Monday, May 17, 1999

Studies elsewhere found sloppy in ethics standards and consent




BY ANNE MICHAUD
The Cincinnati Enquirer

        Citing lax safety oversight, the federal agency investigating psychiatric research at the University of Cincinnati froze most of 2,000 human studies at Duke University for four days last week.

        The ban was lifted on Friday after Duke officials agreed to overhaul its protection for human subjects.

        It was the third such shutdown in six months by the Office for Protection from Research Risks (OPRR), a division of the National Institutes of Health.

        In March, OPRR suspended research at the West Los Angeles Veterans Affairs Medical Center, the country's largest VA hospital, saying informed consent documents overstated the scientific value of many studies and understated risks.

        In October, regulators briefly suspended new research on humans at Rush-Presbyterian-St. Luke's Medical Center in Chicago, alleging the hospital had badgered elderly patients into participating in a study.

        At Duke, OPRR found problems with its Institutional Review Board, the body that reviews each proposed human experiment for scientific merit and ethical standards.

        The review board failed to correct problems OPRR had warned about in December, including lack of training of board members, potential financial conflicts of interest, poor attendance and bad record-keeping.

        The problems sound like paperwork issues, but they reflect concern with how humans are treated, OPRR Director Gary Ellis told the New York Times.

        Laura Lee Hall, research director for the National Alliance for the Mentally Ill, said review boards “are the major safeguard in the U.S. system.”

        UC's review board received an OPRR warning in early April. The agency ordered the board, which also oversees the Cincinnati VA Medical Center and Shriners Burns Institute, to re-review its federally funded medical research, about 98 studies.

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



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