Beneficial and Unusual Punishment: An Argument in Support of Prisoner Participation in Clinical Trials

Protection clauses.Because many clinical trials involve potential cures for diseases that frequently affect prison populations, such as hepatitis,'^HIV infection, and tuberculosis,'"^regulations that are excessively stringent may deprive prisoners of life-saving therapy.'^Currently,1.8 million people are in jail in the United States at any given time.'^Therefore,polices that bar prisoner participation in biomedical research adversely affect a very large number of Americans.This Article will analyze the constitutional issues implicated in biomedical research involving prisoners.It will argue that, in light of contemporary regulatory safeguards, the constitutional rights of prisoners enrolled in clinical studies will not be jeopardized.Moreover, the Article will encourage the inclusion of prisoner subjects in biomedical research involving potentially beneficial experimental treatment for life-threatening diseases and will assert that regulations banning the inclusion of prisoners in clinical studies are constitutionally suspect.This Article begins with an overview of clinical trials and informed consent.Next, a brief history of the abuses suffered by prisoners in clinical trials will be presented.The Article will then discuss the Nuremberg Code and the federal regulations applicable to research involving inmates.The constitutional issues relating to prisoners' participation in or exclusion from clinical trials will be analyzed at length.Finally, the author will address the practical and ethical difficulties of conducting biomedical experimentation in which prisoners participate and will provide specific recommendations regarding these impediments.I. Clinical Trials and Informed Consent Clinical trials for drugs and devices are regulated by the Food and Drug Administration (FDA).'^Clinicaltrials for procedures such as surgeries or bone marrow transplants are not regulated by the FDA but often must comply with DHHS regulations.'^Drugsstudied in clinical trials are called Investigational New Drugs ("INDs").'^Sponsorswishing to conduct a clinical trial to test a new 13.