National Human Research Protections Advisory Committee (NHRPAC)


July 30-31, 2001 Meeting

Meeting Agenda PDF document, see bottom of page to obtain free reader

To review the meeting daily transcripts via viewer (full indexing), click [07/30 Transcript Viewer] or [07/31 Transcript Viewer] and use Save As, executing on your PC after downloading. However, if you have a PC or operating system that doesn't support Microsoft executables, click [07/30 Transcript Text]or [07/31/2001 Transcript Text]



NHRPAC/Congresswoman DeGette's Speech PDF document, see bottom of page to obtain free reader


ACTION ITEMS

At  its July 30-31, 2001 meeting NHRPAC approved the following document, provided that some stipulations requested by Committee members were made.  

Letter transmitted from the Chair to the FDA commenting on Docket #00N-0074 April 24, 2001 Interim Rule: Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products. This letter pertains to provision (408c) of 45 CFR 46 Subpart D, which provides for limited exceptions that waive the requirement for parental permission for participation in research of certain minors and allows the minor to give informed consent given certain safeguards are in place to protect the interests of the minor.




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Updated January 13, 2003