On January 15, 2013, the National Cancer Institute (NCI) Central Institutional Review Board (CIRB) began a transition from its historic facilitated protocol review model to an independent protocol review model.
The CIRB Initiative, sponsored by the NCI in consultation with the Department of Health and Human Services Office for Human Research Protections, is designed to help reduce the administrative burden on local IRBs and investigators, while maintaining a high level of protection for human research participants. The CIRB enables an investigator to enroll patients into adult and pediatric NCI-sponsored clinical trials significantly faster than if the traditional method of IRB review is employed.
The ECOG-ACRIN Cancer Research Group designs and conducts biomarker-driven clinical trials involving adults who have or are at risk of developing cancer. The majority of ECOG-ACRIN’s therapeutic trials are conducted under the sponsorship of the NCI through its Cancer Therapy Evaluation Program (CTEP), and the CIRB Initiative pertains to these trials. The CIRB Initiative includes an Adult CIRB that reviews all CTEP-sponsored phase 3 cooperative group trials, as well as any other studies opened in the Cancer Trials Support Unit.
In the independent protocol review model, the CIRB is the sole IRB of record and is responsible for both study review and review of local context considerations for enrolled institutions. In the facilitated protocol review model, the local IRB conducted the review. A pilot study completed in October 2012 showed that the CIRB could add the review of local context considerations to its current review of studies for participant protections without significantly adding to the burden of the institutional staff or CIRB members.
It is expected that all institutions will be transitioned to the independent protocol review model by the end of 2013. ECOG-ACRIN has notified all principal investigators (PIs) at its member institutions that they will be contacted by the CIRB Operations Office on a rolling basis. PIs interested in transitioning their institution early may contact the CIRB Helpdesk by sending an email or calling 1-888-657-3711.
ECOG-ACRIN has posted the following CIRB documents on its website for use by its member institutions:
These documents and other information about the independent protocol review model can also be found at the CIRB website.
|Trial Educational Materials|
|ECOG Performance Status|