Jan. 18, 2006

IRB ‘Shopping’ Not a Problem, FDA Concludes

It’s not often that the federal government (or company or university or other large organization, for that matter) says openly: Never mind. We were wrong.

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But that’s essentially what the Food and Drug Administration did Tuesday, when it announced in the Federal Register that it would withdraw a 2002 plan that would have required scientists seeking approval for a particular piece of research to inform “institutional review boards” on their campuses of any previous attempts to gain that approval.

The FDA, which oversees significant amounts of federal research funds and regulates IRB’s, which are the campus panels charged with approving clinical trials involving human subjects, said it was considering the 2002 rules because of concerns raised in a 1998 report by the Department of Health and Human Services’s inspector general about what it called “IRB shopping.” The report suggested that in at least “a few” cases, researchers “who were unhappy with one IRB’s reviews [of their proposed study] switched to another without the new IRB being aware of the other’s prior involvement.” Many large universities and medical centers have multiple review boards.

FDA officials sought comments on a proposed change in the rules governing IRBs that would require researchers to include in their research proposals information about prior attempts to seek approval for the experiments. “These disclosures,” the FDA wrote at the time, “could help ensure that sponsors and clinical investigators who submit protocols to more than one IRB will not be able to ignore an unfavorable IRB review decision and that IRBs reviewing a protocol will be aware of what other IRBs reviewing similar protocols have concluded.”

But the agency acknowledged, in seeking comments from universities and other research entities, that it was not at all clear how widespread the “shopping” problem was and whether the proposed change made sense.

Research associations weren’t shy in their responses. Groups like the Association of American Medical Colleges and the American Society of Gene Therapy argued that instances of “IRB shopping” were rare, and that the proposed solution would “be an onerous task and will significantly add to the work required of IRBs, sponsors and investigators,” as the gene therapy group put it. “Mandating remedies appear premature until the scope, reasons and impact for ‘IRB shopping’ are known.

In its Federal Register announcement Tuesday, the FDA said the general drift of the 55 commenters who wrote was that “they had little or no first hand knowledge of instances of IRB shopping, and did not believe IRB shopping presented a significant problem.” The logistics of a new reporting system, the FDA concluded, “would substantially increase the IRBs’ workload and not provide any additional human subject protection.”

The FDA notice also said that the Office for Human Research Protections, the Health and Human Services Department agency that directly oversees the protection of human subjects, “had no reason to believe that IRB shopping was occurring with any regularity in the review of HHS conducted or supported human subjects research.”

“Based on these reasons,” agency officials wrote, “FDA concluded that IRB shopping either does not occur or does not present a problem to an extent that would warrant rule making at this time.”

— Doug Lederman

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