Wayne State University

IRB forms and submissions requirements

Where & How to Submit to the IRB 

WSU IRB Administration Office Location & Office Hours

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)

 


IRB Pre-Review Service & Self Review Tool

The IRB is excited to provide pre-review of initial full board study submissions! The IRB is piloting offering a pre-review of submission documents before submission to the full board. In addition, the IRB now has a Self Pre-Review Assessment Tool that can be used prior to IRB submission. This service is part of a pilot project aimed at improving overall completeness of new study submissions by providing investigator support. 

Pre-Review Process: 

  •  Complete the Protocol Summary Form, Protocol/Proposal, Consents/Assents, and all other application documents
  • Submit documents to: IRBQuestions@wayne.edu The subject line stating: "Pre-Review"
  • Submit pre-review request at least 2 weeks prior to the IRB submission deadline you are aiming for to give enough time address the pre-reviewer's recommendations.
  • Pre-review requests will be reviewed in the order in which they are received.
  • At the conclusion of the pre-review an acknowledgement letter will be sent to the submitter listing the documents that have been received, reviewed, along with a stamped pre-review checklist.
  • The Pre-Review Acknowledgement Letter and stamped Pre-Review Checklist must be included in the final submission package for the full board's deadline

New Self Assessment Pre-Review Tool

The Self Assessment Pre-Review tool is useful for completing before submitting to the IRB. The tool walks you through the submission requirements based on the many different scenarios unique to each study. This tool can be used as part of the IRB pre-review or used solely by the submitter.  The tool helps submitters know what documents and forms are required for IRB, as well as the type of IRB reviews and a Check for Completeness Assessment. The self-pre-review is not a required IRB form. 

Self-Assessment/Pre-Review Tool

Note: Pre-review is designed to prepare submissions for IRB review and ensure the study meets criteria for review. While the expected outcome is approval of the submission, this is not a guaranteed outcome. Official review and determinations are made by the full board. The pre reviewed final submission will be stamped "pre-reviewed", however the submission must be received according to the submission instructions (described on the last page of the Investigator Self-Review Tool). Submission deadlines still apply for pre-reviewed studies that require a full board review. 


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 (4/2018)

For information regarding activities that are not considered Human Participant Research please view the HPR Guidance Tool.


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


Initial Submissions

IRB Submission Instructions and Checklist (PDF)

Exempt Review

Expedited and Full Board Review

NOTE: Full Board Initial Submissions submitted to MP4

will be redirected to M1 for Adult Studies and MP2 for Pediatric Studies

ELECTRONIC SUBMISSION NOTE:

PH1 Initial Submissions must use eProtocol

Effective December 1, 2018 M1 & B3 Full Board Initial Submissions must use eProtocol

VA Submissions will continue to use the traditional submission process (see Protocol Summary Form for Instructions)

For more information regarding submitting using eProtocol see the eProtocol section of the IRB Education website.

eProtocol

 


Other Initial Submissions

Appendices

Additional Forms That May Be Required

Please note: For Data Use Agreements which are not Limited Data Set Data Use Agreements, please contact the MTA Assistant at mtainfo@wayne.edu from the WSU's Technology Commercialization Office. 

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 consent document(s) language provided with the CoC. 

Current Submissions

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.

In addition, at the point of continuing review the IRB Administration Office will review NIH submissions to determine if certificate of confidentiality language is needed.  

Click here to review suggested CoC consent form 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.

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.