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April 27, 1994

Ethicist Faults Human Research Subject Protection

JAMA. 1994;271(16):1228-1229. doi:10.1001/jama.1994.03510400014004

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THE SYSTEM that is supposed to protect human subjects who participate in research studies is flawed. The result is failure to protect such persons adequately, said speakers at a Washington, DC, meeting.

Two recently publicized examples illustrate the point: In controlled field trials of the efficacy of pertussis vaccine, some children were denied the benefits of the vaccine; in another study involving schizophrenic patients, the subjects were not told the full extent of the risks of participation.

The flaw in the system is the failure to keep in working order the mechanism of open public discussion of difficult cases by the Ethics Advisory Board that was set up in 1977 and allowed to lapse in 1980, says noted medical ethicist Albert R. Jonsen, PhD, of the University of Washington School of Medicine, Seattle.

If that mechanism had been in place, Jonsen argued at a meeting of the Congressional Biomedical Research

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