19.1(a) General Principles
In consultation with the Department of Health and Human Services Office for Human Research Protections (OHRP), the National Cancer Institute implemented a Central IRB (CIRB). This is designed to reduce the administrative burden on local IRBs and investigators while continuing a high level of protection for human research participants. Use of the CIRB facilitated review mechanism is available to investigators seeking to enroll subjects into adult and pediatric, national, multi-center (Cooperative group) cancer treatment trials.
The Adult CIRB has been meeting twice monthly and reviewing clinical trials since January 2001. The Adult Board currently reviews all Phase 3 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 Pediatric CIRB was constituted in June 2004 and began meeting in November 2004. It reviews all NCI-approved COG Phase 2, 3, and Pilot protocols. Both Boards are composed of individuals who represent a broad range of oncology scientific and nonscientific disciplines.
The NCI CIRB processes are incorporated into the UM IRB policies and procedures per approval by both organizations. This permits participating investigators to log into the CIRB website and submit studies for CIRB review as outlined in the NIC CIRB Operations Office Standard Operating Procedures. The CIRB may take one of the following actions for each study: approve, approve pending modification, table or disapprove. After approval or disapproval, the Study Chair of the Cooperative Group shall be formally notified.
For each study, the CIRB's primary reviews, minutes, notification letters, and any other correspondence are posted in its web site for participating institutions to access.
In addition to conducting initial reviews, the CIRB conducts Continuing Reviews and reviews of Serious Adverse Events (SAEs), Data Safety Monitoring Board (DSMB) reports, protocol amendments, national subject recruiting materials, etc. These actions are also posted on the CIRB web site for access by participating institutions.