Introduction.

• Author: McDonald, Michael

Jazz great Count Basic often told his band to play the melody "One more time" and on occasion would ask for an additional reprise with the command - "One more, 'One more time'".

Because this is the third special issue of the Health Law Review on the governance of health research involving humans that I have edited, it seems like a case of "One more, "One more time'". The first special issue was published in 2005, the second in 2009 and now the third in 2011. Each of these special issues was the outcome of intensive workshops that brought together experienced scholars and practitioners to reflect on substantive governance issues in Canadian research participant protection. The workshops have been supported by research grants from the Canadian Institutes for Health Research.

My introduction has four sections. In the first, I focus on the process used to create the three special issues. In the second I review the themes identified in the first two workshops and resulting publications. In part three, I offer an overview of the contents of this issue and relate them to the earlier issues. And finally in the fourth, I wish to offer brief concluding reflections and express my appreciation to those who have been part of this collective and sustained dialogue on research ethics in this country.

Part 1: The Network Process

As the convenor and the principal investigator for the grants that supported the workshops, I have two reasons for discussing the process used for creating these three special issues of the Health Law Review. First, this will identify some of the concerns that brought together a highly talented group of experts in research ethics. Second, I think that it is important to share "the recipe" used for generating a significant amount of sustained reflection on important ethical issues in health research. My belief and hope is that others in Canada and elsewhere will share the concerns that led to the Canadian network and take similar steps to spur in depth examinations of important ethical issues in health research and health care.

The initial impetus for bringing together these Canadian experts was in some respects the end result of the process that began with the creation of the first version of the Tri-Council Policy Statement on the Ethical Conduct of Research Involving Humans (TCPS1). (1) To prepare TCPS1, the three research Council presidents appointed various disciplinary experts to the Tri-Council Working Group on Ethics. I was one of those appointed with expertise in ethics. The TCWG worked together productively and skilfully to prepare a unified code of ethics for all research involving humans that in the end was only partially adopted as policy. (2)

My experience on the Tri-Council Work Group on Ethics led me to reflect on the results of this process. On one side the work was creative and productive but on the other side it fell far short of the aspirations set by those of us who were initially involved, I wanted to understand not only what had happened and why there had been this gap between initial efforts and final results, but also to look forward to finding ways of addressing what seemed to me pervasive and serious shortcomings in Canadian participant protection.

At that time the Law Commission of Canada (LCC) was interested in looking at Canadian participant protection from a governance perspective. My sense was that the LCC's interest was in having a sustained examination of a significant area in Canadian life that had complex and messy governance arrangements. Participant protection has those characteristics "in spades" (to use a colloquialism) including a complex mix of federal provincial, commercial, institutional and professional oversight along with major inputs from international agencies and bodies as well as domestic stakeholders and authorities.

I assembled a team with a wide range of legal, medical, social science and bioethical expertise as well as practical and policy experience in participant protection. We prepared a major report for the LCC on Governance for Health Research Involving Human Subjects (3) (hereafter, the LCC Report). The result was the first (and still only) in depth exploration of Canadian oversight of research involving humans. Following the publication of the report, I thought that it would be worthwhile to find other ways of bringing together those who had academic and practical knowledge to explore in greater detail the significant opportunities and challenges for Canadian participant protection in the many biomedical and non-biomedical modalities involved in contemporary health research.

The next opportunity for assembling such a group came as part of a CIHR operating grant. I used this to further advance lines of enquiry suggested in the LCC report. So in the summer of 2004 at Whistler B.C., I brought together a group of individuals drawn from law, bioethics, medicine, and the social and human sciences to explore current challenges in Canadian governance for ethical research involving humans. This resulted in the 2005 special issue of the HLR on this topic.

Participants in "the first Whistler summit on governance" were so enthusiastic about the process followed and results achieved that I was encouraged to submit grant applications for a CIHR Ethics Network grant in 2006. Our first grant application was not successful - in part because the peer review committee felt the area was already well investigated and, strangely enough, because we had too many experts in the area as co-applicants. However, the main point raised was that there were sufficient venues for those in the area to work together without any additional funding since many of the participants already had support from various agencies for particular projects in research ethics.

We took considerable care in addressing this latter point in a second (and successful) application. Our responses to this criticism are worth repeating in this Introduction since they are even more relevant today.

We responded that the venues in which Canadians working in research ethics came together to address issues facing the Canadian system of human research protection were largely limited...