Human Research Subject Protections Act of 2000

Summary

Human Research Subject Protections Act of 2000 - Title I: Human Subject Protections - Amends the Public Health Service Act to apply the common rule and vulnerable-populations rules of subparts A and B through D, respectively, of part 46 of title 45, Code of Federal Regulations (CFR) (rules requiring informed consent, with an emphasis on certain vulnerable populations) to all human-subject research. Authorizes the Secretary of Health and Human Services to permit any Federal agency involved in such research to establish additional protections for human subjects. Requires the Secretary to promulgate regulations to enhance the protection of people with diminished decision making capacity with respect to their participation in clinical 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.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 8 June 2000

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• Introduced in House (PDF)

  Introduced in House · EN · 8 June 2000

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• Introduced in House

  summary · EN · 8 June 2000

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