3.0.0 1715 2019-11-15T21:19:17Z 2019-11-15T21:19:17Z House H HR 2009-03-25 111 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2009-03-26T18:12:31Z Referred to 2009-03-25T14:02:41Z 2009-03-26 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2009-03-25 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2009-03-25 Introduced in House IntroReferral Intro-H 9 Library of Congress 2009-03-25 Introduced in House IntroReferral 1000 9 Library of Congress D000197 Rep. DeGette, Diana [D-CO-1] DIANA DEGETTE D CO 1 N D000399 Rep. Doggett, Lloyd [D-TX-25] LLOYD DOGGETT D TX 25 2009-03-30 False B001248 Rep. Burgess, Michael C. [R-TX-26] Michael Burgess R TX C. 26 2009-03-30 False Health Administrative law and regulatory procedures Department of Health and Human Services Disability and health-based discrimination Education programs funding Executive agency funding and structure Government studies and investigations Higher education Medical ethics Research administration and funding Health 00 2009-03-25 Introduced in House 2009-05-21T18:56:37Z Protection for Participants in Research Act of 2009 - 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.

Requires the Secretary of Health and Human Services to review and harmonize such regulations.

Requires informed consent before an individual may be a subject of human research.

Requires an Institutional Review Board to approve all human subject research proposals.

Directs the Secretary to establish criteria for determining whether a human subject research project must be conducted in accordance with a data safety and monitoring plan.

Prohibits grants or awards to a public entity or private academic institution that does not have a program to educate investigators and Board members on the protection of human research subjects.

Prohibits the use of federal funds for classified human subject research if: (1) the Board has waived the informed consent requirement; or (2) the research is exempt from Board review.

Establishes the Office of Human Research Protections within the Office of the Secretary. Requires the Director of the Office to: (1) provide for the protection of human research subjects; (2) establish criteria regarding assurance of compliance with Common Rule requirements; and (3) coordinate federal activities with respect to the protection of human research subjects. Authorizes the Director to make grants for a model education program.

Requires the Secretary to: (1) promulgate regulations enhancing the protection of people with diminished decision-making capacity participating in human subject research; and (2) study whether the number of certain members of Institutional Review Boards should be increased.

]]> Protection for Participants in Research Act of 2009 Short Titles as Introduced Protection for Participants in Research Act of 2009 Display Title Protection for Participants in Research Act of 2009 Official Title as Introduced To amend the Public Health Service Act with respect to the protection of human subjects in research. Introduced in House 2009-03-25T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-111hr1715ih/xml/BILLS-111hr1715ih.xml 2009-03-26 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.