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FDA Publishes Draft Guidance on the Use of Independent IRBsEarlier this year, the Food and Drug Administration published a draft guidance on "Using a Centralized IRB Review Process in Multicenter Clinical Trials."1 Quorum is pleased that the FDA published a strong affirmation of the role that independent IRBs can play in providing review services for non-affiliated sites. The FDA acknowledged the efficiencies that independent IRBs can introduce when acting as the central IRB for multi-site trials. Quorum also is pleased that the FDA outlined a variety of mechanisms that independent IRBs can use to understand the local context of proposed research projects. Historically, clinical research was conducted almost exclusively in academic medical centers or hospitals. These institutions developed their own ethics committees, or "institutional review boards," to review the propriety of the research. Even today, most IRBs are based in such institutions. Typically each institutionally based IRB reviews only the research conducted by investigators affiliated with that institution. It is estimated that there are 3,000 to 5,000 such IRBs. In the 1980s clinical research started moving away from academic settings and into private clinics. With this shift, a new type of review board was needed to provide review services to researchers in non-affiliated sites. "Independent" IRBs, including the Quorum Review IRB, fill this need. Today it is estimated that there are 30 to 50 independent IRBs in the U.S. Independent IRBs often review research conducted by researchers across the nation. Quorum Review, for example, currently has oversight of approximately 7,500 researchers located in all parts of the country. The FDA's Draft Guidance indicates how much attitudes about central IRBs have changed. Initially, the community of institutionally based IRBs was highly skeptical when independent IRBs emerged. The federal Office for Protection from Research Risks (the predecessor of today's Office of Human Research Protections (OHRP)) at first would not allow independent IRBs to review federally funded research. Today, however, regulators and researchers alike appreciate that independent IRBs can provide sophisticated and appropriate human research participant protection oversight. One challenge for an independent IRB is to develop an understanding of the local context in which a proposed research project will occur. In the Draft Guidance, the FDA outlined a number of mechanisms that IRBs can use. These mechanisms include:
Quorum is pleased that its procedures are consistent with the mechanisms outlined by the FDA. Quorum strives to understand its researchers' communities and research sites with a variety of mechanisms, including the following:
Quorum believes that maintaining a diverse membership is a key mechanism by which an independent IRB can appropriately address the local aspects of IRB review. Diversity of IRB membership along gender, cultural, ethnic, religious, socio-economic and professional lines as well as along geographic lines allows an independent IRB to comprehensively consider the attitudes present in a diverse participant population. Moreover, diversity of IRB membership allows an independent IRB to take into account the "local" considerations of the wide-ranging and varied research sites and communities it serves. Attitudes toward research appear to vary more significantly among groups of individuals with different education levels, income levels, religious backgrounds and disease condition than they vary among geographic locations. The Draft Guidance devotes some discussion to the notion that a central IRB should understand a site's "community attitudes" as suggested by federal regulations.2 Quorum would like to see the FDA to expand upon the notion that a "community" can be defined as a community of similarly situated individuals, such as individuals who share a certain disease. The Draft Guidance briefly raises this concept. For independent IRBs who oversee large, multicenter clinical trials comprised of a participant population that spans state or even national borders, it is appropriate and essential to consider human commonalities that are not confined to geographic location alone. Local factors other than "community attitudes" would seem to be critical in assessing the human subject protection issues raised by proposed research. Probably the most critical factors would include:
For example, a multisite study could include two different principal investigators in one city. If a local consultant were engaged, the consultant probably would report on a single set of community attitudes towards research in that particular city. However, if one investigator in that city intended to solicit participants from his or her own suburban clinical practice while another intended to solicit from a nearby homeless shelter, the IRB would have to consider significantly different local factors prior to approving the research. In any event, Quorum is pleased that the FDA has so openly embraced the activities of independent IRBs. Quorum will continue to monitor the FDA's position on this subject. Quorum also will continue to scrutinize its own policies and procedures to confirm that Quorum is collecting the right information about local research sites to make the right decisions in the best interests of human research participants.
1 70 Fed. Reg. 15635 (March 28, 2005). |
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