Monday, 18 August 2003: 09:00-10:30
Erie Room (Sheraton Hotel and Towers)

S001 Ethical Issues in Cutting Edge Research: The Role of Research Monitoring Boards

Ethical Issues in Cutting Edge Research: The Role of Monitoring Boards This symposium on real-time monitoring boards will have two parts. First, three speakers from the United States will set the stage, bringing to bear their diverse experiences to raise arguments for and against real-time monitoring by research review boards. The first two speakers will discuss such boards in terms of four questions: why we should have them; when they should be used; what they should do; and who should serve on them. The third speaker will discuss research in vulnerable populations in particular, exploring what the right balance is between protecting human subjects and making progress in research. The second main part of the symposium will consist of an internationally diverse panel that will react to the material presented by the speakers and indicate briefly how review boards function in their countries. If there are no such boards, they will discuss whether they would like to continue the status quo or not, and why. Representatives from Australia, England, Japan, and Korea have been recruited. The commentators will also include a community member among the panelists, someone familiar with clinical trials in the United States from the patientís vantage point; and someone from the pharmaceutical industry, whose perspective we also seek. Time will be allotted for discussion with the audience. The purpose of the symposium is to stimulate thought, and possibly action. Attending to the balance between protection and progress is essential for the integrity of research, as well as the continued support of the public.
Chairs:Lissy F. Jarvik
Henry Brodaty
 S001-001 Research Monitoring Boards in the United States: An Overview
Elyn Saks
 S001-002 The Case for Real-Time Monitoring of Clinical Trials
Lissy F. Jarvik
 S001-003 Research on Vulnerable Populations: Striking the Right Balance of Protection and Progress
Greg A. Sachs
 S001-004 Responder
Alistair Burns
 S001-005 Responder
Byoung-Hoon Oh
 S001-006 Responder
Brian Draper
 S001-007 Responder
Caryn Berman
 S001-008 Responder
Vinod Kumar
 S001-009 Responder
Masatoshi Takeda

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