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)
PH1, M1, & B3 Full Board New/Initial Submissions Now Accepted via eProtocol (excluding VA)
For training and submission assistance click here.
Please review the Common Rule Changes website before preparing your submission
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.
- 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.
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.
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 (RCR update)
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
Informed Consent Templates
Continuations & Status Check In Reports
Treatment Use (Investigational Drugs and Devices)
Unexpected Problem and Adverse Event Reports
Shortcuts to Submission Requirements and Other Information
Please note: Effective January 21, 2019 the Exempt Submission Forms have been updated and appendices added due to the Revised Common Rule (RCR). The most current exemption forms (below) will be accepted ONLY. Please download forms at each use. Previous versions of the exempt forms are no longer in use.
- Medical Exempt Protocol Summary Form (RCR update)
- Social/Behavioral/Education Exempt Protocol Summary Form (RCR update)
- Exempt Form Appendices (please complete the applicable appendix below based on the exempt category selection):
Expedited and Full Board Review
- Medical/Behavioral Protocol Summary Form (12/2018) (previous version accepted until 2/11/2019)
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, M1 & B3 Full Board New/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.
Exempt & Expedited studies are currently not accepted via eProtocol.
Expedited submissions use the Protocol Summary Form
Exempt submissions use the applicable Exempt Submission Form
eProtocol users Unexpected Problem Reporting- Please use the IRB Unexpected Problem Form found on this website
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 (RCR update)
- 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 (RCR update)
- 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)
- Limited Data Set Data Use Agreement (04/2015)
Please note: For Data Use Agreements which are not Limited Data Set Data Use Agreements, please contact the MTA Assistant at firstname.lastname@example.org from the WSU's Technology Commercialization Office.
Informed Consent Templates
- Expedited Medical/Behavioral Amendment Submission Form (03/2018)
- 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 (RCR update) previous version accepted until 2/11/2019
- Minimal Risk Status Update Report Form (new RCR)
- Revised Common Rule Transition Appendix (new RCR)
- 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 (02/2017)
- 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 consent document(s) 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.
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.
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.