Françoise Baylis and Jocelyn Downie issue a Mayday call to Parliament with respect to ethics at the Canadian Institutes of Health Research (CIHR).
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The Final Report from the Task Force on Ethics Reform at the Canadian Institutes of Health Research was presented to CIHR Governing Council in June 2013.  While Governing Council has not yet provided a formal public response to the Task Force Report, it has been working in the shadows to develop an Ethics Action Plan. This plan effectively ignores key findings and recommendations of the Task Force on Ethics Reform.

In brief, the Task Force on Ethics Reform found that CIHR was failing to meet its statutory mandate. Now, without intervention from Parliament, it appears that CIHR will soldier on and not remedy the serious problems identified by the Task Force.

The mandate of the Task Force was “to evaluate whether CIHR currently meets its ethics mandate and whether the current organizational structure is optimal to do so.”  The Task Force made a series of findings and recommendations.

The Task Force’s findings make it clear that CIHR has not been meeting its statutory mandate:

…CIHR has a clear legal obligation to have a strong and substantive ethics programme as an essential part of its broader mandate to improve the health of all Canadians. [emphasis added]

…CIHR’s ethics mandate is derived directly from the CIHR Act. As a result, CIHR is obligated legally to ensure that ethics has a central place within the organization. This is not optional; it is legally required. No one at CIHR has the authority to denigrate the value or place of ethics because the central place of ethics is proscribed [sic] by law. A refreshed vision for ethics must reclaim and re-establish the centrality of CIHR’s ethics mandate by recommitting to its obligations outlined by statute through strong leadership. [emphasis added]

The Task Force’s recommendations included the following unequivocal statements:

We have one key recommendation from which all others flow: provide ethics leadership to CIHR. Fulfilling its legislated mandate in ethics requires both a vision for ethics and responsible ethics leadership at every level of the CIHR corporate structure (including GC and the executive leadership) across all Institutes and programs. [emphasis added]

A first (and this is only the first) step is to create a position of Vice President of Ethics (VP Ethics) or a position of equivalent stature, and then hiring a strong individual to fill that role.

On November 22, 2013, in a “Message from the President – Update on Ethics Reform at CIHR” the President, Alain Beaudet, indicated that “CIHR’s role in ethics in research is an issue that CIHR and its Governing Council take very seriously.”  He also reported that “[f]ollowing extensive discussions with Science Council, CIHR management proposed options to Governing Council for enhancing and embedding the ethics function within CIHR, along the lines recommended by the Task Force.”

Sadly, CIHR’s role in ethics in research does not appear to be being taken “very seriously” and the changes being made are not “along the lines recommended by the Task Force”.

At its February 2014 meeting, Governing Council unanimously approved the CIHR Management Response to the Report of the Task Force on Ethics Reform.  According to this Response, the Standing Committee on Ethics will be “refreshed” and “revised”, with expanded membership.  Further, “[t]he Governing Council, Science Council and the CSO/VP [Chief Scientific Officer/Vice-President, Research and Knowledge Translation] will be strategically advised by a new Ethics Advisory Board.  The Governing Council member will chair this new Ethics Advisory Board that will be a Standing Committee of Governing Council.”  There will be a “new ethics structure (referred to above as the SCE and Ethics Advisory Board)”.

Rather than having a Vice President Ethics, Jane Aubin, a bone biologist and geneticist (Chief Scientific Officer/Vice-President, Research and Knowledge Translation at CIHR) will be the “Champion of Ethics at CIHR”.  According to Dr. Aubin, the new Chair of the Standing Committee on Ethics will be Dr. Paul Garfinkel, a professor of psychiatry at the University of Toronto and member of CIHR Governing Council.  There has been no indication given as to who will be head of the Ethics Advisory Board. This response from Governing Council is deeply disturbing for a number of reasons.

First, the Governing Council appears to have made a final decision about ethics at CIHR that does not include the creation of a position of VP Ethics.  This, despite the fact that the position of VP Ethics was the key recommendation of the Task Force on Ethics Reform, with all but five of the 20 Task Force recommendations referring to the pivotal role of VP Ethics. Importantly, this recommendation was based on feedback from the ethics community in Canada:

By far, the overwhelming majority of submissions identified a lack of leadership in the ethics programme at CIHR as the key issue in need of redress. While ethics leadership goes beyond any one person, the absence of a permanent EO [Ethics Office] Director was commonly cited as the prime example of this lack of leadership.

Second, while Jane Aubin and Paul Garfinkel are distinguished in their disciplines (medical biophysics and psychiatry respectively), neither of them has ethics expertise, and certainly neither is “recognized nationally and internationally as a leading scholar and researcher in ethics”.  In the Task Force report, there was deep concern about the lack of ethics expertise among those with responsibility for ethics at CIHR.  Indeed, the Task Force insisted that the VP Ethics:

… have the knowledge, skills and experience to elevate the status of ethics to a position within the organization that more fairly reflects the prominence of ethics in the CIHR mandate, and to develop and execute innovative, world-class programming in research ethics and related research policy. The person in this position should be recognized nationally and internationally as a leading scholar and researcher in ethics familiar with interdisciplinary approaches to research in and application of ethics. [emphasis added]

Third, the Governing Council response was developed and endorsed without the benefit of meaningful consultation with the persons within CIHR with relevant ethics expertise and experiential knowledge (the response to the Task Force Report has been managed by Science Council, Governing Council, and the CIHR Executive).  Members of the CIHR Standing Committee on Ethics and the CIHR Institute Advisory Board Ethics Designates were sidelined in the development of the response to the Task Force Report.

In sum, the CIHR Governing Council reforms are not “along the lines” recommended by the Task Force on Ethics Reform and are not an adequate response to the very serious deficiencies identified by the Task Force.  It is now imperative that Parliament make it clear to the CIHR President and Governing Council that the mandate set out for CIHR in the Canadian Institutes of Health Research Act must be met.

Leaders in Parliament in the areas of health, industry, and science and technology must now take whatever steps are necessary to ensure that the President and Chair of the CIHR Governing Council (Alain Beaudet) is called to appear before the relevant House/Senate Committees. This would be an important first step in holding him accountable for the inadequate way the ethics portfolio has been managed to date and the way in which CIHR is responding to the deficiencies identified by the Task Force on Ethics Reform. Only then can Parliament ensure that the legislated ethics mandate will indeed be met.

The public interest and trust in health research in Canada depend upon this.

Correction: The original blog post included a paragraph that misdescribed the Governing Council’s decision with respect to the Standing Committee on Ethics/Ethics Advisory Committee/Ethics Advisory Board.  This has been corrected.

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Françoise Baylis is a Professor and Canada Research Chair in Bioethics and Philosophy at Dalhousie University, Halifax, Canada. @francoisebaylis

Jocelyn Downie is a Professor of Law and Medicine at Dalhousie University, Halifax, Canada. @jgdownie

Conflict of Interest: Françoise Baylis was the CIHR Institute Advisory Board Ethics Designate for the Institute of Genetics in 2000.  From 2001 to 2003, she was the ethics member of the CIHR Governing Council and Co-Chair of the CIHR Standing Committee on Ethics.  Since 2009, she is the CIHR Institute Advisory Board Ethics Designate for the Institute of Gender and Health.  The views expressed herein are her own.