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.
Submission Forms & Instructions
External IRB NCI CIRB requests must be submitted and emailed to CIRB@wayne.edu.
Initial External IRB Request Cover Sheet and Review Authorization Form (updated 10.2020 admin correction 2/2021)
External IRB Request Modification & Event Reporting Form - (updated 10.2020 admin correction 2/2021) This Form should be used for submission of key personnel modifications, HIPAA changes, event reporting, or any other local context modifications.
See the IRB Forms & Submission Requirements web page for PI Attestation and Electronic signature
HIPAA Summary Form (.doc)
HIPAA Authorization Form NEW for CIRB submissions ONLY (Per NCI CIRB submission requirements the HIPAA Authorization must be detached from the consent form) effective 10.21.2020
Additional Key Personnel List (New with esignature update 3/2020) open and save as an Adobe Acrobat document
SUBMISSION ALERT: Please check this website regularly for the most current version of templates and forms. Current Institutional Worksheet Approval Dated: 12.2.2020, released 12.8.20
CIRB Approved Informed Consent Template (DMC) UPDATED 10.29.2020, NCI CIRB APPROVED 12.2.2020, released 12.8.20
CIRB Approved McLaren Informed Consent Template UPDATED 10.29.2020, NCI CIRB APPROVED 12.2.2020, released 12.8.20
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).
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.
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
Regulatory Reporting & Site Visits
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
External IRB Policy: To view the External IRB & Reliance Agreements for Multi Site Research Policy (policy 4-17) visit the IRB's policy website.
Please be aware that CITI Program has added a new module entitled "External IRB Review" to their curriculum. To access, visit www.citiprogram.org.