Oncology research is largely conducted by clinical trials conducted across multiple institutions and community practices. As such, there is a tremendous opportunity to employ a centralized mechanism to provide ethical review by highly trained institutional review board (IRB) members, allowing local IRBs to take advantage of the financial and time efficiencies that central review provides. Centralized review boards (whether independent, regional, or collaborative among institutions) would also contribute consistency and efficiency to the process. Once successfully completed, the review could represent an approval to open the protocol at all of the institutions that have subscribed to the centralized review system. Local IRBs would be able to devote time usually spent on initial review to ongoing monitoring of the trial taking place at their institution.
ASCO adopted this position as part of its November 2002 policy statement on oversight of clinical research (below). The Society is working with federal agencies and advisory bodies to address real and perceived barriers to greater use of central review.
ASCO Cosponsored November 2006 National Conference on Alternatives to Local IRBs: In collaboration with the National Institutes of Health (NIH), the Office for Human Research Protections (OHRP) of the Department of Health and Human Services (HHS), and the Association of American Medical Colleges, ASCO cohosted a national conference to enhance the protection of human subjects of research by encouraging the use of innovative IRB models as alternatives to local IRBs under appropriate circumstances. The conference explored the issues identified at the November 2005 workshop, developed and prioritized recommendations, and clarified the actions necessary for successful implementation. Results of this conference will be presented to the HHS Secretary's Advisory Committee on Human Research Protections, which commissioned the meeting in March 2006. The conference information and agenda can be found here.
Summary Report on November 2005 Workshop “Alternative Models of IRB Review”: ASCO assisted in planning and hosting this workshop in collaboration with the National Institutes of Health (NIH), the Office for Human Research Protections (OHRP) of the Department of Health and Human Services (HHS), and the Association of American Medical Colleges. The workshop included invitees representing all segments of the medical research system. Participants identified alternative models to local IRB review. The workshop was commissioned by the HHS
Secretary’s Advisory Committee on Human Research Protections (SACHRP). The summary was presented to SACHRP at its
March 13 & 14, 2006, meeting.
ASCO Comment Letter to the FDA Draft Guidance on Use of Central Review: In March 2005, the Food and Drug Administration (FDA) released for public comment a draft guidance for trial sponsors on use of a centralized IRB review process. This letter includes ASCO's comments. The FDA released a
final guidance in March 2006.
ASCO Presentation to SACHRP during its Panel Discussion on Central Review: At its
October 4-5, 2004, meeting, SACHRP hosted a panel discussion regarding central review of clinical trials. Dr. Lowell Schnipper (Beth Israel Deaconess Medical Center, Boston), who led the effort to develop ASCO’s oversight of clinical research policy statement, presented ASCO’s position on central review. This panel discussion led to SACHRP’s decision to host the November 2004 workshop.
ASCO Letter to OHRP Regarding Guidance on Use of Centralized Review: ASCO sent this letter to OHRP recommending that it seek guidance from SACHRP on use of a centralized or cooperative review process. This request led to the panel discussion at the October 2004 SACHRP meeting.
Summary of ASCO Roundtable Meeting on Use of Centralized Review: In May 2004, ASCO hosted a roundtable meeting including investigators, IRB chairs and staff, institutional counsel, patient advocates, and representatives from OHRP, FDA, and the National Cancer Institute (NCI) to discuss use of centralized review. Presentations from federal regulators made it clear that the regulations allowed for central review, but that some institutions were reluctant to use central review. The meeting outlined a number of the real and perceived barriers to central review and included discussion of how ASCO could help address these barriers.
ASCO Policy Statement on Oversight of Clinical Research
