Medical Experiments

The Ethics of Experimentation

Initially, there were no guidelines or regulations for medical experiments or experimental drug tests, and there was no supervision by agencies such as the Food and Drug Administration (FDA). It was not prisoner research specifically that led to closer government scrutiny and participant protections. Instead, reforms were most often initiated following the disclosure of high-profile projects conducted in communities where poor, uneducated, and mostly minority subjects were involved, such as the Tuskegee syphilis study. In this case, between 1932 and 1972, poor sharecroppers in rural Alabama were injected with this serious venereal disease to test the utility of drugs at all stages of infection. Half, the control group, were left untreated, and others were given medicine only in the advanced stages of the disease so that researchers could study the drugs' effect on the most serious cases. Although cases such as this have received much media attention, particularly in recent years, culminating in presidential apologies and compensation programs, less focus has been given to the many varied medical research projects involving prisoners.

The reform of medical research procedures outside prisons eventually carried over into these facilities as well. Over the years, the FDA as well as a number of other regulatory agencies set up guidelines to ensure that all experiments would be approved and monitored by an independent institutional review board (IRB). In addition, research that involves prisoners must also pass a special layer of scrutiny in contemporary research settings. In most cases, an inmate representative or an advocate who reviews proposals on behalf of the inmates, such as a chaplain or a staff attorney, is also included in the funding or approval-granting process. These days, anyone wishing to use prisoners in a research project must obtain the prisoners' informed consent. All researchers are required to establish that the people participating in their study understand what the experiment involves. “Informed consent” implies that someone is intellectually able to assess the risks surrounding the research endeavor. This usually precludes a significant number of inmates who, because of a language barrier, developmental or physical disability, illiteracy, or mental impairment, would be limited in their ability to evaluate meaningful information offered about the research and its possible effects. Participants may not be [Page 582]coerced into participating in the study, nor should they have unrealistic or false perceptions of the potential rewards that may or may not be attached to participation. Finally, the research should not involve deception. Therefore, subjects may not be given false information about the nature of the experiment, treatment, drug, or information they are receiving for the purpose of achieving some other goal that is withheld from the participant. Although some researchers have argued that for some investigations, it is important that their subjects be unin-formed and thus unbiased in their subsequent behaviors, there are always serious ethical risks to this type of inquiry.

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