National Cancer Institute Central IRB (CIRB) Independent Review Process
Overview of the CIRB Initiative
The Central Institutional Review Board (CIRB) Initiative is sponsored by the National Cancer Institute (NCI). The Adult NCI CIRB reviews Cooperative Group trials from the ACOSOG, CALGB, ECOG, GOG, NCCTG, NCIC, NSABP, RTOG, and SWOG, as well as any other studies opened in the Cancer Trials Support Unit (CTSU). The Early Phase Emphasis (EPE) IRB reviews Phases 0-2 Cooperative Group trials. The Late Phase Emphasis (LPE) IRB reviews Phase 3 trials. In this Single IRB review model, the NCI CIRB serves as the IRB of record for eligible NCI cooperative group trials. UCI IRB remains responsible for monitoring the conduct of the research at UCI.
NCI CIRB Templates
for Use at UCI
CIRB provides expert IRB review at the national level prior to Cooperative Group distribution of the protocol to local investigators. The CIRB is composed of individuals who represent a broad range of oncology disciplines and may include oncology physicians, nurses, patient representatives, pharmacists, ethicists and attorneys. Because UCI has established a formal agreement with the Adult NCI CIRB, investigators who wish to participate in these Cooperative Group trials can take advantage of this single IRB review model.
Criteria for Use of NCI CIRB
- Early Phase Emphasis (EPE) – Phase 0, 1 or 2 studies
- Late Phase Emphasis (LPE) – Phase 3 studies
- No Waiver (partial or full) of HIPAA Research Authorization is required. NCI CIRB is not a Privacy Board.
- Subject population will not include prisoners. NCI CIRB is not constituted to review prisoner research.
UCI IRB Registration for Single IRB Review by NCI CIRB
- Identify The Study: Check the CIRB website at www.ncicirb.org and confirm that the study is on the CIRB menu.
- Confirm the Annual Principal Investigator Worksheet About Local Context is approved by the CIRB
- Complete Single IRB Review Registration Form: The Lead Researcher completes the CIRB Study Specific Worksheet via IRB Manager @ https://irbmanager.becirb.com
- Submit a new application online via Kuali Research (KR) Protocols. Upload the following documents:
- Master Protocol
- Investigator Brochure(s)
- Annual Principal Investigator Worksheet About Local Context and its corresponding CIRB approval
- Draft Study-Specific Worksheet About Local Context
- CIRB-approved Consent Template
- Draft UCI-specific CIRB Consent Form (includes UCI specific language – most current approved UCI-specific CIRB template is available under Resources - right column). NOTE: No revisions to the CIRB-approved consent template are allowed except the addition of the study team and replacing CIRB consent form language with the CIRB-approved UCI specific language, where applicable.
- Initial CIRB Approval Letter
- Most recent CIRB Approved transaction (e.g., continuing approval or amendment approval that list the expiration date)
- Draft HIPAA Research Authorization Form(s)
- Any other UCI approvals required (RSC, IBC, etc.) or a statement that no ancillary committees’ approvals are needed.
- UCI IRB Member will Confirm the Study Meets The Criteria for NCI CIRB Review
- Confirms that all applicable institutional requirements have been met (e.g., RSC, COIOC, IBC, etc.)
- Confirms the draft UCI-specific consent form is accurate
- UCI IRB sends a memo to the LR and Administrative Contact(s) confirming that the study meets NCI CIRB criteria
- UCI Lead Researcher Submits The Study-Specific Worksheet About Local Context To NCI CIRB
- CIRB Reviews and Approves Study-Specific Local Context
- CIRB is the IRB of Record for this study. Submit CIRB approval letter to UCI IRB.
- IRB Staff will provide IRB Registration Letter in Kuali Research (KR) Protocols.
Post Approval Lead Researcher Responsibilities
- Revise the Informed Consent Form form(s) to match the CIRB Approval, when applicable. NOTE: UCI IRB will not provide an approved footer on CIRB approved documents. The LR must be sure to use the most current CIRB-approved version of the consent form.
- UCI Specific Changes: once approved by CIRB, submit a UCI amendment request for the following local context revisions:
- Adding new or translated version of a CIRB approved consent form
- Any change in the informed consent process (e.g., adding short form consent)
- Any change in research site
- Any change in a research team member’s disclosable financial interests
- Adding new or revised recruitment materials
- Change in Lead Researcher
- Adding or removing Co-Researchers or Research Personnel (when adding individuals UCI IRB approval must be provided prior to the individual engaging in research activities)
- Prior to study expiration submit a renewal application to Kuali Research (KR) Protocols. Upload a copy of CIRB approval and routine monitoring reports in the attachments section.
- When closing a study, submit closing report to UCI IRB via Kuali Research (KR) Protocols. Include a copy of CIRB study closure report in the attachments section.
- Notify UCI IRB of UCI-specific potential problems through Kuali Research (KR) Protocols. Include a copy of CIRB’s Potential Unanticipated Problem or Noncompliance Form in the attachments section.
- Notify UCI IRB and Internal Audit Services in advance of any audit or non-routine monitoring of study records to be conducted by an external entity (e.g., FDA, OHRP, study sponsor, CRO). The IRB and/or Internal Audit Services may wish to send a representative to observe proceedings including the "exit interview."
- Any audit or non-routine monitoring written reports must be submitted to UCI, Routine monitoring findings by study sponsor or CRO must also be submitted to UCI IRB for their review and records. Reports that include significant findings (potential Unanticipated Problem, Serious or Continuing Noncompliance) should be reported as listed above.
For more information about the NCI CIRB process see their Handbook for Local Institutions under Resources.