Compensating Injured Research Subjects: II. The Law

O ne reason for public concern about human experimentation is the awareness that research subjects in the past have suffered physical injury, pain, or even death. Although Institutional Review Boards and informed consent may minimize intentional abuse of subjects, they cannot eliminate subject injury altogether. Injuries will occur because of human error, ignorance about drug or treatment effects, or fraud or abuse. While the frequency of research-related injuries is unknown, and may be much rarer in nontherapeutic than therapeutic research, a recent survey (New England Journal of Medicine, September 16, 1976) suggests that they are pervasive and serious enough to warrant public attention.