December 28, 2011

Presidential Commission Advocates Compensation for Human Subject Injuries in Federal Research

The Presidential Commission for the Study of Bioethical Issues released its report, Moral Science, on the state of human subject research in federally-funded studies. The report was commissioned following the revelations that the U.S. Public Health Service had conducted unethical research studies in Guatemala in the 1940’s, in which individuals were deliberately infected with venereal disease in order to study prevention and treatment. Following that report, a formal apology from the U.S. government to Guatemala was issued by Secretaries Clinton and Sibelius (State and Health and Human Services). This new report from the Commission concluded favorably that many protections are in place for human subjects (chiefly underpinned by the Common Rule norms of informed consent, independent ethical review and the minimization of risks) but that some further measures could increase transparency and monitoring. Over 55,000 federally-funded studies were identified by the commission, including medical and social science research. Specifically, the report strongly urges the U.S. to follow the lead of other countries which have established formal compensation schemes for victims of unethical research conduct. In that vein, this move echoes an earlier report here on the North Carolina state compensation fund for victims of state-mandated sterilization procedures. There is precedent for this commission and its work: a long line of bioethics-related advisory commissions established by the executive or legislative branches for the last forty years. These groups can respond to presidential requests for timely expert advice on new developments in life sciences (e.g., Clinton and human cloning; Bush and embryonic stem cell research).  An interesting note to this report is the commission's acknowledgement that some of its work duplicates earlier recommendations of other advisory panels regarding formal compensation for research-related injuries: it calls on the executive branch to "publicly release reasons for changing or maintaining the status quo." This might be a useful mechanism to insert in other studies where redundancy of effort is apparent (a special trap for advisory committees without formal power) and the requesting party (here, the Obama administration) should be held accountable for a formal response to the committee's work, rather than silence, which often translates to disregard.

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