1 / 16

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

grace
Download Presentation

NCI Pediatric Central IRB Initiative

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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)

More Related