Protection of human subjects; informed consent--Food and Drug Administration. Final rule.
The Food and Drug Administration (FDA) is issuing regulations to provide protection for human subjects of clinical investigations conducted pursuant to requirements for prior submission to FDA or conducted in support of applications for permission to conduct further research or to market regulated products. The regulations clarify existing FDA requirements governing informed consent and provide protection of the rights and welfare of human subjects involved in research activities that fall within FDA's jurisdiction.
D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration