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Secretary's Advisory Committee on Human Research Protections (SACHRP)
SACHRP November 1-2, 2005 Meeting Presentations and Report
November 1, 2005 – Presentations
- Subcommittee on Research Involving Children Presentation – 8th Report for SACHRP Consideration Clarifying 45 CFR 46 Subpart D Definitions – November 1, 2005
By: Celia B. Fisher, Ph.D., and Susan Z. Kornetsky, M.P.H.
- OHRP’s Draft Guidance on Adverse Events and Unanticipated Problems
By: Michael A. Carome, M.D.
- Subpart A Subcommittee Update – Continuing Review
By: Felix Gyi, Pharm.D., M.B.A., CIP, Daniel K. Nelson, M.S., CIP, and Gary Chadwick, Pharm.D., M.P.H., CIP
November 2, 2005 – Presentations
IOM Update: Report on Research Involving Prisoners
By: Larry Palmer, LL.B. Update of FDA/OHRP Joint 407 Review Process
By: Kevin Prohaska, D.O., CDR-PHSC, and Sara Goldkind, M.D., Ph.D. Identification of Future SACHRP Priorities:
International Research – Dr. Peg Barrett (NSF) and Joan Porter, DPA, MPH (VA)
Alternatives for Reviewing Multi-site Studies – K. Lynn Cates, M.D. (VA)
Levels of Evidence Based Practice – Sally Flanzer, Ph.D. (AHRQ)
Regulatory Burden in Public Health Practice – Deborah Holtzman, Ph.D. (CDCP) Levels of Evidence Based Practice
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