Special issue: Canadian governance for ethical research involving humans.

• Author: McDonald, Michael

Dedication

This double issue of the Health Law Review is dedicated to the memory of our friend and colleague T. Douglas Kinsella, CM, MD, FRCP.

Doug Kinsella was a leader in the effort to bring about the reform of Canadian governance for research involving humans. He founded and headed the Office of Medical Bioethics at the University of Calgary and served for years as Chair of the University's Biomedical Research Ethics Board. As a founder of the National Council on the Bioethics of Research Involving Humans he led the first (and only) systematic survey of the treatment of human subjects by those working in Canadian medical schools. (1) In 1994 he became a member of the Tri-Council Working Group on Ethics, which was charged by the Presidents of the Councils with the responsibility of developing "new policies and guidelines to replace the Councils' existing guidelines for research involving humans." (2) It was here that I came to know Doug very well especially as we served as co-members, along with Dr. Jean Joly, of the Working Group's Editorial Committee. I do not believe that the Working Group would ever have completed its task without Dr. Kinsella's insight, determination, and hard work. His deep commitment to the highest principles of accountability and integrity along with the depth of experience he brought as a physician, researcher and bioethicist were essential to the production of the Code of Ethical Conduct for Research Involving Humans. (3)

After we submitted the Code to the Council Presidents, Doug continued his involvement in governance issues. He was a member of my team when we prepared a state of the art assessment of Canadian governance for research involving humans for the Law Commission of Canada. (4) In that report, he wrote about one of his abiding concerns--the role of the physician-researcher and the need for effective governance of physician-researchers whether they were in research institutions or operating within their private offices. (5) In the latter regard, he played a leading part in establishing a Research Ethics Board at the Alberta College of Physicians and Surgeons. To this day, Alberta remains the only province where the provincial regulatory body for physicians has taken effective responsibility for ensuring that all physicians receive the ethical review of research called for in the CMA Code of Ethics. (6)

In 2002, I invited Doug to join the small team that I organized for a research proposal on governance being prepared for CIHR. We were successful in that proposal. With the support from the CIHR one of the major projects we undertook was to bring together scholars interested in the governance of ethical health research involving humans, in order to prepare this special volume of the Health Law Review. We scheduled a meeting for August 2004 at Whistler BC. It is with great sadness that I recall Doug contacting me in May to say that due to serious illness he would be unable to attend. He died on June 15, 2004.

So it is to the memory of Dr. T. Douglas Kinsella that we dedicate this publication. We are confident that the theme of this special issue reflects a central concern of his professional career as a physician, medical researcher, and bioethicist.

Introduction

In August 2004 with the help of research funding from CIHR, I brought together the individuals who have contributed to this issue as well as others who were part of the discussion. Because we met in Whistler, British Columbia, we playfully described ourselves as "the Whistler Summit on Governance." We were a multi-disciplinary group with a wide range of perspectives on research ethics. Some of us have been intimately involved in the formation of policy at the international and national levels. Many of us have written on this subject matter before. Others were new to the area.

We came together with the following objectives:

* To consider the positive and negative features of current governance in Canada for research involving humans

* To propose new directions for such governance in areas identified at the workshop

* To produce articles on this topic for publication in a special issue of the Health Law Review

* To offer useful insights for those making or influencing policy in this area.

For several days we engaged in a remarkably open dialogue around governance issues. We asked ourselves about what was necessary for the effective and accountable governance of ethical health research involving humans. We asked why governance (in Canada and elsewhere) had taken the shape it had--relying almost solely on the front-end application of guidelines for health research by ethics committees--but seriously lacking with respect to key criteria of independence, effectiveness, and accountability. (7) We questioned these developments and sought to articulate practical alternatives. These ranged from complete overhaul of the current system to more localised (but still significant) partial reforms. The discussion was intense but highly amicable. We learned greatly from each other.

We readily recognize that the topic of this issue is large and complex with diverse aspects--legal, social, cultural, political, economic and ethical. Thus, in their article "A Cultural Understanding of Research Ethics Governance," Burgess and Brunger state:

All uses of power in relation to research constitute the field of governance of research ethics. All parties who influence research through their various forms of power (legal, bureaucratic, financial, rhetorical, etc.) will have inevitable influence on the standards and practices of research and research ethics. Explicitly powerful forces such as industry can be negative or positive in terms of how they promote, or are antithetical to, the goals of research ethics. Research ethics itself--its definition, its purpose, its process--is also shaped by cultural, political and economic forces. In the papers that follow we take up various aspects of governance and examine a series of important topics including the conduct of clinical trials, information data-bases, and many other issues. As Guest Editor, I have grouped the papers under four headings:

1. The legal context of governance

2. Clinical trials

3. The social and cultural context of governance

4. Reforming governance

   Common Themes

   While each of the authors is responsible for his or her views, I think that it is fair to say that our discussion at Whistler reflected a number of common concerns which I would formulate as follows.

   First, research involving humans is not a right but a privilege. The privilege of conducting research on human subjects requires meeting basic norms. These are reflected in major statements of ethical conduct of research involving humans. They include respect for human dignity, honouring informed consent, ensuring that subjects do not face excessive risk, sound research with overall potential benefit...