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July 21-22, 2009 Meeting Agenda


The Department of Health and Human Services
Meeting of the Secretary's Advisory Committee on Human Research Protections (SACHRP)
Tuesday, July 21, 2009 — Wednesday, July 22, 2009
The Sheraton National Hotel
900 South Orme Street, Arlington, Virginia


Tuesday, July 21, 2009


8:30 am — 8:35 am

Welcome: Opening remarks
Barbara Bierer, M.D.

8:35 am — 8:45 am

Report of Issues/Remarks
Jerry Menikoff, M.D., J.D.,
Director, OHRP

8:45 am — 10:45 am

ANPRM: Holding External IRBs Accountable
Julie Kaneshiro, MA
Team Leader, Division of Policy and Assurances, OHRP

Felix Gyi, PharmD, M.B.A.
Chief Executive Officer,
Chesapeake Research Review, Inc.

Darrell Wilson, M.D., Stanford University
Professor and Chief of Pediatric Endocrinology and Diabetes, Stanford University and the Lucile Packard Children's Hospital at Stanford

David Wynes, Ph.D.
Vice President for Research Administration
Emory University

Susan Loess-Perez, M.S.
Director, Office of Research Protections
DePaul University

10:45 am — 11:00 am


11:00 am — 12:00 am

CTSA Pediatric Multisite IRB Issues
Steven Hirschfeld, M.D., Ph.D.
Captain, U.S. Public Health Service
Associate Director for Clinical Research
National Institute of Child Health and Human Development

12:05 pm — 1:00 pm


1:00 pm — 1:45 pm

Summary of Comment: Education Requirements RFI
Elyse Summers, J.D.
Acting Director, Division of Education Development OHRP

1:45 pm — 3:15 pm

SACHRP Future Planning

3:15 pm — 3:30 pm


3:30 pm — 5:30 pm

Panel: How to Measure IRB Effectiveness?
Holly Taylor, M.P.H., Ph.D.
Assistant Professor, Johns Hopkins Bloomberg School of Public Health and Core Faculty, Johns Hopkins Berman Institute of Bioethics

Steve Joffe, M.D., M.P.H.
Assistant Professor, Pediatrics, Harvard Medical School
Pediatric hematologist/oncologist, Dana-Farber Cancer Institute (DFCI) and Children's Hospital, Boston

Norm Fost, M.D., M.P.H.
Professor, Pediatrics and Medical History and Bioethics
Director, Program in Bioethics
University of Wisconsin

5:30 pm — 5:45 pm

Public Comment

5:45 pm — 6:00 pm

Wrap-up discussion and Adjourn

Wednesday, July 22, 2009


8:30 am — 8:45 am

Barbara Bierer, M.D.

8:45 am — 9:00 am

Remarks of Acting Assistant Secretary for Health
Howard K. Koh, M.D., M.P.H.

9:00 am — 10:30 am

Report of Subpart A Subcommittee (SAS)
Dan Nelson, M.S., CIP
Elizabeth A. Bankert, M.A.
SAS Co-chairs

10:30 am — 10:45 am


10:45 am — 11:45 pm

Report of Subpart A Subcommittee (SAS), cont'd

11:45 pm — 12:45 pm


12:45 pm — 3:00 pm

Conflict of Interest in Human Subjects Research
Marilyn Field, Ph.D.
Senior Program Officer, Institute of Medicine

Ross McKinney, Jr., M.D.
Director, Trent Center for Bioethics, Humanities, and History of Medicine, Duke University School of Medicine

Guy Chisolm, Ph.D.
Vice Chairman of the Lerner Research Institute of Cleveland Clinic, Director of Cleveland Clinic's Innovation Management and Conflict of Interest Program

Jack Harris, M.D.
Vice President, US Medical Division
Lilly USA, LLC

3:00 pm — 3:15 pm

Public Comment

3:15 pm — 3:30 pm

Wrap-up Discussion and Adjourn