The national commission determined that research involving prisoners was so complex that a special section of regulations was needed to (1) provide severe restraints on the sorts of research that could be performed to protect the rights and interests of inmates, and (2) impose specific rules and procedures for institutional review boards reviewing protocols for correctional settings. The current inquiry, almost 30 years later, asks whether that special set of regulations is still sufficient and valid. The national commission noted that research in correctional settings presented problems largely relating to coercion and challenges to autonomous consent and refusal.

The national commission conducted a number of information-gathering activities as part of the development of its report on prisoners. Commission members made site visits to four prison facilities that conducted research with their inmate populations and two research facilities that were not penal institutions but that used prisoners as research subjects. During these visits, commission members and staff talked with inmates who did and did not participate in research projects, with prison administrators who had oversight responsibilities, and with directors of the research programs at the facilities.

When the National Commission visited the Jackson State Prison in Michigan on November 14, 1975, they met with a group of highly articulate prisoners. The leader of the group greeted them with the following opening statement: “Ladies and gentlemen: You are in a place where death at random is a way of life. We have noticed that the only place in this prison that people don’t die is in the research unit. Just what is it that you think you are protecting us from?” (Dubler and Sidel, 1989).

In addition, commission members held hearings to allow for comment by those who would be most affected by any proposed protections. Groups represented at these hearings included members of the scientific community, advocates for the rights of prisoners, attorneys who provided legal services to prisoners, representatives from the pharmaceutical industry, and members of the general public. A National Minority Conference on Human Experimentations was also held to allow for groups representing minority concerns to receive a more in-depth hearing.

In addition to these activities, members of the commission staff authored papers, completed surveys, and wrote other reports that helped to inform the commission’s deliberations. Papers were written by others as well. Topics for these papers were

  • alternatives to the use of inmates as research subjects,

  • a review of foreign practices on developing new pharmaceutical medications with prison subjects,

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