IRB forms and submissions requirements
Due to anticipated heavy snow conditions the IRB Administration Office is closing today December 13, 2017 at 2:30pm.
Submit hard copies of forms to:
IRB Administration Office
87 E. Canfield, 2nd Floor
Detroit, MI 48201
Hours: Monday - Friday, 8:30am - 5:00pm
CLOSED 12:00pm - 1:00pm (for lunch)
Shortcuts to Forms
Always download the most current version of the forms from this website. If you submit an older version of the form, your submission will be returned to you.
Determining If IRB Review Is Required
Informed Consent Templates
Treatment Use (Investigational Drugs and Devices)
Unexpected Problem and Adverse Event Reports
Shortcuts to Submission Requirements and Other Information
If you are not sure that a project requires IRB review, use the following tool to describe the project and email to IRBQuestions@wayne.edu for assistance. Also, send any written proposal or data collections tools, if available.
- Medical Exempt Protocol Summary Form (03/2016)
- Social/Behavioral/Education Exempt Protocol Summary Form (03/2016)
Expedited and Full Board Review
- Medical/Behavioral Protocol Summary Form (03/2016)
Other Initial Submissions
- Humanitarian Use Device (HUD) Form (04/2015)
- Administrative Application (04/2015)
- Authorization to Use Another IRB for Protocol Approval Agreement (04/2015)
- Authorization to be the IRB of Record for Collaborating Entity (04/2015)
- Appendix A - International Research (04/2015)
- Appendix B - Internet Use in Research (04/2015)
- Appendix C - Children as Research Participants (04/2015)
- Appendix D - Cognitively Impaired or Mentally Disabled Research Participants (04/2015)
- Appendix E - Prisoners as Research Participants (04/2015)
- Appendix F - Use of Drugs, Biologic Agents, or Devices (04/2015)
- Appendix G - Imaging/Diagnostic Radiation (04/2015)
- Radiation Exposure Calculation
- Appendix H - The Use of Biological Specimens (04/2015)
- Appendix I - Research Funded by a Component of the Department of Defense (DoD) (04/2015)
- Appendix J - Studies Conducted at or by the VA (04/2015)
- Appendix K - Pregnancy, Fetuses, Neonates (04/2015)
- Appendix L - NIH Genomic Data Sharing (04/2015)
- Institutional Certification: Genetic/Genomic Data Sharing
Additional Forms That May Be Required
- HIPAA Summary Form (04/2015)
- Additional Key Personnel List (04/2015)
- Coordinating Center Application (04/2015)
- Data Use Agreement (04/2015)
Informed Consent Templates
- Expedited Medical/Behavioral Amendment Submission Form (03/2016)
- Full Board Medical/Behavioral Amendment Submission Form (03/2016)
- Change in PI Form (04/2015)
- Key Personnel Change Form (04/2015) (use the Additional Key Personnel List if all key personnel changes cannot fit on the Key Personnel Change Form)
- Administrative Application (04/2015) - To Amend an Administrative Application
- Include any Appendices or Additional Forms, if necessary
All IRB approved research reviewed as expedited or by the full board requires either a continuation or closure before the date of expiration.
Please submit continuations 6 weeks prior to the expiration date.
- Continuation Submission Form (03/2016)
- Administrative Application (04/2015) - To Continue/Renew an Administrative Application
All IRB approved research reviewed as expedited or by the full board requires either a continuation or closure before the date of expiration. Exempt studies do not need require a closure form.
- Closure Form (04/2015)
- Single Time Emergency Use of a Test Article (Drug, Biologic or Device) Form (04/2015)
- Compassionate Use Form (04/2015)
- FDA Decision Chart
Unexpected Problems and reportable Adverse Events must be reported to the IRB as soon as possible, but within 5 working days.
- Unexpected Problem Form (04/2015)
- Unexpected Problem Follow-up Form (04/2015)
- Adverse Event Algorithm
- Determining which Adverse Events are Unexpected
National Institutes of Health (NIH)
Effective October 1, 2017 NIH now automatically issues Certificates of Confidentiality (CoC) to all NIH funded or conducted research studies that are collecting or using identifiable, sensitive information (see Determining CoC Policy Applicability below). This policy is retroactive to December 13, 2016.
Questions Determining NIH CoC Policy Applicability
- Is the activity biomedical, behavioral, clinical, or other research?
If the answer to this question is no, then the activity is not issued a Certificate. If the answer is yes, then investigators will need to answer the following questions:
- Does the research involve Human Subjects as defined by 45 CFR Part 46?
- Are you collecting or using biospecimens that are identifiable to an individual as part of the research?
- If collecting or using biospecimens as part of the research, is there a small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual?
- Does the research involve the generation of individual level, human genomic data?
If the answer is yes to one the above questions the policy applies and NIH will automatically issue a CoC.
Submitting to the IRB
When the policy applies please include for the Consent document(s) the language provided with the CoC.
If the study is a NIH funded or conducted study please review the Determining Applicability questions. If the policy applies and a CoC is issued to investigators, an amendment should be submitted to the IRB with the updated consent language.
Extending or Amending Current CoC with NIH
Not sure if you need to extend or amend an existing CoC with NIH? click here to view the NIH kiosk page on extending and amending an existing Certificate of Confidentiality.
Reliance Agreements-External IRB Requests
- WSU-External IRB Request Cover Sheet and Review Authorization Form (.doc)
- Consent document with HIPAA Authorization
- HIPAA Summary Form
Questions regarding reliance agreements please email: firstname.lastname@example.org
WSU External IRB Policy (.doc)
WSU is a SMART IRB participating institution. To submit an External IRB Request using SMART IRB please submit the documents indicated above along with the SMART IRB Acknowledgement of Site Agreement to CEDE IRB Review letter (.doc)
For a listing of SMART IRB participating institutions see https://smartirb.org/participating-institutions/
A Guide to the WSU IRB and Human Research Protection Program. Everything you need to know about the IRB review process in one place. Download the Handbook for Investigators (.docx)
Join our Listserv to keep up to date on changes to the forms, IRB training opportunities, policy changes, and other occasional announcements.
Refer to the research categories below to determine if the research meets the requirements for an Exempt or Expedited approval. If the research does not meet requirements for either, then it should be submitted for Full Board review.
A letter of approval from the scientific review committee for research conducted at or by investigators from the following institutions or departments is required:
Detroit Medical Center (DMC), DMC Nursing Research Council, Karmanos Cancer Institute, Veterans Administration Medical Center, Oakwood Hospital, WSU Department of Psychiatry, and any other internal review that may be required by your department, but not by the IRB.
For more information on the DMC Research Review process, see: http://www.dmc.org/researchreviewprocess/
To check on the status of an IRB submission for expedited or exempt review, please wait a minimum of two weeks after the date of submission and email email@example.com. Provide the project title and the PI name in the subject line. IRB memos will be sent (inter-office mail or post mail) and emailed approximately 7-10 business days following the review of the submission by the assigned IRB member.
To check on the status of an IRB submission for full board review, please wait to the end of the 10 business days after the IRB meeting date and email firstname.lastname@example.org. Provide the project title, the committee submitted to, and the PI name, in the subject line. IRB memos will be sent (inter-office mail or post mail) and emailed approximately 7-10 business days following the the date of the full board meeting.
Please note, in order to receive information about an IRB submission you must be listed on the study documents.