Under scrutiny: IRB shopping
Is regulatory attention warranted?
Is IRB shopping widespread? If so, what should be done about it? Those are two questions the Food and Drug Administration (FDA) is asking those involved in human subject research. In April, the FDA issued an advanced notice on proposed rule making (ANPR) to solicit comments on a proposal that would require sponsors and investigators to report any previous IRB reviews to new IRBs reviewing the same study.
The FDA is looking at the issue of IRB shopping because of a report issued by the Office of the Inspector General in 1998 that cited anecdotal evidence that it was taking place. The report made clear that no empirical evidence exists to support claims of widespread IRB shopping but should it exist, the practice could result in a circumvention of the guidelines established to protect human subjects. Concerned about such a possibility, the FDA decided to take a closer look at the issue with an eye toward establishing regulatory guidelines if necessary.
The comments, coming from IRB members, pharmaceutical companies, and research-related associations such as ARENA (Applied Research Ethics National Association), are mixed, with some supporting the proposed rule and others declaring that it is unnecessary and could be burdensome.
Those in favor of such a rule believe that IRB shopping is common. Wrote Robert Nelson, MD, PhD, chair of the Committees for the Protection of Human Subjects, associate professor of anesthesia and pediatrics at The Children’s Hospital of Philadelphia, and member of IRB Advisor’s editorial board, "I believe that the problem of IRB shopping is significant and may be widespread."
Nelson cited two recent protocols that were rejected by The Children’s Hospital of Philadel-phia’s IRB "out of ethical and scientific concerns about the inappropriateness of an invasive outcome measure in young children" and "safety concerns." In one instance, the sponsor did not respond to the IRB’s concerns, he explained. The other study is being conducted at other institutions, he wrote, with no assurance that his IRB’s concerns were shared with the new IRB.
"By not allowing a committee access to the results of the review of a protocol by other committees, the current process undercuts public trust," Nelson wrote. "Every institutional review board at an institution should be informed of all subsequent IRB reviews."
Helen Panageas, associate director of the Winthrop-University Hospital in Minneola, NY, echoed Nelson’s remarks. "It would be constructive for IRBs to know that other IRBs share similar concerns," she wrote. "By not having this information, IRBs and investigators are operating in a vacuum."
Those who do not support the proposed rule point to the lack of data that IRB shopping is indeed a problem. "In the absence of substantive evidence that current safeguards are inadequate, we believe that no new rulemaking is necessary with regard to disclosure of prior IRB decisions," wrote Peter G. Traber, MD, senior vice president of clinical development and medical affairs and chief medical officer of GlaxoSmithKline, and David E. Wheadon, MD, senior vice president of U.S. regulatory affairs at GlaxoSmithKline.
The American Society of Gene Therapy (ASGT) pointed out potential liability issues related to enforced IRB disclosure. "Will an IRB and/or institution feel at risk in allowing a study to move forward knowing that another site disapproved the trial?" wrote Malcom Brenner, MD, PhD, president, and Kenneth Cornetta, MD, chair of the Clinical and Regulatory Affairs Committee for ASGT, which is based in Milwaukee. "The IRB or institution may be concerned that disapproval at another site could be used in legal proceeding against the institution should an adverse event occur."
Some more simply state that if an IRB does its job, deficiencies in protocol will be discovered regardless of how many protocols IRBs are asked to review. "Because every IRB has the responsibility to conduct a complete review of every protocol, there is no value to an IRB to learn that another IRB has approved that protocol, either outright or with stipulations," wrote Stacey Berg, MD, chair of Institutional Review Boards for Human Subject Research for Baylor College of Medicine in Houston.
The FDA received comments through June 4, 2002, and offers no timeframe for when a decision will be made to either move forward or dismiss the proposal. "We’ll review all comments received and then make a determination whether to propose a new rule or not," says Bonnie M. Lee, associate director for Human Subject Protection Policy for the FDA.
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