Monday, May 17, 1999

National commission finds rules too loose

The Cincinnati Enquirer

        A presidential commission has called for a nationwide review of “challenge” studies that provoke psychotic symptoms.

        That was among the 21 recommendations for reform issued by the National Bioethics Advisory Commission in January. The commission heard 18 months of testimony from patients, their families, researchers and others.

        At a time when more research into mental illness is being conducted than ever before, the commission found “considerable confusion” about the principles and procedures that should govern such research.

        The entire report can be read on the commission's Web site,

        Among its findings:

        • The Department of Health and Human Services should contract with the Institutes of Medicine to conduct a comprehensive review and evaluation of challenge, washout and placebo controlled studies.

        • When study proposals present greater than minimal risk, institutional review boards should require an independent, qualified professional assess the potential subject's capacity to consent.

        • The National Institutes of Health should study decisionmaking capacity of patients and other issues of informed consent.

        • Patients should be able to give consent to a study before they have a relapse.

        The commission “encourages researchers and institutions to voluntarily adopt the spirit and substance of these recommendations immediately.”

UC called leader for ending controversial research
- National commission finds rules too loose
Studies elsewhere found sloppy in ethics standards and consent

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