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.
Professor Bernard Dickens used the expression “the tunnel at the end of the light” in his presentation at the 1998 Canadian Bioethics Society Annual meeting in Toronto when he was reflecting on the process of the drafting and ultimate publication of the Tri-Council Policy Statement.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
For a description of the cases mentioned here, see Downie 2003.
- 2.
The final draft of this revision prepared by the Interagency Advisory Panel on Research Ethics (PRE) is expected to be submitted to the funding agencies in February 2010. See Interagency Advisory Panel on Research Ethics (2008).
- 3.
See Starkman 1998, 272–3.
- 4.
Interagency Advisory Panel on Research Ethics. Introducing the TCPS: Development of Canadian Guidelines. http://pre.ethics.gc.ca/english/tutorial/00_intro_overview_context.cfm. Accessed 14 Apr 2008.
- 5.
Some commentators have also observed that the study undertaken by the National Council of Bioethics on Human Research (NBCHR) (now the National Council on Ethics in Human Research), which found that the MRC guidelines did not provide a functional environment for research ethics in Canada and that there existed a disarray in procedures and processes in Canadian REBs was motivated the establishment of the policy on integrity. The NBCHR recommended many procedural revisions, including increased regulation of REBs and research ethics in Canada. See Kinsella.
- 6.
This had been the initial task set by the Chair of the Working Group, that is, the revision of the MRC guidelines. See Working Group on Ethics Guidelines for Research with Human Subjects, Minutes of Meeting, Toronto, June 1994 at 7, cited in Feminist Health Care Ethics Research Network 1998, 234.
- 7.
See McDonald (2009) for an overview of the motivations for creating the TCPS.
- 8.
See for example, Scissons 1997.
- 9.
Interagency Advisory Panel on Research Ethics. About us: Mandate. http://pre.ethics.gc.ca/eng/panel-group/about-apropos/mandate-mandat/. Accessed 14 Apr 2008.
- 10.
See section 4 of the Act for other objectives of the CIHR.
- 11.
This has, however, been criticized by several researchers in the humanities.
- 12.
Even with increasing commercial funding of research, the three Councils remain, as Palys puts it, “an important and valued source of research funding in Canada.” See Palys 1996a.
- 13.
See the Memorandum of Understanding online at: http://www.nserc-crsng.gc.ca/institution/mou_e.htm. Accessed 20 Mar 2008.
- 14.
See for example, the CIHR 2010.
- 15.
See Panel on Research Ethics.2009. FAQs: About the TCPS. http://www.pre.ethics.gc.ca/eng/panel-group/faq/tcps-eptc/. Accessed 14 Oct 2009. See Hadskis 2007, 263.
- 16.
See Hadskis 2007, 263.
- 17.
The author notes, however, that a common conclusion in reports and the literature is that research ethics is becoming a matter of following rules and procedures—a bureaucratic process—as required by funding agencies or regulators and implemented by REBs. See also McDonald 2000.
- 18.
Quebec’s Civil Code has provisions on research involving humans. Other provinces have legislation which impact research involving humans in several respects, including Newfoundland which has recently passed a legislation making ethics review a law. Also, Health Canada, in its role as the federal health regulator regulating drugs and medical devices under the Food and Drugs Act has introduced regulations governing the conduct of clinical trials for drugs, the Regulations Amending the Food and Drug Regulations (1024 - Clinical Trials) (Clinical Trials Regulations).
- 19.
In this respect, Montpetit observes that: “Input-oriented legitimacy emerges not just when people are listened to and heard but when more people are listened to and heard” (Montpetit 2003, 102).
- 20.
See for example, Palys 1996a.
- 21.
And this would appear to be the case, see McDonald 2009, 13.
- 22.
They also included ex-officio members plus two ex officio members, the Honourable Mr. Justice T. David Marshall, chair of the MRC’s Standing Committee on Ethics, and Dr. Abbyann Lynch, president of the National Council on Bioethics in Human Research. See Squires 1994.
- 23.
Information from conversation with Prof. Bernard Dickens (May 8, 2008).
- 24.
Indeed in Section 6 of the TCPS, it is pointed out that: “During the drafting of this Policy Statement, suggestions were made to create a section dealing with research involving Aboriginal Peoples. The Agencies, however, have not held sufficient discussions with representatives of the affected peoples or groups, or with the various organizations or researchers involved. The Agencies have therefore decided that it is not yet appropriate to establish policies in this area. The text of Section 6, which builds on the extensive literature on research involving Aboriginal Peoples, is intended to serve as a starting point for such discussions” (TCPS, 1998, Section 6). See also, McDonald 2000, 82.
- 25.
Another essay however suggests that the criticisms may not stand under scrutiny. See Ells and Gutfreund 2001.
- 26.
See generally, Baylis et al 1997.
- 27.
Ted Palys, for instance, in his criticism of the 1997 draft of the Working Group’s Code notes a change of a tone in the document different from the tone employed in the previous drafts. This must have been a result of the consultations and communications received by the Working Group. See Palys 1997 and Palys 1996b. See Adair 2001, 30–31 describing his partial success with having several wordings changed at the Council level. He had been a member of the Working Group.
- 28.
Open meetings, it must be noted, are not necessarily always the best option in all policymaking situations. As Weijer notes, “openness is a clear expression of commitment to democratic process, but closed meetings may allow for greater consensus building” Weijer 1997.
- 29.
See also Baylis et al. 1999.
- 30.
See Joly 2001, 155. The Code stated: “Public health officers may be mandated by law to undertake research and in such cases REB approval is not required; this does not, however, exempt public health officers from seeking REB approval when the research is outside their mandate. In such case, REB approval is mandatory and, in all cases, respect for persons must be observed.” The TCPS has no equivalent provision.
- 31.
See also, for instance, Flagel 2000. In the area of psychological research, the word “deception” which was allowed in the Working Group’s draft code was eliminated in order to ensure that it would pass through the scrutiny of the Department of Justice. See Adair 2001, 31. See also, McDonald 2009, 18.
- 32.
Interagency Advisory Panel on Research Ethics. About Us: Mandate. http://pre.ethics.gc.ca/eng/panel-group/about-apropos/mandate-mandat/. Accessed 14 Oct 2009.
- 33.
Ibid. See for instance, Jones 2007.
- 34.
Ibid.
- 35.
Comments made here are based on the provisions of the forthcoming edition as at October 2009.
- 36.
Chapter 10 of TCPS (PRE 2008).
- 37.
Generally, a placebo control is considered appropriate when there is no proven treatment for the study condition. Where established treatment exists, placebos should not be used, except in extraordinary circumstances, in keeping with the principle of clinical equipoise. See Freedman 1987, 141.
- 38.
See also, National Placebo Working Committee 2004.
- 39.
See AREI PRE 2008.
- 40.
CIHR. Aboriginal Ethics Policy Development. http://www.cihr-irsc.gc.ca/e/29339.html. Accessed 14 Oct 2009.
- 41.
CIHR. Aboriginal Ethics Policy Development. http://www.cihr-irsc.gc.ca/e/29339.html. Accessed 14 Oct 2009.
- 42.
For example, distilling of ethical principles which numbered seven in the TCPS One (Respect for Human Dignity, Respect for Free and Informed Consent, Respect for Vulnerable Persons, Respect for Privacy and Confidentiality, Respect for Justice and Inclusiveness, Balancing Harms and Benefits, Minimizing Harm, Maximizing Benefit into three, namely: Concern for welfare; Respect for autonomy; and Respect for the equal moral status of all humans); Article 2.1 of TCPS Two: Change of definition of “research;” from systematic investigation which produces generalisable knowledge as stated in TCPS One p.1.1; Allowing for the use of deception in clearer terms (taking into consideration the concerns of researchers in the social sciences like psychologists); A more exhaustive list of types of research exempt from REB review (research using information exclusively from publicly available information, creative practices, public policy research, quality assurance and quality improvement studies, program evaluation, and performance reviews or testing within normal educational requirements. Article 6.4 - Composition – TCPS Two – community member must have relevant training and experience; Composition – TCPS Two – member knowledgeable in law (not risk manager or legal counsel, and not restricted to biomedical research as in TCPS One); Article 6.2 (see Application) Conflict of interest – senior administrators not to serve on REBs, A fuller section on conflict of interest in TCPS Two, Chapter Seven; Provisions on privacy and confidentiality in the context of internet research in TCPS Two, Article 10.3 has no equivalent in TCPS One; Ad hoc appeal boards not allowed in TCPS Two (Art. 1.11), but may be allowed under TCPS Two (Article 6.19, application); A fuller section on multi-centre research, including choice of model of REB; More details on research in public health emergencies, Article 6.21 in TCPS Two; More details on international research; Article 11.12 – New requirement for Clinical trial registries; and so on. See also 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 12 Oct 2009.
- 43.
What’s New in the TCPS. http://www.pre.ethics.gc.ca/policy-politique/initiatives/docs/What’s%20New%20in%20the%20TCPS.pdf. Accessed 12 Oct 2009, 2. For a list of these reports, see PRE 2009a, b, c.
- 44.
- 45.
- 46.
The past and current members of the Panel are listed on the website. PRE. About Us: Panel Members Interagency Panel on Research Ethics. http://pre.ethics.gc.ca/eng/panel-group/about-apropos/members-membres/. Accessed 12 Oct 2009.
- 47.
There are currently four women on the Panel, not including the Executive Director of the Secretariat on Research Ethics. See PRE. About Us: Panel Members Interagency Panel on Research Ethics. http://pre.ethics.gc.ca/eng/panel-group/about-apropos/members-membres/. Accessed 12 Oct 2009. It will be recalled that the Feminist Network complained of the gross gender imbalance on the Working Group. See Baylis et al. 1997 and accompanying text.
- 48.
- 49.
See also PRE. Conference Presentations. http://www.pre.ethics.gc.ca/eng/activities-activites/events-actualites/conferences/. Accessed 29 Sept 2009.
- 50.
Several comments available online requested an extended period for comment. See for example, Palys and Lowman 2009, 21. See also, Sherry Ann Chapman, 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 Sept 2009.
- 51.
Sherry Ann Chapman, 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 Sept 2009, 2.
- 52.
Ibid.
References
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]
Adair, John G. 2001. Ethics of psychological research: New policies, continuing issues, new concerns. Canadian Psychology 42(1): 25–37.
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.
Angell, M. 1994. Setting the record straight in the breast-cancer trials. New England Journal of Medicine 330: 1448–1450.
Baer, Nicole. 1996. New draft code for research involving humans proved a major challenge. Canadian Medical Association Journal 155(4): 442–444.
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.
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.
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.
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.
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.
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.
Canadian Institutes of Health Research Act. 2000. http://laws.justice.gc.ca/en/ShowFullDoc/cs/C-18.1///en. Accessed 13 Apr 2008.
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]
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]
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]
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.
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.
Convention on Human Rights and Biomedicine, April 4 1997, ETS No 164.
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.
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.
Dinsdale, Henry B. 1998. Editorial. NCEHR Communiqué Winter/Spring 1998. http://ncehr.medical.org/english/communique2/editor_e.html. Accessed 13 Apr 2008.
Dodds, Susan, and Colin Thomson. 2006. Bioethics and democracy: Competing roles of national bioethics organisations. Bioethics 20(9): 326–338.
Downie, Jocelyn. 2003. Contemporary health research: A cautionary tale. Health Law Journal Special Supplement Special Edition:1–20.
Ells, Carolyn, and Shawna Gutfreund. 2001. Myths about qualitative research and the Tri-Council Policy Statement. Canadian Journal of Sociology 31(3): 361–373.
Finance Canada. 1999. Strengthening health care for Canadians. February 1999. http://www.fin.gc.ca/budget99/pamph/healpae.html. Accessed 13 Apr 2008.
Flagel, David C. 2000. Children as research subjects: New guidelines for Canadian IRBs. IRB: A Review of Human Subjects Research 22(5): 1–3.
Freedman, B. 1987. Equipoise and the ethics of clinical research. New England Journal of Medicine 317(3): 141–145.
Guillemin, Marilys. 2004. Ethics, reflexivity, and “ethically important moments” in research. Qualitative Inquiry 10(2): 261–280.
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,.
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.
Halushka v. University of Saskatchewan et al. 1965. 53 D.L.R. (2d) 436, 52 W.W.R. 608 (Sask. C.A.).
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.
Hirtle, Marie. 2003. The governance of research involving human participants in Canada. Health Law Journal 11: 137–152.
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]
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/.
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]
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]
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]
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.
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.
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.
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.
Kondro, Wayne. 1998. New rules on human subjects could end debate in Canada. Science 280(5369): 1521.
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.
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.
McDonald, Michael. 2001. Canadian governance of health research: Is anyone minding the store? Health Law Journal 9: 1–21.
McDonald, Michael. 2009. From code to policy statement: Creating Canadian policy for ethical research involving humans. Health Law Review 17(2–3): 12–25.
Medical Research Council of Canada. 1978. MRC Report No. 6: Ethics in human experimentation. Ottawa: Ministry of Supply and Services. [MRC 1978]
Medical Research Council of Canada. 1987. Guidelines on research involving human subjects. Ottawa: Medical Research Council of Canada. [MRC 1987]
Montpetit, Eric. 2003. Public consultations in policy environments: The case of assisted reproductive technology in Canada. Canadian Public Policy 29(1): 95–110.
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.
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.
Nuremberg Code. 1947. http://ohsr.od.nih.gov/guidelines/nuremberg.html. Accessed 10 Dec 2007.
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.
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.
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.
Palys, Ted. S. 2003. The Tri-Council Policy Statement: A chronicle. http://www.sfu.ca/~palys/TriCncl.htm. Acceesed 28 July 2009.
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.
Prescott, Steven. 1999. The Canadian institutes of health research. McGill Journal of Medicine 5(2): 73–74.
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.
Rocher, Guy. 1999. Origin and development of the Tri-Council Policy Statement on the ethics of research involving humans. NCEHR Communique 9: 2.
Sampson, Heather, Charles Weijer, and Daryl Pullman. 2009. Research governance lessons from the national placebo initiative. Health Law Review 17(2–3): 26–32.
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.
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.
Social Sciences and Humanities Research Council of Canada. 1979. Ethics: Guidelines for research with humans. Ottawa. [SSHRC 1979]
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.
Squires, Bruce P. 1994. Ethics of human research. Canadian Medical Association Journal 151(8): 1103.
The Feminist Health Care Ethics Research Network. 1998. The politics of women’s health: Exploring agency and autonomy. Philadelphia: Temple University Press.
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.
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.
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.
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.
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.
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.
Weiss c. Solomon, 1989. A.Q. no. 312 (C.S. civ.).
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].
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.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2016 Springer International Publishing Switzerland
About this chapter
Cite this chapter
Downie, J., Onyemelukwe, C. (2016). The Tunnel at the End of the Light? Development of the Tri Council Policy Statement in Canada. In: Dodds, S., Ankeny, R. (eds) Big Picture Bioethics: Developing Democratic Policy in Contested Domains. The International Library of Ethics, Law and Technology, vol 16. Springer, Cham. https://doi.org/10.1007/978-3-319-32240-7_8
Download citation
DOI: https://doi.org/10.1007/978-3-319-32240-7_8
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-32239-1
Online ISBN: 978-3-319-32240-7
eBook Packages: Religion and PhilosophyPhilosophy and Religion (R0)