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Article: Ethics review of multi-centre trials: where do we stand?
- Article from:
- Health Law Review
- Article date:
- March 22, 2009
- Author:
CopyrightCOPYRIGHT 2009 Health Law Institute. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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It has been a decade since the Office of the Inspector General, U.S. Health and Human Services (OIG), issued its landmark report, Institutional Review Boards: A Time for Reform. (1) The OIG report talked of major changes in the research environment, with more multi-centre trials (MCTs) and increased commercialization of research. The purpose of this article is to review recent developments in terms of ethics (2) review of MCTs within the Canadian context.
The OIG report described a number of important findings, all of which apply to the Canadian context as well:
* The number of studies reviewed by each REB has increased enormously, without a commensurate ...