Unfinished Business: Ongoing Ethical Exceptionalism in the Oversight of Human Pluripotent Stem Cell Research in Canada

Abstract

In this article, we critically examine the arguments for and against the exceptional status given human pluripotent stem cell research in Canada (through the latest [December 2010] revision of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans), and conclude that this exceptionalism is unwarranted and ethically unsound. In our view, the three federal research granting agencies should honor their longstanding commitment that researchers, research sponsors, and Research Ethics Boards in Canada have access to “a single reference document for all research involving humans conducted under the auspices of institutions eligible for Agency funding.” As well, responsibility for the development, interpretation, and implementation of Canada's research ethics guidelines should be under the authority of a single oversight body that is independent of the federal research granting Agencies.

Keywords:

• ethics guidelines
• governance
• oversight
• research ethics
• stem cells

Notes

1. The organizational structure of the Interagency Panel on Research Ethics is available at: http://www.pre.ethics.gc.ca/eng/panel-group/about-apropos/structure/. Accessed September 2, 2011.

2. The most recent Agency statement concerning the commitment to a single reference document can be found on the CIHR website in relation to the CIHR decision to eliminate its policy document Registration and Results Disclosure of Controlled and Uncontrolled Trials Available at: http://www.cihr-irsc.gc.ca/e/43756.html. Accessed September 2, 2011.

3. See, for example, correspondence dated March 6, 2009 (http://noveltechethics.ca/files/files/Policy/Research_Ethics/TCPS_Archive/TCPS%20Proposed%20Revisions.pdf at page 22, item 9); correspondence dated March 31, 2009 (http://noveltechethics.ca/files/files/Policy/Research_Ethics/TCPS_Archive/Incorporation_of_Stem_Cell_Guidelines.pdf); and correspondence dated February 25, 2010 (http://www.pre.ethics.gc.ca/pdf/eng/Comments2009/45_Baylis,%20Francoise.pdf OR http://noveltechethics.ca/files/files/Policy/Research_Ethics/stemcells_Baylis.pdf). Accessed September 2, 2011.

4. Canadian Bioethics Society Annual Meeting. June 12, 2009 (http://noveltechethics.ca/files/files/Policy/Research_Ethics/TCPS_Archive/TCPS_CBS.pdf). Accessed September 2, 2011.

5. This second Revised Draft 2nd edition of the TCPS is not (and never was) publicly available. Publicly available versions—Draft 2nd edition of the TCPS and Revised Draft 2nd edition of the TCPS—can be accessed at: http://www.pre.ethics.gc.ca/eng/archives/Default/. Accessed September 2, 2011.

6. Excerpt from the Minutes of the Interagency Steering Committee meeting (Presidents of the three Agencies) July 7, 2010 (Provided by Susan Zimmerman, personal communication to Jocelyn Downie, June 10, 2011).

5b. Incorporation of Stem Cell Guidelines

Dr Beaudet [President of CIHR] noted that approval of the recommendation to fully incorporate the CIHR Stem Cell Guidelines into the TCPS would require approval by CIHR's Governing Council. The Steering Committee agreed in principle to incorporate the CIHR Stem Cell Guidelines into the TCPS, subject to approval by CIHR's Governing Council. The Secretariat will present both options (incorporation by reference and full incorporation) in the August 2010 version of the TCPS. Dr Beaudet undertook to consult Governing Council by email on its preferred option and inform the Secretariat of the result. If the option of full incorporation is adopted, the Panel will have the mandate to recommend future revisions to the Stem Cell Guidelines to the Steering Committee as part of annual revisions to the TCPS. CIHR's Stem Cell Oversight Committee will continue to review stem cell research applications and report on those directly to CIHR's Governing Council.

7. Personal communication from Christine Fitzgerald (Executive Vice-President of CIHR) to Françoise Baylis, May 2010. Personal communication from Christine Fitzgerald (Executive Vice-President of CIHR) to Françoise Baylis and Jocelyn Downie, May 7, 2011. Personal communication from Susan Zimmerman (Executive Director, Interagency Secretariat on Research Ethics) to Jocelyn Downie, June 11, 2011.

8. Personal communication from Susan Zimmerman (Executive Director, Interagency Secretariat on Research Ethics) to Jocelyn Downie, June 11, 2011.

9. We use the term “erased” because the Policy is no longer available on the CIHR website. A cached copy is available at http://sjlibrarian.wordpress.com/2011/04/06/cached-copy-policy-on-registration-and-results-disclosure-of-controlled-and-uncontrolled-trials-funded-by-cihr/. Accessed September 2, 2011.

10. The mandate of the SCOC is not limited to review of the stem cell research guidelines, but also includes ethics review of “human stem cell research funding applications submitted to CIHR and approved by CIHR's peer review committees … [and] stem cell research proposals submitted by other public or private granting agencies, by mutual agreement.” Available at: http://www.cihr-irsc.gc.ca/e/20410.html. Accessed September 2, 2011. Our discussion of conflicts of interest, however, is limited to the SCOC's mandate with respect to review of the guidelines, as only this aspect of the mandate is relevant to our conclusion about incorporation of the stem cell research guidelines into TCPS 2.

11. We do not here take a position on whether other aspects of the SCOC's mandate should also be amended. For example, research ethics review of specific protocols is an important governance issue. However, it is a distinct governance issue from that concerning responsibility for the development, implementation and interpretation of the guidelines. To remove the SCOC's mandate with respect to review of the stem cell research guidelines has no necessary implications for the SCOC's mandate with respect to ethics review of specific protocols.

12. See, for example, various CIHR meeting minutes: Standing Committee on Ethics, Meeting Minutes (May 6–7, 2002). Available at: http://www.cihr-irsc.gc.ca/e/1169.html; Standing Committee on Ethics, Meeting Minutes (September 19–20, 2002). Available at: http://www.cihr-irsc.gc.ca/e/16771.html; Standing Committee on Ethics, Meeting Minutes (December 3, 2002). Available at: http://www.cihr-irsc.gc.ca/e/18180.html; Standing Committee on Ethics, Meeting Minutes (February 27–28, 2003). Available at: http://www.cihr-irsc.gc.ca/e/18182.html; Standing Committee on Ethics, Meeting Minutes (May 8–9, 2003). Available at: http://www.cihr-irsc.gc.ca/e/19036.html; CIHR Governing Council, Meeting Minutes (November 20–21, 2002). Available at: http://www.cihr-irsc.gc.ca/e/13135.html; CIHR Governing Council, Meeting Minutes (March 19–20, 2003). Available at: http://www.cihr-irsc.gc.ca/e/18016.html; CIHR Governing Council, Meeting Minutes (June 18–19, 2003). Available at: http://www.cihr-irsc.gc.ca/e/19817.html. Accessed September 2, 2011.