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9/5/2000

Research Ethics a Hot Topic of Debate

Katherine M. Bennett

A recent report in American Medical News highlighted the troubling rise in the number of research facilities being cited for ethics violations. The Nov. 1 article, which detailed the suspension of research at five institutions during 1998-99, cited health care experts who surmise that the Health and Human Services Department's Office for Protection from Research Risks (OPRR) may be "taking a tougher stance" in investigating the protections for human subjects. The five institutions in question were guilty of a variety of problems, according to OPRR officials, including using ineligible patients as research subjects, failing to gain adequate consent, having inadequate staff and resources, or failing to conduct appropriate and timely review of research. Compounding the complex issues involved in human research is the fact that funds are, in some cases, outpacing the ability of internal review boards to review protocols. Clinical research is also now expanding beyond the institutional setting and its accompanying oversight into physician offices, according to the article. For more information, go to www.ama-assn.org/sci-pubs/amnews/pick_99/prfa1101.htm.