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Central IRBs: why are some institutions reluctant to sign on?

There are several good reasons why hospitals and cancer centers would want to use central institutional review boards (IRBs) to supplement their often overburdened local boards that are charged with overseeing research involving human subjects. What’s more, several national agencies support central IRBs: The U.S. Food and Drug Administration issued a draft guidance in March to help increase awareness of central IRBs, the Offi ce for Human Research Protections (OHRP) looks favorably on them, and the American Society of Clinical Oncology offi cially endorses their use. So does the National Cancer Institute, which has established two central IRBs for institutions participating in its phase III cooperative group trials. Centralized review, according to representatives from all of these organizations, can be more effi cient and more effective in protecting clinical trial participants because it reduces the burdens on local IRBs, eliminates duplication of effort, and can bring to bear expertise that may not be available at the local level. Nevertheless, “lots of institutions are not buying into it,” said Ernest Prentice, M.D., associate vice chancellor for academic affairs at the University of Nebraska Medical Center and chairman of the Health and Human Services Secretary’s Advisory Com mittee on Human Research Protections (SACHRP). Worries about liability, confusion over how local and central IRBs should work together, and concerns about administrative hassles account for some of their reluctance, according to Prentice and others who have been involved in IRBs. In addition, local IRBs have traditional ties to and a sense of responsibility for their own communities. Decades ago when institutional review of clinical trials became mandatory, most trials took place at a single academic institution and the IRB regulations were “founded on the premise of local autonomy,” said Prentice. “The idea was that IRBs would know their own culture and participants best.”