3.0.0 2625 2023-01-11T13:22:43Z 2023-01-11T13:22:43Z House H HR 2011-07-22 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Ms. DeGETTE:H.R. 2625.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8.[Page H5398]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2011-08-01T19:52:53Z Referred to 2011-07-22T04:00:35Z 2011-08-01 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2011-07-22 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2011-07-22 Introduced in House IntroReferral Intro-H 9 Library of Congress 2011-07-22 Introduced in House IntroReferral 1000 9 Library of Congress D000197 Rep. DeGette, Diana [D-CO-1] DIANA DEGETTE D CO 1 N L000480 Rep. Lowey, Nita M. [D-NY-18] NITA LOWEY D NY M. 18 2012-01-25 False 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 Health 00 2011-07-22 Introduced in House 2011-09-21T21:43:25Z 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 Display Title Research Participants Protection Modernization Act of 2011 Official Title as Introduced To amend the Public Health Service Act with respect to human subject research to improve protections for human subjects and, where appropriate because of the type research involved, to reduce regulatory burdens. Introduced in House IH Short Titles as Introduced Research Participants Protection Modernization Act of 2011 Introduced in House 2011-07-22T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr2625ih/xml/BILLS-112hr2625ih.xml 2011-08-01 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.