To amend the Public Health Service Act with respect to the protection of human subjects in research.
Title II: Informed Consent - Prohibits any investigator from involving a living human being in research unless such investigator has obtained the legally effective informed consent of such individual or his or her authorized representative.
Title III: Institutional Review Boards - Prohibits such research from being conducted unless an accredited Institutional Review Board has approved the proposal for such research in light of the common rule and vulnerable-populations rules.
Title IV: Federal Oversight - Establishes the Office for Protection of Research Subjects.
Prohibits the Secretary from entering into research grants, cooperative agreements, or contracts unless the receiving entity or institution has a comprehensive and ongoing program to educate investigators and Board members on the protection of human subjects in research.
Establishes the National Bioethics Advisory Commission to provide advice and recommendations on bioethical issues arising from the delivery of health care, research on human biology and behavior, and the applications of such research.
Introduced in House
Introduced in House
Referred to the House Committee on Commerce.
Referred to the Subcommittee on Health and Environment.
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