The members of Simon Fraser University’s Research Ethics Board (REB) returned to work after the New Year to an email informing the Chair, Vice-Chair, and two other committee members that their services were no longer required and their appointments would not be renewed. The reason? Dugan O’Neil, SFU’s Vice-President of Research & International (VPRI) and Trevor Davis, his Executive Director of Research Operations, who sent the email, were introducing changes to the process of ethics review at SFU that ostensibly would be more efficient and do a better job of considering Indigenous research and the increased workload that would come with SFU’s recent decision to create a medical school.
The VPRI later said, “Procedural changes like this don't have to go to Senate for approval,” but that he would be informing Senate nonetheless in “a short memo” at its February meeting.
Their planned changes violate the University’s ethics policy, the federal granting agencies’ Tri-Council Policy Statement (TCPS) on the ethics of research with human participants, and the system of collegial governance that is the bedrock of all universities in Canada.
At SFU, REB independence has been maintained in several ways:
- Final responsibility for the university’s ethics policy lies with the Senate rather than the VPRI, although the latter is given the responsibility and budget for implementing it.
- SFU ethics policy is explicit in stating that, “The REB shall operate in an impartial manner and be independent in its decision making,” and further that, “The decisions of the REB are not subject to review or interference by the Vice-President, Research and International, the Senate, or any other person or body[.]”
- Preliminary review by Office of Research Ethics (ORE) staff of minimal risk proposals – which comprise most of the social science ethics workload – are subject to the oversight of the REB in any matters related to ethics decision-making. This includes managing the nomination process for Board members, which the ORE does at the behest of the REB, and providing initial advice to researchers submitting proposals for ethics review and doing preliminary delegated review, all of which is subject to REB oversight and final approval.
- The VPRI is to play no role in the choice of REB Chair; that decision is left instead to members of the REB, who make that decision anew each year.
The Tri-Council Policy Statement on the ethics of research with human participants spells out the minimal ethical standards institutions must meet if an institution is to be allowed access to federal granting funds, outlines how ethical integrity is compromised when institutional conflicts of interest occur, and requires that ethics review infrastructures to be created that manage those potential conflicts. Various examples of such conflicts are cited, including, “conflicting roles carried out by one institutional official (e.g., a vice-president who is responsible for the promotion of research activity and funding and also for oversight of research)” (p.125). The VPRI’s proposals create exactly the institutional conflict of interest the TCPS prohibits by undermining REB independence and attempting to seize their role as the final arbiter of research ethics oversight.
Finally, the VPRI is taking final authority away from SFU’s Senate which is merely being informed of changes the VPRI is making. The proposed changes the VPRI is describing as no more than “procedural changes” are full policy changes which include the following:
- Instead of committee membership being managed by ORE at the behest of the REB, the VPRI’s proposed changes would allow him to appoint members to the REB for an initial probationary period, potentially followed by re-appointment and would make recruitment and vetting of members the responsibility of the Director of Research Ethics (who he appoints) without REB oversight;
- The proposals would give the VPRI discretion to invite “individuals with competence in special areas” – thereby usurping a discretion that currently lies with the REB Chair -- should he decide the relevant expertise does not exist on the committee. The concern here is that institutional conflicts of interest might create bias in the choice of experts;
- Instead of the current measure of REB autonomy that sees REB members deciding on a Chair, the proposed changes would see the VPRI make the appointment in conjunction with his Director of Research Ethics, with the Chair serving and being renewed, or not, at his discretion;
- The staff of ORE, who now do preliminary ethics review on “minimal risk” proposals with the oversight of the REB, would continue doing so, but now be under the direction of the Director of Research Ethics, a VPRI appointee;
- Perhaps most perniciously, the VPRI also would give himself the power to remove members, a level of control that would have a chilling effect on the REB’s independence.
These proposed changes take final authority over ethics matters from an independent REB and move them to the VPRI’s authority and the institutional conflicts of interest that involves, leaving members of SFU’s research community aghast. In a recent member bulletin, the SFU Faculty Association (SFUFA) affirms these interventions are violations of the current ethics policy as they involve direct intervention into the membership of the committee, including its choice of Chair. Dan Laitsch, a Faculty Senator who has been fighting a series of recent challenges to collegial governance at SFU, characterized these actions by the VPRI as nothing less than a “hostile takeover of the REB by the VPRI [that] has created uncertainty at SFU as to the status of ethics approvals and who, if anyone, is making those approvals.” Wendy Thornton, the now-former REB Chair after having served in that role for 7 years, agrees with that characterization. At the time of this writing close to 200 faculty members have signed a petition to be presented to Senate expressing their concern. The Canadian Association of University Teachers (CAUT) also made its position clear in a letter to SFU President Joy Johnson:
CAUT is of the view that this represents a serious interference by the Administration with the independence of the REB, undermines widely established principles of collegial governance, violates SFU’s own policies and practices, and potentially threatens academic freedom and research integrity.
The federal regulatory bodies which oversee the TCPS – the Secretariat on Responsible Conduct of Research and the Interagency Advisory Panel on Research Ethics -- have been informed of these developments at SFU.
Why does all this matter not only for SFU but for universities across Canada?
The TCPS came into existence at the turn of the millennium after university funding from federal and provincial governments was drastically reduced and universities and associated research institutions (e.g., hospitals) were encouraged to engage communities and establish research partnerships in order to better serve communities as well as to provide new revenue streams through partnerships with the private sector. Along with this came recognition that these new relationships could create institutional conflicts of interest whereby the desire to shore up revenues through royalty agreements and donations of infrastructure might lead them to place financial priorities ahead of ethics.
One concern was that institutions might accept revenue-generating opportunities while glossing over ethics issues. Michael McDonald (1998), one of the authors of the original TCPS, described growing concern regarding “increasing private sector dollars pouring particularly into medical research, much of this in the private sector,” and “pressures on REBs to issue quick and favourable verdicts on research proposals.” (p2).
A related concern was that institutions might reject liability-generating responsibilities that could have implications for those who participate in research, as occurred when several university administrations across the country, SFU among them, refused to provide legal support for researchers subpoenaed by legal authorities (see Palys & Lowman, 2019). A similar reluctance to commit to research participant protection appeared more recently when revisions to the TCPS encouraged, but did not require, institutions to create policies articulating procedures to be followed in the event of a researcher being subpoenaed. A follow-up study showed that only 2 of the more than 200 institutions who have created MOUs with the granting agencies to access federal funding had done so. Resistance typically came from administration authorities who did not want their hands tied when no one was forcing them to do so (see Palys & Ivers, 2017), despite recognition in the legal community that when and if a subpoena arrives, quick and direct response provides the best protection (e.g., Traynor, 1996).
As someone who participated in early debates at SFU and nationally about ethics and the TCPS’s role in charting an ethical path (see Palys & Lowman, 2014), it was always my hope that SFU would show national leadership on ethics issues, and for a time we did. The VPRI’s proposals undermine that progress by undermining REB independence and envisioning an infrastructure in which the VPRI “is responsible for the promotion of research activity and funding and also for oversight of research,” i.e., creating institutional conflicts of interest that are rightfully disallowed by the TCPS because they pit legitimate administrative interest in efficiency and liability management against the rights and interests of research participants.
The VPRI’s actions to date – terminating committee members, including the Chair and Vice-Chair – should be reversed because the existing SFU ethics policy does not give the VPRI that power. The proposals the VPRI offers as mere “procedural changes” should be abandoned because they represent substantive changes to the ethics policy and thereby usurp Senate’s jurisdiction to initiate and manage that process.
The idea of reconsidering SFU’s ethics policy and ethics review structure is not the issue. Such reviews are required periodically. A review also makes sense because a medical school and all the money at stake will create new opportunities where ethics issues will abound. Now may well be a good time to start considering the implications of that change for our ethics review structures while it is still years away. But the changes the VPRI has proposed place administrative convenience ahead of research participant rights and interests – non-starters relative to the standards embodied in the TCPS -- and the VPRI’s unilateral changes to the ethics policy violate our system of collegial governance. The future of ethics regulation at SFU and all other universities in Canada calls for a process managed by Senate that engages all stakeholders at the university, reflects national ethics standards, and has no taint of institutional conflicts of interest. Research participants, who are the fuel on which so much research runs, deserve no less.
McDonald, M. (1998). The Tri-Council Policy Statement on ethical conduct for research involving humans. Canadian Bioethics Society Newsletter, 3(3), 1-2.
Palys, T., and Ivers, A. (2018). "Hope for the best, plan for the worst": Understanding administrative inertia in developing confidentiality protection policies. Journal of Empirical Research on Human Research Ethics, 13(4), 438-451.
Palys, T., and Lowman, J. (2014). Protecting Research Confidentiality: What Happens When Ethics and Law Collide. Toronto: Lorimer. (Published as part of the CAUT Academic Freedom series.)
Palys, T., and Lowman, J. (2019). Eight challenges to research confidentiality in Canada: Invoking and protecting research-participant privilege. In C. Hunt (ed.) Perspectives on Evidentiary Privileges. Toronto: Thomson Reuters, pp.213-237.
Traynor, M. (1996). "Countering the excessive subpoena for scholarly research." Law and Contemporary Problems, 59(3): 119-148