Agenda: Central/Regional versus Local Review Mechanisms and Action to Improve Human Protections
June 26, 2003
9:00 am Introduction: Goals for the day and new members
Queta Bond, Ph.D.
Chair, Clinical Research Roundtable
President, Burroughs Wellcome Fund
9:30 Problems and proposed solutions for research oversight
Anne Wood, MA
National Human Genome Research Institute
10:00 Break
10:30 Central Review Mechanisms (15 minutes each)
Eileen Hilton, M.D.
Chief Executive Officer
Biomedical Research Alliance of New York, LLC (BRANY)
Daniel Schuster, M.D.
Director, Center for Clinical Studies
Washington University School of Medicine
Multicenter Academic Clinical Research Organization (MACRO)
Jaci Goldberg, JD
Administrator, Central Review Board
Cancer Therapy Evaluation Program (CTEP)
National Cancer Institute
Duane T. Smoot, M.D., FACP, FACG
Professor and Chief, Gastroenterology Section
Department of Medicine
Howard University College of Medicine
11:30 ROUNDTABLE DISCUSSION
12:00 Lunch
1:00 Central review perspectives - implementation of CIRB
Cara Laubach
Regulatory Coordinator, Washington Cancer Institute
MedStar Research Institute
1:15 Central review perspectives - survey results
Eva Loh, Ph.D.
Staff Associate
Association of American Medical Colleges
1:45 Steps to improve the risk environment associated with human protections a CRO perspective
Doug Peddicord, Ph.D.
Legislative Director
Association of Clinical Research Organizations
2:10 Steps to improve the risk environment associated with human protections an industry perspective
Janet Keyser
Senior Director of Worldwide Clinical Quality Assurance and Research
Merck & Co., Inc.
2:35 Steps to improve the risk environment associated with human protections an academic perspective
Robert Bishop, J.D.
Associate General Counsel
University of Arkansas
College of Medicine
3:00 Break
3:15 IOM recommendations to reform the system - key action needed
Fran Visco, J.D.
President, National Breast Cancer Coalition
Member, Committee on Assessing the System for Protecting Human
Research Participants
Robert M. Nelson, M.D., Ph.D.
Associate Professor, Department of Anesthesia and Critical Care Medicine
Children's Hospital of Philadelphia
Member, Committee on Clinical Research Involving Children
3:45 Discuss approaches for OHRP to promote use of streamlined mechanisms
Bernard Schwetz, D.V.M., Ph.D. (Moderator)
Acting Director
Office for Human Research Protections
Senior Advisor for Science
U.S. Food and Drug Administration
4:15 Discuss approaches for FDA to promote use of streamlined mechanisms
Joanne Rhoads, M.D., M.P.H. (Moderator)
Director, Division of Scientific Investigations
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
5:45 Adjourn
June 27, 2003
8:30 am Basic versus Applied Research: Five easy questions
Jessie Gruman, Ph.D.
President, Center for the Advancement of Health
Sharon Begley
Science Editor, Wall Street Journal
9:15 Funding of Evaluative Research
Joel Kupersmith, MD
Scholar in Residence
Board on Health Sciences Policy
Institute of Medicine
10:30 Break
10:45 Identifying Roundtable and Member action: public engagement
Fran Visco, J.D.
President
National Breast Cancer Coalition
Susan Weiner, Ph.D.
President
The Children’s Cause, Inc.
12:00 Lunch
1:00 Identifying Roundtable and Member action: workforce and career development
Harold Slavkin, D.D.S.
Dean
University of Southern California
School of Dentistry
Nancy Sung, Ph.D.
Program Officer
Burroughs Wellcome Fund
2:00 Adjourn
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