Advertisement

The Tunnel at the End of the Light? Development of the Tri Council Policy Statement in Canada

  • Jocelyn DownieEmail author
  • Cheluchi Onyemelukwe
Chapter
Part of the The International Library of Ethics, Law and Technology book series (ELTE, volume 16)

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 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.

Keywords

Research ethics Governance Canada Regulation Tri-Council Policy Statement 

Notes

Acknowledgements

This study was undertaken in conjunction with the Australian Research Council Discovery Project grant “Big Picture Bioethics: Policy-Making and Liberal Democracy” (DP0556068), and a Neuroethics New Emerging Team (NET) grant funded by the Canadian Institutes of Health Research.

This chapter is a substantially revised version of: Cheluchi Onyemelukwe and Jocelyn Downie. 2011. The tunnel at the end of the light? A critical analysis of the development of the Tri-Council Policy Statement, Canadian Journal of Law and Society: 159–176.

References

  1. Aboriginal Research Ethics Initiative (AREI) of the Interagency Advisory Panel on Research Ethics (PRE). 2008. Issues and options for revisions to the Tri-Council Policy Statement on ethical conduct of research involving humans (TCPS): Section 6: Research Involving Aboriginal Peoples (Ottawa: Interagency Advisory Panel and Secretariat on Research Ethics. http://www.pre.ethics.gc.ca/english/workgroups/aboriginal/Aboriginal_Peoples_Research.cfm. Accessed. [AREI 2008]
  2. Adair, John G. 2001. Ethics of psychological research: New policies, continuing issues, new concerns. Canadian Psychology 42(1): 25–37.CrossRefGoogle Scholar
  3. Altman, Lawrence K. 1994. Researcher falsified data in breast cancer study. New York Times, March 14. http://query.nytimes.com/gst/fullpage.html?res=9F01EEDC133DF937A25750C0A962958260. Accessed 12 Apr 2008.
  4. Angell, M. 1994. Setting the record straight in the breast-cancer trials. New England Journal of Medicine 330: 1448–1450.CrossRefGoogle Scholar
  5. Baer, Nicole. 1996. New draft code for research involving humans proved a major challenge. Canadian Medical Association Journal 155(4): 442–444.Google Scholar
  6. Barnes, Marian, Andrew Knops, Janet Newman, and Helen Sullivan. 2004. Recent research: The micro-politics of deliberation: Case studies in public participation. Contemporary Politics 10(2): 93–110.CrossRefGoogle Scholar
  7. Baylis, Françoise. 2009. Formal Incorporation of the update guidelines for pluripotent stem cell research into the revised TCPS. http://www.noveltechethics.ca/pictures/File/Health_Policy_Private/TCPS%20Documents/Incorporation_of_Stem_Cell_Guidelines.pdf. Accessed 2 Oct 2009.
  8. Baylis, Françoise, Jocelyn Downie, and Susan Sherwin. 1997. Ensuring proper attention to gender in health-related research: One group’s story. Paper presented at the Gender and Health Conference, July 4–5, Halifax.Google Scholar
  9. Baylis, Françoise, Jocelyn Downie, and Susan Sherwin. 1999. Women and health research: From theory, to practice, to policy. In Embodying bioethics: Recent feminist advances, ed. A. Donchin and L. Purdy, 253–268. Lanham: Rowman & Littlefield.Google Scholar
  10. Beaudet, Alain, Suzanne Fortier, and Chad Gaffield. 2008. Invitation to participate in the consultations on the draft Second Edition of the TCPS. December 2008. http://www.nserc-crsng.gc.ca/Media-Media/NewsRelease-CommuniqueDePresse_eng.asp?ID=108. Accessed 24 Sept 2009.
  11. Canadians for Health Research. 1997. What’s right, what’s missing, what’s next? – Discussion. http://www.chrcrm.org/main/modules/pageworks/index.php?page=015&id=249. Accessed 14 Oct 2009.
  12. Canadian Institutes of Health Research Act. 2000. http://laws.justice.gc.ca/en/ShowFullDoc/cs/C-18.1///en. Accessed 13 Apr 2008.
  13. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada. 1998. Tri-Council Policy Statement: Ethical conduct for research involving humans. [CIHR, NSERC, SSHRC 1998]Google Scholar
  14. Canadian Institutes of Health Research. 2007. CIHR guidelines for health research involving aboriginal people. http://www.cihr-irsc.gc.ca/e/documents/ethics_aboriginal_guidelines_e.pdf. Accessed 14 Oct 2009. [CIHR 2007]
  15. Canadian Institutes of Health Research. 2010. CIHR procedure for addressing allegations of non-compliance with tri-agency policies. http://www.cihr-irsc.gc.ca/e/25178.html. Accessed 20 Mar 2008. [CIHR 2010]
  16. Chapman, Sherry Ann. Letter to the PRE by Community-Partnerships for Health: RE: Extension of consultation time period and engagement strategy for community feedback. http://www.noveltechethics.ca/pictures/File/Health_Policy_Private/TCPS%20Documents/CCPH-Letter-031809.pdf. Accessed 21 Sep 2009.
  17. Christie, T., E. Wood, M. Schechter, and M. O’Shaughnessy. 2004. A comparison of the new federal guidelines regulating supervised injection site research in Canada and the Tri-Council Policy Statement on ethical conduct for research involving human subjects. International Journal of Drug Policy 15(1): 66–73.CrossRefGoogle Scholar
  18. Convention on Human Rights and Biomedicine, April 4 1997, ETS No 164.Google Scholar
  19. Council for International Organizations of Medical Sciences. 2002 [1993]. International ethical guidelines for biomedical research involving human subjects. http://www.cioms.ch/publications/layout_guide2002.pdf.
  20. Dickens, Bernard. 2000. Governance relations in biomedical research. In Governance of health research involving humans in Canada, ed. M. Macdonald,. Ottawa: Law Commission of Canada, Section C-1:93–108.Google Scholar
  21. Dinsdale, Henry B. 1998. Editorial. NCEHR Communiqué Winter/Spring 1998. http://ncehr.medical.org/english/communique2/editor_e.html. Accessed 13 Apr 2008.
  22. Dodds, Susan, and Colin Thomson. 2006. Bioethics and democracy: Competing roles of national bioethics organisations. Bioethics 20(9): 326–338.CrossRefGoogle Scholar
  23. Downie, Jocelyn. 2003. Contemporary health research: A cautionary tale. Health Law Journal Special Supplement Special Edition:1–20.Google Scholar
  24. Ells, Carolyn, and Shawna Gutfreund. 2001. Myths about qualitative research and the Tri-Council Policy Statement. Canadian Journal of Sociology 31(3): 361–373.Google Scholar
  25. Finance Canada. 1999. Strengthening health care for Canadians. February 1999. http://www.fin.gc.ca/budget99/pamph/healpae.html. Accessed 13 Apr 2008.
  26. Flagel, David C. 2000. Children as research subjects: New guidelines for Canadian IRBs. IRB: A Review of Human Subjects Research 22(5): 1–3.CrossRefGoogle Scholar
  27. Freedman, B. 1987. Equipoise and the ethics of clinical research. New England Journal of Medicine 317(3): 141–145.CrossRefGoogle Scholar
  28. Guillemin, Marilys. 2004. Ethics, reflexivity, and “ethically important moments” in research. Qualitative Inquiry 10(2): 261–280.CrossRefGoogle Scholar
  29. Hadskis, Michael. 2007. The regulation of human biomedical research in Canada. In Canadian health law and policy, eds. Jocelyn Downie, Timothy Caulfield and Colleen Flood. Ontario: Lexis Nexis,.Google Scholar
  30. Halperin, Scott et al. 2009. Canadian center for vaccinology comments on the TCPS draft 2nd ed. http://www.noveltechethics.ca/pictures/File/Health_Policy_Private/TCPS%20Documents/CCfV_TCPS.pdf. Accessed 9 Oct 2009.
  31. Halushka v. University of Saskatchewan et al. 1965. 53 D.L.R. (2d) 436, 52 W.W.R. 608 (Sask. C.A.).Google Scholar
  32. Health Canada. 1999. Rock introduces legislation to create the Canadian institutes of health research. November 4. http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/1999/1999_130_e.html. Accessed 13 Apr 2008.
  33. Hirtle, Marie. 2003. The governance of research involving human participants in Canada. Health Law Journal 11: 137–152.Google Scholar
  34. Interagency Advisory Panel on Research Ethics. Social Science and Humanities Special Research Ethics Working Committee. 2004. Giving voice to the spectrum. Ottawa: Minister of Supply and Services. [PRE 2004]Google Scholar
  35. Interagency Advisory Panel on Research Ethics. 2008. Draft 2nd Edition of the Tri-Council Policy Statement: Ethical conduct for research involving humans. http://www.pre.ethics.gc.ca/policy-politique/docs/TCPS-Draft2-eng.pdf. Accessed 1 Sept 2009. [PRE 2008] and http://www.pre.ethics.gc.ca/eng/archives/draft-preliminaire/page1/.
  36. Interagency Advisory Panel on Research Ethics (PRE). 2009a. Policy initiative. http://pre.ethics.gc.ca/eng/policy-politique/initiatives/reports-rapports/. Accessed 14 Oct 2009. [PRE 2009a]
  37. Interagency Advisory Panel on Research Ethics (PRE). 2009b. TCPS regional consultation tour schedule 2009. http://www.pre.ethics.gc.ca/policy-politique/initiatives/docs/CONSULTATION_TOUR_SCHEDULE_2009_ENG.pdf. Accessed 30 Sept 2009. [PRE 2009b]
  38. Interagency Advisory Panel on Research Ethics (PRE). 2009c. Extension of release date and expanded opportunities to comment on revised draft 2nd Edition of the TCPS. http://www.pre.ethics.gc.ca/eng/resources-ressources/news-nouvelles/nr-cp/2009-08-26_Extension/. Accessed 10 Oct 2009. [PRE 2009c]
  39. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 1997. ICH harmonized tripartite guideline for good clinical practice. http://www.ich.org/LOB/media/MEDIA482.pdf. Accessed 11 Apr 2008.
  40. Joly, Jean. 2001. Public health research and public health non-research: Who governs what?. In Governance of health research involving humans in Canada, ed. M. Macdonald, Section D2. Ottawa: Law Commission of Canada.Google Scholar
  41. Jones, Derek J. and Interagency Advisory Panel on Research Ethics (PRE). 2007. Interface of law and ethics in Canadian research ethics standards: An advisory opinion on confidentiality, its limits and duties to others. McGill Journal of Health and Law 1(1):101–115.Google Scholar
  42. Kinsella, Douglas. 2010. Research ethics boards: A historical background. Canadians for health research, http://www.chrcrm.org/en/conference-proceedings/research-ethics-boards-historical-background. Accesssed 12 Apr 2008.
  43. Kondro, Wayne. 1998. New rules on human subjects could end debate in Canada. Science 280(5369): 1521.CrossRefGoogle Scholar
  44. Lowy, Frederick. 1997. Research ethics boards: Potential conflicts of interest for institutions. http://www.chrcrm.org/main/modules/pageworks/index.php?page=015&id=23. Accessed 14 Oct 2009.
  45. McDonald, M. 2000. The current context of HRIHS. In Governance of health research involving humans in Canada, ed. M. Macdonald, 77–90. Ottawa: Law Commission of Canada.Google Scholar
  46. McDonald, Michael. 2001. Canadian governance of health research: Is anyone minding the store? Health Law Journal 9: 1–21.Google Scholar
  47. McDonald, Michael. 2009. From code to policy statement: Creating Canadian policy for ethical research involving humans. Health Law Review 17(2–3): 12–25.Google Scholar
  48. Medical Research Council of Canada. 1978. MRC Report No. 6: Ethics in human experimentation. Ottawa: Ministry of Supply and Services. [MRC 1978]Google Scholar
  49. Medical Research Council of Canada. 1987. Guidelines on research involving human subjects. Ottawa: Medical Research Council of Canada. [MRC 1987]Google Scholar
  50. Montpetit, Eric. 2003. Public consultations in policy environments: The case of assisted reproductive technology in Canada. Canadian Public Policy 29(1): 95–110.CrossRefGoogle Scholar
  51. MRC, NSERC, SSHRC. Tri-Council Policy Statement on integrity in research and scholarship. http://www.sshrc.ca/web/apply/policies/integrity_e.asp. Accessed 12 Apr 2008.
  52. National Placebo Working Committee. 2004. Final report of the national placebo working committee on the appropriate use of placebos in clinical trials. Ottawa: Canadian Institutes of Health Research. http://www.cihr-irsc.gc.ca/e/25139.html. Accessed 14 Oct 2009.
  53. Nuremberg Code. 1947. http://ohsr.od.nih.gov/guidelines/nuremberg.html. Accessed 10 Dec 2007.
  54. Palys, Ted S. 1996a. The ethics of ethics: Comments regarding the tri-council working group’s March 1996 Draft code of conduct for research involving humans. http://www.sfu.ca/~palys/codecomm.htm. Accessed 13 Mar 2008.
  55. Palys, Ted S. 1996b. Councils rethink proposed ethics code. University of Waterloo Gazette. http://communications.uwaterloo.ca/Gazette/1996/November13/Councils%20rethink%20proposed%20ethics%20code. Accessed 14 Aug 2008.
  56. Palys, Ted. S. 1997. Bulldozers in the garden: Comments regarding the tri-council working group’s July 1997 Draft code of ethical conduct for research involving humans. http://www.sfu.ca/~palys/tcwg97.htm. Accessed 14 Aug 2008.
  57. Palys, Ted. S. 2003. The Tri-Council Policy Statement: A chronicle. http://www.sfu.ca/~palys/TriCncl.htm. Acceesed 28 July 2009.
  58. Palys, Ted. S. and John Lowman. 2009. One step forward, two steps back: Draft TCPS2’s assault on academic freedom. 1–21. http://www.sfu.ca/~palys/Palys-LowmanCommentsOnDraftTCPS2.pdf. Accessed 14 Oct 2009.
  59. Prescott, Steven. 1999. The Canadian institutes of health research. McGill Journal of Medicine 5(2): 73–74.Google Scholar
  60. Public Health Agency of Canada Health. 1999. Canadian institutes of health research. http://www.phac-aspc.gc.ca/ph-sp/phdd/determinants/determinants2.html. Accessed 13 Apr 2008.
  61. Rocher, Guy. 1999. Origin and development of the Tri-Council Policy Statement on the ethics of research involving humans. NCEHR Communique 9: 2.Google Scholar
  62. Sampson, Heather, Charles Weijer, and Daryl Pullman. 2009. Research governance lessons from the national placebo initiative. Health Law Review 17(2–3): 26–32.Google Scholar
  63. Scissons, Hannah. 1997. Universities hesitant about draft ethics code. The Peak, October 27. www.peak.sfu.ca/the-peak/97-3/issue9/ethics.html. Accessed 13 Apr 2008.
  64. Sherwin, Susan. 2009. Recommended revisions to the draft 2nd Edition of the TCPS: Further suggestions regarding the ethics framework. http://www.noveltechethics.ca/pictures/File/Health_Policy_Private/TCPS%20Documents/Further_Revisions_Sherwin.pdf. Accessed 9 Oct 2009.
  65. Social Sciences and Humanities Research Council of Canada. 1979. Ethics: Guidelines for research with humans. Ottawa. [SSHRC 1979]Google Scholar
  66. Starkman, B. 1998. Models for regulating research: The Council of Europe and International Trends. In Research on human subjects: Ethics, law and social policy, ed. David N. Weistubb, 264–285. Elsevier Science Ltd: Oxford.Google Scholar
  67. Squires, Bruce P. 1994. Ethics of human research. Canadian Medical Association Journal 151(8): 1103.Google Scholar
  68. The Feminist Health Care Ethics Research Network. 1998. The politics of women’s health: Exploring agency and autonomy. Philadelphia: Temple University Press.Google Scholar
  69. Tri-Council Working Group on Ethics. 1996. Code of conduct for research involving humans [draft]. Ottawa: Minister of Supply and Services. http://www.ethics.ubc.ca/newsletter/sept96fax.html. Accessed 13 Apr 2008.
  70. Tri-Council Working Group on Ethics. 1997. Code of conduct for research involving humans [final version]. Ottawa: Minister of Supply and Services. http://www.ethics.ubc.ca/code/july97/j97-1.pdf. Accessed 13 Mar 2008.
  71. UNESCO. 2005. UNESCO declaration on bioethics and human rights. http://portal.unesco.org/en/ev.php-URL_ID=31058&URL_DO=DO_TOPIC&URL_SECTION=201.html. Accessed 11 Apr 2008.
  72. Verdun-Jones, Simon and David N. Weistubb. 1996–1997. The regulation of biomedical research experimentation in Canada: Developing and effective apparatus for the implementation of ethical principles in a scientific milieu. University of Ottawa Law Review 28: 297–341.Google Scholar
  73. Weijer, Charles. 1997. Book review: Society’s choices: Social and ethical decision making in biomedicine. NCEHR Communiqué 18(1). http://www.ncehr-cnerh.org/uploads/editor/file/communique/english/communique/npubs_e.html#book%20review%201. Accessed 12 Mar 2008.
  74. Weijer, Charles, Gary Goldsand, and Ezekiel J. Emanuel. 1999. Protecting communities in research: Current guidelines and limits of extrapolation. Nature Genetics 23(3): 275–280.CrossRefGoogle Scholar
  75. Weiss c. Solomon, 1989. A.Q. no. 312 (C.S. civ.).Google Scholar
  76. World Medical Association. 2000 [1964]. Declaration of Helsinki: Ethical principles for research involving human subjects, adopted by the 18th WMA June 1964, latest amendment made by the 59th WMA General Assembly http://www.wma.net/en/30publications/10policies/b3/. Accessed 1 Mar 2007. [WMA].

Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  1. 1.Faculties of Law and MedicineDalhousie UniversityHalifaxCanada
  2. 2.School of LawBabcock UniversityIlishan-RemoNigeria

Personalised recommendations