Some institutional review board members have ties to Rx, medical device firms

About 15% of institutional review board members, who are charged with deciding whether proposed clinical trials are ethical and safe, in the past year were asked to judge at least one proposal involving a drug or medical device company in which they have a financial stake or involving one of those company's competitors, according to a survey published in the New England Journal of Medicine, the AP/Hartford Courant reports (Stobbe, AP/Hartford Courant, 11/30).

Eric Campbell of Harvard Medical School and the Institute for Health Policy at Massachusetts General Hospital and colleagues surveyed 574 institutional review board members at 100 universities. Of the 15% of respondents who said they had made judgments in the previous year on proposals in which they had a financial stake, about one-third said they "never" or "rarely" disclosed such conflicts. A similar proportion said they "always" or "sometimes" vote on such proposals, which is a violation of federal research rules (Weiss, Washington Post, 11/30). The survey of IRB members also found the following:

• 36% had at least one financial relationship with a drug or medical device company in the past year;
• More than 85% said they did not believe their colleagues' relationships influenced the colleagues' decisions; and
• One-third said that their institution did not have a formal disclosure process or that they were unaware of such a process.

Comments
Campbell said, "My sense is that relationships with industry are a fundamental part of the modern life-science enterprise. They are not universally bad and not universally good." David Korn, senior vice president of the Association of American Medical Colleges, said he was most concerned with the IRB members' apparent lack of understanding of the rules governing financial conflicts of interest. "If it were my institution, I'd want to make sure my IRB members damn well knew what a conflict was and how to deal with them," Korn said (Washington Post, 11/30). Sidney Wolfe, director of Public Citizen's Health Research Group, said if the review board "is riddled with financial conflicts of interest, it's not going to be as protective as it should be" (AP/Hartford Courant, 11/30).

The study is available online.

Broadcast Coverage
NPR's "All Things Considered" on Wednesday reported on the study. The segment includes comments from Campbell and David Rothman, professor and historian at Columbia University (Prakash, "All Things Considered," NPR, 11/29).

Audio of the segment is available online.