Human Research Subject Protections Act of 1997

Summary

TABLE OF CONTENTS: Title I: General Research Requirements Title II: Classified Research Human Research Subject Protections Act of 1997 - Title I: General Research Requirements - Applies the requirements of specified provisions of the Code of Federal Regulations (common rule protections) to research conducted by research facilities using human subjects. Requires that the Office of the Secretary of Health and Human Services handle human subject protection, either through establishment in the Secretary's Office of the Office for Protection of Human Research Subjects or through reassignment to the Secretary's Office of the Office for Protection from Research Risks. Requires research facilities, in order to conduct research using human subjects, to have a registration with the Secretary. Authorizes the Secretary to carry out inspections or investigations to determine whether any facility has violated or is violating this Act. Amends the Federal Criminal Code to mandate fines or imprisonment (or both) for assault, resistance, interference, etc., regarding the performance of official duties under this Act. Provides for suspension of registration for suspected violations and suspension or revocation of registration and fines or imprisonment for violations. Title II: Classified Research - Prohibits the expenditure of Federal funds for the conduct of any classified research (research involving human subjects that is authorized under certain criteria established by an Executive Order to be kept secret) where a board has waived informed consent as defined in the common rule protections or where a determination has been made that the research is exempt from board review. Requires that, in addition to the common rule protections, subjects be informed: (1) of the identity of the Federal agency providing funds; (2) that the research involves classified information; and (3) regarding an unclassified description of the purpose of the research.

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3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 22 January 1997

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 22 January 1997

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• Introduced in Senate

  summary · EN · 22 January 1997

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