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The Tunnel at the End of the Light? A Critical Analysis of the Development of the Tri-Council Policy Statement

Published online by Cambridge University Press:  02 January 2013

Cheluchi Onyemelukwe  and
Jocelyn Downie
Cheluchi Onyemelukwe
Affiliation:
Schulich School of Law, Dalhousie University, Halifax, NS B3H 4H9,Canada, E-mail: conyemel@dal.ca
Jocelyn Downie
Affiliation:
Schulich School of Law, Dalhousie University, Halifax, NS B3H 4H9, Canada
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Abstract

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 conducted at institutions funded by the councils. This article examines the process of developing the TCPS, a historic and very important document in Canada's research ethics landscape, and the application of the democratic values of legitimacy, transparency, representation, accountability, and community engagement in that process. The authors argue that efforts were made to ensure basic democratic values in the process but that these attempts should have been taken farther. This examination is a timely exercise in light of the new draft now being prepared to replace the current version of the TCPS. The authors also consider this ongoing process of establishing a new edition and reflect on lessons to be learned.

Résumé

En 1998, les trois conseils subventionnaires fédéraux publiaient l'Énoncé de politique des trois Conseils (EPTC) afin de réglementer toute recherche canadienne avec des sujets humains effectuée dans des institutions financées par ces organismes. Dans cet article, nous examinons le processus d'élaboration de l'EPTC, un document historique très important en matière d'éthique de la recherche au Canada, ainsi que l'application de certaines valeurs démocratiques dans ce processus, à savoir la légitimité, la transparence, la représentativité, l'obligation de rendre compte et l'engagement communautaire. Bien que des mesures ont été prises afin d'assurer la présence de certaines valeurs démocratiques fondamentales dans ce processus, de telles valeurs auraient put être présentes davantage au sein de l'EPTC. Cette constatation est importante, d'autant plus qu'une nouvelle ébauche de l'EPTC viendra bientôt remplacer la version actuelle. De plus, nous examinons le processus d'élaboration d'une nouvelle version et soulignons les leçons à retenir.

Keywords

democracydemocratic valuesresearch ethics policypolicy-making processTri-Council Policy Statementdémocratievaleurs démocratiquespolitique relative à l'éthique de la rechercheprocessus d'élaboration des politiquesÉnoncé de politique des trois Conseils
Type
Research Article
Information
Canadian Journal of Law and Society / La Revue Canadienne Droit et Société , Volume 26 , Issue 1 , April 2011 , pp. 159 - 176
Copyright
Copyright © Canadian Law and Society Association 2011

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References

1 Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (1998) [TCPS 1998]Google Scholar.

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3 Perry, Laura B., “Education for Democracy: Some Basic Definitions, Concepts, Clarifications,” in International Handbook on Globalisation, Education and Policy Research, ed. Zajda, J. (Dordrecht: Springer, 2005), 687Google Scholar. There are other key concepts, such as equality and choice, but all of these are linked fundamentally to the right to participate in decision making.

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5 Obviously there is much debate as to what these are. Given space constraints, we can hope neither to do justice to that debate nor to present a full defense of the values we use in our analysis. Rather, we stipulate the values of legitimacy, transparency, representation, accountability, and community engagement and refer the reader to the literature cited in the article for the defence.

6 For examples of some issues on which consensus has emerged and on which there are still conflicting opinions in clinical research see Brody, Baruch A., McCullough, Laurence B., and Sharp, Richard R., “Consensus and Controversy in Clinical Research Ethics,” (Journal of the American Medical Association 294 (2005), 1411CrossRefGoogle ScholarPubMed. See generally Brouillet, Miriam and Turner, Leigh, “Bioethics, Religion, and Democratic Deliberation: Policy Formation and Embryonic Stem Cell Research,” HEC Forum 17, 1 (2005), 49CrossRefGoogle Scholar; Kim, S. et al. , “Assessing the Public's Views in Research Ethics Controversies: Deliberative Democracy and Bioethics as Natural Allies,” Journal of Empirical Research on Human Research Ethics 4, 4 (2009), 3CrossRefGoogle ScholarPubMed.

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10 Feminist Health Care Ethics Network, The Politics of Women's Health: Exploring Agency and Autonomy (Philadelphia: Temple University Press, 1998), 234Google Scholar. Although it was the intention to create a “code,” the document that emerged became a “policy statement.” For the reasons see McDonald, , “From Code to Policy Statement,” 17Google Scholar.

11 Tri-Council Working Group on Ethics, Code of Conduct for Research Involving Humans [final version] (Ottawa: Minister of Supply and Services, 1997)Google Scholar, http://www.ethics.ubc.ca/code/july97/j97-1.pdf [Working Group Code]

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13 See, e.g., Palys, Ted S., “The Ethics of Ethics: Comments Regarding the Tri-Council Working Group's March 1996 Draft Code of Conduct for Research Involving Humans” (1996)Google Scholar, http://www.sfu.ca/~palys/codecomm.htm.

14 Indeed, they have explicitly done so. For instance, in December 2009, the president of CIHR publicly expressed the position that CIHR should align its agenda and vision with industry: Beaudet, Alain, Testimony before the federal Standing Committee on Health, 40th Parl, 2nd Sess (30 November 2009)Google Scholar, http://www2.parl.gc.ca/HousePublications/Publication.aspx?Docld=4275165&Language=E&Mode=1&Parl=40&Ses=2#Int-2984056. See Steven Lewis, “Neoliberalism, Conflict of Interest, and the Governance of Health Research in Canada,” Open Medicine 4, 1 (2010), http://www.openmedicine.ca/article/view/379/302.

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16 Baylis, F. et al. , “Women and Health Research: From Theory, to Practice, to Policy,” in Embodying Bioethics: Recent Feminist Advances, ed. Donchin, A. and Purdy, L. (Lanham, MD: Rowman & Littlefield, 1999), 247Google Scholar.

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18 See Members of the Tri-Council Working Group on Ethics, Appendix A of Tri-Council Working Group, Draft Code of Conduct for Research Involving Humans (July 1997), http://www.ethics.ubc.ca/code/july97/app-abc.doc.

19 Palys, “The Ethics of Ethics.”

20 Baylis, Françoise, Downie, Jocelyn, and Sherwin, Susan, “Ensuring Proper Attention to Gender in Health-Related Research: One Group's Story” (Paper presented at the Gender and Health Conference, Halifax, July 4–5, 1997), 8Google Scholar.

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22 Feminist Health Care Ethics Network, The Politics of Women's Health, 247Google Scholar. See also Furedy, John, “SAFS and the Proposed Canadian Tri-Council Code of Ethical Conduct for Research Involving Humans: Ethical Humility But Epistemological Arrogance” (Handout for SFN Symposium: Social Policy Masked as Ethics Hurts Science: Some Perspectives from Working Scientists, October 1997), http://www.psych.utoronto.ca/users/furedy/bioethic.htmGoogle Scholar.

23 See TCPS, s. 6. McDonald notes, however, that the working group had anticipated this criticism and opted not to create a section specifically on research with Aboriginal communities. See McDonald, , “From Code to Policy Statement,” 16Google Scholar.

24 CIHR Guidelines for Health Research Involving Aboriginal People (Ottawa: CIHR, 2007), http://www.cihr-irsc.gc.ca/e/documents/ethics_aboriginal_guidelines_e.pdfGoogle Scholar. See Interagency Panel on Research Ethics [PRE], Draft 2nd Edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) (December 2009), http://www.pre.ethics.gc.ca/pdf/eng/Revised%20Draft%202nd%20Ed%20PDFs/Revised%20Draft%202nd%20Edition%20TCPS_EN.pdfGoogle Scholar, chapter 9 [PRE, “Draft 2nd Edition”].

25 Social Science and Humanities Special Working Committee on Research Ethics, Giving Voice to the Spectrum (Ottawa: PRE, 2004)Google Scholar.

26 McDonald, , “From Code to Policy Statement,” 16Google Scholar.

27 McDonald, Michael, “Canadian Governance of Health Research Involving Human Subjects: Is Anyone Minding the Store?” Health Law Journal 9, 1 (2001), 17Google Scholar. See Palys, Ted, “Bulldozers in the Garden: Comments Regarding the Tri-Council Working Group's July 1997 Draft Code of Ethical Conduct for Research Involving Humans” (n.d.), http://www.sfu.ca/~palys/tcwg97.htmGoogle Scholar.

28 Feminist Health Care Ethics Network, The Politics of Women's Health, 251Google Scholar.

29 See generally Baylis et al. “Ensuring Proper Attention to Gender in Health-Related Research.”

30 Canadians for Health Research, “What's Right, What's Missing, What's Next?—Discussion” (1997)Google Scholar, http://www.chrcrm.org/main/modules/pageworks/index.php?page=015&id=249 (accessed October 14, 2009).

31 Frederick “Research Ethics Boards: Potential Conflicts of Interest for Institutions” (1997)Google Scholar, http://www.chrcrm.org/main/modules/pageworks/index.php?page=015&id=235 (accessed October 14, 2009).

32 TCPS 1998, Introduction.

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34 Ibid.; see also Baylis, et al. , “Women and Health Research,” 253Google Scholar.

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36 See McDonald, Michael, “The Current Context of HRIHS,” in The Governance of Health Research Involving Human Subjects, by McDonald, Michael et al. (Ottawa: Law Commission of Canada, 2000), 81Google Scholar.

37 “Research Involving Women,” ss 6.3–6.4, subsection A of Working Group Code, http://www.ethics.ubc.ca/code/july97/.

38 See Baylis, et al. , “Women and Health Research,” 253Google Scholar.

39 TCPS 1998, art 5.2.

40 McDonald, , “Canadian Governance,” 2 n21Google Scholar.

41 Joly, Jean, “Public Health Research and Public Health Non-research: Who Governs What?” in McDonald, et al. , Governance of Health Research, 155Google Scholar.

42 See McDonald, “Canadian Governance of Health Research,” note 2, for a discussion of the significance of this change. See also, e.g., Flagel, David C., “Children as Research Subjects: New Guidelines for Canadian IRBs,” IRB: A Review of Human Subjects Research 22, 5 (2000), 1CrossRefGoogle ScholarPubMed.

43 See Adair, John G., “Ethics of Psychological Research: New Policies, Continuing Issues, New Concerns,” Canadian Psychology 42, 1 (2001), 31CrossRefGoogle ScholarPubMed. See also McDonald, , “From Code to Policy Statement,” 18Google Scholar. This term has been restored in the new TCPS, as it is clearly a method that is essential in most psychological research.

44 Panel on Research Ethics, “About Us: Mandate,” http://pre.ethics.gc.ca/eng/panel-group/about-apropos/mandate-mandat/.

45 One example of this is research in the social sciences and humanities. In 2003, the PRE created the Social Science and Humanities Special Working Committee on Research Ethics (SSHWC); in 2004, after consultation with the social science and humanities research community, SSHWC submitted the report Giving Voice to the Spectrum (see note 25 above).

46 “Draft 2nd Edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans” (Ottawa: PRE, 2008), http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/draft-preliminaire/ (accessed June 20, 2009)Google Scholar.

47 Ibid.

48 PRE, “Draft 2nd Edition.”

49 See PRE, “What's New in the TCPS,” http://www.pre.ethics.gc.ca/policy-politique/initiatives/docs/What's%20New%20in%20the%20TCPS.pdf (accessed October 12. 2009), 2. For a list of these reports see PRE, “Policy Initiative” (2009), http://pre.ethics.gc.ca/eng/policy-politique/initiatives/reports-rapports/Google Scholar.

50 See McDonald, “From Code to Policy Statement.”

51 See, e.g., Walton, Nancy, “The New Draft Canadian Federal Guidelines: Is There More to Say?” Research Ethics Blog (February 2, 2009), http://researchethicsblog.com/2009/02/07/the-new-draft-canadian-federal-guidelines-is-there-more-to-say/Google Scholar.

52 See http://www.noveltechethics.ca, for example, for some comments on the TCPS.

53 PRE, “Public Participation: Public Comments on the Revised Draft 2nd Edition of the TCPS (December 2009),” http://www.pre.ethics.gc.ca/eng/policy-politique/participation/comments-commentaires2009/> (accessed June 26, 2010).

54 McDonald, , “From Code to Policy Statement,” 20Google Scholar.

55 Experts Committee for Human Research Participant Protection in Canada, Moving Ahead: Final Report (Ottawa, 2008), http://www.hrppc-pphrc.ca/english/movingaheadfinalreport2008.pdfGoogle Scholar.

56 Jocelyn Downie, Letter to the Interagency Panel on Research Ethics (March 1, 2010), http://www.pre.ethics.gc.ca/pdf/eng/Comments2009/114_%20Downie,%20Jocelyn.pdf.

57 For past and current members see PRE, “About Us: Panel Members Interagency Panel on Research Ethics,” http://pre.ethics.gc.ca/eng/panel-group/about-apropos/members-membres/.

58 See Hirtle, Marie, “The Governance of Research Involving Human Participants in Canada,” Health Law Journal 11 (2003), 151Google Scholar.

59 Ted Palys and John Lowman, “One Step Forward, Two Steps Back: Draft TCPS 2's Assault on Academic Freedom” (March 15, 2009), http://www.sfu.ca/~palys/Palys-LowmanCommentsOnDraftTCPS2.pdf, 17.

60 Françoise Baylis, “Formal Incorporation of the Updated Guidelines for Pluripotent Stem Cell Research into the Revised TCPS” (March 31, 2009), http://www.noveltechethics.ca/pictures/File/Health_Policy_Private/TCPS%20Documents/Incorporation_of_Stem_Cell_Guidelines.pdf.

61 Canadian Institutes of Health Research Guidelines for Human Pluripotent Stem Cell Research (2008).

62 Revised Draft Second Edition, art 12.10.

63 Downie, Letter to the PRE (March 1, 2010); Françoise Baylis, Letter to the Interagency Panel on Research Ethics (February 25, 2010), http://www.pre.ethics.gc.ca/pdf/eng/Comments2009/45_Baylis,%20Francoise.pdf.

64 PRE, “TCPS Regional Consultation Tour Schedule 2009” (2009), http://www.pre.ethics.gc.ca/policy-politique/initiatives/docs/CONSULTATION_TOUR_SCHEDULE_2009_ENG.pdf; see also PRE, “Conference Presentations,” http://www.pre.ethics.gc.ca/eng/activities-activites/events-actualites/conferences/.

65 Several comments available online requested an extended period for comment. See, e.g., Sherry Ann Chapman, Letter to the PRE by Community-Campus Partnerships for Health (March 18, 2009), http://www.noveltechethics.ca/pictures/File/Health_Policy_Private/TCPS%20Documents/CCPH-Letter-031809.pdf.

66 PRE, “Extension of Release Date and Expanded Opportunities to Comment on Revised Draft 2nd Edition of the TCPS,” http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/revised-revisee/Default// (accessed October 10, 2009).

67 Chapman, Letter to the PRE, 2.

68 Ibid.

69 Alain Beaudet, Suzanne Fortier, and Chad Gaffield, “Invitation to Participate in the Consultations on the Draft Second Edition of the TCPS” (News release, December 2008), http://www.nserc-crsng.gc.ca/Media-Media/NewsRelease-CommuniqueDePresse_eng.asp?1D=108.

70 PRE, “Public Participation.”