HR 2625 · 112th Congress · Health
Research Participants Protection Modernization Act of 2011
Bill Progress
✓
Introduced2
Committee3
House Vote4
Senate5
EnactedLatest: Referred to the Subcommittee on Health.(2011-08-01)
Plain Language Summary
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Research Participants Protection Modernization Act of 2011 - Amends the Public Health Service Act to require all human subject research conducted or supported by the Department of Health and Human Services (HHS) or otherwise subject to HHS regulation to be conducted in accordance with HHS Human Subject Regulations and, if applicable, the vulnerable-population rules. Requires all human subject research on drugs or biological products to be conducted in accordance with Food and Drug Administration (FDA) regulations and, if applicable, the vulnerable populations rule. Requires the Secretary of HHS to make assistance available to any federal department or agency seeking to: (1) improve the regulation or oversight of human subject research, or (2) apply the HHS Human Subject Regulations or the vulnerable populations rules. Requires the Secretary to determine whether any HHS Human Subject Regulations should be modified after considering specified matters, including financial conflicts of interest. Sets forth notification requirements for investigators submitting a proposal for human subject research to an institutional review board, including regarding any significant financial interest.…
Summarized by Claude AI · Non-partisan · For informational purposes only