicable.”.
Composition of IRB Where Prisoners are Involved
“A majority of the Board (exclusive of prisoner members) shall
have no association with the prison(s) involved, apart from their
membership on the Board. At least one member of the Board shall be a
prisoner, or a prisoner representative with appropriate background and
experience to serve in that capacity, except that where a particular research
project is reviewed by more than one Board only one Board need satisfy
this requirement. The IRB shall review research and approve such
research only if it finds that:
 The research under review represents one of the categories of research
permissible under §46.306(a)(2). The proposed research involves
solely the following:
 Study of the possible causes, effects, and processes of incarceration,
and of criminal behavior, provided that the study presents no more
than minimal risk and no more than inconvenience to the subjects;
 Study of prisons as institutional structures or of prisoners as
incarcerated persons, provided that the study presents no more than
minimal risk and no more than inconvenience to the subjects
 Research on conditions particularly affecting prisoners as a class (for
example, vaccine trials and other research on hepatitis which is much
IRB Guidance and Procedures
20







more prevalent in prisons than elsewhere; and research on social and
psychological problems such as alcoholism, drug addiction, and sexual
assaults) provided that the study may proceed only after the Secretary
has consulted with appropriate experts including experts in penology,
medicine, and ethics, and published notice, in the FEDERAL
REGISTER, of his intent to approve such research; or
Research on practices, both innovative and accepted, which have the
intent and reasonable probability of improving the health or well-being
of the subject. In cases in which those studies require the assignment
of prisoners in a manner consistent with protocols approved by the
IRB to control groups which may not benefit from the research, the
study may proceed only after the Secretary has consulted with
appropriate experts, including experts in penology, medicine, and
ethics, and published notice, in the FEDERAL REGISTER, of the
intent to approve such research (46.306).
Any possible advantages accruing to the prisoner through his or her
participation in the research, when compared to the general living
conditions, medical care, quality of food, amenities and opportunity
for earnings in the prison, are not of such a magnitude that his or her
ability to weigh the risks of the research against the value of such
advantages in the limited choice environment of the prison is impaired;
The risks involved in the research are commensurate with risks that
would be accepted by nonprisoner volunteers;
Procedures for the selection of subjects within the prison are fair to all
prisoners and immune from arbitrary intervention by prison authorities
or prisoners. Unless the principal investigator provides to the Board
justification in writing for following some other procedures, control
subjects must be selected randomly from the group of available
prisoners who meet the characteristics needed for that particular
research project;
The information is presented in language which is understandable to
the subject population;
Adequate assurance exists that parole boards will not take into account
a prisoner's participation in the research in making decisions regarding
parole, and each prisoner is clearly informed in advance that
participation in the research will have no effect on his or her parole;
and
Where the Board finds there may be a need for follow-up examination
or care of participants after the end of their participation, adequate
provision has been made for such examination or care, taking into
account the varying lengths of individual prisoners' sentences, and for
informing participants of this fact.”
C. Children
IRB Guidance and Procedures
21
Children are persons who have not attained the legal age for
consent to treatments or procedures involved in the research, under the
applicable law of the jurisdiction in which the research will be conducted
(46.202). In Pennsylvania, the age of consent is 18 years, unless an
emancipated minor (not of legal age, but treated as an adult because of
assuming adult responsibilities, e.g., self-support, marriage, or
procreation).
Research not involving greater than minimal risk. 46.404
HHS will conduct or fund research in which the IRB finds that no
greater than minimal risk to children is presented, only if the IRB finds
that adequate provisions are made for soliciting the assent of the children
and the permission of their parents or guardians, as set forth in §46.408.
Research involving greater than minimal risk but presenting the prospect
of direct benefit to the individual subjects. 46.405
HHS will conduct or fund research in which the IRB finds that
more than minimal risk to children is presented by an intervention or
procedure that holds out the prospect of direct benefit for the individual
subject, or by a monitoring procedure that is likely to contribute to the
subject's well-being, only if the IRB finds that:
 The risk is justified by the anticipated benefit to the subjects;
 The relation of the anticipated benefit to the risk is at least as favorable
to the subjects as that presented by available alternative approaches;
and
 Adequate provisions are made for soliciting the assent of the children
and permission of their parents or guardians, as set forth in §46.408.
Research involving greater than minimal risk and no prospect of direct
benefit to individual subjects, but likely to yield generalizable knowledge
about the subject's disorder or condition. 46.406
HHS will conduct or fund research in which the IRB finds that
more than minimal risk to children is presented by an intervention or
procedure that does not hold out the prospect of direct benefit for the
individual subject, or by a monitoring procedure which is not likely to
contribute to the well-being of the subject, only if the IRB finds that:
 The risk represents a minor increase over minimal risk;
 The intervention or procedure presents experiences to subjects that are
reasonably commensurate with those inherent in their actual or
expected medical, dental, psychological, social, or educational
situations;
 The intervention or procedure is likely to yield generalizable
knowledge about the subjects' disorder or condition which is of vital
importance for the understanding or amelioration of the subjects'
disorder or condition; and
IRB Guidance and Procedures
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
Adequate provisions are made for soliciting assent of the children and
permission of their parents or guardians, as set forth in §46.408.
Research not otherwise approvable which presents an opportunity to
understand, prevent, or alleviate a serious problem affecting the health or
welfare of children. 46.407
HHS will conduct or fund research that the IRB does not believe
meets the requirements of §46.404, §46.405, or §46.406 only if:
 the IRB finds that the research presents a reasonable opportunity to
further the understanding, prevention, or alleviation of a serious
problem affecting the health or welfare of children; and
 the Secretary, after consultation with a panel of experts in pertinent
disciplines (for example: science, medicine, education, ethics, law) and
following opportunity for public review and comment, has determined
either:
 that the research in fact satisfies the conditions of §46.404, §46.405, or
§46.406, as applicable, or the following:

the research presents a reasonable opportunity to further
the understanding, prevention, or alleviation of a serious problem
affecting the health or welfare of children;

the research will be conducted in accordance with
sound ethical principles;

adequate provisions are made for soliciting the assent of
children and the permission of their parents or guardians, as set forth
in §46.408.
Note: Categories of individuals not specifically addressed in
45CFR46, can include:
D. Persons Who are Cognitively Impaired
An impaired person is one whose cognitive or emotional functions are
affected or whose capacity for judgment and reasoning is significantly
diminished by a psychiatric disorder (psychosis, neurosis, personality,
or behavior disorder), an organic impairment (dementia), a
developmental disorder (mental retardation), or a neurological
disorder. Other persons in this category may include those under the
influence of or dependent on drugs or alcohol, terminally ill persons,
and persons with sever disabling handicaps.
These individuals may be vulnerable to coercion or incapable of giving
legally valid informed consent.
IRB should include having a person who is knowledgeable about and
experienced in working with those subjects during review of studies
involving these subjects
IRB Guidance and Procedures
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DHHS has no additional regulations specifically governing research
involving persons who are cognitively impaired.
E. Student
A person enrolled at an institution of learning.
The fact that a person is a student can affect that person’s ability to
make a voluntary and non-coerced decision about participation as a
subject of research. If prospective subjects are students at any
institution associated with the study, the consent form must state that
class standing, grades, or status on an athletic team will not be affected
by refusal to participate or by withdrawal from the study. If students
are to receive class credit for participation, other opportunities must be
available for students electing not to participate in the study to earn
credit and the consent form must so indicate.
F. Associates or Subordinates
An associate is a person considered to be a peer.
A subordinate is a person who is subject to or under the authority of
another.
Except in special circumstances, the IRB will approve a protocol
involving the investigator’s current employees or subordinates as
subjects only if the study is designed to assure anonymity, including
whether or not any particular individual elected to participate. One
method of assuring anonymity is for all contact with human subjects to
be made by persons other than the investigator.
G. Illiterate Subjects or Those Whose Primary Language Is Not English
An illiterate is a person who cannot read or write at a basic level.
Those who primary language is not English is one whose first
language is different than English or who has English as a second
language.
 The consent may need to be read to the individual
 The consent may need to be written in the person’s native
language
H. Elderly/Aged
Those individuals who are 65 years or older
 No age should prohibit participation in a research study, unless
the nature of the study is focused on specific age group
 A decline of mental capabilities in the elderly may contribute
to poor judgment, making some elderly individuals vulnerable
IRB Guidance and Procedures
24
to coercion or incapable of giving legally valid informed
consent.
12. Payment to Research Subjects
It is not uncommon for subjects to be paid for their participation in research,
especially in the early phases of investigational drug, biologic or device
development. Payment to research subjects for participation in studies is not
considered a benefit, it is a recruitment incentive. Financial incentives are often
used when health benefits to subjects are remote or non-existent. 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 is coercive nor presents
undue influence [21 CFR 50.20].
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, an 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.
While the entire payment should not be contingent upon completion of the entire
study, payment of a small proportion as an incentive for completion of the study is
acceptable to FDA, providing that such incentive is not coercive. The IRB should
determine that the amount paid as a bonus for completion is reasonable and not so
large as to unduly induce subjects to stay in the study when they would otherwise
have withdrawn. All information concerning payment, including the amount and
schedule of payment(s), should be set forth in the informed consent document.
(http:www.fda.gov/oc/ohrt/IRBS/toc4.html)
VII. Reviewing the Informed Consent
According to 45 CFR 46.115, no investigator may involve a human being as a subject in research
unless the investigator has obtained the legally effective informed consent of the subject or the
subject's legally authorized representative. Legally effective informed consent provides the
subject or representative the ability to determine if he/she wants to participate. The consent
information must be in language understandable to the subject or the representative. No informed
consent, whether oral or written, may include any exculpatory language through which the
subject or the representative is made to waive or appear to waive any of the subject's legal rights,
or releases or appears to release the investigator, the sponsor, the institution or its agents from
liability for negligence.
IRB Guidance and Procedures
25
Basic elements of informed consent
Except as provided in the section Consent alteration or waiver, in seeking informed consent the
following information shall be provided to each subject:
1. A statement that the study involves research, an explanation of the purposes of the
research and the expected duration of the subject's participation, a description of the
procedures to be followed, and identification of any procedures which are experimental;
2. A description of any reasonably foreseeable risks or discomforts to the subject;
3. A description of any benefits to the subject or to others which may reasonably be
expected from the research;
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that
might be advantageous to the subject;
5. A statement describing the extent, if any, to which confidentiality of records identifying
the subject will be maintained;
6. For research involving more than minimal risk, an explanation as to whether any
compensation and an explanation as to whether any medical treatments are available if
injury occurs and, if so, what they consist of, or where further information may be
obtained;
7. An explanation of whom to contact for answers to pertinent questions about the research
and research subjects' rights, and whom to contact in the event of a research-related
injury to the subject; and
8. 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.
Additional elements of informed consent
When appropriate, one or more of the following elements of information shall also be provided
to each subject:
1. A statement that the particular treatment or procedure may involve risks to the subject (or
to the embryo or fetus, if the subject is or may become pregnant) which are currently
unforeseeable;
2. Anticipated circumstances under which the subject's participation may be terminated by
the investigator without regard to the subject's consent;
3. Any additional costs to the subject that may result from participation in the research;
4. The consequences of a subject's decision to withdraw from the research and procedures
for orderly termination of participation by the subject;
IRB Guidance and Procedures
26
5. A statement that significant new findings developed during the course of the research
which may relate to the subject's willingness to continue participation will be provided to
the subject; and
6. The approximate number of subjects involved in the study.
Documentation
Informed consent “shall be documented by the use of a written consent form approved by the
IRB and signed by the subject or the subject's legally authorized representative (an individual or
judicial or other body authorized under applicable law to consent on behalf of a prospective
subject to the subject’s participation in the procedure(s) involved in the research.). A copy shall
be given to the person signing the form.”
Short Form Written Consent
According to 46.117, “a short form written consent document stating that the elements of
informed consent required by §46.116 have been presented orally to the subject or the subject's
legally authorized representative. When this method is used, there shall be a witness to the oral
presentation. Also, the IRB shall approve a written summary of what is to be said to the subject
or the representative. Only the short form itself is to be signed by the subject or the
representative. However, the witness shall sign both the short form and a copy of the summary,
and the person actually obtaining consent shall sign a copy of the summary. A copy of the
summary shall be given to the subject or the representative, in addition to a copy of the short
form.”
Consent alteration or waiver
Can occur when the only record linking the subject and the research would be the consent
document and the principal risk would be potential harm resulting from a breach of
confidentiality. Each subject will be asked whether the subject wants documentation linking the
subject with the research, and the subject's wishes will govern; or
When the research presents no more than minimal risk of harm to subjects and involves no
procedures for which written consent is normally required outside of the research context.
Exceptions to All Elements of Consent
An IRB may approve a consent procedure, which does not include, or which alters, some or all
of the elements of informed consent set forth above, or waive the requirement to obtain informed
consent provided the IRB finds and documents that:
1. The research or demonstration project is to be conducted by or subject to the approval of
state or local government officials and is designed to study, evaluate, or otherwise
examine:
a. public benefit or service programs;
b. procedures for obtaining benefits or services under those programs;
c. possible changes in or alternatives to those programs or procedures; or
d. possible changes in methods or levels of payment for benefits or services under those
programs; and
2. The research could not practicably be carried out without the waiver or alteration.
IRB Guidance and Procedures
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Additionally, an IRB may approve a consent procedure, which does not include, or which alters,
some or all of the elements of informed consent set forth in this section, or waive the
requirements to obtain informed consent provided the IRB finds and documents that:
1.
2.
3.
4.
The research involves no more than minimal risk to the subjects;
The waiver or alteration will not adversely affect the rights and welfare of the subjects;
The research could not practicably be carried out without the waiver or alteration; and
Whenever appropriate, the subjects will be provided with additional pertinent information
after participation.
Assent
Assent means a child’s affirmative agreement to participate in research. Mere failure to object
should not, absent affirmative agreement, be construed as assent. At University, assent is sought
when the child is 3 years old. Documentation of the assent is advised. (See appropriate
appendices)
The IRB shall determine that adequate provisions are made for soliciting the assent of the
children, when in the judgment of the IRB the children are capable of providing assent. In
determining whether children are capable of assenting, the IRB shall take into account the ages,
maturity, and psychological state of the children involved. This judgment may be made for all
children to be involved in research under a particular protocol, or for each child, as the IRB
deems appropriate. If the IRB determines that the capability of some or all of the children is so
limited that they cannot reasonably be consulted or that the intervention or procedure involved in
the research holds out a prospect of direct benefit that is important to the health or well-being of
the children and is available only in the context of the research, the assent of the children is not a
necessary condition for proceeding with the research. Even where the IRB determines that the
subjects are capable of assenting, the IRB may still waive the assent requirement under
circumstances in which consent may be waived in accord with §46.116 of Subpart A.
Revisions
Study protocols may be changed during the course of the research. When these changes require
revision of the informed consent document, the chair of the IRB must be contacted. The changes
may be approved through an expedited review.
VIII. Reporting Decisions
General Reporting
The PI will be informed of the IRB’s decision regarding his/her protocol by email. The IRB’s
decision cannot be overruled by any person or committee. Should the IRB disapprove a
protocol, the PI may not begin the project. The PI of a disapproved project has two options.
First, the PI may request the board reconsider the determination. This would require that the PI
provide a written response that addresses the IRB’s concerns. The IRB will review the response
and provide a decision. Should the determination be “not approved,” there would be no further
recourse. The second option is for the PI to adjust the protocol to meet the IRB’s concerns and
resubmit it for consideration.
IRB Guidance and Procedures
28
On an annual basis, the IRB Chair will provide the Dean of Graduate Studies and Research a
report of the IRB’s activities. The report will include the name of the PI, the title of the
protocols and its disposition.
Compliance Reporting
The IRB enacts the following reporting conditions when one or more of the following occurs:
1. The IRB determines an unanticipated problem report represents an unanticipated problem
involving risks to participants or others; or
2. The IRB makes a determination of serious or continuing non-compliance with the federal
regulations,University policies and procedures, or IRB determinations; or
3. The IRB, the IRB Chair, or Dean of Graduate Studies and Research suspends or
terminates a previously approved research protocol.
The IRB Chair will prepare a report within 21 days of the incident. The report is delivered to the
PI and copied to:
1.
2.
3.
4.
5.
6.
7.
Dean, Graduate Studies and Research
Dean of PI’s School
Chairman of PI’s Department
Chair of the IRB
Project File
Faculty Advisor (if applicable)
Any federal department that has oversight due to funding, conduct, or assurance,
including but not limited to, OHRP, NIH, FDA, Department of Education, etc.
8. The complainant (when necessary)
Unanticipated problems are appropriately reported to the IRB, and are reflected in the
committee’s minutes.
IX.
Determining Which Projects Require More Than Annual Review
The IRB will make this determination based on the potential risks to the human subjects. Any
study requiring more than annual review will have a limited set approval time period. The
frequency of continuing review is to be determined by the IRB appropriate to the protocol under
review. The IRB will require more than annual review because of any of the following:





Noncompliance history
Margin of risk / benefit ration
Type of procedures being used
Use of chemicals and/or drugs
As necessitated by the protocol
IRB Guidance and Procedures
29
X.
Determining which projects require additional verification
The IRB will make this determination based on the potential risks to the human subjects or noncompliance history from any of the listed investigators.
Once additional verification is required, the IRB will work with the Dean of the Principal
Investigator’s department to determine who will be assigned the oversight responsibilities of the
project. The IRB will request participation from the independent person. Once the observer is
retained, he/she will receive the necessary training to ensure that they are able to observe the
research in an independent manner. He/she will have to provide the IRB the following
information:




Date of observations
Who was observed
What was observed
Was the procedures in compliance with the guidelines set by the IRB
After the observation is complete, the observer will forward his/her report to GSP for
administrative processing. The report will be forwarded to the IRB for review and
determination. The IRB may determine that the additional verification provided:



XI.
sufficient reassurance that the project is being executed in compliance
will need to continue with verification
that the project should be discontinued immediately
Reporting changes
Occasionally, the best-laid plans will require some adjustments. Should the proposed and
approved procedures not reflect what is needed to perform successful research with human
subjects, the Principal Investigator (PI) must notify the IRB immediately before changing
anything.
The PI will need to complete the IRB protocol form and indicate that it is a revision. The project
description will need to reflect the requested changes only. After completing the form and
providing any necessary additional documents, like a revised consent form, the PI will forward
the protocol package to IRB Chair for processing.
IRB Chair will review the application for determination. Once a determination has been reached,
the IRB Chair will notify the PI of the IRB’s decision.
IRB Guidance and Procedures
30
XII. Non-compliance and Unanticipated Problem Reporting
The IRB requires PIs to promptly report a summary of each unanticipated problem to the IRB
using the IRB Unanticipated Problem Report (Appendix E) and on the EU IRB homepage at
www.edinboro.edu Keyword IRB
DEFINITIONS: The University defines an “unanticipated problem involving risks to participants
or others” as an event that was (1) unforeseen, (2) more likely than not related to the research,
(3) either caused harm to participants or others, or placed them at increased risk of harm.
An unanticipated problem may be any of the following:
1. An actual unforeseen harmful or unfavorable occurrence to participants or others that
relates to the research protocol (injuries, side effects, deaths);
2. An unforeseen development that potentially increases the likelihood of harm to
participants or others in the future;
3. A problem involving data collection, data storage, privacy, or confidentiality;
4. A participant complaint about IRB approved research procedures;
5. New information about a research study (e.g., a publication in the literature, interim
findings, safety information released by the sponsor or regulatory agency, or safety
monitoring report) that indicates a possible increase in the risks of the research;
6. Changes in approved research initiated without IRB review and approval to eliminate
apparent immediate hazards to the participant;
7. Incarceration of a subject.
The process for reporting an unanticipated problem is as follows:
A. PI’s reporting responsibilities
1. Within 5 days of knowledge of the unanticipated problem, the PI is asked to submit the
Unanticipated Problem Report to the IRB Chair.
2. Expected adverse events (adverse events described in the risks section of the consent
form) are to be reported in the annual continuing review application.
B. IRB reviewing and reporting responsibilities
1. Unanticipated problems not meeting the definition above involving risks to participants
or others (foreseen, not related to the research procedures, and caused harm to
participants or others, or place them at increased risk of harm): The IRB Chair will confer
to determine if the reported unanticipated problem meets the criteria of the definition that
an event was
a. unforeseen,
b. more likely than not related to the research,
c. caused harm to participants or other, or placed them at an increased risk of harm.
2. For those unanticipated problems failing to meet the criteria, IRB Chair will work with
the PI and work towards a satisfactory and reasonable resolution for all parties.
3. If the event is determined to be an unanticipated problem, it will be referred to the full
IRB for review. The IRB Chair will formally report back to the PI all submitted
unanticipated problem reports determined to be not unanticipated problems.
IRB Guidance and Procedures
31
4. Unanticipated problems found to meet the definition above are placed on the agenda for
the next IRB review.
a. The unanticipated problem form is distributed to all IRB members in advance of the
meeting. All IRB members will be provided with a copy of the report. The primary
reviewer will be provided with a copy of the report, the protocol with all approved
modifications, and currently approved consent documents.
b. If after reviewing the information, the IRB determines that the event was not an
unanticipated problem, the issue will be handled administratively by the IRB Chair.
c. The IRB votes to take one of the following actions:
i.
Accept the actions taken by the PI to report and resolve the incident;
ii. Notifying current participants when information about the unanticipated
problem might affect their willingness to continue to take part in the research;
iii. Alter the continuing review schedule
iv. Peer review monitoring
v. Approve with explicit changes:
(1) Notification of previous subjects;
(2) Modification of consent and/or protocol;
vi. Suspension of some or all research activities
vii. Approve the study for a shorter period of time (e.g. 6 months versus 12
months);
viii. Terminate the study for cause.
2. The IRB follows the Reporting Policy procedures taken when reporting unanticipated
problems that involve risk to participants or others.
3. Deliberations and determinations of the IRB will be fully documented in the minutes.
Additional Reporting Requirements:
1. If a sponsor funds or supports the study, then the PI is responsible for notifying the
sponsor. For any studies under FDA jurisdiction, it is the PI and / or sponsor’s
responsibility to notify the FDA within 24 hours.
2. Similarly, if the study is a multi-site project, and the unanticipated problem occurs at a
site other than University, then the sponsor is required to inform investigators of
unanticipated problems or reactions that occur at other sites. When PIs are informed of
unanticipated problem(s) in sponsor safety memos or other correspondence, then the PI
must notify the IRB using the IRB Unanticipated Problem Report. Reports to the IRB
should be submitted as promptly as possible after receipt of the report from the sponsor.
3. Note that notifying the IRB does not relieve the PI from his/her responsibility to notify
the sponsor and / or FDA (as applicable).
XIII. Internal Audits
The School of Graduate Studies and Research will audit the IRB records on a yearly basis to
ensure that University is in compliance with all federal regulations governing human subjects of
research and institutional IRB policies and procedures.
IRB Guidance and Procedures
32
XIV. Research Involving Multiple Sites or Collaborating Agencies or
Institutions
Any research that is performed on Edinboro University’s campus must be reviewed by the IRB.
There are two types of multiple sites/collaborating agencies research. The first type of review is
when Edinboro is selected to be the IRB reviewer for multiple PASSHE sites. The second type
of review is for any external person wishing to use the University’s faculty, staff and/or students
for their research.
PASSHE site review
The IRB Chairs of the PASSHE schools agreed to rotate the review of multi-site proposals. What this
means is that PASSHE will designate an IRB at a particular school as the IRB of records for the proposal.
The principal investigators will need to submit their protocol to that school for consideration and
approval.
Once approval is received, the principal investigators need to provide that approval to the institutions
involved in their research.
External Person requesting review
External people may approach a faculty, staff, or administrator and request to conduct research involving
the University’s employees and/or students. Such requests will need EU IRB approval prior to
conducting the research at EU
IRB Guidance and Procedures
33
XV. Appendices
A. US Department of Health and Human Services (DHHS), Office for Human Research
Protections (OHRP), Human Subject Regulations Decision Charts
B. Glossary
C. IRB Protocol Form
D. IRB Research Description Guidance
E. IRB Approved Project Renewal Form
F. EU IRB Second Review Form
G. OHRP guidance on when to report unanticipated problems
H. Unanticipated Problems Report Form
I. Consent template
J. Group consent template
K. Assent sample under 3-10 years template
L. Assent sample 11-18 years template
M. Online survey consent template
IRB Guidance and Procedures
34
OHRP Charts
IRB Guidance and Procedures
Appendix A
35
OHRP Charts
IRB Guidance and Procedures
Appendix A
36
OHRP Charts
IRB Guidance and Procedures
Appendix A
37
OHRP Charts
IRB Guidance and Procedures
Appendix A
38
OHRP Charts
IRB Guidance and Procedures
Appendix A
39
OHRP Charts
IRB Guidance and Procedures
Appendix A
40
OHRP Charts
IRB Guidance and Procedures
Appendix A
41
OHRP Charts
IRB Guidance and Procedures
Appendix A
42
OHRP Charts
IRB Guidance and Procedures
Appendix A
43
OHRP Charts
IRB Guidance and Procedures
Appendix A
44
OHRP Charts
IRB Guidance and Procedures
Appendix A
45
Glossary
Appendix B
Abstain is when an IRB member does not vote upon a protocol under review.
Agent is a representative who acts on behalf of other persons or organizations.
Assent is the affirmative agreement by a child, or an adult who lacks full decision-making
capacity to participate in a research or clinical investigation. Mere failure to object may
not, absent affirmative agreement, be construed as assent. [45 CFR §46.402(b)] [21 CFR
§50.3(n)]
Assurance is an agreement between an Organization and a federal agency that stipulates that the
Organization will comply with the agency's regulatory requirements. [45 CFR §46.103]
Children are persons who have not attained the legal age for consent to treatments or procedures
involved in research or clinical investigations, under the applicable law of the jurisdiction
in which the research or clinical investigations will occur.
Conflict of Interest a PI or Co-PI is said to have a conflict of interest whenever that PI or IRB
member, his or her spouse, or dependent child falls under any of the following
conditions:
• Is an investigator or sub-investigator on the protocol (IRB members only, not applicable
to PIs);
• If the IRB member, the member's spouse, or dependent children are involved in the
conduct of research;
• Has entered into a financial arrangement with the sponsor or agent of the sponsor,
whereby the outcome of the study could influence the value of the economic
interest;
• Acts as an officer, director, or agent of the sponsor;
• Has any equity interest in the sponsor that when aggregated for the investigator or
member and the investigator's or member's spouse and dependent children is
$10,000 or greater as determined through reference to public prices (e.g., NYSE
or NASDAQ), any amount if the value cannot be determined through reference to
public prices, or 5% or greater of the equity of the sponsor;
• Has received payments or other incentives from any sponsor when aggregated for the
investigator or member and the investigator's or member's spouse and dependent
children that of $10,000 or greater;
• Has identified him or herself for any other reason as having a conflicting interest.
Consent/Permission - The agreement of participant or the parent(s) of or guardian to the
participation of their child or ward in the research/clinical investigation.
Continuing Review is the periodic review of a research study by an IRB to evaluate whether the
study continues to meet organizational and regulatory requirements. Federal regulations
stipulate that continuing review should be conducted at intervals appropriate to the level
of risk involved in the study, and not less than once per year. [45 CFR §46.109 (e)] [21
CFR §56.109(f)]
IRB Guidance and Procedures
46
Glossary
Appendix B
Data and Safety Monitoring plan (DSMP) is a process that reviews the integrity, safety, and
progress of a research protocol with the purpose of protecting participants during the
course of study and makes decisions regarding continuance, modification, or stopping of
the study for reasons of efficacy or safety. A DSMP may take a variety of forms, such as
an investigator reviewing his or her own data, a review by another faculty member not
otherwise involved in the conduct of the research, a committee of investigators, an
independent committee, or an independent data and safety monitoring board. The type of
safety monitoring that is adequate depends on the specifics of the research.
Dead Fetus means a fetus that exhibits neither heartbeat, spontaneous respiratory activity,
spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.
Decision Making Capacity is the ability to understand the choices presented, to appreciate the
implications of choosing one alternative rather than another, and to make – and
communicate -- a choice.
Delivery means complete separation of the fetus from the woman by expulsion, extraction, or
any other means.
Emancipated Minor A minor can petition to be "emancipated,” but must do so by filing a
petition and meeting the statutory requirements of Pennsylvania law. Only if a minor
were "emancipated" as described above; or was adjudicated to be an adult for the purpose
of criminal prosecution under the Juvenile Justice Code would the state of Pennsylvania
consider the minor an "adult."
Engaged in Research An institution becomes “engaged” in human subjects research when its
employees or agents (all individuals performing institutionally designated activities or
exercising institutionally delegated authority or responsibility) (i) intervene or interact
with living individuals for research purposes; or (ii) obtain individually identifiable
private information for research purposes [45 CFR 46.102(d),(f)]. Solicitation of consent
by performance site staff would be considered engagement.
FDA means the Food and Drug Administration.
Federal Wide Assurance (FWA) means a document that fulfills the requirements of 45 CFR
Part 46 and is approved by the Secretary of Health and Human services. Edinboro
University of Pennsylvania has an approved FWA on file with DHHS.
Fetus means the product of conception from implantation until delivery.
Guardian means a person who is appointed guardian of the person and/or the estate of an
incapacitated person under a court order.
HIPAA is the Health Insurance and Portability and Accountability Act of 1996 (HIPAA) that
protects the privacy of a research participant's health information.
Human Subject Research is defined by the institution as any activity that either:

Meets the DHHS definition of “Research” and involves “Human Subjects” as defined by
DHHS; or

Meets the FDA definition of “Research” and involves “Human Subjects” as defined by
FDA;
IRB Guidance and Procedures
47
Glossary
Appendix B
Human Subject is a human subject is defined by DHHS as a living individual about whom a
research investigator (whether a professional or a student) obtains data through
intervention or interaction with the individual or from individually identifiable
information.

“Intervention” as defined by DHHS regulations means both physical procedures by
which data are gathered (for example, venipuncture) and manipulations of the subject
or the subject’s environment that are performed for research purposes. [45 CFR
46.102(f)]

“Interaction” as defined by DHHS regulations means communication or interpersonal
contact between investigator and subject. [45 CFR 46.102(f)]

“Private information” as defined by DHHS regulations means information about
behavior that occurs in a context in which an individual can reasonably expect that no
observation or recording is taking place, and information which has been provided for
specific purposes by an individual and which the individual can reasonably expect
will not be made public (for example, a medical record). [45 CFR 46.102(f)]

“Identifiable information” as defined by DHHS means information that is
individually identifiable (i.e., the identity of the subject is or may readily be
ascertained by the investigator or associated with the information).
A human subject is defined by FDA is an individual who is or becomes a participant in
research, either as a recipient of a test article or as a control who may be either a healthy
human or a patient. [21 CFR 50.3(g), 21 CFR 56.102(e)]. A human subject according to
FDA includes an individual on whose specimen a medical device is used [21 CFR
812.3(p)].
Informed Consent means the agreement to participate in research that is made voluntarily by an
individual with legal and mental competence and the requisite decision-making capacity,
after disclosure of all material information about the research. Informed Consent means
the knowing consent of an individual or his legally authorized representative, so situated
as to be able to exercise free power of choice without undue inducement or any element
of force, fraud, deceit, duress, or other form of constraint or coercion.
Institution means any public or private institution or agency (including Federal, State, and local
Government agencies).
Institutional Review Board (IRB) is an independent committee comprised of scientific, nonscientific, and non-affiliated members established according to the requirements of
federal regulations. Any board, committee, or other group formally designated by an
organization to review research involving humans as participants, to approve the
initiation of and conduct periodic review of such research. [45 CFR §46.402(g)] [21 CFR
§50.3(i)]
Interaction includes communication or interpersonal contact between investigator and subject.
Intervention includes both physical procedures by which data are gathered (for example,
venipuncture) and manipulations of the subject or the subject’s environment that are performed
for research purposes.
IRB Guidance and Procedures
48
Glossary
Appendix B
Investigational Device Exemption (IDE) The exemption by which the FDA permits a device
that otherwise would be required to comply with a performance standard or to have
premarket approval, to be shipped lawfully in interstate commerce for the purpose of
conducting investigations of that device. (21 CFR part 812)
Investigational New Drug (IND) – An investigational drug or biologic application by which the
FDA allows testing in human beings of a substance having an effect in the body. (21 CFR
part 312, subpart B)
Investigator is a faculty member, principal investigator, or other researcher responsible for the
design, conduct, or reporting of the research or other educational activity proposed for
funding. In some cases, even graduate students and postdoctoral fellows may be
responsible for the design, conduct, or reporting of research such that the graduate
student or postdoctoral fellow is considered to be an Investigator under this policy and
may be required to complete a financial disclosure statement. The principal investigator
on each grant or contract should ensure that all researchers on the project are aware of
and comply with this policy.
Key Personnel are defined as the principal investigators, co-principal investigators, and others,
specified within each project, as having decision-making power over the investigation.
Legally Authorized Representative means an individual, judicial, or other body authorized
under applicable law to consent on behalf of a prospective participant to that subject's
participation in the procedures involved in the research. [45 CFR §46.402(c)] [21 CFR
§50.3(l)].
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 the
participant's daily life or during the performance of routine physical or psychological
examinations or tests. [45 CFR §46.102(i)] [21 CFR §50.3(k)] In research involving
prisoners, minimal risk is also 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. [45 CFR §46.303(d))]
Minimal Risk Research is Research in which 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 (of normal subjects) or during the performance of
routine physical or psychological examinations or tests. Clinical investigations are
usually more than minimal risk.
Monitoring may refer either to data monitoring or monitoring the conduct of research. Data
monitoring means the systematic tracking of data from a research study with the intent to
evaluate the harms and benefits that accrue to participants. Monitoring the conduct of
research mean the systematic tracking of the implementation of a research study with the
intent to maintain compliance with the protocol and regulations, and maintain the
integrity of the data.
Neonate means a newborn.
Nonviable Neonate means a neonate after delivery that, although living, is not viable.
IRB Guidance and Procedures
49
Glossary
Appendix B
OHRP means the Office for Human Research Protections. This is an office in the Office of the
Secretary of Health and Human Services that is responsible for regulatory oversight of
human subject research.
Parent means a child's biological or adoptive parent.
Permission means the agreement of parent(s) or guardian to the participation of the child in the
research or clinical investigation.
Pregnancy encompasses the period of time from implantation until delivery. A woman shall be
assumed to be pregnant if she exhibits any of the presumptive signs of pregnancy, such as
missed menses, until the results of pregnancy testing are negative or until delivery.
Principal Investigator (PI) is that individual with signatory power on all documents related to
the research project. This person has final authority over the project is accountable for the
overall conduct of a particular research protocol and is accountable for the overall
conduct of a study. The principal investigator accepts responsibility for training all
personnel associated with the study in compliance with the human subjects regulations of
45 CFR 46. "Co-principal investigator" is that individual who co-signs on documents
related to the project or who may be designated as a co-principal investigator in grantrelated documents. This person has decision making power with regard to the conduct of
the research. The co-principal investigator reports to the principal investigator who is
ultimately responsible for the conduct of the research.
Others with decision-making power may include such persons as project managers,
directors, and trainers. These designations are not all-inclusive. Operationally, these
individuals have some oversight responsibility for one or more portions of the project.
Individuals in this category are determined uniquely for each project by the principal
investigator.
Private information includes information about behavior that occurs in a context in which an
individual can reasonably expect that no observation or recording is taking place, and
information which has been provided for specific purposes by an individual and which
the individual can reasonably expect will not be made public (for example, a medical
record). Private information must be individually identifiable (i.e., the identity of the
subject is or may readily be ascertained by the investigator or associated with the
information) in order for obtaining the information to constitute research involving
human subjects."
Protocol is a formal plan that includes, at minimum, the objectives, rationale, design, methods,
and other conditions for the conduct of a research study. (ICH-GCP)
Quality Improvement (QI) Periodic examination of organizational activities, policies,
procedures and performance to identify best practices and target areas in need of
improvement; includes implementation of corrective actions or policy changes when
needed. (Preserving Public Trust, 2001)
Research is defined by DHHS is a systematic investigation, including research development,
testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Research as defined by FDA is means any experiment that involves a test article and one
or more human subjects, and that either must meet the requirements for prior submission
IRB Guidance and Procedures
50
Glossary
Appendix B
to the Food and Drug Administration under section 505(i) or 520(g) of the Federal Food,
Drug, and Cosmetic Act, or need not meet the requirements for prior submission to the
Food and Drug Administration under these sections of the Federal Food, Drug, and
Cosmetic Act, but the results of which are intended to be later submitted to, or held for
inspection by, the Food and Drug Administration as part of an application for a research
or marketing permit. The terms research, clinical research, clinical study, study, and
clinical investigation are synonymous for purposes of FDA regulations. [21 CFR 50.3(c),
21 CFR 56.102(c)]
Experiments that must meet the requirements for prior submission to the Food and Drug
Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act
means any use of a drug other than the use of an approved drug in the course of medical
practice. [21 CFR 312.3(b)]
Experiments that must meet the requirements for prior submission to the Food and Drug
Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act
means any activity that evaluates the safety or effectiveness of a device. [21 CFR
812.2(a)]
Research Staff are individuals who are delegated responsibility by the Investigator for specific
research tasks.
Secretary means the Secretary of Health and Human Services and/or any other officer or
employee of the Department of Health and Human Services to whom authority has been
delegated.
Serious Unanticipated problem (SAE) -- Any event that results in death, a life-threatening
situation, hospitalization or prolonged hospitalization, persistent or significant
disability/incapacity or a congenital anomaly/birth defect or requires medical intervention
to prevent one of the outcomes listed above. SAEs require prompt reporting to the
Sponsor, the FDA, and the IRB.
Site means a place whose staff, facilities, or private records of identifiable individuals are
engaged in the conduct of research; or, a site that receives HHS funds. The performance
site is the actual place where the research activity takes place (e.g., clinic or hospital).
The performance site’s location may be different from the location where the IRB review
takes place.
Sponsor is an entity who takes responsibility for and initiates research, but who may not conduct
the investigation. A person other than an individual (e.g., corporation or agency) that uses
one or more of its own employees to conduct research it has initiated is considered to be a
sponsor, and the employees are considered to be investigators. [21 CFR §50.3(k)] [21
CFR §50.102(j)] [21 CFR §312.3]
Sponsor Investigator is an individual who both initiates and actually conducts, alone or with
others, a clinical investigation, i.e., under whose immediate direction the test article is
administered or dispensed to, or used involving, a subject. The term does not include any
person other than an individual, e.g., it does not include a corporation or agency. (21 CFR
56.102 (k))
Student is any individual who is enrolled at Edinboro University of Pennsylvania.
IRB Guidance and Procedures
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Glossary
Appendix B
Staff is all other employees of Edinboro University of Pennsylvania, including faculty.
Unanticipated Problems (UP) -- The University defines an unanticipated problem as any of the
following:

An actual unforeseen harmful or unfavorable occurrence to participants or others that
relates to the research protocol (injuries, side effects, deaths);

An unforeseen development that potentially increases the likelihood of harm to
participants or others in the future.

A problem involving data collection, data storage, privacy, or confidentiality

A participant complaint about IRB approved research procedures

New information about a research study (e.g., a publication in the literature, interim
findings, safety information released by the sponsor or regulatory agency, or safety
monitoring report) that indicates a possible change in the risks of the research;

Changes in approved research initiated without IRB review and approval to eliminate
apparent immediate hazards to the participant
Unanticipated Problem Involving Risks to Participants or Others is an event that was (1)
unforeseen, (2) related to the research procedures, (3) either caused harm to participants
or others, or placed them at increased risk of harm.
Unexpected Unanticipated Problem (UAE) -- Any unanticipated problem that was
unanticipated or not previously observed (e.g., not included in the consent form or
investigator brochure). This includes adverse effects that occur more frequently or with
greater severity than anticipated. Events that are unexpected and serious require prompt
reporting to the Sponsor, the FDA, and the IRB.
Test Article means any drug (including a biological product for human use), medical device for
human use, human food additive, color additive, electronic product, or any other article
subject to regulation under the Federal Food Drug and Cosmetic Act or under Sections
351 and 354- 360F of the Public Health Services Act (42 USC 262 and 263b-263n).
Viable as it pertains to the neonate, means being able, after delivery, to survive (given the
benefit of available medical therapy) to the point of independently maintaining heartbeat
and respiration. The Secretary may from time to time, taking into account medical
advances, publish in the Federal Register guidelines to assist in determining whether a
neonate is viable for purposes of this subpart. If a neonate is viable, then it may be
included in research only to the extent permitted and in accordance with the requirements
of subparts A and D of this part.
Vulnerable Subjects/Participants mean individuals who lack the capacity to provide informed
consent or whose willingness to participate in research may be subject to undue
influenced or coercion. Vulnerable subjects include, for example, children, prisoners,
individuals with emotional or cognitive disorders/impairments, and economically or
educationally disadvantaged persons. [45 CFR §56.107] [45 CFR §56.111(a)(3)] [45
CFR §56.111(b)] [21 CFR §56.107] [21 CFR §56.111(a)(3)] [21 CFR §56.111(b)]
IRB Guidance and Procedures
52
IRB Protocol Form
Appendix C
IRB#:
For GSP use only
Edinboro University of Pennsylvania
Application for Institutional Review Board (IRB) Approval of Human Subjects Research
Date:
Type:
New
Revision
Renewal
Title of Study:
RESEARCHERS’ INFORMATION: For student and non-university employee’s applications, list an
Edinboro University advisor or sponsor as Principal Investigator.
Principal Investigator:
Co-Investigator:
Co-Investigator:
Last name:
First name:
Department:
Affiliation:
Phone:
E-mail:
Fax:
Mailing Address:
Faculty/Staff/Student:
Completed CITI
training:
Yes
No
Yes
No
Yes
No
*Applications will not be forwarded to the IRB committee for review until CITI training is verified and
the application is complete.
Students:
1.
2.
3.
4.
List any other individuals who will assist or view data:
1.
2.
3.
PROJECT TYPE
Type of Project:
Faculty/Staff project to be submitted for external funding
(Include copies of grant applications with this application)
-Funding institution or agency:
-Date of grant submission:
Faculty/Staff project NOT to be submitted for external funding
Master’s thesis
Undergraduate research project
Class project (Provide course name and number):__________________________________
Other_____________________________________________________________________
Revised 8/11/2014
IRB Guidance and Procedures
53
IRB Protocol Form
IRB Guidance and Procedures
Appendix C
54
IRB Protocol Form
IRB Guidance and Procedures
Appendix C
55
IRB Protocol Form
IRB Guidance and Procedures
Appendix C
56
IRB Research Description Guidance
IRB Guidance and Procedures
Appendix D
57
IRB Research Description Guidance
IRB Guidance and Procedures
Appendix D
58
IRB Research Description Guidance
IRB Guidance and Procedures
Appendix D
59
IRB Research Description Guidance
IRB Guidance and Procedures
Appendix D
60
IRB Research Description Guidance
IRB Guidance and Procedures
Appendix D
61
IRB Research Description Guidance
IRB Guidance and Procedures
Appendix D
62
IRB Research Description Guidance
IRB Guidance and Procedures
Appendix D
63
IRB Approved Project Renewal Form
Appendix E
Edinboro University
Institutional Review Board
Human Subjects Protocol Continuing Review Report
Principal Investigator:
Click here to enter text.
IRB Protocol #:
Click here to enter text.
IRB Protocol Title:
Click here to enter text.
IRB Approval Category:
Expedited
Co-Principal Investigator:
Click here to enter text.
Date of Original Approval:
Click here to enter text.
Full Review
1) Current Status of Research:
Research extension request (Check if you would like to request an extension on an already approved research)
Check whichever apply:
project has not yet started
participant recruitment and data collection is on-going
participant enrollment is closed but data collection procedures are still underway
all data collection activities have been completed; renewal is needed for data analysis only
other (please explain Click here to enter text.
2) How many subjects have participated up to this date? Click here to enter text.
3) Have any subjects withdrawn from participation? Yes
If yes, please describe: Click here to enter text.
No
4) Have there been any unanticipated problems or adverse effects on the subjects? Yes
If yes, please describe: Click here to enter text.
5) Are the current informed consent/assent documents still accurate and complete? Yes
If no, please include the new consent. Click here to enter text.
6) Is the study protocol being followed as approved? Yes
If no, please describe: Click here to enter text.
No
No
7) Did any subjects enrolled on this protocol have complaints? Yes
If yes, please describe: Click here to enter text.
8) Have any changes to personnel been made? Yes
If yes, please describe: Click here to enter text.
No
No
No
9) Expected date of complete: Click here to enter text.
10) Will there be any changes to the previously approved protocol? Yes
If yes, describe any proposed changes to the project:
Click here to enter text.
No
Signatures:
I understand that I am the primary responsible party for legal and ethical performance of this project. I certify that I this information is complete
and correct, and confirm that I will continue the project in accordance with all governing laws, regulations and institutional policies.
9/4/14
Principal Investigator’s Signature
Email can serve as an electronic signature
Date
Return completed form to the EU IRB Chair at [email protected]
IRB Guidance and Procedures
64
EU IRB Second Review Form
Appendix F
IRB# ___________________
Edinboro Unive rsity
Application for Institutional Review Board (IRB) Approval of Human Subjects Research
Review form for proposals approved by an outside institution.
* Please complete all designated areas to avoid any delays in processing
Date:
IRBof original approval:
Title of Study:
Researchers’ Information
Principal Investigator (PI)
Co-Investigator
Last name
First name
Department
Institution
Faculty/ Staff
Phone
E-mail
Fax
Mailing Address
1. Please attach the original IRBproposal and approval notification to thisdocument. E-mail all
information to the IRBChair at [email protected]
2. Please include both researchers’ signatures- electronic signaturesare permitted
__________________________________________________________________________________
Principal Investigator (PI) Signature
Date
Co-Investigator Signature
IRB Guidance and Procedures
Date
65
OHRP – what should be reported
IRB Guidance and Procedures
Appendix G
66
Unanticipated Problems Report Form
Appendix H
Unanticipated Problems Report
Human Subjects Research
Institutional Review Board
This form is to be used when reporting unanticipated problems in Humans Subjects Research to the
Institutional Review Board. Please complete the form in its entirety and submit it to the Chair of
the EU IRB. If you feel additional documents will be useful to the IRB, they may be included. If you
need further assistance in completing this form or need any other information regarding human
subjects research, please contact the Chair of the EU IRB at [email protected]
Study Number:
Project Title:
Principal Investigator:
Co-Principal Investigators:
1.
2.
3.
4.
5.
Date of unanticipated problem:
Type of unanticipated problem:
Did the problem occur at a EUP site?
Did the problem involve a EUP PI?
Provide a summary of the problem(s):
Yes
Yes
No
No
6. Is the problem related to the study and its procedures, protocols, etc.?
Yes
No
7. Is the problem already described in the consent/authorization forms?
Yes
No
8. If the problem isn’t already described in the consent/authorization forms, should the
consent/authorization form be updated?
Yes
No
9. Should the research study be changed in a way to reflect this problem?
Yes
No
10. Will previously enrolled subjects:
a. Be given this information?
Yes
No
b. Be asked to re-consent/authorize?
Yes
No
11. Has there been a change in the risk/benefit ratio?
Yes
No
12. Have any correct actions or measure been taken to address this unanticipated problem and
to prevent future problems?
Yes
No
13. Provide a brief summary of corrective measures: (Please limit to eight lines or less.)
IRB Guidance and Procedures
67
Consent template
Appendix I
EDINBORO UNIVERSITY OF PENNSYLVANIA
Edinboro, Pennsylvania
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
Title of Study: Use a general title of the study.
Principal Investigator:
Co-investigator(s):
Introduction
This section makes it clear that a study is to be conducted and the individual is being
“asked” to participate. It can also indicate why the individual was chosen.
You are being asked by _____ to be in a research study. You should understand that this
study involves research. This consent describes your role as a participant in the study.
Purpose of The Study
Include purpose(s) (either short or long term) of the research AND the expected duration
of participation including any follow-up.
What Will Happen During the Study?
Outline the procedures, in a time-sequence fashion. If there are two groups with different
treatments, outline how an individual is selected for each group. Indicate if any
procedures are experimental. This should be VERY clear and in terms that someone who
is not familiar with the study area would understand. Think - What information would I
want to know about a study before agreeing to participate?
What Are the Possible Risks or Discomforts?
Explain the most serious and common risks that could happen as a consequence of
participating in the study (include physical, emotional, psychological, social, financial,
and spiritual effects).
What Are the Possible Benefits of Being in This Study?
Include benefits to the participant OR to society as a whole.
Are Other Treatments Available? (Include only if appropriate - if not delete)
You may choose not to have any treatment.
How Will the Data Collected Be Kept Confidential?
You should know that your name will be kept as confidential as possible, within local,
state and federal laws. Records that identify you and this signed consent form may be
looked at by the Edinboro University Institutional Review Board (IRB). The results of
this study may be shared in aggregate form at a meeting or in a journal, but your name or
individual results/score(s) will not be revealed. (Explain how information from the study
IRB Guidance and Procedures
68
Consent template
Appendix I
will be kept, if pseudonyms will be used how that will work, and if ultimately the data
will be destroyed).
What Happens If I Have More Questions?
Your questions about a research-related injury or the research study will be answered
by_____ at (814) _______. If you have a question about your rights as a research
participant that you need to discuss with someone, you can call the Edinboro University
Institutional Review Board at (814) 732-2856 or at [email protected]
What Will Happen If You Decide Not To Be in the Study?
Your participation is strictly voluntary. Also, you may decide to quit at any time without
any penalty, retribution, or repercussion.
SUBJECT’S STATEMENT
I had a chance to ask questions about the study. These questions were answered to my
satisfaction.
I realize that being part of this study is my choice. I am at least 18 years of age. I have read the
consent form. I was given a copy of this consent form for my own records.
SUBJECT’S SIGNATURE
DATE
Rev. 09/04/14
IRB Guidance and Procedures
69
Group Consent template
APPENDIX J
EDINBORO UNIVERSITY OF PENNSYLVANIA
Edinboro, Pennsylvania
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
Title of Study: Use the exact name of the study as it appears in the IRB application
Principal Investigator:
Co-investigator(s):
Introduction
This section makes it clear that a study is to be conducted and the individual is being
“asked” to participate. It can also indicate why the individual was chosen. Who are you
and why are you conducting this research?
You are being asked by _____ to be in a research study. You should understand that this
study involves research. This consent describes your role as a participant in the study.
Purpose of The Study
Include purpose(s) (either short or long term) of the research AND the expected duration
of participation including any follow-up.
What Will Happen During the Study?
Outline the procedures, in a time-sequence fashion. If there are two groups with different
treatments, outline how an individual is selected for each group. Indicate if any
procedures are experimental. This should be VERY clear and in terms that someone who
is not familiar with the study area would understand. Think - What information would I
want to know about a study before agreeing to participate?
An example statement:
(Researcher name here) will supervise and facilitate several small focus groups consisting of #
recruited participants. Using a series of interview questions, you and other members of the
focus group will be asked to describe and discuss your _______________:
Specific topics to be explored include: ___________ (Place sub topics to be discussed or
more specific areas the focus group will cover here).
All focus group interviews will be audio recorded for later transcription and analysis. Your
identity in verbatim transcriptions will be concealed by a coding system.
What Are the Possible Risks or Discomforts?
Explain the most serious and common risks that could happen as a consequence of
participating in the study (include physical, emotional, psychological, social, financial,
and spiritual effects).
An example statement:
Focus groups are public in nature. The risk of discussed materials being disseminated outside
the focus group is a potential risk. However, in reported findings, your identity and the
confidentiality of information you disclose in your focus group will be maintained by a coding
IRB Guidance and Procedures
70
Group Consent template
APPENDIX J
system. The content of the information you disclose or recall or that is disclosed or recalled by
one or more participants during focus group discussions may create anxiety, fear, discomfort,
and/or psychological distress. You will be provided with a handout of campus resources where
help can be sought should you choose to follow up on any emotional discomfort.
What Are the Possible Benefits of Being in This Study?
Include benefits to the participant OR to society as a whole.
How Will the Data Collected Be Kept Confidential?
Explain how information from the study will be kept, if pseudonyms will be used how
that will work, and if ultimately the data will be destroyed.
An example statement:
You should know that your name will be kept as confidential as possible, within local, state and
federal laws. Records that identify you and this signed consent form may be looked at by the
Edinboro University Institutional Review Board (IRB). The results of this study may be shared in
aggregate form at a meeting or in a journal, but your name or individual results/score(s) will
not be revealed.
What Happens If I Have More Questions?
Your questions about a research-related injury or the research study will be answered
by_____ at (814) _______. If you have a question about your rights as a research
participant that you need to discuss with someone, you can call the Edinboro University
Institutional Review Board at (814) 732-2856.
What Will Happen If You Decide Not To Be in the Study?
Your participation in the focus group activity is strictly voluntary. You may decide to quit at any
time without any penalty, retribution, or repercussion.
PARTICIPANT’S STATEMENT
I had a chance to ask questions about the study. These questions were answered to my
satisfaction.
I realize that being part of this study is my choice. I am at least 18 years of age. I have read the
consent form. I was given a copy of this consent form for my own records.
PARTICIPANT’S SIGNATURE
DATE
Rev. 09/10/14
IRB Guidance and Procedures
71
Group Consent template
APPENDIX J
Example introductory statement for focus group studies
Name of study
Introductory Statement (to be read by facilitators)
Thank you for agreeing to participate in our study. The purpose of this study is to (reexplain purpose of study here).
We ask that all participants remain respectful of other participants during the focus
group session. We also request that given the nature of the topic, you would not discuss
what occurs in the focus group discussion outside the session. Furthermore, we ask that
you refrain from using the specific names of individuals (such as give appropriate list)
during the session.
Focus groups are public in nature. The risk of discussed materials being disseminated
outside the focus group is a potential risk. However, in reported findings, your identity
and the confidentiality of information you disclose in your focus group will be maintained
by a coding system. The content of the information you disclose or recall or that is
disclosed or recalled by one or more participants during focus group discussions may
create anxiety, fear, discomfort, and/or psychological distress. You will be provided with a
handout of resources where help can be sought should you choose to follow up on any
emotional discomfort.
Example debriefing statement for focus group studies
Debriefing Statement (to be given to participants after focus group session)
Thank you for participating in our study. If talking about any of the material today has
made you feel upset and you’d like to talk to someone about your feelings, you can
contact the following resources:
Give names and phone numbers for appropriate resources.
IRB Guidance and Procedures
72
Assent – Under 9
APPENDIX K
General Guidelines for obtaining assent from juveniles being asked to participate in human research
approved by the Edinboro University of Pennsylvania IRB. Assent from juveniles should be obtained
beginning at an age that the child can reasonably understand what is being asked of them (generally, this
would be around the age of 3 or 4 years old). For juveniles ages 3-8 years, you should read the assent to
them and document that you have read it and they have verbally agreed to participate, whereas older
juveniles (i.e., 8 – 10 year olds) can be asked to read and sign the assent as you read it to them. For
those 10 and under use the example below as your template and attempt to keep the Flesch reading ease
score to 90 or higher (Flesch grade level of 4 or less). The Flesch score can be obtained via Microsoft
Word and other word processing programs. The template is at an approximate Flesch Score 94.7/Grade
3.4.
Delete the above before printing for inclusion in the application packet.
EDINBORO UNIVERSITY OF PENNSYLVANIA
Edinboro, Pennsylvania
ASSENT TO PARTICIPATE IN A RESEARCH STUDY
I am (insert person working with juvenile participant) and I am part of a research
project called
(insert the title of project).
I would like you to be in a research study. Your parent/guardian has said it is okay if I ask
you to be in this study, but you get to say if you want to do it. In this study, you will be
asked to __(age appropriate explanation of the study)____. Nothing bad will happen to
you in this study. It will take about (insert minutes) minutes to do the study. It is up to
you if you want to be in this study. You do not have to be a part of this study if you don’t
want to. You do not have to answer any question if you do not want to. You can stop at
any time you want. Only the researcher will see your answers and they will not be shown
to your parent or teacher.
If you do not want to be in the study or if you want to stop, no one will be mad at you. If
you decide you want to stop all you have to do is tell me you want to quit. Do you have
any questions about what you are being asked to do?
Do you want to be in this study? You know you can stop at any time.
________________________________
_____________
Signature of the Subject
Date
IRB Guidance and Procedures
73
Assent – 10 and over
APPENDIX L
General Guidelines for obtaining assent from juveniles being asked to participate in human research approved by the
Edinboro University of Pennsylvania IRB. Assent from juveniles should be obtained beginning at an age that the child can
reasonably understand what is being asked of them (generally, this would be around the age of 3 or 4 years old). Older
juveniles can be asked to read and sign the assent as you read it to them. When working with juveniles from 11 to 18 years
old use this as your template and attempt to keep the Flesch reading ease score to 75 or higher (Flesch grade level of 8). The
Flesch score can be obtained via Microsoft Word and other word processing programs. The template is at an approximate
Flesch Score 78/Grade 7.8.
Delete this and the above before printing for inclusion in the application packet.
EDINBORO UNIVERSITY OF PENNSYLVANIA
Edinboro, Pennsylvania
ASSENT TO PARTICIPATE IN A RESEARCH STUDY
Title:
(Enter project title)
Researcher's name: (person working with juvenile participant)
You are being asked to be in a research study that looks at ____(give a short statement
as to the purpose of the study)_. Your part in this study will be to __(age appropriate
explanation of the study)_ and nothing bad will happen to you during study. The study
will take about _(enter time) minutes for you to do. Your parent/guardian has been told
about the study and knows you are being asked to take part but it is up to you to decide if
you want to do the study. Your answers will only be seen by the researcher and will not
be shown to your teachers or parents.
You understand that you are volunteering to take part in the study and that you do not
have to be in this study unless you want to. You do not have to answer any questions you
do not want to, and you can stop being in the study whenever you want. If you choose not
to answer a question or to stop taking part in the study it is okay and no one will be upset
with you. If you want to stop taking part in the study you just need to tell _(enter
name)_ that you want to stop. If you do not want to be in the study or if you want to quit
the study once you have started, no one will be mad or upset at you.
If you have any questions about the study, you may ask now or at any time during the
study. After the study, if anything about what you did worries or upsets you, you should
talk to your parent/guardian about it.
I agree to be in this study, have had all my questions about the study answered, and know
I can stop at any time.
__________________________________
_____________
Signature of the Subject
Date
IRB Guidance and Procedures
74
Online consent Template
APPENDIX M
Example Informed Consent for Online Surveys
EDINBORO UNIVERSITY OF PENNSYLVANIA
Edinboro, Pennsylvania
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
Title of Study: Use the exact name of the study as it appears in the IRB application
Principal & Co- investigators:
Introduction
“You are being asked by _____ to be in a research survey. This consent describes
your role as a participant in the survey.”
Study Purpose
Include purpose(s) of the survey and why the individual is being “asked” to
participate. It can also indicate why the individual was chosen.
What Will Happen During the Study?
Outline the survey procedures, including the estimated amount of time the survey
will take. You should include the topics to be covered by the survey questions.
This should be VERY clear and in language that someone who is not familiar
with the study area would understand. Think - What information would I want to
know about a survey before agreeing to participate?
What Are the Possible Risks or Discomforts?
Explain the most serious and common risks that could happen as a consequence
of participating in the survey (include physical, emotional, psychological, social,
financial, and spiritual effects). While most surveys involve no or very minimal
risk it is advisable to add a line that indicates that if the participant “should feel
uncomfortable about any question(s), then you may skip it or elect to stop taking
the survey. “
What Are the Possible Benefits of Participating in This Study?
Include benefits to the participant OR to society as a whole.
How Will the Collected Data Be Kept Confidential?
Here you need to explain how confidentiality and/or anonymity will be protected.
This includes tracing IP addresses or e-mail information (i.e., Surveys will NOT
be linked to IP addresses and if you elect to leave your e-mail address, it will
NOT be connected to your responses on the survey). Explain how information
from the study will be kept, who will have access to it, whether individual
responses will be present or just the aggregated ones, and if, ultimately, the data
will be destroyed.
What Happens If I Have More Questions?
“Your questions about a research-related injury or the research study will be
answered by_____ at (give PI e-mail address). If you have a question about your
IRB Guidance and Procedures
75
Online consent Template
APPENDIX M
rights as a research participant you can contact the chairperson of Edinboro
University Institutional Review Board, at [email protected] “
What Will Happen If You Decide Not To Be in the Study?
“Your participation is strictly voluntary; you may elect not to answer any or all of
the questions in the survey. If you change your mind about participating, there
will be no penalty, retribution, or repercussion for withdrawing from the study. To
stop taking the survey, exit out of your web browser. “
“By clicking the next button and beginning the survey, you acknowledge that you have
read the informed consent and agree to participate in the survey. You also acknowledge
that you are at least 18 years of age and that you understand that you have the right not to
answer any or all of the questions in the survey. Finally, you understand that you can
quit the survey, without penalty, at any time. “
Rev. 09/10/14
IRB Guidance and Procedures
76
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