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

SACHRP April 18 -19, 2005 Meeting Presentations and Report

• Subcommittee on Research Involving Children Report/Issues
  6th Report for SACHRP Consideration Clarifying 45 CFR 46 Subpart D Definitions - April 18, 2005
  By: Celia B. Fisher, Ph.D., and Susan Z. Kornetsky, M.P.H.



• Subpart A Subcommittee - Formation, Charge, and Future Plans - April 18, 2005
  By: Felix Gyi, Pharm.D, M.B.A., CIP, and Daniel K. Nelson, M.S., CIP



• SACHRP- Final Report of Subpart C Subcommittee - April 18, 2005 [PDF - 62KB]
  By: Mark Barnes, J.D., LL.M., and Nancy N. Dubler, LL. B.

Perspectives on the Role of the Institutional Official - April 19, 2005

• The Institutional Official - Influence and Culture
  By: Judith L. Brookshire, M.S.



• Perspectives on the Role of the Institutional Official
  By: Richard W. Bianco, M.D.

HRPP Accreditation Standards for Investigator Education - April 19, 2005

• Investigator Training and Performance
  By: Jessica Briefer French, Ph.D.



• Investigator Competency in Conducting Ethically Sound Human Research
  By: Marjorie A. Speers, Ph.D.

Issues Involving Investigator Education - April 19, 2005

• Education of Clinical Physician Investigators
  By: David Korn, M.D.



• Training Clinical Investigators: Do Best Practices Exit, and Who Needs Them?
  By: Charles Flexner, M.D.



• Instructions in the Protection of Human Research Subjects
  By: Paul Braunschweiger, Ph.D.

Incentives and Disincentives for IRB Monitoring/Audit Programs - April 19, 2005

• HSR Auditing Program - University of Pittsburgh
  By: Dennis P. Swanson, R. Ph, M.S.



• Lessons Learned During the Evolution of an IRB Quality Improvement Program
  By: Ada Sue Selwitz, M.A.

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