Regulating ethical research: Canadian developments

Abstract

The Canadian experience and current trend in research ethics regulation provides a useful model for consideration by other jurisdictions, including Australia. The creation of the Canadian Institutes of Health Research and recent amendments to federal Canadian regulations governing clinical trials should provide the impetus for implementation of much-needed reforms in the oversight of research activities. It is submitted that existing legal structures in Canada are inadequate, which the regulations go partway to solve. Further reforms must be undertaken in order to provide a uniform system of ethical governance and to protect properly human research subjects across Canada, regardless of whether funding derives from public or private sources. A set of five criteria is proposed as essential precursors to the implementation of an effective regulatory framework that would respond to these concerns.