From code to policy statement: creating Canadian policy for ethical research involving humans.

• Author: McDonald, Michael

Introduction

While the history of U.S. and international research ethics is well documented, little has been written on the formation of Canadian policy and practice. (2) Most commentary on Canadian policy has centred on content, particularly on gaps and shortcomings. (3) This is an unfortunate situation with both practical and intellectual implications. If Canadians are to understand and assess our policies and practices in this area, it is vital to have a sound historical understanding of our situation. Otherwise policy-making is likely to be erratic and ineffective. Intellectually the history of research ethics has become a subject in its own right. Beyond Canada the lack of a good Canadian history adds to the misperception that all national policies are clones of Belmont. It is vital, then, to have a sound intellectual history of key periods in Canadian research ethics policy.

My intention is to provide a sketch of the formation of the 1998 Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans (TCPS). (4) My primary focus will be on process and contextual elements with less emphasis on content issues. This is in part due to space limitations--each of the multiple content issues deserve detailed treatment in their own right. However, I also believe that what is most lacking at this stage is a discussion of process and context.

I have several reasons for focussing on TCPS. The TCPS is now Canada's policy for research ethics in most of the public research sector even though other policies (particularly ICH-GCP) are also relevant. (5) Moreover, issues arising during the TCPS process continue to this day. This history may also have particular relevance as a new formulation of the TCPS is being advanced for fall 2008, (6) and the Sponsors' Table continues its deliberations on research governance. (7)

The formation of any policy for advancing ethical practice is a complex matter requiring a context sensitive balancing of matters of principle with practical considerations. The challenge is to balance these in a realistic and ethical way. Locating our situation historically helps answer the question of whether a good balance has been struck. In this paper I will first address two questions: what were the circumstances that led to the creation of the TCPS and how was the TCPS created? In the final section I will draw some lessons from this history.

This paper draws on my experience as a member and deputy chair of the Tri-Council Working Group on Ethics (TCWG)--the group that drafted the document (the "Code") that led to the TCPS. I draw also on the subsequent work that my colleagues and I did for the Law Commission of Canada (LCC) and on a CIHR-sponsored study on Canadian governance of ethical health research involving humans and a comparison of US and Canadian governance. (8)

As part of the latter, Dr. Fern Brunger (MUN) interviewed key participants (n=9) in the formation of TCPS. I have also drawn on documentation from the TCWG period and afterwards.

1. Circumstances Leading to the TCWG

   Prior to the TCPS, the key Canadian policies for governing research involving humans were the 1987 Medical Research Council Guidelines on Research Involving Human Subjects (9) and the 1979 Social Sciences and Humanities Research Council Guidelines (10) which originated with Canada Council in 1976. Guy Rocher, who was involved in the Canada Council process, says that the SSHRC Guidelines "did not have much influence on social sciences and humanities researchers, the majority of whom were unaware of their existence, including members of the research ethics committees of Canadian universities. (11) The third federal research council, the Natural Sciences and Engineering Research Council (NSERC), had no guidelines in this area even though it funded research in such sensitive areas as experimental psychology and biomedical devices. (12)

   Closely connected to the MRC and its Guidelines was the National Council on Bioethics in Human Research (NCBHR). NCBHR was an expert group of bioethicists, REB members, and health researchers sponsored by the Royal College of Physicians and Surgeons and the MRC. (13) As will be seen shortly, some members had aspirations to play leadership roles in the creation of national policy, which led to important tensions later. Suffice it to say that MRC tended to view the NCBHR as a support and service organization assisting biomedical REBs. Whereas bioethics members of the NCBHR took the view that they were a national ethics body primarily charged with formulating national policy. The NCBHR did perform both roles including conducting site visits to REBs and producing policy statements on such issues as informed consent and research with children. (14)

   Four sets of factors favoured establishing a single unified policy rather than continuing with separate area-specific policies. First, there were contextual factors that remain relevant today. These include growing global competition in research and development (R & D) with R & D being increasingly seen as a major driver of economic growth and community well-being. As well, there were important new areas of research. For example, within two years of the adoption of the 1987 MRC Guidelines a new set of guidelines had to be created to cover somatic cell gene therapy research. (15) New research tools including computers and biobanks raised important questions about privacy and consent to future unspecifiable use of data. In addition there were new modes of interdisciplinary research that transcended the medical-behavioural divide. This raised the question of whether the MRC or the SSHRC Guidelines were applicable and the prospect that such research would be stymied by discordant rules and REBs. (16)

   Second, there were significant changes in ethical perspectives around human subjects research. In the period following the 1966 publication of Henry Beecher's landmark paper in NEJM, the main task was seen as protecting actual and potential subjects from excessive research risks. (17) By the late 1980s, activists, including feminists and people with HIV or breast cancer, pushed strongly to include disease-specific groups as well as women and children in research so that they might reap the benefits. (18) As well, norms in some areas of research were seen as unsatisfactory or unsettled (e.g., emergency room research and research involving Aboriginal people).

   Third, various international developments favoured a comprehensive re-evaluation of national policy. The US model with the Common Rule based on the Belmont Report had spread world wide. Canada was the largest foreign recipient of NIH funding, (19) Since institutions receiving NIH funding had to provide assurance that US standards were met for NIH projects, there was pressure for harmonizing standards. Indeed, one informant noted that in the 1980s there were informal discussions about bringing Canada's medical research under the US Federal assurance system. This would have involved using the Office for Protection from Research Risks (OPRR). This however raised the acutely embarrassing question of why Canada lacked a domestic system of assurance and how, without one, could the MRC assure the OPRR of Canadian compliance with US rules. There were also important ethical challenges with regard to research in developing countries represented in the 1991 CIOMS Guidelines. (20)

   The fourth set of factors was domestic. The MRC was launched on a trajectory that would eventually lead in 2000 to the establishment of the CIHR--moving from a model supporting basic biomedical research towards one of supporting health research broadly conceived. In 1993 there was the important report of the Royal Commission on New Reproductive Technologies that highlighted ethical and social challenges in a major area of medical research. (21) In 1990 an NCBHR task force headed by T.D. (Douglas) Kinsella revealed significant deficits in human research protection in Canadian medical faculties. (22) The 1986 Supreme Court decision in Eve also raised important question about whether more than minimal risk paediatric research was legally permissible. (23)

   Moreover, by the early 1990s universities were developing a patchwork quilt of local human research protection policies which created new obstacles to multisite research. It also raised a challenge to Canada's three councils--whether researchers at funded institutions would be expected to play by local or national rules. The absence of NSERC from human research protection provisions was clearly anomalous. Finally in the early 1990s, the three councils had developed a uniform policy on research integrity. (24) The moment seemed ripe for the development of a common policy on the ethical conduct of research involving humans.

   Thus, in 1994 the three Council Presidents created the Tri-Council Working Group on Ethics (TCWG) to address these issues. Informants report that at the start there was ambiguity about whether the mandate was to update MRC Guidelines or to do something wider in scope covering research in non-medical as well as medical areas. The group formed was quite interdisciplinary with members drawn from medicine, law, bioethics, biomedical engineering, and the social sciences. (25) The TCWG had the "... mandate to develop new policies and regulation to replace the Councils existing guidelines for research involving humans." (26) The move then was for more prescriptive and enforceable standards to replace current "guidelines".

2. History of the Working Group: the Four Seasons

   In reflecting on the history of the TCWG, the metaphor of the four seasons seems a propos. I was there for summer, fall and winter. My account of spring is drawn from documentation, interviews and discussions with those who were there.

   Spring

   In the "spring" phase which lasted about a year, there were, so to speak, spring showers and even late winter blasts. Fred Lowy, head of the University of...