Introduction.

• Author: McDonald, Michael

This special issue of the Health Law Review is a product of the Canadian Network for the Governance of Ethical Health Research Involving Humans. The Network held a four-day retreat in July 2008 at the University of Victoria's Dunsmuir Lodge Conference Centre. Twenty-two participants met in plenary sessions to identify major issues and develop themes for network discussion, investigation and action. As the meeting progressed, writing groups coalesced around important topics. Many of the resulting papers appear in this issue. Still other papers are in process for later publication. One topic--the summer 2008 U.S. Government withdrawal from the Declaration of Helsinki and the significant implications this has for human subject safety in other countries including Canada--was identified as so urgent that it was sent to The Lancet where it appeared as an invited comment in January of this year. (1)

In this introduction, I describe the context, origins and objectives of the Governance Network. Next I outline ideas and concerns identified at our first meeting. Finally, I offer an overview of the contents of this issue as well as the process used in producing it.

The Governance Network

The Network is supported by a three-year Ethics Network Grant from the Canadian Institutes of Health Research (CIHR). The grant's title is the "Canadian Network for the Governance of Ethical Health Research Involving Humans: Evidence, Accountability and Practice."

The Network's origins come from a group that we dubbed the "Whistler Summit." The Summit was supported by my CIHR Operating Grant. That group produced the special double issue of the Health Law Review in 2005. (2) Several participants in the Whistler Summit along with others put forward the Network application. The applicants include a wide range of individuals from across Canada involved in the practice and study of research ethics as well as collaborating organizations and international scholars.

In our Network proposal, we described an important shift in scholarship on research ethics:

... since the late 1960s ... research in this area was cast primarily in regulatory terms involving critical scrutiny of (mainly) biomedical research practices and the development of prophylactic professional, national and international standards. In recent years, a small group of researchers including the applicants have shifted from this mainly regulatory orientation to one that is more performance-oriented, e.g., what actually does REB review accomplish, what is the extent of individual and institutional conflict of interest in drug approval testing, and what do research subjects actually experience and want? (3) We linked these developments to increasing concerns about governance "in particular (for) the structural and systemic requirements for ensuring unbiased high quality research along with effective and reliable human research protection." (4) We also noted "a national concern and desire to develop an effective evidence-based best-practice approach to human research protection, addressing our uniquely Canadian circumstances and challenges while benchmarking these circumstances and challenges against international experiences." (5) We argued that these factors have fuelled the emergence of evidence-based approaches to research ethics. Of course, this does not mean that the study of regulations and norms is unimportant. It is rather that there is a need for complementary empirical enquiries.

For the Network we identified six objectives:

1. Bring together established and new researchers working on evidence-based approaches to human research protection;

2. Link potential producers and users of such research to find collaborative ways of moving from research to practice/policy and back;

3. Establish appropriate engagement of clinical research participants/subjects as stakeholders;

4. Develop Canadian capacity in research ethics and governance;

5. Inform and influence policy relevant to the Canadian situation; and

6. Create a permanent national network in this area

In our 2008 meeting at Dunsmuir we took significant steps towards reaching these objectives.

Dunsmuir Retreat

The 2008 retreat included most of the Network applicants along with other academics interested in this area. Participants represented a wide range of disciplines including medicine, nursing, law, social sciences and the humanities. (6) Both well-established and new practitioners and scholars in research ethics and governance participated. Most retreat participants (and Network applicants) have served on domestic, foreign or international policy advisory groups on research ethics. (7) Many are or have been members of institutional, professional, national and international research ethics boards (REBs)--many as chairs or founding members. As well, most are extensively involved in research ethics education across a wide range of academic and clinical contexts.

At the retreat our concern was with the governance of ethical health research involving humans. This includes research across the four pillars of health research. (8) That is, our concerns extend to biomedical and social science research (including ELSI type research) as well as to basic health-directed scientific research. (9) In our view "research ethics governance" means more than regulations (e.g., Division 5 of the Food and Drugs Act, various privacy...