The Regulation of Biomedical Research Experimentation in Canada: Developing an Effective Apparatus for the Implementation of Ethical Principles in a Scientific Milieu
46 Pages Posted: 11 Jan 2016
Date Written: 1997
Although there appears to be an emerging international consensus as to the general nature of the basic ethical principles that should guide the conduct of biomedical experimentation with human subjects, a debate exists in relation to the critical question of exactly how these principles should be implemented in practice. Among the key concerns of this debate are whether biomedical experimentation should be regulated, in whole or in part, by legislation or whether control of the research enterprise should be left primarily in the hands of the granting agencies, universities, the medical profession and researchers themselves through a process of self-regulation.
This article addresses the fundamental question of how biomedical experimentation should be regulated in the Canadian context. The authors discuss the social control of biomedical experimentation in the context of the range of alternative regulatory mechanisms, the existing structure of research review, and the central role of the Research Ethics Board (REB) in the United States, the United Kingdom and Canada, with a focus on reforming the regulatory system in Canada.
The authors recommend that the various provinces and territories of Canada enact legislation that unequivocally establishes the authority of REB's to review all research protocols involving biomedical experimentation with human beings. Such legislation should emphasize that it is an offence to conduct experimentation without the prior approval of a local REB, and should articulate general rules governing the conduct of researchers.
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