Captive subjects: pharmaceutical testing and prisoners.

Abstract

The debate about using prison inmates for medical testing has again surfaced. A federal panel of medical advisors from the Institute of Medicine (IOM) of the National Academy of Sciences has recommended that the government loosen restrictions limiting testing of pharmaceutical agents on prisoners [1]. Current regulations, passed in 1978, allow prison inmates to participate in federally financed biomedical research if the experiments pose no more than “minimal” risks to the subjects. The IOM report advises, however, that experiments with greater risk be permitted if they have the potential to benefit prisoners. Additionally, while current regulations only cover federally funded prison research, the new recommendations also advise the inclusion of privately funded research. The new recommendations would include individuals on probation and parole—increasing the overall number of “prisoners” effected by these regulations from 2 million to nearly 7 million. The current regulations (regarding the use of prisoners as subjects in pharmaceutical research) were created in response to revelations of harmful and coercive practices that occurred in prison research conducted during the1950s and through 1970. This was a period of increased awareness of abuse in prisons, and with it came revelations regarding the treatment of the subjects in the Tuskegee Study of Untreated Syphilis in the Negro Male. The climate was right for increased oversight and regulation. A recent New York Times editorial, written in response to the IOM report, further discusses this context and highlights specific instances and institutions where abuse was rampant [2].