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
- Complete the Initial External IRB Worksheet (revised May 2023 previous version accepted until June 5, 2023) and attach to eProtocol submission.
- Create an eProtocol submission.
- For detailed guidance regarding the eProtocol external IRB submission process see the External IRB Guidance Tool
Changes to local research arrangements (i.e. key personnel & HIPAA) should be submitted to the IRB Administration Office for review.
- For Active protocols on the submitter's dashboard select "Start Amendment" and complete the Amendment Form.
- Follow instructions on the eProtocol Amendment Form.
- Provide highlighted copies of revised documents and attach for the appropriate sections of eProtocol
- Do not submit any additional Amendment or Modification Forms.
- Key Personnel Changes:
- make modifications to the eProtocol Personnel Information section
- complete the applicable sections of the eProtocol Amendment Form
- HIPAA Changes
- make modifications to the eProtocol HIPAA section and applicable HIPAA Authorization Forms.
- Consent/Assent Changes:
- Attach highlighted revised consent/asents for the consent/assent sections.
- For detailed guidance regarding the eProtocol Amendment submission process see the External IRB Guidance Tool.
Non eProtocol submissions:
- Complete the External Modification Worksheet (admin correction 6.2023) and email to firstname.lastname@example.org
- Follow instructions on the External Modification Worksheet
- Provie highlighted copies of revised documents (i.e. consent/assents)
- If making key personnel additions or HIPAA changes additional submission forms may be required (noted below).
Additional Submission Forms:
- HIPAA Summary Form (upated 8/2023) 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.
Protocol Violations/Deviations submitted/being submitted to the Reviewing (External) IRB:
Non eProtocol submissions:
- complete the External IRB Modification Worksheet follow the instructions for the External Modification Worksheet, include any supporting documents/forms provided to the external IRB, and email to: email@example.com
- start and submit a Protocol Violation/Deviation Form and attached any supporting documents/forms provided the external IRB.
Local Context Protocol Violations/Deviations:
Local Context Protocol Violations/Deviations iclude HIPAA, key personnel, and breach of confidentiality.
- Complete the Unanticipated Problem Event & Reporting Form (pdf) (pdf) and followng submssion instructions for this form.
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.