Incompetent Persons as Research Subjects and the Ethics of Minimal Risk

Abstract

In this paper we trace the history of protection of incompetent adult research subjects as found in codes and guidelines regulating the conduct of research, define the gap in the ethical justification for inclusion of such subjects when there is no intended benefit for them, and develop a rationale to fill this gap based upon existing ethical and legal notions of trust, family privacy, and social responsibility. In so doing, we review the reasoning in relation to research with children insofar as it is relevant to incompetent adults.