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New Focus on Research Participant Protection
Brian Vastag
JAMA. 2002;288:1973.
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Washington—After an exhaustive 18-month review, an Institute of Medicine (IOM) committee has handed down broad recommendations for overhauling the nation's fractured system of human research protections. The report advocates sweeping changes at the national, institutional, and community levels, including comprehensive monitoring of all research, revamping strained institutional review boards (IRBs), and providing litigation-free compensation for participants harmed during research.
The current arrangement—federally funded institutions generally police themselves while industry answers to the Food and Drug Administration—is so disparate that estimates of the number of research volunteers in the United States vary from 2 to 20 million, said committee chair Daniel Federman, MD, distinguished professor of medicine and medical education at Harvard Medical School.
NATIONAL EFFORT SOUGHT
That alarming range prompted the committee's first recommendation, the establishment of a national data collection effort to track research participation. While Congress and various medical organizations ponder how to implement such . . . [Full Text of this Article]
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