Résumé
In 1998, the three major government funding Councils put in place the Tri-Council Policy Statement (TCPS) to regulate all research involving humans in Canada funded by them. In this paper, we examine the process of developing the TCPS, a historic and very important document in Canada’s research ethics landscape, and the application of the concepts of democratic legitimacy, transparency, representation, accountability and community engagement in that process. This exercise, important as it is, has been only marginally conducted elsewhere in the past. We attempt to put the process in historical, legal and political context, and argue that efforts were made to ensure basic democratic values in the process, but that these attempts should have been taken farther. The objective of this paper is to highlight the extent to which these values have shaped research ethics policy in Canada and draw lessons for how future policies in this area and other areas that are possibly as contentious may profit from this experience. As this paper was being written, the TCPS was under revision. As the process of drawing up a second edition was ongoing, we also considered, briefly, the direction in which that process appeared headed, and what, if any, lessons could be drawn from the process of putting in place the first edition. The text that follows is current to Fall 2009.
| Langue d'origine | English |
|---|---|
| Titre de la publication principale | International Library of Ethics, Law and Technology |
| Maison d'édition | Springer Science and Business Media B.V. |
| Pages | 133-163 |
| Nombre de pages | 31 |
| DOI | |
| Statut de publication | Published - 2016 |
Séries de publication
| Prénom | International Library of Ethics, Law and Technology |
|---|---|
| Volume | 16 |
| ISSN (imprimé) | 1875-0044 |
| ISSN (électronique) | 1875-0036 |
Note bibliographique
Funding Information:funded by the agencies. It thus applies, indirectly, to research which is funded by other sources, including by private or commercial organisations. The certification process requires the entering into a formal “Memorandum of Understanding” with any of the three funding agencies or all, as the case may be, which requires the institution to comply with the TCPS. 13 In addition, sanctions may be imposed on institutions and researchers who fail to comply with the requirements of the TCPS. 14 Moreover, other funding bodies, including provincial or federal funding bodies, require compliance with the TCPS. These include several Canadian federal government organizations such as the National Research Council Canada (NRC), the Canadian Space Agency, Health Canada and National Defence, provincial funding bodies such as the Nova Scotia Health Research Foundation and the Manitoba Health Research Council. 15
Funding Information:
320). The Natural Sciences and Engineering Research Council (NSERC) had developed no research ethics guidelines, although it had the largest research budget of the three agencies (McDonald 2000, 82; Feminist Health Care Ethics Research Network 1998, 257, note 2). However, research funded by the NSERC was subject to the SSHRC or MRC guidelines, depending on which was most appropriate. 4
Funding Information:
The significance of research ethics in Canada was recognized by the three major funding agencies – the Social Sciences and Humanities Research Council, the Medical Research Council, and the Natural Sciences and Engineering Research Council–when they began a process of developing research ethics guidelines in 1994. That process culminated in the Tri-Council Policy Statement on Ethics in Human Research (TCPS) in 1998. The TCPS has since become the foremost policy guideline for the governance of research involving humans in Canada. The establishment of the TCPS was thus an historic step in Canada’s research ethics landscape, and thus deserves attention. As McDonald points out in the first treatment of this subject (McDonald 2009), it is important to have a sound historical understanding of Canada’s research ethics history, not only for purposes of academic interest, but also to inform future policymaking. McDonald brings an insider’s perspective to the process of creating the TCPS, having served as Deputy Chair of the Tri-Council Working Group—the group that drafted the document which evolved into the TCPS—from 1996 to 1998. In his paper, McDonald calls for more objective discussion and reflection on the process of bringing into being the TCPS (McDonald 2009, at 21).
Funding Information:
The historical and practical importance of the TCPS is further emphasized by the transformation of the Medical Research Council and the National Health Research Development Program (NHRDP) into the Canadian Institutes of Health Research (CIHR). This followed the 1998 work of the National Task Force, comprising leaders in Canadian health research, which found that the health research system was highly fragmented and that a more organized forum for promoting health research was required. It recommended that the government increase funding for health research, and create a modern organization consisting of networks which would fashion an integrated health agenda, bring together all fields of health research and encourage collaborations between these areas and multidisciplinary research (Prescott 1999). The CIHR was created in 2000 by an Act of Parliament (Canadian Institutes of Health Research Act 2000, c. 6), following the federal government’s promise earlier in the 1999 federal budget (Health Canada 1999; Finance Canada 1999; Public Health Agency of Canada Health 1999). One of the main motivations for the creation of the CIHR, then, was to bring together different disciplines which deal with health research. It is also one of its mandates under the CIHR Act. 10 The efforts to enact the TCPS, with its focus on all types of research involving humans, seem therefore prescient. The increase in government funding of health research that has come with the creation of the CIHR also increases the need to ensure high ethical standards for such research. The TCPS provides a policy for the research funded by the CIHR.
Funding Information:
With these guidelines in place, why was there a further move to implement a common ethics policy for research involving humans for the three Councils? Several controversies relating to research involving humans in the immediately preceding years appear to have been contributory. A 1992 incident, where a Concordia University professor murdered four of his colleagues after his complaints to his university of improper scientific conduct in research funded by the NSERC went unheeded, resulted in the Tri-Council Policy Statement on Integrity in Research and Scholarship in 1994 (MRC, NSERC, SSHRC DATE; Adair 2001, 28). 5 This policy required universities to develop procedures to deal with complaints of scientific misconduct (Adair 2001, 28, note 12). This policy paved the way for the three Councils to begin the process of developing a policy for research ethics (Adair 2001, 30). Other incidents of ethical misconduct which took place during this period, including falsifications of patients’ records in a breast cancer study by Roger Poisson, a breast cancer researcher at St. Luc Hospital in Montreal, and other researchers’ use of fraudulent data in several publications, may also have influenced the three Councils to seek a common solution with regards to ensuring high research ethics standards in Canada (Adair 2001, 29; Kinsella 2010; Altman 1994; Angell 1994). A 1994 report by the Royal Commission on New Reproductive Technologies, which recommended legislation to govern certain scientific activities, could also have motivated the decision by the three Councils to put in place a policy, in an attempt to preempt possible legislation on aspects of research involving humans (Kondro 1998 , 1521).
Publisher Copyright:
© 2016, Springer International Publishing Switzerland.
ASJC Scopus Subject Areas
- Biomedical Engineering
- Information Systems
- Public Administration
- Safety Research