Currently, approximately 1.8 million people are incarcerated in the United States at any given time. A disproportionately large percentage of the prisoner population has serious illnesses, such as AIDS and tuberculosis. Prisoners most often, however, are barred from participation in clinical trials, even when conventional therapy has failed, and experimental treatment might provide them with their only hope of survival.
Much of the reluctance to include prisoners in biomedical research is based on history. In the past, prisoners have been severely abused and even tortured in medical studies conducted in the Nazi death camps, Japanese prisoner camps, and correctional facilities in the United States. By 1969, eighty-five percent of new drugs were tested on incarcerated persons in forty-two American prisons. In the 1970s regulations regarding the use of biomedical experimentation on prisoners were issued by the federal government, designed to provide rigorous review of research protocols involving prisoners and to protect inmates from abuse in the research context. Abuse of prisoner subjects in clinical studies can lead to violations of their constitutional rights. The author argues, however, that prohibiting seriously ill prisoners from participating voluntarily in clinical research may constitute an equivalent contravention of their constitutional rights under the Eighth Amendment and the Due Process and Equal Protection clauses. The article reviews the history of prisoner participation in biomedical research, analyzes the relevant constitutional issues, and encourages the inclusion of prisoners in clinical studies involving potentially beneficial experimental treatment for life-threatening diseases.
Prisoners, Clinical Trials
Place of Original Publication
Indiana Law Review
33 Indiana Law Review 475 (2000)
Hoffman, Sharona, "Beneficial and Unusual Punishment: An Argument in Support of Prisoner Participation in Clinical Trials" (2000). Faculty Publications. 222.