CONSORTIUM OF
INDEPENDENT REVIEW BOARDS

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Brief History of CIRB and Independent IRBs

 
The Consortium of Independent Review Boards (CIRB) was established in 1993. CIRB is a non-profit organization committed to promoting the integrity, high quality and effectiveness of the independent review board process in connection with the protection of human subjects involved in clinical research.

In 1981, the Food and Drug Administration (FDA) adopted regulations that for the first time required Institutional Review Board (IRB) review of clinical research. Prior to this time, IRBs had existed only within research institutions (such as academic medical centers and hospitals) and provided review only to their affiliated investigators. The new regulations created a gap, as very few IRBs were available to provide review services to nonaffiliated researchers in private practice and community clinics.

In the early 1980’s, independent IRBs began to emerge to fill this gap. Although it is difficult to produce a single definition of the term “independent IRB,” an independent IRB is, in general, a review board that is not owned or operated by the research organization for which it provides review services.

In its early years, CIRB focused on educating the regulatory community about independent IRBs. Along those lines, CIRB contributed important information for the 1998 report by the Office of the Inspector General of the Department of Health and Human Services (OIG), “Institutional Review Boards: The Emergence of Independent Boards“, as well as the two OIG reports issued in 2000 regarding the recruitment of research participants (“Pressures in Industry-Sponsored Clinical Research” and “Sample Guidelines for Practice“). Additionally, a CIRB member submitted a white paper to the National Bioethics Advisory Commission on “The History, Function and Future of Independent Institutional Review Boards“.

In the 1990’s, the Department of Health and Human Services (DHHS) Office for Protection from Research Risks (OPRR) (predecessor of today’s Office for Human Research Protections) did not authorize independent IRBs to act as review bodies for DHHS-funded research. In 1995, OPRR changed its position and authorized independent IRBs to serve as the IRB for federally funded research. CIRB was at the forefront in meeting with OPRR following this policy change to foster an understanding of the independent IRB’s role in reviewing federally funded clinical research. Independent IRBs now frequently review federally funded research.

CIRB also has contributed to the development of educational resources designed to enhance human subject protection. In 2001, CIRB developed a database compilation of state laws relating to research and human subject protection. The database has since been transferred to a private publishing house and is available to the public on a subscription basis at www.thompson.com/public/offerpage.jsp?promo=CLIN

In 2005, CIRB actively participated in federally sponsored discussions regarding the role of an IRB in collecting reports of adverse events and presented public comments at the hearing sponsored by the FDA. CIRB also submitted written comments and participated in a roundtable sponsored by the NIH regarding adverse events.

Independent IRBs have played an important role in providing centralized review of multi-center studies. Regulatory agencies, sponsors and researchers have begun to realize that greater reliance on a centralized IRB review process in appropriate circumstances can reduce costs and duplication of effort in the conduct of multicenter trials (click here to reach FDA guidance on centralized IRB review and a report on alternative models of IRB review). In addition, in recognition of the structured and efficient reviews that independent IRBs can provide, many academic and hospital IRBs now delegate some or all of their work to independent IRBs.

Over the years CIRB has submitted written comments on close to a dozen proposed laws or regulations. CIRB has been a strong and consistent voice for the independent IRB community and remains dedicated to improving the entire spectrum of human subject protection.