• Federal register · Jan 1981

    Protection of human subjects; informed consent--Food and Drug Administration. Final rule.

    • Fed Regist. 1981 Jan 27; 46 (17 pt 2): 8942-58.

    AbstractThe 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.

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