Recurrent Issues in the Review of Medical Research on Human Subjects

Abstract:     
Medical researchers must enlist the participation of human subjects to conduct their investigations. Some subjects are healthy; others are ill. All must understand, however, that the studies in which they participate are intended, wholly or in part, to benefit others rather than themselves. Individual institutions’ IRBs (Institutional Review Boards) bear the responsibility to review, evaluate, and approve or disapprove researchers’ plans to include human subjects in their investigations. This article suggests several approaches that IRB members may take in reviewing proposals for research projects involving human subjects. Each approach is intended to strike a reasonable balance among the competing considerations while allowing IRB members to fulfill their responsibilities to human subjects.

Keywords: Human subjects, IRB

Accepted Paper Series