RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY
INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION
OF HUMAN SUBJECTS IN RESEARCH (IRB)
REQUEST FOR EXEMPTION FROM FULL IRB REVIEW
Version 6.08
___ No - STOP 1
Does this activity involve research*?
___ Yes
Note: Program evaluation MAY NOT meet the definition of
submission to the
research.
IRB is not
Note: Students investigators must review the special criteria for
required.
students listed in section D of the instructions.
___ No - STOP 2
Do the individuals that will participate in this activity meet the
___ Yes
definition of human subjects*?
submission to the
Note: For an individual to be considered a human subject, data
IRB is not
ABOUT them must be collected.
required.
Note: IRB review is ONLY required if an activity involves BOTH research AND human subjects. If you have
answered “Yes” to questions 1 AND 2, proceed with completion of this form. Investigators may not self exempt.
Title of Project:
PRINCIPAL INVESTIGATOR (type name here):
_____________________________________________
Please note that undergraduate student investigators may not be named as the principal investigator on
protocols and must instead name their faculty advisor. Graduate students may serve as a Principal
Investigator, with their advisor serving as CO-Principal Investigator.
CHECK ONE:
Faculty ______ Title:
Staff
______ Title:
Graduate Student Ph.D.
______
Graduate Student Masters ______
Department/Unit: (DO NOT ABBREVIATE):
Mailing Address:
Cell Phone (optional):
Office Phone:
E-Mail:
Dr. ______
Mr.______
Ms.______
Home phone (optional):
Fax:
I certify that the statements made in this request are accurate and complete, and fall within the exemption categories
described below to qualify for exemption from Full/IRB review. I will conduct this study in accordance with the
recommendations of the Institutional Review Board for the Protection of Human Subjects in Research (IRB). I will not
begin work on this project until I receive a Notice of Exemption from the IRB. I understand that I am responsible for
reporting any serious adverse events or emergent problems to the IRB and for obtaining IRB approval before
implementing modifications. I have read the Federal Wide Assurance (FWA), which is available at
<http://orsp.rutgers.edu/Human.asp>, and understand my responsibilities as a Principal Investigator. If work will be
done by an undergraduate student, I will properly mentor them.
Signature of Principal Investigator: ______________________________________
Date ___________________
Name of Undergraduate Investigator: _________________________________
E-Mail: _________________________
Signature of Student: _____________________________________Date:___________________
Indicate the date that the undergraduate successfully completed the Human Subjects Certification Program:
If this project is being performed as part of an honors program, please check here  and specify the program:
______________________________
* See definition in the instructions.
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Faculty Advisor as Co-Principal Investigator for Graduate Student Principal Investigator:
Faculty Advisor must serve as the Co-Principal Investigator if their graduate student serves as the Principal
Investigator:
As faculty advisor for the graduate student named as Principal Investigator for this protocol, I certify that I am familiar
with Rutgers University policies and federal regulations as they apply to research involving human subjects. I have
advised and/or assisted the student in the preparation of this application and have reviewed it for completeness and
accuracy. I endorse the study and certify that it fulfills all the guidelines and requirements for IRB review. I agree to
serve as the Co-Principal Investigator for this project.
Name: (printed)
Signature: ______________________________ Date: ___________
Title:
Cell Phone (optional):
E-Mail:
Department:
Home Phone (optional):
Office Phone:
Fax:
Human Subjects Certification Completion Date: _______________________
Graduate Program Director:
The graduate program director will be contacted if problems arise from the protocol. Provide program director‘s
information below:
Name: (printed)
Title:
Cell Phone (optional):
E-Mail:
Department:
Home Phone (optional):
Office Phone:
Fax:
Complete this section if someone in addition to the PI is designated to receive and respond to correspondence.
CONTACT PERSON:
Title:
Department/Unit:
Mailing Address:
Phone:
Fax:
E-Mail:
EDUCATION
Effective January 1, 2001, successful completion of the web-based Human Subjects Certification Program by the
principal investigator and all other key personnel will be required prior to the Notice of Approval being issued for a
protocol.
Indicate the date that the Principal Investigator successfully completed the Human Subjects Certification Program:
Date of Completion: ________________________.
List below other key personnel including undergraduate investigators, who are responsible for the design OR
conduct of the study. Attach additional sheets if necessary, marked ‘Attachment 2'.
Name
Email Address
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Date of HSCP Certification
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Funding Status:
_____ Funded
_____Funding Request Submitted
_____ Not Funded
If the project is funded, or an application for funding has been submitted, indicate the name of the funding agency or
organization:
Does any member of the research team have a financial interest in the research or its products or in the study
sponsor? ___Yes ___No
If yes, please describe. (University policies regarding Conflict of Interest
should be reviewed at <http://orsp.rutgers.edu/policies/ > ) Attach additional sheets if necessary.
Instructions: Answer each of the following questions, in order, (unless specifically directed otherwise) as they relate
to the research project you would like to initiate. The comments immediately following each response will assist you in
determining whether exemption is appropriate for this protocol. Continue until you reach “STOP”. Relevant definitions
and clarifications are contained in Section B of the instructions. Failure to comply with directions will result in a return
of the Request for Exemption and a delay in the review process.
___ Yes - STOP - the
protocol is not eligible
for exemption. Stop
here on this checklist.
You must complete an
IRB application for full
review.
___ Yes - STOP - the
protocol is not eligible
for exemption. Stop
here on this checklist.
You must complete an
IRB application for full
review.
___ No
Will the research be conducted in established or commonly
accepted educational settings, involving normal educational
practices, such as (i) research on regular and special education
instructional strategies, or (ii) research on the effectiveness of,
or the comparison among, instructional techniques, curricula, or
classroom management methods?
TESTS, SURVEYS, INTERVIEWS, OBSERVATION OF BEHAVIOR
___ Yes- Exemption
#1 may be applicable.
___ No Exemption #1
does not apply.
6
___ Yes - Exemption
#2 may apply.
___ No Exemption #2
does not apply.
Go to question
10.
3
Does the activity present more than minimal risk* to subjects?
4
Does the research involve prisoners*, fetuses, pregnant
women, human in vitro fertilization, deception or incomplete
disclosure?
___ No
EDUCATIONAL ENVIRONMENTS
5
Will the research involve the use of educational tests (cognitive,
diagnostic, aptitude, achievement), survey procedures,
interview procedures or observation of public behavior?
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7
Is information that is obtained recorded in such a manner that:
•
subjects can be identified, directly or through
identifiers linked to the subjects;
AND
•
any disclosure of the human subjects' responses
outside the research could reasonably place the subjects at risk
of criminal or civil liability or be damaging to the subjects'
financial standing, employability, or reputation?
8
9
For projects that involve the use of educational tests, survey
procedures, interview procedures, or observation of public
behavior, will minors be involved in this project, other than as
subjects in public observation of activities in which the
investigator does not participate? (If minors will ONLY be asked
questions about standard educational practices in an accepted
educational setting, “NO” is the appropriate response. In this
situation, Category 1 is appropriate.)
Will the research:
___ Yes - the protocol
is not eligible for
exemption under
Category #2. Proceed
to question #9 to
determine whether
exemption category #3
may apply.
___ Yes - STOP - the
protocol is not eligible
for exemption. Stop
here on this checklist.
You must complete an
IRB application for full
or expedited review.
___ No - If
subjects can be
identified,
Exemption #2
may apply only if
their responses, if
disclosed, would
not be harmful to
them.
___ No Exemption #2
may be
applicable.
___ Yes - Exemption
#3 may be applicable.
___ No Exemption 3
does not apply.
•
involve the use of educational tests (cognitive,
diagnostic, aptitude, achievement), survey procedures,
interview procedures or observation of public behavior that is
not exempt under exemption #2 (see questions 6 through 8
above);
AND
•
(i) the human subjects are elected or appointed
public officials or candidates for public office; OR
•
(ii) federal statute(s) require(s) without exception
that the confidentiality of the personally identifiable information
will be maintained throughout the research and thereafter?
USE OF EXISTING DATA
10
Will the research involve 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?
___ Yes - Exemption
#4 may apply.
___ No
Exemption #4
does not apply.
Go to question
12.
11
Are the records involved those of Rutgers students?
___ Yes - STOP - the
protocol is not eligible
for exemption. Stop
here on this checklist.
You must complete an
IRB application for full
or expedited review.
___ No
Exemption #4
may be
applicable.
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RESEARCH OF FEDERAL GOVERNMENT BENEFIT/SERVICE PROGRAMS
12
Is the research or demonstration project conducted by or
subject to the approval of Federal department or agency heads,
and designed to study, evaluate, or otherwise examine:
___ Yes - Exemption
#5 may be applicable.
___ No
Exemption #5
does not apply.
13
Do the activities involve taste and food quality evaluation and
___ Yes - Exemption
consumer acceptance studies wherein, (i) wholesome foods
#6 may be applicable.
without additives are consumed or (ii) a food is consumed that
contains a food ingredient at or below the level and for a use
found to be safe, or agricultural chemical or environmental
contaminant at or below the level found to be safe, by the Food
and Drug Administration or approved by the Environmental
Protection Agency or the Food Safety and Inspection Service of
the U.S. Department of Agriculture?
ANY OTHER RESEARCH PROCEDURES:
___ No
Exemption #6
does not apply.
14
Do ALL procedures of the proposed research activity fall into
one or more of the exemption categories described in questions
#5 through 13?
___ Yes - All
procedures fall into
one or more of the
categories described
above. The protocol is
eligible for exemption
under the
category(ies)
indicated.
___ No - STOP There are other
procedures that
do not fall into
these category
descriptions.
The protocol is
not eligible for
exemption.
15
Will any of the research under this protocol be conducted
outside of the U.S.A?
See Guidance and procedures at:
___ Yes - Complete
and attach Appendix
D. Exempt Studies
involving International
Research.
___ No
•
(i) public benefit or service programs;
•
(ii) procedures for obtaining benefits or services
under those programs;
•
(iii) possible changes in or alternatives to those
programs or procedures; or
•
(iv) possible changes in methods or levels of
payment for benefits or services under those programs?
FOOD TESTING
http://orsp.rutgers.edu/Humans/irb_guidance.php
In order to perform a substantive review of the protocol, and to ensure that exemption is appropriate, a complete
research protocol (narrative description of the project), consent documents and study instruments are required. If
study instruments, consent forms or assent forms have not yet been developed, please supply sample
documents. The final versions must be submitted to the IRB for review and approval prior to implementation.
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Please attach one copy of each of the following (if applicable):
Appendix A
Appendix B
Appendix D
Attachment 1
Use of Rutgers Students as Experimental Subjects in Research (included in following page)
Investigator Checklist
Exempt Studies Involving International Research
Research Protocol (narrative description of the project) including, but not limited to:
(required)
Background, Objectives, Subject population & recruitment, Methodology, Provisions for
protection of private, identifiable information
Attachment 2 Additional Key Personnel Information, if all information did not fit in the space provided on p.1
Attachment 3 Advertisement or Recruitment Notice, if applicable
Attachment 4 Consent Form(s), if applicable
Attachment 5 Assent or Script for Oral Consent, if applicable
Attachment 6 Authorization from Non-Rutgers Research Sites, if applicable (e.g., school, business)
Attachment 7 Questionnaire(s), Survey(s), Interview Questions, if applicable
Attachment 8 Focus Group Guide, if applicable
Attachment 9 Use of Rutgers Students as Experimental Subjects in Research form, if applicable (see
instructions).
Attachment 10 Authorization to Use Data, if existing data will be used and the data are not publicly available
Attachment 11 IRB Approval Notices from Participating Institutions, if applicable.
****NOTE THAT YOU MUST SUBMIT ONE ORIGINAL OF THE APPLICATION AND ALL
RELEVANT MATERIALS****
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APPENDIX A
Version 6.08
RUTGERS - THE STATE UNIVERSITY OF NEW JERSEY
USE OF RUTGERS STUDENTS AS EXPERIMENTAL SUBJECTS IN RESEARCH
The procedures outlined in this statement are designed to reduce the element of coercion or influence in any
use of Rutgers students as subjects the research projects conducted by faculty or instructional staff. These
procedures DO NOT apply to students studying research techniques in courses that require them to perform
experiments; rather, they apply to experimentation that uses students not as investigators, but as subjects.
The ethical principles of professional societies insist that all consent to participate in research must be
voluntary, and that all potential subjects must be treated as autonomous agents, with the right to choose or not to
choose to take part in experiments. Federal regulations (e.g., 45 CFR 46.116) are explicit: "An investigator shall
seek such consent only under circumstances that provide the prospective subject or the representative sufficient
opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence."
By action of the Rutgers Board of Governors, all research in this university that involves human subjects is required to
conform with federal regulations.
Consequently, individual faculty members and instructional staff, students, and departments that use students
as experimental subjects, or that maintain "subject pools" of students from which investigators may draw research
participants, are asked to adopt procedures that meet the following conditions:
1.
Before they enroll in a course, students must be informed of the possibility that they may be asked to serve as
research subjects in experiments under direction of the faculty.
2.
If there is a course requirement that students serve as research subjects in such experiments, then alternative
ways must be provided for students to meet this requirement. During the first week of classes, students
should receive a written description of the various ways of meeting the requirement.
3.
Each department that regularly requires students to act as research subjects should establish a committee
composed of faculty and students to review the research projects involved. This committee should be
responsible for hearing and acting on any student complaints in connection with the research-participation
requirement.
4.
All members of the faculty who invite students to act as subjects in their research must be acquainted with the
ethical standards that govern such activities, such as those promulgated by the American Psychological
Association or other discipline-related professional organization, or those in the so-called Belmont Report of
the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. A
copy of the latter report is obtainable from ORSP. (Website: <http://orsp.rutgers.edu/>)
Please check one box below, sign your name, and include this form with your application:
___I have read the above statement and agree to follow the procedures recommended.
OR
___I will not be using Rutgers students as subjects in this protocol.
Name (Printed):
Signature: _______________________________________________
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APPENDIX B
Rutgers, The State University of New Jersey
Version 6.08
INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH
INVESTIGATOR CHECKLIST
This checklist is to be completed by the PI and submitted with the IRB application.
Principal Investigator: ____________________________________________ Date:_________________________
Type of IRB review requested:
__full panel
__expedited
__exempt
APPLICATION: (use X if "yes" and NA if "not applicable")
___Justification provided for expedited review or exemption, if requested
___Application typed or computer-generated, not hand written
___Summary in non-technical terms (2 sentence maximum)
___Risks specified
___Benefits specified
___Informed Consent Form appended
___All instruments appended (e.g. questionnaires, standardized tests, interview schedules)
___Form: "Use of Rutgers Students as Experimental Subjects..." signed, appended
___Advertisement for recruitment of participants appended, if relevant
___Performance site(s) specified
___Principal Investigator's signature on application
___Names of all investigators specified
___Study dates specified (beginning, ending)
___Funding source(s), if any, specified
___Approval letter(s) from ALL relevant off-campus site(s) (e.g. school principal, other IRB's) appended
___FINAL disposal of data (and time) specified
___If applicant is a STUDENT, advisor signature on page 2
___Inclusion/exclusion criteria specified
___Inclusion of women and/or minorities addressed in text
___ Appendix C: FULL / EXPEDITED studies involving International Research, attached.
___ Appendix D: EXEMPT studies involving International Research, attached.
Check ONLY ONE of the following:
Participants' identity will be: ___anonymous
___confidential
__neither
INFORMED CONSENT FORM (must be written in non-technical terms for participants)
___Study description and goals
___Clear description of what will be done to the participant (e.g. withdraw _ amount of blood)
___Clear description of what will be required of participant (e.g. physical exertion)
___Risks (e.g. side effects, toxicities, radiation) to participant specified
___Benefits to participant specified
___Duration of participation (e.g. minutes, days, months, number of sessions, etc.)
___Provision and procedure for accessing counseling specified, if participants may be affected adversely
___Alternatives to participation, if applicable
___Payment to participant specified, including reimbursement for expenses, if applicable
___Freedom to withdraw from study at any time without penalty: STATED PROMINENTLY
___Pro-rating specified, if participant withdraws early from study
___Costs to participant specified (i.e. those not reimbursed, if any)
___Conditions under which INVESTIGATOR may terminate subject's participation, if relevant
___Number of participants in overall study
___Line for participant to initial EACH page of informed consent form
___Rutgers Disclaimer / Coverage for adverse effects specified
___Names, phone numbers, addresses of contact persons (investigators AND IRB)
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___Signature lines for participant AND investigator; witness signature line if appropriate
___Video, audio, and/or photographic consent, if applicable
___Consent for the use of subjects’ genetic material, if applicable
___Translation into appropriate foreign language, if applicable
___Pregnancy waiver, if applicable
___Specification of any groups to be excluded from the study (e.g. women, minorities)
___Specification of whether research results (individual, group) will be provided to participant
___Explicit assurance of participant's confidentiality/anonymity in investigator's reports of findings
___Consistent use of "I / you" in the text
****Full/ Expedited Protocols: SUBMIT ONE ORIGINAL AND TWO COPIES OF THE APPLICATION AND ALL
RELEVANT MATERIALS****
****Exemptions Protocols: SUBMIT ONE ORIGINAL OF THE APPLICATION AND ALL RELEVANT
MATERIALS****
Investigator Comments (optional):
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IRB PROTOCOL FORM INSTRUCTIONS
DO NOT SUBMIT THIS SECTION WITH YOUR APPLICATION!!!
IT IS PROVIDED FOR YOUR INFORMATION ONLY
This application should be submitted to the Institutional Review Board for The Protection of Human Subjects in
Research (IRB) in the Office of Research and Sponsored Programs (ORSP) to request Review and Approval, or
Exemption, of any Research Protocol Involving Human Subjects.
IRB APPROVAL IS REQUIRED BEFORE ANY RESEARCH INVOLVING HUMAN SUBJECTS CAN BE INITIATED.
REQUIREMENT OF IRB REVIEW AND APPROVAL PRIOR TO PERFORMING RESEARCH ON HUMAN
SUBJECTS:
In accordance with action taken by the University's Board of Governors, all full-time and part-time members of the
university faculty, staff, and student body who propose to undertake any research studies that involve human
participants and/or the use of existing data collected from human beings are obliged to conform with procedures
prescribed by the US Department of Health and Human Services (DHHS) and set forth most recently as a Common
Federal Policy for the Protection of Human Subjects. The procedures apply to externally funded, internally funded,
and non-funded studies, including course-related research projects at the undergraduate and graduate level, honors
projects, masters theses, and dissertations. All applicable research projects must be reviewed and approved by the
University's IRB before the research begins. Additionally, projects covered under one of the six allowable "exemption"
categories require review and approval by a subcommittee of the IRB before the research begins.
Definition of Research: A systematic investigation (i.e., the gathering and analysis of information) designed to
develop or contribute to generalizable knowledge [Federal Policy 45 CFR 46.102(d)].
Definition of Human Subject: Living individual(s) about whom an investigator conducting research obtains: (1) data
through intervention or interaction with the individual; or (2) identifiable private information [Federal Policy 45 CFR
46.102(f)].
SUBMISSION DATES for Full and Expedited Review:
The IRB meets monthly, except during August. All Requests for Full and Expedited Review must be received in the
IRB office by the 12th of the month in order to be considered at the imminent meeting (e.g. received by January 12th
for review at the February meeting). Requests received later than the 12th will be held until the subsequent month’s
meeting (e.g. received on January 13th for review at the March meeting).
SUBMISSION DATES for Exempt Review:
There are no deadlines for submission of requests for exemption, which are reviewed on a continuous basis by a
subcommittee of the IRB. However, if you are unsure whether your project qualifies for an exemption, you are
advised to adhere to the deadline schedule listed above and submit the Full / Expedited form, or contact the IRB unit.
Then, if an exemption request is denied by the subcommittee, the case can be referred to the imminent IRB meeting.
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SUBMISSIONS SHOULD BE SENT TO:
Institutional Review Board (IRB)
Office of Research and Sponsored Programs
Rutgers, the State University of New Jersey
ASB III, 3 Rutgers Plaza
New Brunswick, NJ 08901
Phone: (848) 932-0150
Fax: (732) 932-0163
Submission Contact:
Inquiries should be directed to:
Cathy Rivera
Michelle Gibel, IRB Administrator
Phone: (848) 932-4052
Phone: (848) 932-4058
Email: [email protected]
Email: [email protected]
Gloria Gaines, IRB Administrator
Phone: (848) 932-4018
Email: [email protected]
Lauren Zizza, Compliance Administrator
Phone: (848) 932-4012
Email: [email protected]
PROCEDURE TO REQUEST IRB REVIEW:
To request IRB review, 3 copies (1 original and 2 copies) for Full and Expedited Reviews and 1 original for Exemption
Reviews are required of each of the following items must be submitted to the IRB office, assembled in the following
order:
1.
The attached IRB Protocol Form, which may be downloaded from the Rutgers ORSP website:
<http://orsp.rutgers.edu/Human.asp> and is available at the Office of Research and Sponsored Programs.
2.
Appendix A, “Use of Rutgers Students as Experimental Subjects in Research”. This form describes the
procedures designed to reduce the risk of coercion or undue influence on Rutgers students who are
participating in research, and must be signed and returned. If you are NOT using Rutgers students, check the
appropriate box on the form, sign and return.
3.
Appendix B, “Investigator and Reviewer Checklist”. This checklist is designed to assist the investigator in
ensuring the completeness of the IRB Protocol Form. It must be filled out completely and submitted with the
application (i.e. “X” or “NA” for each item).
4.
Appendix C, Full/Expedited Studies Involving International Review. This form should only be completed by
investigators who intend on doing human subjects research with people in foreign countries.
5.
Appendix D, Exempt Studies Involving International Research. This form should only be completed by
investigators who intend on doing human subjects research with people in foreign countries.
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6.
Attachment 1 - A complete copy of the research proposal, plan or protocol, that sets forth the objectives of the
research and describes the procedures designed to reach that objective, OR A copy of the proposal or plan
for a dissertation leading to an advanced degree.
Three copies (1 original and 2 copies) for Full and Expedited Review and one original for Exempt Review of the
following items must also be submitted, IF APPLICABLE TO YOUR PROPOSAL, in the following order:
7.
Attachment 2 - Information for additional key personnel, if more than five individuals are involved.
8.
Attachment 3 - All advertisements or other recruitment material, which must include a contact name and
number, a brief description of the research, inclusion criteria, and payment to the subject, if any.
9.
Attachment 4 - The informed consent form that the subjects will sign and that can be used to document their
informed consent. (Note: If exemption from review is requested and approved, an informed consent form is
not required, but may still be desirable).
For subjects who are unable to sign for themselves (e.g. infants, children ages six and below, adults who are
cognitively impaired, and the mentally disabled), written informed consent must be obtained from the subject's
legally authorized representative. Investigators using minor subjects, (ages 7 to 17), must obtain not only the
consent of their legal representative (e.g. parent or guardian), but also the assent of the subject – Attachment
5.
Definition of Assent: Agreement by an individual not competent to give legally valid informed consent (e.g. A
child or cognitively impaired person) to participate in research.
In these cases, the informed consent form should provide for a signature of a witness for the subject's
signature, in addition to that of the legally authorized representative.
10.
Attachment 6 - Authorization letters from research sites that are not affiliated with Rutgers University (e.g.
schools).
11.
Attachment 7 - All questionnaires, surveys, interview schedules, tests, and any other test instruments
proposed to be used, and Attachment 8 - focus group guides.
12.
Attachment 8 - The debriefing statement that will be used if deception is involved in the study.
13.
Attachment 9 - Authorization to use data if it is not publicly available.
14.
Attachment 10 - Letters of collaboration and IRB approval notices from institutions or organizations other than
Rutgers that are participating in the research.
MANDATORY EDUCATION IN HUMAN SUBJECTS RESEARCH:
Effective January 1, 2001, successful completion of the web-based Human Subjects Certification Program by the
principal investigator and all other key personnel will be required prior to the Notice of Approval being issued for a
protocol.
Definition of Key Personnel:
All individuals who are responsible for the design or conduct of the study.
Information about the program is available on the website for the Office of Research and Sponsored Programs at
<http://orsp.rutgers.edu/Human.asp> or you may contact the IRB Administrator at the address above. It is strongly
recommended that all principal investigators and key personnel (including Faculty Advisor if appropriate) named on
protocols involving human subjects complete the program as soon as possible.
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THE BASIC IRB REVIEW CRITERIA:
In order to approve research covered by the Common Rule (45 CFR 46), the IRB shall determine whether all of the
following requirements have been satisfied, as applicable:
1.
Risks to subjects are minimized, a) by using procedures that are consistent with sound research design and
that do not unnecessarily expose the 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 the subjects, and the importance
of the knowledge that may reasonably be expected to result.
3.
Selection of subjects is equitable, and the special problems of research involving vulnerable populations are
adequately addressed.
4.
Informed consent will be sought from each prospective subject or the subject's legally authorized
representative.
5.
Informed consent will be appropriately documented.
6.
The research plan makes adequate provision for monitoring the data to ensure the safety of the subjects.
7.
Adequate provisions are made to protect the privacy of the subjects and to maintain the confidentiality or
anonymity of data.
8.
Appropriate additional safeguards have been included in the research plan when some or all of the subjects
are likely to be vulnerable to coercion or undue influence. This includes children, prisoners, pregnant women,
cognitively impaired persons, or economically or educationally disadvantaged persons.
9.
The purpose of the research is consistent with the environmental setting in which it will be conducted.
10.
If the subjects may be expected to require mental health counseling as a result of the research procedure
(e.g. an interview that raises emotionally-distressing issues), specification must be provided regarding
whether counseling will be provided by the investigator, or another qualified individual. In addition, it must be
specified who will bear financial responsibility for the counseling.
THE INFORMED CONSENT FORM -- BASIC ELEMENTS:
The following information is to be provided to each subject in the informed consent form:
1.
A statement that the study involves research, an explanation (in non-technical language) of the purposes of
the research, a description of the procedures to be followed, and identification of any procedures that are
experimental.
2.
A description of any reasonably foreseeable risks or discomforts to the subject.
3.
A description of any benefits to the subjects or other persons, that may reasonably be expected to result from
the research.
4.
A disclosure of appropriate alternative procedures or treatments that might be beneficial to the subject.
5.
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be
maintained. Your proposal must specify precisely whether the identity of your subjects will be: a)
Anonymous; b) Confidential; or c) Neither.
Note: Your subjects’ responses may be recorded and maintained as confidential or anonymous, but not both.
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Definition of Anonymous: Data are recorded such that no identifier whatsoever exists to link a subject's identity to
that subject's response. Examples: (1) subject fills out and mails back to the investigator a questionnaire that does
not provide subject's name, social security number, phone number, or any other identifier; (2) investigator interviews
subject by phone and notes responses, but does not have any record connecting any response to any phone number.
Definition of Confidential: There exists a documented linkage between a subject's identity and his/her response in
the research, and the investigator provides assurance in the protocol and in the informed consent form that the
identity of any individual subject will not be revealed in any report of the study. Example: a subject's data record is
assigned a code, and a "master list" that links the code to the subject's identity is maintained in a secure location.
Cautionary Note: Even research records that are obtained via a "confidential" protocol may be subject to subpoena.
If the investigator and/or the IRB deem(s) it necessary to prevent the possibility of such compelled disclosure of the
research records (e.g. in the case of potential revelation of criminal activity), the investigator may, in advance of
initiating the research, apply to any of several government agencies (e.g. NIH) for a "Certificate of Confidentiality,"
which legally prevents any governmental agency from obtaining the investigator's records. Contact the Sponsored
Programs Administrator for instructions on how to apply for this document.
6.
For research involving more than minimal risk, a statement that Rutgers will not provide compensation or
medical treatment in the event of a research-related injury.
7.
A statement specifying the amount of time required for participation in the study (e.g. a realistic estimate of
the number of minutes required to complete a questionnaire, the number of separate sessions, the overall
duration [days, weeks, months] that the subject will be involved in the study).
8.
A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits
to which the subject is otherwise entitled, and that the subject may discontinue participation at any time
without penalty or loss of benefits to which the subject is otherwise entitled. Specify the consequences, if
any, to the subject of his/her decision to withdraw from the research before completing the protocol (e.g. loss
of pro-rated compensation for participation in the study) and procedures for orderly termination of participation
by the subject (e.g. exit interview).
9.
Statement regarding financial or other compensation, if any, to the subjects, giving precise amounts and
providing for prorating of payment if a subject withdraws before completing the study. Also, specify any
uncompensated costs to the subject that may result from participation in the research (e.g. travel costs,
absence from the workplace).
10.
A statement regarding accessibility of the investigator to the subjects for questions related to the research
(e.g. phone number, email address, institutional address).
11.
The following statement regarding subjects’ rights:
If you have any questions about your rights as a research subject, you may contact the IRB
Administrator at Rutgers University at:
Rutgers University Institutional Review Board for the Protection of Human Subjects
Office of Research and Sponsored Programs
3 Rutgers Plaza
New Brunswick, NJ 08901-8559
Tel: 848 932 4058
Email: [email protected]
ADDITIONAL ELEMENTS OF INFORMED CONSENT:
When appropriate, one or more of the following elements of information should be provided to each subject:
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12.
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.
13.
Anticipated circumstances under which the subject's participation may be terminated by the investigator
without regard to the subject's consent.
14.
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.
15.
The approximate number of subjects involved in the study.
FORMAT OF THE INFORMED CONSENT FORM:
Text should be written in non-technical terms, at a sixth-grade reading level, with non-technical explanation of any
specialized terms. If the consent form is more than one page, include a notation, “Subject’s Initials ______”, at the
bottom of each page except the signature page.
If non-English speaking subjects will be involved, a consent form that has been translated into the relevant language
is required.
Signature lines for the Principal Investigator and the subject, with corresponding lines for the date of each signature,
are required. Signature lines for a legally authorized representative or minor subject may also be necessary,
depending upon the categories of subjects that are involved. A witness signature is not required in most cases;
exceptions are oral consent verification (below) and situations in which a legally authorized representative signs for
the subject.
If the protocol involves videotaping, audiotaping, or photographing of subjects, the consent form must include either a
separate statement of agreement for these procedures within the consent document, with signature line, or an
addendum to the consent form describing the recording procedure with a statement of agreement and signature line.
The purpose of the distinct signature for these procedures is to ensure that the subject is aware of their inclusion, and
if the study design permits, to allow the subject to participate in the study without being recorded.
Provide either : a)
b)
a detailed written form that incorporates the elements of informed consent,
OR
a brief written document stating that the elements of informed consent will be presented orally
to the subject or the subject's legally authorized representative and witnessed by a third
party. In either case, a copy of the document should be given to the person signing the form.
A written summary of the oral presentation should be included in your Request for Review.
THE THREE CATEGORIES OF IRB REVIEW:
Based on the criteria provided below, investigators should request, on the IRB application and on the checklist
provided, one and only one of the following three possible types of review:
1) full IRB panel review,
2) expedited IRB review,
3) exemption from IRB panel review.
1. FULL IRB PANEL REVIEW:
All proposals that do not qualify for expedited review or exemption (criteria specified below) shall be reviewed by
the full IRB Panel.
2. EXPEDITED REVIEW:
a. 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 in 45 CFR 46.110 and 21 CFR 56.110 (dated
November 1998).
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Definition of Minimal Risk: A risk is minimal where the probability and magnitude of harm or discomfort
anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered
in daily life or during the performance of routine physical or psychological examinations or tests [Federal
Policy 45 CFR 46.102(i)]
b. General Criteria:
1) The activities listed should not be deemed to be of minimal risk simply because they are included on this
list. Inclusion on this list merely means that the activity is eligible for review through the expedited review
procedure when the specific circumstances of the proposed research involve no more than minimal risk to
human subjects.
2) The categories in this list apply regardless of the age of subjects, except as noted.
3) The expedited review procedure may not be used where identification of the subjects and/or their
responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects'
financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and
appropriate protections will be implemented so that risks related to invasion of privacy and breach of
confidentiality are no greater than minimal.
4) The expedited review procedure may not be used for classified research involving human subjects.
5) The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless
of the type of review - expedited or convened - utilized by the IRB.
6) Categories 1-7 pertain to both initial and continuing IRB review.
c.
Specific research areas that qualify for expedited review: Specify one or more categories that pertain to your
proposal:
1) Clinical studies of drugs and medical devices only when condition a) or b) is met:
a) research on drugs for which an investigational new drug application (21 CFR Part 312) is
not required.²
b) research on medical devices which (1) do not require an investigational device exemption
application (21 CFR Part 812); OR (2) are cleared/approved for marketing and are being
used in accordance with their cleared/approved labeling.
2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
a) from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the
amounts drawn may not exceed 550 ml in an eight-week period and collection may not occur
more frequently than twice 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
3ml/kg in an eight-week period and collection may not occur more frequently than twice per
week.
3) Prospective collection of biological specimens for research purposes by non-invasive means.
For example:
a) hair and nail clippings in a non-disfiguring 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 indicated 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 diluted 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;
h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not
more invasive than routine prophylactic techniques;
i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
j) sputum collected after saline mist nebulization.
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4) Collection of data through non-invasive 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.4
For example:
a) physical sensors that are applied either to the surface of the body or at a distance and do not
involve input of significant amounts of energy into the subject or an invasion of the subject's
privacy;
b) weighing or testing sensory acuity;
c) magnetic resonance imaging;
d) electrocardiography, electroencephalography, thermography, detection of naturally occurring
radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow,
and echocardiography;
e) moderate exercise, muscular strength testing body composition assessment, and flexibility
testing where appropriate given the age, weight, and health of the individual.
5) Research involving materials [data, documents, records, or specimens] that have been collected or will be
collected solely for non-research purposes, such as medical treatment or diagnosis.5
6) Collection of data from voice, video, digital, or image recordings made for research purposes.
7) Research on individual or group characteristics or behavior [including but not limited to research on
perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and
social behavior] or research employing survey, interview, oral history, focus group, program evaluation,
human factors evaluation, or quality assurance methodologies.6
8) Continuing review of research previously approved by the convened IRB as follows:
a) where:
1. the research is permanently closed to the enrollment of new subjects;
2. all subjects have completed all research-related interventions; and
3. the research remains active only for long-term follow-up of subjects; OR
b) where no subjects have been enrolled and no additional risks have been identified; OR
c) where the remaining research activities are limited to data analysis.
9) Continuing review of research, not conducted under an investigational new drug application or
investigational device exemption where categories 2 though 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.
Footnotes:
1.
2
3
4
5
6
An expedited review procedure consists of a review of research involving human subjects by the IRB
chair or by one or more experienced reviewers designated by the chair from among member of the
IRB in accordance with the requirements set forth in 45 CFR 46.110 and 21 CFR 56.110 (November
1998).
Research on marketed drugs that significantly increases the risks or decreases the acceptability of
the risks associated with the use of the product is not eligible for expedited review.
Children are defined in the HHS regulations as "persons who have not attained the legal age for
consent to treatments or procedures involved in this research, under the applicable law of the
jurisdiction in which the research will be conducted." [45 CFR 46.402 (a)]
Studies intended to evaluate the safety and effectiveness of the medical device are generally not
eligible for expedited review, including studies of cleared medical devices for new indications.
Some research in this category may be exempt from the HHS regulations for the protection of human
subjects, according to 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.
Some research in this category may be exempt from the HHS regulations for the protection of human
subjects, according to 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not
exempt.
3. EXEMPT REVIEW (effective August 19, 1991) 1
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a.
Research activities that:
1) Present less than minimal risk to human subjects,
AND
2) Involve only procedures listed in one or more of the following categories, may receive exemption from IRB
review as authorized in 45 CFR 46.101(b), unless otherwise required by Federal department or agency
heads.
Definition of Minimal Risk: A risk is minimal where the probability and magnitude of harm or discomfort
anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered
in daily life or during the performance of routine physical or psychological examinations or tests [Federal
Policy 45 CFR 46.102(i)]
b.
Specific research areas that are exempt from IRB review: Specify one or more categories that pertain to your
proposal:
1) Research conducted in established or commonly accepted educational settings, involving normal educational
practices, such as (i) research on regular and special education instructional strategies, or (ii) 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: (i) information obtained is
recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects;
and (ii) 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. 2
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 (2) if:
(i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal
statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be
maintained throughout the research and thereafter.
4) Research involving the collection or study of existing data, documents, records, pathological specimens,
or diagnostic specimens, if these sources are publicly available or if the information is recorded by the
investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the
subjects. 3
5) Research and demonstration projects which are conducted by or subject to the approval of Federal
department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public
benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii)
possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or
levels of payment for benefits or services under those programs.
6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives
are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use
found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe,
by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety
and Inspection Service of the U.S. Department of Agriculture.
Footnotes:
1.
2.
These exemptions do not apply to research involving prisoners, fetuses, pregnant women, or human in vitro
fertilization.
This exemption does not apply to research with children except for research involving observations of
public behavior when the investigator(s) do not participate in the activities being observed.
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3.
If the records involved are those of Rutgers students, the project is not exempt and must be reviewed by the
IRB. Such research must conform with the Family Education Rights and Privacy Act of 1974, also known as
the Buckley Amendment.
COURSE-RELATED STUDENT RESEARCH PROJECTS: (Rutgers University Guidelines)
1.
Student projects that do not require IRB review:
"Classroom exercises" do not qualify for IRB review if the projects:
a)
b)
take place in a Rutgers University classroom, departmental, dormitory, or other (Rutgers University)
campus setting, or in a public setting with generally unlimited access to the public, such as a
shopping center, park or street,
AND
involve only the learning of research techniques.
Such projects should not put the subjects at more than minimal risk, the data must be recorded anonymously
by the student researchers (i.e., with no names, social security numbers, or any other codes that can be
linked to a list of names of the research subjects), and the findings are not to be published.
2.
Student projects that do not qualify under number 1 above, but that do qualify as exempt from IRB full panel
review under the federally-allowed categories defined in Section 3 above:
If student proposals are submitted to the IRB under this category, all the included student projects must be
aggregated by the course instructor as "one classroom project," such that only one, inclusive, IRB exemption
request form is submitted by the course instructor who asserts, in a signed cover letter, that s/he has
reviewed each of the proposals, that EACH is in COMPLETE accordance with the IRB guidelines, and a
separate IRB Checklist for EACH student's proposal has been filled out completely and accurately and
attached to each student's proposal. These proposals will be reviewed by the IRB exemption subcommittee.
If any forms are incomplete, the entire package will be returned to the course instructor without review.
Timetable: Requests for a "one classroom project" IRB exemption must be received at the office of the IRB
not later than September 12 for the fall term or February 12 for the spring term. In the case of a two-semester
course, the request for exemption should be submitted at least one month before the students will begin their
projects.
3.
Student research projects that do not qualify under number 1 or 2 above, but that do qualify for:
a) expedited IRB review, or b) IRB full-panel review (i.e. they use an informed consent form):
If student proposals are submitted to the IRB under either or both of these two categories,
a)
the course instructor must sign the cover page of each proposal, assuring that s/he has reviewed each
of the individual proposals and EACH is in COMPLETE accordance with all the relevant IRB
requirements,
b) if expedited review is requested, the rationale for the request, based on the relevant expeditable category
(defined in Section 2, page 17) must be specified for each proposal, AND
c) an IRB Proposal Checklist is required to be fully and accurately completed and attached to each student's
proposal. If any forms are incomplete, the entire package will be returned to the course instructor without
review.
Timetable: All requests for review of non-exempt projects that are to be completed during the fall semester
must be submitted by September 12 for consideration at the October IRB meeting. For non-exempt projects
to be completed during the spring semester, the requests for review must be submitted by February 12 for
consideration at the March IRB meeting. In the case of a two-semester course, the students should submit
their requests for review at least a month before they wish to start their data collection. Faculty and their
student research advisees should be cognizant that if approval of student projects is not obtained according
to the above schedule, it may not be possible for the projects to be completed in a timely manner.
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IRB REVIEW FREQUENT CONCERNS:
Research protocols involving children in school: sensitivity issue:
If not all children in a classroom will be participants in your study, be sure to specify in the protocol how you will
ensure that the non-participating children are not made to feel "left out." Specify in the protocol what provision will be
made for the non-participants while the subjects are participating in the study.
Permission from an institutional representative:
If the research site will be a school, corporate office, factory, house of worship, or other non-Rutgers institution, you
must provide in your IRB application a letter of permission from a responsible representative of that institution to
perform your project on those premises.
Revisions after IRB review:
If you submit a revised protocol following recommendations in the IRB review, please indicate any revisions(s)
distinctively, e.g. CAPITALIZED, boldface, underlined, and/or [bracketed] in the margins. Do not use a colored
highlighting pen, because the highlighting either does not show up, or it obscures the text in photocopies. In addition,
submit an entire “clean” copy of the revised version that is devoid of the markings that identify the revisions.
MISCELLANY
Continuing review:
For all non-exempt studies, continuing review by the IRB is required at least annually. Approximately two months
before the expiration date of the protocol, the IRB office will mail a form entitled "Request for Continuing Review"
to principal investigators, which must be completed and returned promptly. If the form is not returned by the end
of the approval period, the protocol will be administratively inactivated, in which case the research using human
subjects must be terminated immediately.
Change in protocol or principal investigator:
Whenever an ongoing project acquires a new principal investigator, or whenever there is a change in the protocol
or the subject population, the IRB must be notified in writing. Upon approval of the modification, the IRB will issue
a revised notice of approval.
Adverse Events:
All adverse and/or unexpected events experienced by participants in research studies must be reported
immediately to the IRB on the Adverse/Unexpected Event Report form, which may be downloaded from the
ORSP website: <http://orsp.rutgers.edu/humans1.html>. In addition, a copy of the form will be mailed to the
Principal Investigator with each Notice of Approval.
Federal grant applications:
If the project is being submitted to a Federal agency that requires IRB review, please inform the Office of
Research and Sponsored Programs of this fact, and provide the address of the person in the Federal agency who
is to be notified once the project has received IRB approval.
IRB decisions:
All IRB decisions will be communicated to investigators in writing. On occasion, an investigator may be invited to
appear before the IRB to provide information about matters not covered in the request for review. In the unlikely
event of an unresolvable conflict between the IRB and an investigator, the case will be referred to the Vice
President of Research and the Graduate and Professional Education for further review.
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In the event of non-compliance:
In accordance with the Rutgers University Federalwide Assurance #FWA00003913 “ensuring prompt reporting to
the IRB, appropriate institutional officials, the relevant Department or Agency Head, any applicable regulatory
body, and OHRP of any: (i) unanticipated problems involving risks to subjects or others, (ii) serious or continuing
noncompliance with the Federal Regulations or IRB requirements, and (iii) suspension or termination of IRB
approval” The Federal Office of Human Research Protections (OHRP) may also be informed of non-compliance.
FOR FURTHER REFERENCE:
The review criteria, and the other rules and regulations under which the IRB operates, are set forth in the Federal
Register, Vol. 56, No. 117, for Tuesday, June 18, 1991, (revised November, 1998) and are encompassed in
Rutgers University's Assurance of Compliance as approved by the Division of Compliance, OPRR, U.S.
Department of Health and Human Services. The ethical principles to which the IRB subscribes are set forth in the
Belmont Report, printed in the Federal Register, Vol. 44, No. 76, for Wednesday, April 18, 1979. These
documents are available at the Rutgers University IRB Office, ASB III, 3 Rutgers Plaza, New Brunswick, NJ
08901.
IRB webpage on the Rutgers University ORSP website: < http://orsp.rutgers.edu/Human.asp >.
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