H.R.5641 - Safe Overseas Human Testing Act

To promote safe and ethical clinical trials of drugs and other test articles on people overseas. view all titles (2)

All Bill Titles

  • Short: Safe Overseas Human Testing Act as introduced.
  • Official: To promote safe and ethical clinical trials of drugs and other test articles on people overseas. as introduced.

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Introduced
 
House
Passes
 
Senate
Passes
 
President
Signs
 

 
06/20/06
 
 
 
 
 
 
 

Official Summary

Safe Overseas Human Testing Act - Allows test articles intended for clinical investigations to be exported only pursuant to an export license approved by the President. Directs the President to require an applicant for such license to: (1) identify each clinical investigation for which the

Official Summary

Safe Overseas Human Testing Act - Allows test articles intended for clinical investigations to be exported only pursuant to an export license approved by the President. Directs the President to require an applicant for such license to:
(1) identify each clinical investigation for which the test article is intended; and
(2) secure a certification from an institutional review board that each of the protocols for every clinical investigation has been reviewed by the board and has met substantially the same standards for the protection of the rights and welfare of human subjects as would be required if the protocol were for a clinical investigation of the test article pursuant to the Federal Food, Drug, and Cosmetic Act.

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