Share

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.  CIRB is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).  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.

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

  1. Identify The Study: Check the CIRB website at www.ncicirb.org and confirm that the study is on the CIRB menu.
  2. Confirm the Annual Principal Investigator Worksheet About Local Context is approved by the CIRB
  3. Complete Single IRB Review Registration Form:  The Lead Researcher completes the CIRB Study Specific Worksheet via IRB Manager @ https://irbmanager.becirb.com
  4. Submit a new application online.  Please upload the following documents that comprise the IRB Application Package:
    • Master Protocol
    • Investigator Brochure(s)
    • Annual Principal Investigator Worksheet About Local Context and its corresponding CIRB approval
    • Appendix R (Reliance)
    • 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.
  5. 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
  6. UCI Lead Researcher Submits The Study-Specific Worksheet About Local Context To NCI CIRB
  7. CIRB Reviews and Approves Study-Specifi­c Local Context
  8. CIRB is the IRB of Record for this study. Submit CIRB approval letter to UCI IRB. 
  9. IRB Staff will provide IRB Registration Letter in Document Depot

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 modification 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)
  • Oversee the conduct of the research
  • Monitor protocol compliance
  • Maintain compliance with state, local, or institutional requirements related to the protection of human subjects
  • Prior to study expiration provide a copy of CIRB Approval to UCI IRB by submitting to irbreliance@uci.edu
  • When closing a study, submit closing report to UCI IRB include a copy of CIRB Study Closure report
  • Investigate, manage, and provide notification to the CIRB of any study-specific incident, experience, or outcome that seems to rise to the level of an unanticipated problem and/or serious or continuing noncompliance. 
    • Concurrently, notify UCI IRB of UCI-specific potential unanticipated problems through UCI IRB’s UP Process.  Include a copy of CIRB’s Potential Unanticipated Problem or Serious or Continuing Noncompliance Form.   Also in parallel, report any instance of potential serious or continuing noncompliance by submitting information to EQUIP@uci.edu along with a copy of the corresponding CIRB form.
  • 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. Routine monitoring reports that do not include significant findings should be reported when submitting annual CIRB approval letter to irbreliance@uci.edu. 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.

suggestions and comments