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

SACHRP October 4-5, 2004 Meeting Presentations

Subcommittee on Research Involving Children Report/Issues 4th Report for SACHRP Consideration Clarifying 45 CFR Subpart D Definitions - October 4.2004 Celia B. Fisher, Ph.D., and Susan Z. Kornetsky, M.P.H.
SACHRP - Subpart C Subcommittee Report - October 4, 2004 Mark Barnes, J.D., LL.M. and Nancy N. Dubler, LL.B.
Subpart A Issues Panel - October 5, 2004
- Review of 45 CFR 46 Subpart A: Risks vs Benefits Ada Sue Selwitz, M.A.
- Panel on 45 CFR 46, Subpart A - SACHRP David G. Forster, J.D., M.A., CIP
- Critical Assessment of 45 CFR 46 Subpart A Daniel K. Nelson, M.S., CIP
- Is Subpart A in need of modification? Flexibility: The Life of an Enduring Document Steven Peckman
Definition of Research vs. Non-Research Issues Panel - October 5, 2004
- The Boundaries Between Human Research and Other Activities: A Regulatory Perspective Michael A. Carome, M.D.
- Public Health Practice vs. Research James G. Hodge, Jr., J.D., LL.M.
- The Ethics of Improving Health Care Quality & Safety: A Hastings Center/AHRQ Project Mary Ann Baily, Ph.D.
- Quality Improvement and IRBs Margaret E. O'Kane, M.H.D.
Models for IRB Review Panel, October 5, 2004
- Joint IRB Review Arrangements for Cooperative Research Projects Michael A. Carome, M.D.
- Some FDA Perspectives on Central (and Local) IRBs David A. Lepay, M.D., Ph.D.
- IRB Review of Multi-Center Trials: How Can We Improve Susan Kornetsky, M.P.H., CIP
- Should IRBs Be Local? Robert J. Levine, M.D.
- Models for IRB Review - SACHRP David G. Forster, J.D., M.A.
- ASCO Statement on Central Review of Clinical Trials Lowell E. Schnipper, M.D.

Last revised: November 1, 2004

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