Wayne State University

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
Initial Submissions
Informed Consent Templates
Amendments
Continuations
Study Closures
Treatment Use (Investigational Drugs and Devices)
Unexpected Problem and Adverse Event Reports


Shortcuts to Submission Requirements and Other Information

Handbook for Investigators
IRB Research Listserv
About Exempt and Expedited Research Categories
Institutional or Departmental Review and Approvals
Status of IRB Submissions


Determining If IRB Review Is Required

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.

Human Participant Research (HPR) Determination Tool (4/2015)


Initial Submissions

IRB Submission Instructions and Checklist (PDF)

Exempt Review

Expedited and Full Board Review

Other Initial Submissions

Appendices

Additional Forms That May Be Required

Informed Consent Templates


Amendments


Continuations

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.


Study Closures

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. 


Treatment Use


Unexpected Problem and Adverse Event Reports

Unexpected Problems and reportable Adverse Events must be reported to the IRB as soon as possible, but within 5 working days.


National Institutes of Health (NIH

New NIH Certificates of Confidentiality policy (effective October 1, 2017) 

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.  

Visit the NIH CoC Kiosk (click here and for more information)

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 

Initial Submissions

When the policy applies please include for the Consent document(s) the language provided with the CoC. 

Amendments

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

External IRB Requests outside of WIRB and CIRB please submit the following to the IRB Administration Office:

  • WSU-External IRB Request Cover Sheet and Review Authorization Form (.doc)
  • Consent document with HIPAA Authorization 
  • HIPAA Summary Form 
  • Protocol 

Questions regarding reliance agreements please email: relyirb@wayne.edu 

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/

smart-irb-banner-234x60.png


Submission requirements

Handbook for Investigators:

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)


IRB Research Listserv:

Join our Listserv to keep up to date on changes to the forms, IRB training opportunities, policy changes, and other occasional announcements.


About Exempt and Expedited Research Categories:

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.


Institutional or Departmental Review and Approvals

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/

 


Status of IRB Submissions:

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 irbstatus@wayne.edu.  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 irbstatus@wayne.edu.  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.