Secretary's Advisory Committee on Human Research Protections (SACHRP)

SACHRP January 31 - February 1, 2005 Meeting Presentations

• Subcommittee on Research Involving Children Report/Issues
  5th Report for SACHRP Consideration Clarifying 45 CFR 46 Subpart D Definitions - January 31, 2005
  By: Celia B. Fisher, Ph.D., and Susan Z. Kornetsky, M.P.H.

• SACHRP- The Report of Subpart C Subcommittee - January 31, 2005
  By: Mark Barnes, J.D., LL.M., and Nancy N. Dubler, LL. B.

• Subpart A Subcommittee - Formation, Charge, and Future Plans - February 1, 2005
  By: Felix Gyi, Pharm.D, M.B.A., CIP, and Daniel K. Nelson, M.S., CIP

Adverse Event issues Update and Discussion - February 1, 2005

• Federal Adverse Event Task Force - Status Report
  By: Amy P. Patterson, M.D.

• Improving AE Reporting in Multi-Site Clinical Studies: Some Thoughts on Possible Elements of a New Reporting Model
  By: Jean-Louis Saillot, M.D.

Discussion of Compliance Oversight Activities Panel - February 1, 2005

• Compliance Oversight in Human Subject Protection
  By: Kristina C. Borror, Ph.D.

• FDA Oversight of Clinical Trials
  By: Joanne L. Rhoads, M.D., MPH

• Compliance from the Institutional Perspective
  By: Michael J. Klag, M.D., MPH

• Issues in Compliance Oversight
  By: Thomas Puglisi, Ph.D., CIP

• Common Compliance Issues for ORI
  By: Chris B. Pascal, J.D.

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