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HR 2625 112th Congress House Health Administrative law and regulatory procedures Department of Health and Human Services Disability and health-based discrimination Executive agency funding and structure Medical ethics Medical research Research administration and funding

Research Participants Protection Modernization Act of 2011

Introduced: July 22, 2011 Introduced by: DeGette, Diana Democratic · Colorado See on congress.gov
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 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Aug 1, 2011
Referred to the Subcommittee on Health.
Jul 22, 2011
Referred to the House Committee on Energy and Commerce.
Jul 22, 2011
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now August 1, 2011

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2