Warwick New York Hotel
65 W. 54th Street
New York, NY 10019
Wednesday, May 18
9:30 – 9:45 a.m. Welcome and Opening Remarks
Amy Gutmann, Ph.D.
Commission Chair
James Wagner, Ph.D.
Commission Vice-Chair
9:45 – 10 a.m. Executive Director's Report
Valerie H. Bonham, J.D.
Executive Director
10 – 10:30 a.m. Session 1: Federal Standards - Introduction
Christine Grady, R.N., Ph.D.
Commission Member
10:30 – 10:45 a.m. Break
10:45 – 11:45 a.m. Session 2: Implementing Federal Standards
Connie Celum, M.D., M.P.H.
Professor of Medicine
Professor of Global Health
Adjunct Professor of Epidemiology
Director, International Clinical Research Center, Department of Global Health
University of Washington
David A. Borasky, Jr., M.P.H., C.I.P.
IRB Manager
Office of Research Protection
RTI International
Sergio Litewka, M.D., M.P.H.
International Programs Director
Research Assistant Professor
University of Miami Ethics Programs
11:45 a.m. – 1:15 p.m. Lunch Break
1:15 – 2 p.m. Session 3: Implementing Federal Standards – International Efforts
Murray M. Lumpkin, M.D., M.Sc.
Deputy Commissioner for International Programs
U.S. Food and Drug Administration (FDA)
Jerry Menikoff, M.D., J.D.
Director, Office for Human Research Protections
U.S. Department of Health & Human Services
2 – 2:45 p.m. Session 4: Implementing Federal Standards – Ethics Issues
Ronald Bayer, Ph.D.
Professor and Co-Chair, Center for the History and Ethics of Public Health
Mailman School of Public Health
Columbia University
Joseph J. Fins, M.D., F.A.C.P.
E. William Davis, M.D., Jr. Professor of Medical Ethics
Chief, Division of Medical Ethics
Professor of Medicine, Professor of Public Health, and Professor of Medicine in Psychiatry
Weill Cornell Medical College
2:45 – 3:45 p.m. Session 5: Roundtable
3:45 – 4 p.m. Break
4 – 4:45 p.m. Session 6: Public Comment
4:45 – 5 p.m. Closing Remarks
Amy Gutmann, Ph.D.
James Wagner, Ph.D.
Thursday, May 19
9 – 9:05 a.m. Opening Remarks
Amy Gutmann, Ph.D.
James Wagner, Ph.D.
9:05 – 10:30 a.m. Session 7: Transnational Standards
John R. Williams, Ph.D.
Consultant, World Medical Association (WMA)
Adjunct Professor, Department of Medicine
University of Ottawa
Adjunct Research Professor, Department of Philosophy
Carleton University (Ottawa)
Johannes J. M. van Delden, M.D., Ph.D.
President, Council for International Organizations of Medical Sciences (CIOMS)
Professor of Medical Ethics
Utrecht University Medical Center
Dafna Feinholz, Ph.D.
Chief of the Bioethics Section
Division of Ethics of Science and Technology
Sector for Social and Human Services
United Nations Educational, Scientific and Cultural Organization (UNESCO)
Francis P. Crawley
Executive Director, Good Clinical Practice Alliance – Europe (GCPA)
10:30 – 10:45 a.m. Break
10:45 – 11:30 a.m. Session 8: European Perspectives
Linda Nielsen, J.D.
Vice President, European Group on Ethics in Science and New Technologies (EGE)
Professor of Global Law and Governance
University of Copenhagen, Denmark
Maurizio Salvi, Ph.D.
Policy Advisor (Ethics) to the President of the European Commission
Head of the EGE Secretariat
Member of the Bureau of European Policy Advisors (BEPA)
11:30 a.m. – 12:30 p.m. Session 9: Roundtable
12:30 – 12:45 p.m. Concluding Remarks
Amy Gutmann, Ph.D.
James Wagner, Ph.D.
