The purpose of this contract is to provide administrative, technical and regulatory support to the National Cancer Institute's (NCI's) Cancer Therapy Evaluation Program's (CTEP's) Central Institutional Review Board (CIRB) Initiative. The CIRB Initiative is a key part of the CTEP's efforts to streamline the clinical trials system as originally recommended in the Armitage Report's Clinical Trials Implementation Plan and embraced in 2005 by the Clinical Trials Working Group (CTWG). The CIRB was established in 2001 as an independent review Board tasked with providing full Board review of Cooperative Group clinical trials for human subject?s protections before the study receives final approval from CTEP. This process of a central ethics review results in compliance with OHRP regulations that require these studies to receive IRB review by a full Board thus relieving local IRBs from the responsibility and effort related to conducting their own full Board review. The CIRB Initiative consists of two central IRBs: one reviewing phase 3 and selected phase 2 trials coordinated by the adult Cooperative Groups and the second reviewing trials coordinated by the pediatric Cooperative Group. The CIRB reviews are made available to investigators and IRBs through a secured website. The NCI, in collaboration with OHRP, developed the process of ?facilitated review'which consists of a local IRB designating the IRB Chair or a subcommittee to review the CIRB's minutes and primary reviewer's comments related to a Cooperative Group clinical trial in lieu of convening a full board meeting at the local IRB. If the Chair or subcommittee decides to accept the CIRB's review of the study-related documents, the Chair or subcommittee determines that local context requirements are met. Local context requirements include compliance with local laws, cultural sensitivities, and/or local IRB requirements such as using institutional letterhead for the informed consent document and including local contact information in the consent document. The partnership of the CIRB providing full Board review of the trial in conjunction with the local board providing review for local context by the IRB Chair or subcommittee conserves local IRB members'time and effort as well as that of investigators and research staff. In addition to economies of time and effort, using facilitated review enables a local site to open a Cooperative Group trial more quickly than when using traditional full Board review. Also, it is possible that the CIRB can provide a more expert review as it is comprised of members with expertise dedicated to oncology compared to a local IRB which must review clinical trials pertaining to all disciplines.
