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NCI Pediatric Central IRB Initiative

NCI Pediatric Central IRB Initiative. Bruce Gordon, MD Chairman, NCI Pediatric CIRB Professor, Pediatrics University of Nebraska Medical Center. NCI CIRB Initiative. Purpose: To establish a Central IRB for National Cancer Institute (NCI) Phase 3 multi-center trials

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NCI Pediatric Central IRB Initiative

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  1. NCI Pediatric Central IRB Initiative Bruce Gordon, MD Chairman, NCI Pediatric CIRB Professor, Pediatrics University of Nebraska Medical Center

  2. NCI CIRB Initiative • Purpose: To establish a Central IRB for National Cancer Institute (NCI) Phase 3 multi-center trials • Improve access to clinical trials for participants and their physicians by enabling local IRBs to rapidly approve NCI sponsored multi-site trials through the use of a facilitated review process

  3. NCI CIRB Initiative • Enhance the protection of research participants by providing consistent expert IRB review at the national level before the protocol is distributed to local investigators; • Collaborate more effectively with local IRBs (LIRBs); and reduce the administrative burdens on local IRBs and investigators associated with IRB submission.

  4. Model • The PedCIRB and the LIRB share regulatory responsibilities • The PedCIRB’s primary function is initial and continuing review of protocols • The LIRB’s primary function is consideration of local context and oversight of local performance

  5. Local Context • institutional policies; • applicable law; • standards of professional conduct and practice; • subject populations likely to be involved; • method for equitable selection of subjects; • method for protection of privacy of subjects; • method for maintenance of confidentiality of data; • method for minimizing the possibility of coercion or undue influence in seeking consent; • safeguards to protect the rights and welfare of vulnerable subjects

  6. Ped CIRB Responsibilities • Perform initial reviews • Perform continuing reviews • Perform reviews of adverse events (AEs) • Local AEs reported to NCI and to LIRB • Perform reviews of protocol amendments

  7. LIRB Responsibilities • Ensure the safe and appropriate performance of the research at its institution • monitoring protocol compliance, protocol violations, adverse events occurring at the institution • Ensure that investigators at the local institution who are conducting the research are appropriately qualified

  8. LIRB Responsibilities • As appropriate, add local restrictions, stipulations, or substitutions to CIRB approved informed consents • Maintain compliance with any additional state, local, or institutional requirements related to the protection of human subjects

  9. LIRB Responsibilities • Maintain local IRB records • Maintain an OHRP approved Assurance • Maintain a local IRB whose membership satisfies the requirements of 45 CFR 46 and 21 CRF 56

  10. Current status • 124 affiliated institutions • 62% of eligible COG institutions • 90 (73%) have performed at least one facilitated review • 46 institutions have performed >20 facilitated reviews • 34 institutions have not performed any facilitated reviews

  11. Current status • 60 protocols reviewed • 17 initially tabled, 42 approved w/ modifications • 56 ultimately approved • 46 activated by COG • Mean time for CIRB review • 11/04 – 5/05: 104 ds (33-184 ds) • 6/06 – 12/06: 70 ds (19-122 ds)

  12. Impact of Initiative • Goal: Accelerate pace of local protocol activation and subject enrollment • Limited data available • 25-30% of affiliated institutions utilized facilitated review during the first 3 months that a COG phase III treatment trial was available • Faster accrual?

  13. Impact of Initiative • Goal: Reduced burden on stakeholders • Goal: “Quality” review • Regulatory compliance • Protection of subjects • No data available on progress toward either of these goals

  14. Ethical Issues • Consent form readability • Model for AAMC initiative • Age of assent • Age appropriate information for subjects • Contraception • Reconsent after attaining age of majority • Linking non-therapeutic and therapeutic research

  15. Challenges • Local IRB and/or institutional resistance to participation • Liability issues • Loss of autonomy • Accreditation • Quality • NCI Funding constraints • Scientific review by CIRB

  16. Goals • Full participation • AAHRPP accreditation • enlarged portfolio • Early phase studies (through COG Phase I consortium)

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