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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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