Clarifying the Concepts of Research Ethics

Abstract

O ne of the most important achievements of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the Commission) was to begin the process of correcting the conceptual and semantic errors that had undermined virtually all previous attempts to develop rational public policy on research involving human subjects. The fruits of this achievement are seen most clearly in the later reports of the Commission-on children,1 on those institutionalized as mentally infirm,2 and on Institutional Review Boards (IRBs).3 Earlier reports, for example, on the fetus,4 were flawed in several respects5 because they were prepared before the Commission had completed its conceptual clarifications. Four of these clarifications are especially important. The Commission (1) developed satisfactory definitions of research and practice; (2) abandoned the distinction between therapeutic and nontherapeutic research; (3) clarified the concept of risk; and (4) identified the different purposes of informed consent and the consent form.