NCI's Central Institutional Review Board Initiative
Wayne State University is enrolled in the National Cancer Institute Central Institutional Review Board (NCI CIRB) Initiative. The IRB may carry out "Administrative Review" of certain NCI-sponsored Cooperative Group research studies approved by the CIRB, and once the IRB is satisfied that all local context issues have been met, may recognize the CIRB as the IRB of Record for the study at WSU and its affiliated institutions. The WSU IRB retains responsibilities for local oversight and review of the performance of the research after acceptance of Administrative Review. The documentation for submissions are below.
External IRB Policy: To view the External IRB & Reliance Agreements for Multi Site Research Policy (policy 4-17) visit the IRB's policy website.
Initial External IRB Request Cover Sheet and Review Authorization Form (updated 10.16.2019) previous version accepted until November 15, 2019
External IRB Request Modification & Event Reporting Form - (updated 10.16.2019) previous version accepted until November 15, 2019. This Form should be used for submission of key personnel modifications, HIPAA changes, event reporting, or any other local context modifications.
HIPAA Summary Form (.doc)
CIRB Approved Informed Consent Template (non-McLaren)
Short Form Consent documents are available in Arabic, Bengali, Chinese-Simplified, Chinese-Traditional, Farsi, French-Canada, French-Enrope, German, Greek, Hindi, Italian, Polish, Russian, Spanish-Mexico, Swahili, Tamil, Thai, and Ukranian (along with the Oral Short Form English Translation).
Documents and correspondence should be submitted via email to CIRB@wayne.edu.
Initial submissions and modification requests reviews are conducted 7 -10 business days from receipt of the complete submission. Note, missing items may result in delay of review.
Modifications: Changes to local research arrangements (i.e. key personnel & HIPAA) should be submitted to the IRB Administration Office for review. Change requests should be submitted via email to CIRB@wayne.edu. using the WSU External IRB Request Modification & Event Reporting Form. Please submit highlighted versions of requested revisions and indicate in the e-mail the modifications that are being requested.
UP Reporting: All SERIOUS unexpected problems/adverse events occurring at WSU and its affiliated institutions should be submitted to the WSU IRB within 5 working days. The CIRB UP Protocol Worksheet and WSU External IRB Request & Modification Form should be submitted for review to the WSU IRB Administration Office.
Site Visits: Upon notification of an impending regulatory site visit, hold notification, and/or external audit, the WSU IRB Administration Office must be contacted immediately. Please e-mail Monica Malian, Director HRPP at firstname.lastname@example.org
Note: DMC Review Authorization - If DMC Review is required DMC Review Authorization can be submitted concurrently at the time of IRB submission. However DMC Approval is required for final IRB administrative authorization. For more information regarding DMC Review: https://www.dmc.org/for-health-professionals/clinical-translation-research-office
Please be aware that CITI Program has added a new module entitled "External IRB Review" to their curriculum. To access, visit www.citiprogram.org.
Missed this session..
External IRB Request Half-Day Education Series – The WSU IRB presented an External IRB half day education session on August 15, 2018.
- submitting WIRB, CIRB, and Other External IRB Request to the IRB
- WSU External IRB policy & process
- using the External IRB Request Forms
- Consent Templates
- Modification Request & UP Reporting
To learn more about this session the PowerPoint presentation is available on the WSU IRB's Education Website.