The Regulation of Research Review:
A Comparative International Workshop

June 16-18, 2005

Faculty of Law,
University of Toronto

By invitation only

Biomedical research is now a global enterprise. Industry, national funding agencies and non-governmental organizations sponsor research locally and overseas, and researchers are increasingly involved in research outside their home state. While research activities, in particular clinical trials, have significantly increased in countries all over the world, they  have proportionally increased even much more in countries in the Southern global regions. These trends have already attracted much attention. Concerns have been expressed about the variability of standards and regulatory structures that have been implemented to protect human subjects, to promote research integrity, and to stimulate a fair distribution of the benefits of research. There is a need for a systematic and comparative analysis of the role and of regulatory and legal means and their contribution to achieving these goals. Accordingly, the role of law and regulation in research and research ethics review is the main focus of our invitation-only Workshop, to be held June 16-18 at the Faculty of Law.

"The Regulation of Research Review: A Comparative International Workshop" brings together experts on legal and regulatory issues in biomedical research from selected representative countries in the Northern and Southern hemispheres, and representatives from international organizations such as the Council for International Organizations of Medical Science and the World Health Organization. The goals of the workshop are to discuss various legal, ethical and regulatory challenges in the context of international biomedical research.

The Workshop is part of a project on "International and Comparative Perspectives on Research Regulation of Genomics Research", funded by Genome Canada. The project is led by Professor Trudo Lemmens. Co-investigators and scientific advisors on this initiative include Professor Bernard Dickens, Professor Dominique Sprumont, Dr. James Lavery, Mr. Sev Fluss and Dr. Solomon Benatar. Tom Archibald coordinates the project and administrative assistance is provided by Linda Hutjens.

Workshop Themes

  1. Research Ethics Review Structures: International Comparisons
  2. Research Ethics Committee Oversight: Accreditation v. Direct Regulation
  3. Commercialization, Research Ethics and REC Independence: Open Discussion
  4. Specialized Review Bodies: Recent Initiatives, Future Possibilities
  5. Specialized Review Bodies for Public Health Research: Open Discussion
  6. Research Ethics Review: The Role of International Bodies
  7. International Instruments: Conventions & Declarations v. Legislation & Directives
  8. Promotion of Equitable Research Practices
  9. Liability in the Context of Research Review