Federal Research Informed Consent Act

Summary

Federal Research Informed Consent Act - Amends the Public Health Service Act to direct the Secretary of Health and Human Services to establish the requirement that, in federally qualified research in which any human subject is to be used, the principal researcher obtain the informed consent of the subject. Allows the Secretary to exempt categories of research from such consent requirement. Requires congressional notification of such exemptions and a 60-day waiting period before the exemption is effective. Directs the Secretary to establish requirements for obtaining informed consent. Provides for civil actions by those from whom no such consent was obtained, allowing damages, equitable relief, and attorney's fees and costs. Preempts any State law concerning the obtaining of such consent.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 23 February 1994

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• Introduced in House (PDF)

  Introduced in House · EN · 23 February 1994

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• Introduced in House

  summary · EN · 23 February 1994

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