Directions for Submitting a
Social/Behavioral/Education Exempt Study
(Please do not include this page with your submission)

If requesting exempt review for a social/behavioral/education research study, please submit to
the IRB Administration Office all of the following:
Hardcopy dropped off or mailed to the IRB Administration Office:
o One completed Behavioral Exempt Protocol Summary Form (containing original signatures),
the entire descriptive protocol and/or grant application, all instruments (survey tools), a
HIPAA Summary Form (if applicable), and
o Two copies of other documentation as applicable (informed consent, assent, information
sheets, HIPAA authorization, advertisements, flyers, etc.).
AND
One copy of everything e-mailed:
o One copy of everything via e-mail to: "B3 Board" <b3board@wayne.edu>




There is no deadline for submission of Behavioral Exempt protocols.
If children are participants in the research and there is to be interaction with them or if there is
observation of public behavior where the PI is participating in the activities being observed, a
research exemption will NOT apply.
Prisoners cannot be enrolled in exempt research.
If the Detroit Medical Center is a part of your study, you must obtain a DMC Research Review
Authorization from them (an e-mail). This is needed before IRB approval for your study can be
given, BUT it can be gained concurrently with the IRB process. For more info:
http://www.dmc.org/researchreviewprocess/


If this protocol does not qualify for exempt review, you will be instructed to complete the
Medical/Behavioral Protocol Summary Form and resubmit your protocol for approval. Please see
our policies for what qualifies for exempt review: http://irb.wayne.edu/policies-human-research.php
Questions? Please call us if you have any questions along the way: (313) 577-1628.
Behavioral Exempt
Page 1
Form date: 10/2013
Before You Get Started on Your Submission,
Here is Some Help from the IRB…
Like a beacon in the night, we are always there protecting human research
participants.
Handbook for Investigators
The Handbook for Investigators is designed to provide comprehensive direction and assistance to faculty, staff, students or other
personnel who are conducting human participant research at Wayne State University or any of its affiliated institutions. Download
your copy today! This document is located on the IRB’s website at: http://www.irb.wayne.edu/forms-requirementscategories.php
On-Going IRB Training and Helpful Tools
Our Website has the on-going training calendar (4 - 5 a month); helpful tools, resources and documents; policies; and helpful
links to federal agencies: http://www.irb.wayne.edu/education.php Always download the forms from our website for the most
recent version.
Join the WSU IRB Info Listserv
The WSU IRB Administration Office has created a listserv for all researchers and research staff using the WSU IRB. This
listserv provides a means for us to occasionally share information, make announcements, advertise the training calendar, share
answers to questions, etc. with the research community. It is easy to join: To subscribe send a blank e-mail to irb-infosubscribe-request@lists.wayne.edu. Be sure to confirm the reply e-mail. To unsubscribe at any time, send an e-mail to irb-infosignoff-request@lisits.wayne.edu. To send a message to all of the people currently subscribed to the list, just send an mail to irbinfor@lisits.wayne.edu
Join the WSU Study Coordinators' Advisory Committee
Are you a researcher or research staff person? Join the Study Coordinator’ Advisory Committee (SCAC). This listserv lets
research staff and researchers from WSU and it’s affiliates share information, make announcements, ask questions, share
answers, etc. with each other. It is easy to join: To subscribe to the listserv send a blank e-mail to scac-subscriberequest@lists.wayne.edu. To send a message to all of the people currently subscribed to the list, just send mail
to scac@lists.wayne.edu. To learn more about SCAC, visit their website at: http://irb.wayne.edu/study_coord_adv_comm.php
Behavioral Exempt
Page 2
Form date: 10/2013
IRB Administration Office
87 E. Canfield, SecondFloor
Detroit, MI 48201
Office (313) 577-1628
http://irb.wayne.edu/index.php
Social/Behavioral/Education Exempt Protocol Summary Form
 All IRB submission forms must be the current form date (down load from http://irb.wayne.edu/forms-requirements-categories.php)
and typed or computer generated.
 Submit with original signatures—no faxed or copied signatures.
 *Forward your @wayne.edu e-mail to your @med.wayne.edu, @karmanos.org, etc. e-mail in order to receive important e-mail
communications regarding your study if you do not access your @wayne.edu e-mail OR go to Pipeline and enter the e-mail account
that you wish to use. Non-WSU employees, please enter your e-mail.
 Please call us if you have any questions along the way: (313) 577-1628
IRB Number
IRB Use ONLY
Section A: Principal Investigator (PI), Project Title & Endorsements
1.
2.
Name of PI:
Phone:
(
)
Department:
Fax:
(
)
Division:
*E-mail:
Campus Address:
Pager:
NOTE: PIs who are students or trainees; or those who are not WSU faculty or employees of WSU or an affiliated
health care institution must provide home mailing address and phone number in addition to the above information.
(NOTE: If provided, all correspondence from the IRB office will be sent to the home address.)
N/A
Home
Phone:
Home Address:
3.
Name of Study
Coordinator:
Phone:
4.
(
)
N/A
(
)
*E-mail:
Title:
Form completed by:
Phone:
5.
Date:
(
)
*E-mail:
Project Title:
Behavioral Exempt
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Form date: 10/2013
6. CITI Training:
The PI and all of their study personnel must have completed the CITI training program at https://www.citiprogram.org/Default.asp
Further directions at: http://irb.wayne.edu/mandatory-training.php. Affiliate with WSU at CITI for courses to count. You may be
directed in the forms and Appendices to take additional CITI trainings. Please complete these prior to submission to avoid delays.
HIPS= Health Information, Privacy & Security RCR= Responsible Conduct of Research (under “Human Subject Research” tab)
Have you taken all of these?:
HIPS
RCR
Basic/Refresher Course for Human Subjects
If these were taken under a different name (maiden, etc.), please list that name here:
Yes
No - STOP: do not submit this form until above training is complete.
7. Endorsements and Financial Conflict of Interest Disclosure (FCOI):
If any response below is “yes,” there must be a “Financial Conflict of Interest Detailed Disclosure Form” submitted directly to the
Financial Conflict of Interest Committee prior to the time of this submission and then annually or when changes occur.
If any response below is “yes,” the FCOI committee communication must be included with this submission. If this communication is not
included, the IRB will not accept your submission.
FCOI form and more information are available at www.research.wayne.edu/coi For additional information please contact the Conflict of
Interest Coordinator at 313-577-9064, 5057 Woodward, Suite 6304, Detroit, MI 48202, Fax 313-577-2159.
Endorsements and Financial Conflict of Interest Disclosure:
Objectivity in research is a key component of any research project. One method for maintaining objectivity is to have all individuals involved in
research design, development, or data evaluation/analysis disclose any potential and/or real financial conflict of interest.
Examples of relevant relationships for potential conflict of interest include but are not limited to:
(1) receiving past, current, or expecting future income in the form of salary, stock or stock options/warranties, equity, dividends, royalties,
profit sharing, capital gain, forbearance or forgiveness of a loan, interest in real or personal property, or involvement in a legal
partnership with the sponsor
(2) receiving past, current, or expecting future income in the form of consulting fees, honoraria, gifts, gifts to the University, or payments
resulting from seminars, lectures, or teaching engagements, or service on a non-federal advisory committee or review panel
(3) serving in a corporate or for-profit leadership position, such as executive officer, board member, fundraising officer, agent, member of
a scientific advisory board, member of a scientific review committee, or member of a data safety monitoring committee, regardless of
compensation
(4) inventor on a patent or copyright involving technology/processes/products licensed or expected to be licensed to the sponsor.
See Financial Conflict of Interest policies: http://research.wayne.edu/coi/docs/wsu-financial-conflict-of-interest-and-commitment-researchpolicy.pdf and http://www.irb.wayne.edu/policies-human-research.php
Principal Investigator FCOI:
For students or individuals without a WSU faculty appointment, a WSU faculty supervisor/sponsor or outside authorized signatory (official from
DMC, KCI, Oakwood, Karmanos, etc.) is required (see next section, below). Please answer and sign by hand.
1)
Do you, your spouse or domestic partner, or any of your dependent children have a potential and/or real financial conflict of interest
with the sponsor of this project, including all secondary sources?

NO

YES - see instructions above and attach correspondence
2) In signing the description of this research project, the PI agrees to accept primary responsibility for the scientific and ethical
conduct of the research, as approved by the IRB, and abide by the IRB’s policies and procedures. An Original signature must be
submitted.
PI Signature
Behavioral Exempt
Title
Page 4
Date
Form date: 10/2013
Faculty Supervisor or Sponsor FCOI and Certification:
Please answer and sign by hand. For students or individuals without a WSU faculty appointment, a WSU
faculty supervisor/sponsor or outside authorized signatory (official from DMC, KCI, etc.) is required.
1) Do you, your spouse or domestic partner, or any of your dependent children have a potential and/or real financial conflict
of interest with the sponsor of this project, including all secondary sources?

NO

YES - see instructions above and attach correspondence
Campus Address:
*E-mail:
Phone:
* An e-mail address is required so that we can keep you informed
2) In signing the description of this research project, the faculty supervisor/sponsor certifies that he/she has reviewed the
research plan and has approved the scientific and ethical aspects of this research. The faculty supervisor/sponsor will
supervise all compliance with the IRB’s guidelines.
Signature of WSU Faculty Supervisor/Sponsor
Title
Date
Printed name
Department Chair/Dean or Authorized Signatory:
Please answer and sign by hand.
1) Do you, your spouse or domestic partner, or any of your dependent children have a potential and/or real
financial conflict of interest with the sponsor of this project, including all secondary sources?
__ NO __ YES - see instructions above and attach correspondence
2) In signing the description of this research project, the Department Chair, Dean, Institute Center Director, or
other Authorized signatory certifies that (1) appropriate support will be provided for the research project
including adequate facilities and staff; (2) appropriate scientific and ethical oversight has been and will be
provided; (3) the research uses procedures consistent with sound research design; and (4) the research design
is sound enough to yield the expected knowledge. Any comments or feedback related to this certification
should be in writing and accompany this research proposal submission.
_________________________________________________________________________________
Signature of Department Chair or Dean or Authorized Signatory Official
Title
Date
Printed name
Behavioral Exempt
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Form date: 10/2013
8.
Key Personnel and Co-PIs:
List and briefly describe the role of all personnel in the study and disclose any potential and/or real financial conflict of interest.
Please see previous FCOI section for directions.
If any response below is “yes,” there must be a “Financial Conflict of Interest Detailed Disclosure Form” submitted directly
to the Financial Conflict of Interest Committee prior to the time of this submission and then annually or when changes occur.
If any response below is “yes,” the FCOI committee communication for this amendment must be included with this
submission. If this communication is not included, then the IRB cannot accept the submission.
Key personnel are persons engaged in the collection of data or have access to data through intervention or interaction
with the participant, including the consent process, or have access to the participant’s identifiable private information.
This may include collaborators, fellows, residents, research assistants, etc.
Name
Division/Dept
Research Role
1)
Do you, your spouse or domestic partner, or any of your dependent children have a potential and/or real financial conflict
of interest with the sponsor of this project, including all secondary sources?
 NO

YES—see additional directions above. Complete answer and signature by hand.
Signature:
2)
Do you, your spouse or domestic partner, or any of your dependent children have a potential and/or real financial conflict
of interest with the sponsor of this project, including all secondary sources?
 NO

YES—see additional directions above. Complete answer and signature by hand.
Signature:
3)
Do you, your spouse or domestic partner, or any of your dependent children have a potential and/or real financial conflict
of interest with the sponsor of this project, including all secondary sources?
 NO

YES—see additional directions above. Complete answer and signature by hand.
Signature:
4)
Do you, your spouse or domestic partner, or any of your dependent children have a potential and/or real financial conflict
of interest with the sponsor of this project, including all secondary sources?
 NO

YES—see additional directions above. Complete answer and signature by hand.
Signature:
Behavioral Exempt
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Form date: 10/2013
Name
Division/Dept
Research Role
5)
Do you, your spouse or domestic partner, or any of your dependent children have a potential and/or real financial
conflict of interest with the sponsor of this project, including all secondary sources?
 NO

YES—see additional directions above. Complete answer and signature by hand.
Signature:
B: Research Project Characteristics
9.
Exemption Categories:
Check the applicable categories for exemption: Prisoners cannot be enrolled in exempt research.
Identifying information cannot be retained throughout the study for it to be eligible for exempt review.
(1) Research conducted in established or commonly accepted educational settings, involving normal educational
practices, such as


research on regular and special education instructional strategies, or
research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom
management methods.
(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures or observation of public behavior, where information obtained is recorded in
such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects.
If children are participants in the research and there is to be interaction with them or if there is observation of public
behavior where the PI is participating in the activities being observed, a research exemption will NOT apply.
(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 item (2) of this
section, if:


The human subjects are elected or appointed public officials or candidates for public office; or
Federal statutes require 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.
Behavioral Exempt
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Form date: 10/2013
(5) Research and demonstration projects which are conducted by or subject to the approval of department or
agency heads, and which are designed to study, evaluate, or otherwise examine:




public benefit or service programs;
procedures for obtaining benefits or services under those programs;
possible changes in or alternatives to those programs or procedures; or
possible changes in methods or levels of payment for benefits or services under those programs.
(6) Taste and food quality evaluation and consumer acceptance studies,
 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 Agriculture
10.
State protocol-specific examples of how this research qualifies for the selected exemption category:
11. Status of Principal Investigator
(Check all that apply):
12. Type of Project:
WSU Faculty
VAMC Staff
DMC Staff
Resident/Fellow
Graduate
Undergraduate
KCI Staff
Oakwood Staff
Other (explain):
Research Proposal
Thesis/Dissertation
Master’s Project
Other (explain):
13. Funds for this project are being
provided by or requested from:
*Must answer question #14
Private/Pharmaceutical
Industry*
Governmental agency*
Foundation*
Behavioral Exempt
Non-Profit Organization*
Other (describe):
Departmental (WSU/DMC/VAMC/Oakwood/etc)
14. Funding Source:
Contact Name:
Address:
Phone:
Grant Number:
SPA Proposal Number from FES
Form (eight digit number)
15. Status of Funds:
WSU Institute*
N/A
Approved
Pending
N/A
Page 8
Form date: 10/2013
16. Check all applicable performance sites
where this research will be conducted. It is
essential that this information be
accurate. All human research conducted
at DMC, KCI, or VAMC sites require
authorization through their institutional
review process in addition to IRB approval.
DMC can be gained concurrently with the
IRB process.
Please provide any necessary letters of
support.
Wayne State University
Site:
University Physician Group (UPG)
Site:
Kresge Eye Institute Outpatient Care
Detroit Medical Center Hospital or Institute
Children’s Hospital of Michigan
Detroit Receiving Hospital/University Health Center
Harper University Hospital
Huron Valley / Sinai Hospital
Hutzel Women’s Hospital
Kresge Eye Institute Operating Room
Michigan Orthopedic Specialty Surgery Hospital
Rehabilitation Institute of Michigan
Sinai-Grace Hospital
Barbara Ann Karmanos Cancer Institute
John D. Dingell Veteran’s Administration Medical Center *
*For research being done at JDD VAMC,
please complete Appendix J.
Other: state:
17. a) Indicate all vulnerable groups that will
Minors (under 18 years of age)
be central to the focus of this research and
http://irb.wayne.edu/policies/8-2-vulnerable-participantsanswer b), below, if any are used.
children.pdf
Complete corresponding Appendix
Fetuses and/or Neonates
Check all that apply.
http://irb.wayne.edu/policies/8-1-research-involving-fetuses-andPrisoners cannot be enrolled in exempt
neonates.pdf
research.
N/A
Pregnant Women
Adults with diminished functional abilities that affect capacity
to consent
Other (explain):
b) Provide study-specific justification for
the inclusion of the vulnerable group:
18. Will non-identifying information about the
research participants ( sex, race, age, etc.)
be collected?
Behavioral Exempt
Yes (describe):
Page 9
No
Form date: 10/2013
19. What is the approximate number of
At this site?
At other sites?
N/A
How will they be collected?
N/A
participants, documents, or specimens to
be collected?
20. What biological specimens will be
collected or used?
21. Will medical records or medical databases
be used during data collection?
Blood
Urine
Tissue
Other (describe):
Yes If yes, complete a HIPAA Summary Form and
request a waiver of authorization.
No
All human research conducted at DMC
sites requires DMC Research Review
Authorization which can be gained
concurrently with this review process:
http://content.dmc.org/ResearchReviewProcess/
22. Describe the data, documents, or records
N/A
needed for this project-be specific
regarding origin of data:
23. Describe how the data, documents, or
N/A
records will be obtained for this project:
24. If accessing the medical records initially in
N/A
order to extract anonymized data, describe
how the initial list will be destroyed:
25. How will the research participants/
specimens be identified in the research
documents?
26. Will there be a link kept connecting the
human participants to the coded
specimens/ documents?
If yes, will the investigative team have
access to the link?
N/A
No
Yes
No (Provide a letter from the holder of the link stating that
the investigative team will not have access.)
Yes (Not eligible for exemption, please complete a
Medical/Behavioral Protocol Summary Form)
Behavioral Exempt
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Form date: 10/2013
27.
28.
Describe the recruitment procedures. If
using any advertisements or flyers,
provide a copy of each, identify posting
locations, and provide any necessary
letters of support. Note: If posting on
WSU’s campus, provide a letter of
support from the Dean of Students.
If using the Internet, please submit
Appendix B
Describe the informed consent process,
including measures to protect personal
privacy. If applicable, provide a copy of
any document that will be used to obtain
consent (i.e., information sheet, verbal
consent script, etc.). If request a “waiver”
of consent, please provide protocolspecific justification for the request.
29. If an anonymous survey or anonymous
interview (no identifiers collected) is being
used, will an information sheet be
provided?
N/A
N/A
No
Yes
If using the Internet, please submit Appendix B
30. Describe the benefits, if any, to the
research participants for involvement in
this project.
Note: Financial compensation or free
testing in any form is NOT a benefit)
31. Describe the benefits to society, if any,
that may result from participation in this
research project.
32.
N/A
None
None
N/A
Risks:
Describe the nature and degree of potential risks to research participants in lay terms. Include all risks identified in
the protocol. (Check all that apply) See “Glossary” on the IRB website for a description of the different types of risk.
Risk
Description of Risk
Physical
Psychological
Social
Economic
Legal
Behavioral Exempt
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Form date: 10/2013
Note: All identified risks and benefits must also be listed in the consent document.
33. What precautions will be
taken to minimize each of
the risks described
above?
34.
Narrative Summary:
Provide a complete and concise description of the protocol in non-technical language (lay terms). Do NOT “paste”
text from the full protocol or refer to protocol page numbers. The completed summary should be 1 to 3 pages in length.
One additional page may be added. If the Narrative Summary exceeds four pages, it will be returned to you.
a. Describe the background and
rationale for the study:
b. State the goals/aims/
hypothesis for the study:
c. List inclusion criteria:
d. List exclusion criteria:
Behavioral Exempt
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Form date: 10/2013
e. Describe the methods/
procedures of the study. If
using data collection
instruments, provide a copy of
each instrument and clearly
describe the procedures—
including who will administer
the instrument, how it will be
administered (i.e., in person, email, US mail, website),
frequency of administration,
and the amount of time
required to complete the
instrument.
35.
Submit a copy of each data collection instrument with this application.
3 If a full descriptive protocol is not
4
available, then please provide a
list of references for your
protocol:
36.
37.
Number of documents that
you are submitting:
advertisements/flyers/brochures:
Ensure that all documents
referenced are attached.
assessments/measures:
Number of documents that
you are submitting:
Info Sheets
surveys:
other:
Scripts
N/A
N/A
Please double check to ensure that you answered all of the questions asked.
After printing, hand fill-in your answers and sign for: Q7 on pages 3 and 4 and Q 8 on page 5
Behavioral Exempt
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Form date: 10/2013