Prison Research: Does Locked Up Mean Locked Out?
September 6, 1999
Web posted at: 1:12 p.m. EDT (1712 GMT)
by Jeffrey P. Kahn, Ph.D., M.P.H.
University of Minnesota
(CNN) -- At a recent professional meeting, a Stanford University researcher discussed the results of a test of the effects of a drug to control aggression. The trouble is that the research was carried out on juvenile inmates in a California prison, raising a host of legal and ethical concerns.
The Stanford research gave groups of juvenile inmates varying doses of an anti-aggression drug and assessed its effect on their behavior. The controversy lies in the fact that the researcher reportedly admitted setting the dose so low as to be a placebo, intentionally denying the subjects any therapeutic effect from the drug.
Federal regulations allow research in prisons under only very limited conditions: when the research is on prison environments, or when there is a prospect of direct therapeutic benefit for the subjects. This means no placebo-controlled trials are allowed, since those in the placebo arm are denied direct benefit.
Protecting the 'vulnerable'
Research in prisons was not always so limited. Before the early 1980s, many clinical trials for new drugs were carried out in prisons. But a series of cases exposed the exploitation of subjects in biomedical research: poor African-American men deceived and untreated in the Tuskegee Syphilis Study; mentally retarded children intentionally exposed to hepatitis at the Willowbrook State School; and chronically ill elderly patients injected with live cancer cells at the Jewish Chronic Disease Hospital of New York.
At the time of these cases, prisoners were a sought-after research population. Prisons offered a controlled environment: No prisoners would be "lost to follow-up." Prisoners were highly motivated subjects, whether to earn extra money or other forms of payment, make amends for previous behavior, or get better access to medical care. In fact, a study performed in the early 1980s demonstrated that research participation was a popular and prized activity; the most powerful inmates were the most likely to be research subjects.
But such motivation is precisely why concerned regulators moved to limit research participation by prisoners. How can subjects give truly voluntary consent in a setting where freedom is so severely constrained? In the case of the Stanford research, consent is doubly complicated by the fact that the prisoners were juveniles. And even if consent is possible, how acceptable is participation motivated by access to non-research-related benefits such as time out of cell or increased access to medical care? The requirement for potential direct medical benefit -- and no placebo use -- in all prison research is intended to lessen the concerns about research in the prison environment.
The fine line between protection and access
The Stanford researcher has not yet commented on his motives, but he might have found inmates a desirable research population for a number of reasons. For research into ways to control aggression, whom better to study and who more likely to benefit than aggressive prisoners?
Sometimes research is best performed using placebo control groups. Since such research is not allowed in prisons, researchers are faced with finding ways to avoid placebos or forgoing prison research altogether. But misleading research review boards as well as subjects by using inactive doses of drugs does justice to no one.
Research policy must balance preventing the exploitation of subjects against overprotecting groups to the extent that they lose out on the research benefits offered to others. Deceitfully flaunting the rules upsets this balance and runs the risk of exploiting not only subjects and the system, but the future of such research altogether.
A researcher from Stanford University recently reported findings of research on a drug to control aggression, tested on juvenile prison inmates. The research used placebo-like low doses of the drug, but federal regulations prohibit placebos in prisons. But whom better to study and who more likely to benefit from such research than aggressive prisoners? Shouldn't prisoners be allowed to decide for themselves whether to participate in research?
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