IOM panel urges more oversight
Experts on a panel convened by the Institute of Medicine (IOM) of the National Academy of Sciences (Washington, DC) recommend that the federal government extend its oversight to participants in all clinical trials and other studies involving human subjects. The US Food and Drug Administration (FDA; Rockville, MD) currently regulates such research supported by federal funding, but some private research lies outside FDA jurisdiction. “The public has come to perceive that [private] research institutions put more emphasis on insulating themselves from liability than on protecting people from harm,” says committee chair Daniel Federman of Harvard Medical School (Boston, MA). In its report, the IOM panel calls on Congress to “establish an independent, multidisciplinary, nonpartisan advisory body” to oversee research with human subjects. The panel further recommends that institutions conduct ethical and scientific merit reviews of proposals involving human subjects on a separate basis, noting that current institutional review boards “do not necessarily have the expertise, authority, or resources to carry out all...these tasks on their own.” The panel also calls for “the immediate creation of a no-fault compensation system to provide injured participants or their survivors quicker resolution of claims and relieve some of the burden on the courts.” JLF
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