"Informed" Consent and Human Experimentation: Present Status, Pitfalls, and the Need for Reform

Abstract

To demonstrate the inadequacies of informed consent in the contemporary context and the need for better subject protection, this paper begins by scrutinizing the rise of modern informed consent doctrine in international legal documents as well as in the United States arena. After examining the federal regulatory framework governing experimentation with human subjects, considerable attention is given to the doctrine of informed consent and its shortcomings in the research setting, including lack of competence to grant consent, misunderstandings and conflicts of interest between researcher and subject, and the doctrine's incompatibility with several dynamics of the patient-physician encounter. Flaws pertaining to both the research and therapeutic settings are also noted. IRBs' responsibilities for protecting subjects are then explored, along with the numerous factors preventing these bodies from providing adequate safeguards. The paper then discusses current regulations regarding various groups- the terminally ill, women, children, prisoners, and the decisionally/cognitively impaired, including psychiatric patients and the elderly- as well as considerations unique to each. This uncovers shortcomings of current informed consent doctrine and illustrates that meaningful consent can only be achieved by crafting procedures and policies specifically tailored to the needs of each particular population. Next, problems that modern medical research in the gene therapy area raises are probed, and numerous proposals to ameliorate the informed consent process as well as IRB efficacy are offered.