The Decision Dynamics of Clinical Research

The Context and Process of Informed Consent

Abstract

This article explores the neglected dimensions of informed consent. In such documents as the Code of Federal Regulations that govern clinical research, it is explicitly stated that informed consent is a process, not a form to be signed. However, virtually all research on informed consent has proceeded as if informed consent is an event similar to a Miranda warning. The authors review what is known about the process of informed consent and ask what questions must be explored if the dynamics of the clinical decision-making process are to be better understood. Their investigation takes place in two parts. First, the authors survey what is known or not known about the effect and influence of two major parties to the decision-making process (ie, support groups in which the subject participates and the subject’s primary care physician). Second, they focus on the cultural and demographic factors that contribute to the subject’s identity. Although they do not propose that informed consent must become a complicated and burdensome process, they stress that understanding the process in any meaningful way will mean that one must understand these various influences to get beyond the voluminous, but often facile, research that has characterized work on informed consent.