Research on the Terminally Ill: A Balancing Act Between Facilitating Access to Innovative Therapies and Protecting Vulnerable Subjects in Search of One Last Hope for Survival

Abstract

This paper presents the application of the current federal regulatory system governing clinical research in the United States to research involving terminally ill subjects, with a special emphasis on those patients battling terminal cancer. To begin, I describe the current regulatory system governing the approval process for new drugs, the guidelines established by the federal regulations for the conduct of clinical research involving human subjects, and the federal initiatives that have been developed to increase and expedite access to experimental therapies for terminally ill patients. In addition to tracing the roots of the informed consent paradigm in research with human subjects, I also consider the sufficiency and efficacy of this model as applied to clinical research involving the terminally ill. Addressing in particular the continuing war against cancer, I present some of the most notorious controversies and case law that have emerged in the last century with respect to new experimental cancer therapies, as well as the role of Congress in the ongoing debate concerning access to investigational treatments by terminal patients. Finally, I consider the specific vulnerabilities and experiences of desperately ill individuals fighting to survive, characteristics that make them particularly susceptible to coercion and exploitation, and, therefore, potentially in need of additional safeguards to adequately protect them in the research endeavor.