News of the WeekBioethics

NIMH to Screen Studies for Science and Human Risks

Science  22 Jan 1999:
Vol. 283, Issue 5401, pp. 464-465
DOI: 10.1126/science.283.5401.464

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Summary

For more than a year, patient activists and ethicists have been demanding a more critical, independent review of protocols for clinical studies in psychiatry, arguing that many studies of psychiatric disorders expose subjects to needless risks. Now, a surprising new voice has joined the chorus of reformers: Steven Hyman, director of the National Institute of Mental Health (NIMH), the nation's largest funder of clinical research in psychiatry. At the NIMH advisory council meeting on 5 February, Hyman plans to seek approval of a new review panel that would screen "high risk" human studies before NIMH agrees to fund them. And earlier this month, he suspended enrollment in 29 of 108 intramural clinical protocols and asked that more than 50 be rewritten to clarify scientific objectives or human subjects protections. But researchers worry that singling out clinical psychiatry for extra review would stigmatize that area of biomedicine and discourage young investigators from entering a field with a "politicized" review process.