Deregulators in the Department of Health and Human Services are hard at work to ease the rules covering research on human subjects, research that involves more than 100,000 people annually. At the end of this month, many of the researchers who receive federal money will find their projects exempt from the internal review process required since 1974. Others will find that process streamlined.
Projects such as survey research in which the subjects are anonymous will be exempted. Projects involving "minimal risk," such as taking blood samples from healthy adults, will be eligible for expedited review. But under the rules drafted by the National Institutes of Health, the riskier biomedical and behavorial studies still warrant a thorough check by a five-member Institutional Review Board of the research insitution or university involved.
Meanwhile, lawyers in the Food and Drug Administration are changing their six-month-old regulations covering research on state prison inmates. These rules, which also applied to privately sponsored projects, would have virtually eliminated current research projects by requiring that only subjects who might benefit from the research could be used. Diabetes sufferers could be used in testing a possible diabetes remedy, for instance.
In the wake of a suit by the Upjohn Co., a pharmaceutical manufacturer, the FDA has deferred these rules indefinitely, while promising changes. Meanwhile, experiments involving about 1,100 state prison inmates in Montana and Michigan can continue. (A 1976 Bureau of Prisons rule bans research on federal inmates.)