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The leading US organization of medical schools is sharply criticizing a presidential commission's draft report that recommends new ethical protections for research subjects with mental health problems.

The Association of American Medical Colleges (AAMC) says the report's recommendations threaten to eliminate whole areas of psychiatric research. In a letter of 31 July to the National Bioethics Advisory Commission (NBAC), the association's president, Jordan Cohen, says the report paints an unfair picture of psychiatric researchers as disproportionately unethical. Cohen says that, by focusing on the mentally ill, the report risks stigmatizing people with mental disorders, when many other subjects can be said to have impaired capacity to consent.

The draft report, “Research involving subjects with mental disorders that may affect decisionmaking capacity,” was released on 1 July. It is the product of a year of work by the 17-member commission, which is considering the adequacy of current government research protections for the mentally ill.

In the late 1970s and early 1980s, two national commissions recommended that such protections be enhanced. But the Department of Health and Human Services shelved the recommendations after researchers complained that they would hamper research. There are echoes of those complaints in the current AAMC letter.

The association objects to a recommendation that “any apparent dissent” by a research subject must be honoured. If their surrogate representatives aren't allowed to overrule patients in some cases, it says, this “could make it impossible to complete research projects in Alzheimer's disease and other conditions”.

Similarly, the association attacks a recommendation that research that does not benefit subjects and that is of greater than minimal risk should be conducted only with the subject's informed consent plus the consent of a legally authorized surrogate. The AAMC says that requiring individual consent, coupled with the “vagueness” of the term “greater than minimal risk,” could “effectively eliminate” research that does not benefit subjects.

But Stephen McConnell, vice-president for public policy at the Alzheimer's Association, says his group backs both NBAC recommendations. They “certainly will inhibit some research, but we will always defer to an individual,” he says.

James Childress, the chairman of the NBAC subcommittee that drafted the report, declined to comment on the criticisms. He says the comments received will be taken seriously as the draft report is revised for presentation to the commission in mid-September. The text of the draft is at www.bioethics.gov.