Welcome and Opening Remarks

Amy Gutman, Ph.D.
Commission Chair
James Wagner, Ph.D.
Commission Vice-Chair

Executive Director’s Report

Valerie H. Bonham, J.D.
Executive Director

Session 1: Federal Standards – Introduction

Christine Grady, R.N., Ph.D.
Commission Member

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

Session 2 Q & A

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

Session 3 Q & A

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

Session 4 Q & A

Session 5: Roundtable

Session 6: Public Comment

Opening Remarks

Amy Gutmann, Ph.D.
James Wagner, Ph.D.

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)

Session 7 Q & A

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)

Session 8 Q & A

Session 9: Roundtable

Concluding Remarks

Amy Gutmann, Ph.D.
James Wagner, Ph.D.