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Biomedical Ethics Seminar Series
 Back to Calendar 2007

Wednesday, June 20, 2007

Topic: New Rules for Clinical Trials: Good or Bad News?
Presenters:
Michael P. Caligiuri, Ph.D., Professor and Director,
Clinical Research Protections Program
and
Michael Kalichman, Ph.D., Dept. of Pathology and Director,
Research Ethics Program
Location: Medical Teaching Facility (MTF) 175
Presentation
Abstract:
The Association of American Medical Colleges' (AAMC) recent report, Principles for Protecting Integrity in the Conduct and Reporting of Clinical Trials, grew out of an invitational conference in June of 2005. The conference produced a set of principles and standards meant to address public concerns about access to complete and timely reports on clinical trial results, particularly when trials are industry-sponsored.

The AAMC document (available below) describes new guidelines as of 2006. Although such guidelines are not binding, they serve as a useful starting point to ask the following questions:
   (1) What is required?
   (2) Why is it required?
   (3) Are we meeting the letter and spirit of those requirements?
   (4) What more, if anything, should we be doing?
Summary:
Readings: