Protection for Participants in Research Act of 2003

Summary

Protection for Participants in Research Act of 2003 - Amends the Public Health Service Act to require all human subject research conducted, supported, or otherwise subject to Federal regulation, to be conducted in accordance with the Common Rule and the vulnerable-population rules, as set forth in the Code of Federal Regulations. Defines specified terms. Requires the Secretary of Health and Human Services to review and harmonize such regulations. Requires informed consent before an individual may be a subject of human research. Requires an Institutional Review Board to approve all human subject research proposals. Directs the Secretary to establish criteria for identifying and monitoring high risk clinical trials. Prohibits grants or awards to a public entity or private academic institution that does not have a program to educate investigators and Board members on the protection of human research subjects. Prohibits the use of Federal funds for classified human subject research if: (1) the Board has waived the informed consent requirement; or (2) the research is exempt from Board review. Establishes an Office of Human Research Protections within the Office of the Secretary to make grants, conduct research and Institutional Review Board audits, and coordinate Federal efforts. Authorizes the Director of such Office to make grants for a model education program. Requires the Secretary to promulgate regulations addressing the participation of people with diminished decisionmaking capacity in human subject research.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 21 November 2003

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• Introduced in House (PDF)

  Introduced in House · EN · 21 November 2003

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• Introduced in House

  summary · EN · 21 November 2003

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