Research Revitalization Act of 2002

Summary

Research Revitalization Act of 2002 - Amends the Public Health Service Act to require research involving human subjects conducted in America, funded by the U.S. Government, or subject to Federal regulatory review to meet certain criteria. Establishes within the Department of Health and Human Services an Office of Human Research Protections, with a Director to be appointed by the Secretary of Health and Human Services. Declares that, effective June 1, 2005, certain provisions of the Code of Federal Regulations shall supersede prior Federal laws and regulations relating to the protection of human research subjects. Prohibits investigators from conducting covered research unless it is approved by an Institutional Review Board, effective six years after the enactment of this Act. Allows the Secretary to award demonstration grants to modify the functioning of Institutional Review Boards. Requires the Director, in consultation with the Secretary of State, to periodically publish a list of foreign countries in which protections for human research participants are substantially equivalent to those of the United States. Requires the Director, after appropriate consultation, to promulgate regulations regarding payments for the recruitment or participation of human participants in covered research. Sets forth rules with respect to financial conflicts of interest regarding covered research, and requires the Director to promulgate regulations to cover certain cases of such conflicts of interest involving not-for-profit institutions. Allows the Secretary to bring an action in U.S. District Court to enjoin continuation of covered research deemed harmful to a human participant. Protects individuals who report violations of certain provisions of this Act from being fired or disciplined. Establishes a civil penalty of up to $250,000 for violation of certain provisions of this Act (including of related regulations).

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3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 4 October 2002

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 4 October 2002

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• Introduced in Senate

  summary · EN · 4 October 2002

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