HR 4697 · 107th Congress · Health
Human Research Subject Protections Act of 2002
Bill Progress
✓
Introduced2
Committee3
House Vote4
Senate5
EnactedLatest: Referred to the Subcommittee on Health.(2002-05-17)
Plain Language Summary
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Human Research Subject Protections Act of 2002 - 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 such terms according to different regulations for human subject research subject to the Federal Food, Drug, and Cosmetic Act. Requires the Secretary of Health and Human Services to review all such regulations to harmonize them where feasible with a subsequent proposed rule, explaining remaining differences. Sets forth the authority of the Secretary to modify regulations. Requires informed consent, as specified. 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 the use of Federal funds for classified human subject research, as specified. Requires the Secretary to determine whether an entity has violated these requirements, as specified. Establishes an Office of Human Research Protections within the Office of …
Summarized by Claude AI · Non-partisan · For informational purposes only
Cosponsors (3)
1 Democrat2 Republicans