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The Department of Health and Human Services
Meeting of the
Secretary's Advisory Committee on Human Research Protections (SACHRP)
Thursday, March 29-Friday, March 30, 2007
The Sheraton National Hotel
900 South Orme Street, Arlington, Virginia
DRAFT AGENDA
Thursday, March 29, 2007
8:30 am - 8:45 am |
Welcome: Opening Remarks
SACHRP Chair
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8:45 am - 9:00 am |
Report of Issues
Bernard Schwetz, D.V.M., Ph.D.
Director, OHRP
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9:00am - 9:15 am |
Swearing-In of new members
Deborah Wise
HHS/RHRC
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9:15 am - 10:30 am |
Report of Subpart A Subcommittee
Felix Gyi, M.B.A., Pharm.D.
Dan Nelson, M.S., CIP
Co-Chairs
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10:30 am - 10:45 am |
BREAK |
10:45 am - 12:15 pm |
Subpart A Subcommittee |
12:15 pm - 1:30 pm |
WORKING LUNCH
Ethics Training
John Condray
Office of General Council
HHS
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1:30 pm - 2:30 pm |
Report of Subcommittee on Issues Impacting those with Impaired Decision-Making Capacity
David Strauss, M.D., Co-Chair
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2:30 pm - 2:45 pm |
BREAK |
2:45 pm - 4:30 pm |
Panel on Issues Impacting those With Impaired Decision-making capacity
David Rothman, Ph.D.
Professor of Social Medicine of History
College of Physicians and Surgeons
Columbia University
John Luce, M.D.
Professor of Medicine
University of California at San Francisco
Scott Kim, MD., Ph.D.
Bioethics Program
University of Michigan
Laura Odwazny, Senior Attorney
Office of General Counsel,
Department of Health and Human Services
David Strauss, M.D., Panel Moderator
New York State Psychiatric Institute
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4:30 pm - 4:45 pm |
Public Comment |
4:45 pm - 5:15 pm |
Wrapup and adjourn |
Friday, March 30, 2007
8:30 am - 8:45 am |
Remarks
SACHRP Chair
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8:45 am - 9:45 am |
Remarks
John Agwunobi, M.D.
Assistant Secretary for Health
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9:45 am - 11:00 am |
Discussion on Conflict of Interest Among IRB members
Leslie Wolf, J.D.
University of California at San Francisco
Marjorie Speers
Executive Director
Association for the Accreditation of Human Research Protection Programs
Ernest Prentice, Ph.D.
Associate Vice Chancellor for Academic Affairs and Regulatory Compliance
University of Nebraska
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11:00 am - 11:15 am |
BREAK |
11:15 am - 12:30 pm |
Panel on Investigator Responsibilities/
Training and Certification
Ivor Pritchard, Ph.D.
Office for Human Research Protections
Ron Keeney
Vice President
Pediatric Product Development
INC Research
Erich Lukas
Executive Director
Society of Clinical Research Associates (SoCRA)
Christine Pierre, R.N.
President and CEO
Rx Trials, Inc. and
Chair, Association of Clinical Research Professionals (ACRP)
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12:30 pm - 1:30 pm |
LUNCH |
1:30 pm - 3:00 pm |
Discussion of Investigator Training and
Certification
Linda Tollefson, D.V.M., M.P.H.
Assistant Commissioner for Science,
FDA
Jean-Louis Saillot, M.D.
Vice President, Immunology Department,
Global Project Management,
Schering-Plough Corp.
Chris Pascal, J.D.
Director,
Office for Research Integrity
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3:00 pm - 3:15 pm |
BREAK |
3:15 pm - 3:30 pm |
Public Comment |
3:30 pm - 4:00 pm |
Wrapup and adjourn |
Final agenda
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