Protection of human subjects; informed consent; standards for institutional review boards for clinical investigations--FDA. Proposed rule.
The Food and Drug Administration (FDA) is proposing to amend (1) its regulations that contain the general standards for any institutional review board (IRB) that reviews clinical investigations regulated by the agency and (2) its regulations that establish general requirements for informed consent of human subjects that participate in such research. The agency intends to conform its regulations to the extent possible to the "Federal Policy for the Protection of Human Research Subjects" (Model Policy) published elsewhere in this issue of the Federal Register. Existing FDA regulations governing protection of human subjects share a common core with the Model Policy and implement the fundamental principles embodied in that policy. The purpose of these proposed amendments is to eliminate certain inconsistencies with the Model Policy.
D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D011367:Professional Staff Committees / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration