The role of the institutional review board in research involving human subjects.
Concern with the rights and welfare of human experimental research subjects has given rise to the evolution of institutional review boards. This article describes the basic composition and purposes of these boards, as well as the federal regulations by which they are governed. Since many of these regulations are open to interpretation, the policies and procedures of one such board are included to represent an example of how these regulations are interpreted and applied.
D004282:Documentation; D026724:Ethical Review; D028744:Ethics Committees, Research; D035082:Federal Government; D033161:Government Regulation; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent; D018579:Patient Selection; D011367:Professional Staff Committees; D035842:Research Subjects; D012306:Risk; D014481:United States; D014486:United States Food and Drug Administration