Ethics review boards admit breaching US federal rules

December 22, 2006

Members of institutional review boards at US universities continue to have financial conflicts of interest, raising questions about their objectivity when evaluating the ethics and safety of research that involves human subjects, according to a survey.

The report, published in the New England Journal of Medicine , suggests that some board members are in violation of new federal laws imposed in the wake of earlier conflict-of-interest cases.

Eric Campbell, a Harvard Medical School professor and one of the study's authors, said the conflicts could undermine the purpose of the review boards by casting doubt on their objectivity.

The boards came under scrutiny over a period of time, but was most intense in 2002 after the deaths of several study subjects. The Food and Drug Administration issued new guidance for institutional review boards in 2005.

Members were required to disclose whether they had any financial conflicts of interest relating to specific human-subject research proposals, and to refrain from voting on them. But Dr Campbell and his colleagues report that many still make no such disclosures or are not aware of the rules or what constitutes a conflict.

The authors surveyed 893 review board members at 100 institutions. More than a third admitted having outside ties to industry and 15 per cent said the boards on which they served considered at least one proposal sponsored by a company with which they had financial links or a competitor of a company with which they had such links. More than 40 per cent of these said they did not disclose their conflict and half said they voted on whether to approve the proposals.

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