Summer/Fall 1999

ORIGIN AND DEVELOPMENT OF THE TRI-COUNCIL POLICY STATEMENT ON THE ETHICS OF RESEARCH INVOLVING HUMANS
by Guy Rocher, Centre for Research in Public Law, Faculty of Law, University of Montreal

he notion that there should be ethical standards for research involving humans first arose with regard to medical research. In the social sciences and humanities, this concern developed slowly and fairly late. In the post-war years, up until the 1970s, we researchers in the social sciences and humanities had no sense of there being ethical problems of this kind. Our ethical problems had to do primarily with the moral standards of all research and, to a fairly limited extent, the confidentiality of the documents kept in our researchers’ files.

I was vice-chairman of the Canada Council for the Arts from 1969 to 1974, a time when that Council had the dual responsibility of allocating grants both to the arts community and for research in the social sciences and humanities. Back then, we had developed some ethical principles to which we drew the attention of researchers in the social sciences and humanities. In practical terms, these principles were presented as appendices to the guidelines to be followed by applicants for Council grants. But these principles had no constraining authority; Council management never ensured that they were adhered to. Moreover, I am convinced that these appendices were the section of the guidelines that received the least attention from applicants.

The Social Sciences and Humanities Research Council broke away from the Canada Council in 1976. As of 1977 — and I could not say what inspired or motivated this — SSHRC published what it called Ethics Guidelines for Research with Human Subjects (in French: Code déontologique de la recherche utilisant des sujets humains), which, if you took the trouble to note, were in fact merely a compilation of the former appendices of the guide- lines. The "Guidelines" therefore contributed nothing new, and I must say they did not have much influence on social sciences and humanities researchers, the majority of whom were unaware of their existence, including mem- bers of the research ethics com- mittees of Canadian universities.

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The 1980s and 1990s would, however, mark a gradual change in attitudes. The participation of humans in an ever-growing number of medical and other research projects seemed increa- singly problematic. The question was raised seriously in the United States; in Canada, the 1982 Charter of Rights and Freedoms added a further dimension to the issue. It was in the wake of this, through a joint initiative of the Royal College of Physicians and Surgeons of Canada and the Canadian Government, that the National Council on Bioethics in Human Research was created. But having personally been a member of this Council from 1991 to 1994, I must say that the ethics of social sciences and humanities research had no place on it at that time. Moreover, almost all its members were from the medical com- munity.

And yet, from early 1990, there was a growing questioning of the disparity between ethical stan- dards in medical research and those in social sciences and humanities research. The plan for a single set of guidelines for all researchers began to gain ground. At that same time, the presidents of the three organizations, breaking a long tradition of mutual isolation, decided to meet more often and exchange views. It was then that the plan for a single code of ethical conduct first took shape in 1994, with the creation of a working group mandated for this purpose.

Besides these meetings of the presidents, I feel that three reasons motivated the decision to undertake such a project.

1. A growing number of social sciences researchers were involved in projects in the medical community as co-researchers or contributors: sociologists, anthropologists, demographers, researchers in administration. The disparity in ethical standards seemed blatant and was becoming particularly awkward.
2. Locally, the research ethics committees in each university also found themselves faced with the problem of evaluating research projects in light of very different standards, depending on whether the projects came within the purview of the MRC or SSHRC.
3. Aside from these two practical considerations, the academic community increasingly felt the need for broader and deeper reflection about the ethics of research involving humans — reflection which would be based on fundamental principles and would involve, as much as possible, the entire community of Canadian researchers.

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The desire to develop a single set of guidelines meant undertaking a process full of pitfalls and of uncertain outcome: we knew this from the outset. But I think that the undertaking was even more difficult than anticipated; it was a long and arduous process, which lasted for four years.

In actual fact, the document underwent four successive writings (or, more precisely, four published versions, not counting outlines and drafts): • a so-called issues paper, published in November 1994;

• an initial draft of the Guidelines, published in May 1996;
• a second draft of the Code of Ethical Conduct, published in July 1997;
• finally, the Policy Statement, official since August 1998.

In between versions, three general consultations, open to all Canadian researchers, were held:

• on the issues paper, in 1995-1996;
• on the draft Guidelines, in 1996-1997;
• on the draft Code, in 1997.

This does not include the numerous formal and informal consultations with learned societies, the Canadian Association of University Teachers, the Humanities and Social Sciences Federation of Canada, women’s organizations, and many individual researchers.

As a result of these various consultations, the document in preparation evolved quite substantially from its first formulation to the Policy Statement. It evolved in at least three directions:

• initially strongly marked by philosophical reflection, it became much more pragmatic;
• efforts were made to eliminate as much of the overly legalistic wording of the Code as possible;
• attempts were made to make it a document which, while unique, could be adapted for diverse applications.

Having evolved considerably over the four years of its development, the Policy Statement will no doubt continue to evolve. It can be said that, for now, it is temporarily final. Committed reflection continues. Criticism of the document will continue. And some parts are still openly uncompleted, in particular Section 6, "Research Involving Aboriginal People". This section, which has been drafted and revised several times, is finally down to a simple rough draft, awaiting the results of consultations with Aboriginal Peoples.

The original main objective has been achieved: there is now a single Policy Statement, the fruit of intense consultation. Several times, this Policy Statement nearly failed to materialize: at times, it was feared the views of the three Councils would be impossible to reconcile. The existence of such a document seems to me to be essential, but there is no doubt that the wording of some sections has yet to be revised.