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.

COVID-19 Information 

NCI CIRB Information About COVID-19

Visit the WSU IRB's Forms and Submissions website regarding Phased Resumption of Research Activities


Submission Forms & Instructions


Initial Submissions:

Initial External IRB Worksheet and Guide (revised November 2022) previous version accepted until 12/16/2022

Please follow the instructions noted for the Initial External IRB Worksheet and Guide.


Modifications:

External IRB Modification Worksheet and Guide (November 2022) Previous version accepted until 12/16/2022

Changes to local research arrangements (i.e. key personnel & HIPAA) should be submitted to the IRB Administration Office for review.

The External IRB Modification Worksheet and Guide should be used for submission of key personnel modifications, HIPAA changes, event reporting, or any other local context modifications.

eProtocol submissions:

  • eProtocol Submissions submit modification requests as an amendment via eProtocol
  • Follow the modification instructions noted for the External Modification Worksheet and Guide and update the applicable sections of the eProtocol application.

Non eProtocol submissions: 

  • Complete and email the External Modification Worksheet and Guide and email the following to cirb@wayne.edu

For both submission types please submit highlighted versions of requested revisions.   Please follow the instructions noted for the modification worksheet and guide. 

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.


Additional Submission Forms:

  • HIPAA Summary Form (upated 10/2021) This form is used for Non eProtocol submissions ONLY
  • HIPAA Authorization Form version dated 2.28.2022 for CIRB submissions ONLY
    • (Per NCI CIRB submission requirements the HIPAA Authorization must be detached from the consent form)
  • Key Personnel List (updated 9/2021 open and save as an Adobe Acrobat document)
    • This form is used for Non eProtocol Submissions ONLY. 
    • For eProtocol Submissions updated the Personnel Information section

SUBMISSION ALERT: Please check this website regularly for the most current version of templates and forms. 

Current Institutional Worksheet Approval Dated: March 28, 2022


NCI CIRB WSU IRB Templates:

CIRB Approved Informed Consent Template (DMC) UPDATED version dated 2.28.2022, NCI CIRB APPROVED 3.28.2022

CIRB Approved McLaren Informed Consent Template UPDATED version dated 2.28.2022, NCI CIRB APPROVED 3.28.2022

CIRB Approved Assent Template  version dated 4.2020

CIRB Approval Oral Assent Script version dated 4.2020

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).

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 unanticipated problems/adverse events occurring at WSU and its affiliated institutions should be submitted to the WSU IRB within 5 working days.  See the Unanticipated Problem Event & Reporting Form for submission instructions.

Site VisitsUpon 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 monica.malian@wayne.edu


Reference Information 

External IRB Policy: To view the External IRB & Reliance Agreements for Multi Site Research Policy (policy 4-17) visit the IRB's policy website.

Visit the National Cancer Institute Central Institutional Review Board Initiative website at https://ncicirb.org.  
Download the Quickguide to Opening a Study (PDF).

Please be aware that CITI Program has added a new module entitled "External IRB Review" to their curriculum.  To access, visit www.citiprogram.org.