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Ontario Cancer Research Ethics Board: Lessons Learned From Developing a Multicenter Regional Institutional Review Board

Raphael Saginur, Susan F. Dent, Lisa Schwartz, Ronald Heslegrave, Sid Stacey, Janet Manzo

From the Ottawa Health Research Institute, Ottawa Hospital, Ottawa; McMaster University, Hamilton; University Health Network, Toronto; and Cambridge Memorial Hospital, Cambridge, Ontario, Canada

Corresponding author: Raphael Saginur, MD, Ottawa Health Research Institute, Ottawa Hospital–Civic Campus, 1053 Carling Ave, Ottawa, Ontario K1Y 4E9, Canada; e-mail: rsaginur{at}rogers.com

Purpose: We describe issues and outcomes in the development of a specialized, central institutional review board (IRB) for multicenter oncology protocols.

Numerous authoritative bodies have called for a change to the ethics review system to better manage multicenter trials in terms of quality, timeliness, and efficiency. In 2003, the American Society of Clinical Oncology proposed a network of regional IRBs for cancer. Previous experience with central IRBs has been met with mixed success.

Methods: We took a bottom-up approach to organizing a province-wide IRB, which was led by an IRB chair and a clinical investigator at one cancer center. Participation on the part of institutions was voluntary.

Results: Uptake in the first 2 years was modest and increased from 11 clinical trials in year 1 to 21 in year 2. In the third year, there was an apparent upsurge in the number of involved centers (14) and in the number of submitted clinical protocols (54).

Conclusion: Sponsors and investigators are loath to risk development of a novel IRB until there is a clear demonstration of quality, efficiency, and timeliness of decision. Development of a regional, specialized IRB requires considerable efforts to develop and maintain the trust of sponsors, investigators, and institutions despite prior demands for more efficient and timely ethics review. Voluntary institutional participation, clear delineation of roles and responsibilities, and effective execution promote development of this trust.

Presented in part at the Annual Meeting of Public Responsibility in Medicine and Research, October 29-31, 2004, San Diego, CA.

The Ontario Cancer Research Ethics Board is funded by the Ontario Institute for Cancer Research, a not-for-profit organization created and funded by the government of Ontario.

Research ethics board (REB) is the Canadian terminology equivalent to Institutional Review Board (IRB). The terms REB and IRB are used interchangeably in this paper.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.