US Congress House Bill 2625 (Prior Session Legislation)

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Spectrum: Partisan Bill (Democrat 2-0)
Status: Introduced on July 22 2011 - 25% progression, died in committee
Action: 2011-08-01 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

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. Requires the institution served by an institutional review board to review such significant financial interests and seek to eliminate or manage any conflict of interest. Prohibits the Secretary from awarding a grant, cooperative agreement, or contract to a public entity or private academic institution for research unless the entity or institution maintains or contracts for a program to educate investigators and board members on the protection of human subjects in research. Codifies the establishment of the Office for Human Research Protections in the Office of Secretary of HHS. Authorizes the Director of such Office to make grants for the development of model education programs that may be used by institutions served by institutional review boards to promote best practices in institutional management of human subject research.

Research Participants Protection Modernization Act of 2011

Rep. Diana DeGette [D-CO]

Rep. Nita Lowey [D-NY]

Date	Chamber	Action
2011-08-01	House	Referred to the Subcommittee on Health.
2011-07-22	House	Referred to the House Committee on Energy and Commerce.

Type	Source
Summary	https://www.congress.gov/bill/112th-congress/house-bill/2625/all-info
Text	https://www.congress.gov/112/bills/hr2625/BILLS-112hr2625ih.pdf