News of the WeekClinical Research

Shutdown of Research at Duke Sends a Message

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Science  21 May 1999:
Vol. 284, Issue 5418, pp. 1246
DOI: 10.1126/science.284.5418.1246a

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Summary

After months of urging administrators to correct "serious deficiencies" in procedures for monitoring consent and keeping records, the Office for Protection from Research Risks (OPRR)--a federal watchdog agency that is part of the National Institutes of Health in Bethesda, Maryland--last week suspended the authority of Duke University's Medical Center in Durham, North Carolina, to carry out federally funded research. Although the agency has now accepted Duke's reform plan and lifted the sanctions, OPRR notes that Duke still needs to re-review many projects for compliance with human subjects protection rules, which could take weeks. And with this action--the second shutdown of research at a major clinical center it has ordered in as many months--OPRR has put every federally funded U.S. research institution on notice that its right to conduct clinical research could be summarily yanked.

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