Research Ethics
Update on Research Ethics in Canada
September 16, 2008
(by Tony Porter, CPSA representative on the Federation Ethics Committee)
Two parallel processes are unfolding currently at the national level in Canadian research ethics governance. The first is the creation of a revised Tri-Council Policy Statement (TCPS) by its guardian committee, the Panel on Research Ethics (PRE) and the PRE’s secretariat. The second is the Sponsors’ Table initiatives that have included the Moving Ahead report. The two processes are summarized in turn.
The PRE’s Revision of the TCPS (TCPS II)
The TCPS is the policy statement that guides research ethics boards across the country and which has been seen as problematic for its biomedical bias by social sciences and humanities SSH) scholars. The PRE plans to release a draft of TCPS II by early 2009 with a public consultation period of about four months. The PRE created a number of working committees to advise it on changes needed to the TCPS. The most important of these committees from the CPSA point of view appears to be the Social Sciences and Humanities Research Ethics Special Working Committee (SSHWC), which on the basis of hundreds of submissions from SSH scholars produced a very critical report entitled Giving Voice to the Spectrum in 2004 and a follow up report in 2007. Like the other working committees it has produced a report with specific recommendations for rewording the TCPS in the form of a draft chapter on qualitative research (“Qualitative Research: A Chapter for Inclusion in the TCPS”, February 2008, at http://www.pre.ethics.gc.ca/english/publicationsandreports/publicationsandreports.cfm). The SSHWC report to does a very good job in addressing concerns about qualitative research, especially ethnographic research. There is perhaps, however, more that could be said about two concerns that are more serious in Political Science than in other SSH research: the distinctive practical and ethical problems of burdening elite research with excessive ethics rules and the distinctive problems of survey research. As well the SSWHC report did not recommend actual specific rules for implementing its more conceptual points.
It also isn’t clear whether the PRE will make clearer its apparent intention to have public policy research treated differently than other research. The following two excerpts from the TCPS suggest this intention but in practice REBs seem not to have actually treated public policy research any differently than other research.
Research about a living individual involved in the public arena, or about an artist, based exclusively on publicly available information, documents, records, works, performances, archival materials or third-party interviews, is not required to undergo ethics review. Such research only requires ethics review if the subject is approached directly for interviews or for access to private papers, and then only to ensure that such approaches are conducted according to professional protocols and to Article 2.3 of this Policy” (TCPS 1.1)
Researchers and REBs should also be aware that some research may be deliberately and legitimately opposed to the interests of the research subjects. This is particularly true of research in the social sciences and humanities that may be critical of public personalities or organizations. Such research should, of course be carried out according to professional standards, but it should not be blocked through the use of harms-benefit analysis or because it may not involve collaboration with the research subjects.” (TCPS i.7).
Left unclear in the TCPS is the meaning of “professional standards” and “professional protocols” in these statements. It isn’t certain that the TCPS II will clarify these terms.
A prevailing view among participants in research ethics governance appears to be that the idea of having separate documents for SSH research and for biomedical research is not one that has any realistic chance of succeeding. It isn’t yet clear whether a separate qualitative chapter in the TCPS II will satisfy SSH critics. It may be useful to keep in mind that journalists in Canada, when writing about public policy issues or actors, are not subject to ethical regulation. The UK’s Economic and Social Research Council’s Research Ethics Framework (REF), established in 2006, also has taken a different path than the TCPS. It states: “Other ethical frameworks for research on human subjects, such as that which addresses biomedical research, may not be appropriate, which is why a framework specific to social science is necessary.” Although more investigation would be needed to see how it is working in practice, the wording of the REF suggests that research ethics governance in the UK is much more decentralized and flexible that in Canada. For instance it references a checklist that identifies social science research hazards. If you answer no to the eleven questions then you only need to file the form with the appropriate authority. Only if you answer yes to any question do you then need to write up an ethical plan and get approval from the Research Ethics Committee. In other words, although participants in Canadian research ethics governance seem to set limits around the degree to which the distinctive concerns of social scientists feasibly can be reflected in textual exemptions of SSH research from biomedically-inspired rules these limits do not appear to be a problem in other settings.
The Sponsors’ Table and the Experts Committee
The Sponsors’ Table for Human Research Participant Protection includes 14 research sponsors such as the Alberta Ministry of Health and Wellness, the Association of Canadian Academic Healthcare Organizations, and Canada's Research-Based Pharmaceutical Companies, ten of which are health-related. The other four include the Canadian Federation for the Humanities and Social Sciences, the Association of Universities and Colleges of Canada and the Natural Sciences and Engineering Research Council and the Social Sciences and Humanities Research Council. The Sponsors’ Table created an Experts Committee that issued a report, Moving Ahead, that appeared in draft form in August 2007 and in final form in 2008. This report proposed the replacement of the TCPS with a drastically reworked and strengthened set of governance arrangements. The CPSA submitted concerns to the Experts Committee about the August 2007 draft of the Moving Ahead report. Other critical responses were submitted. For instance the SSHWC stated:
we believe that this structure will actually entrench – rather than reverse – the problems…We have worked tirelessly to identify the problems with the imposition of just this type of biomedical ethics model on the SSH in Canada, so we are saddened and frustrated that this is the model presented here for ‘solving’ our existing problems.
The Association of Universities and Colleges of Canada (AUCC) was also very critical of the report, probably in part because they feared having to fund the new Council that the report proposed and the Council’s 51 staff, estimated at $9-10 million. The need for the proposed system of accreditation, which in effect would be required to be applied to all research, was also seen as unsubstantiated.
One concern about the Moving Ahead proposals of August 2007 was that they appeared to advocate the abolition of the PRE without making clear how the process described above would be incorporated in the new system.
Six hundred pages of feedback in response to the draft report were received and they were summed up by a consulting company. The consultant’s report on the feedback has been posted at http://www.hrppc-pphrc.ca/english/consultationreport.pdf. After considering the feedback it received, the Experts Committee submitted a final version of Moving Ahead to the Sponsors’ Table (available at http://www.hrppc-pphrc.ca/english/movingahead.html). The changes made by the Experts Committee in response to this feedback were relatively marginal. The Sponsors’ Table met in June 2008 to consider what to do with the Moving Ahead report. In a July 2008 press release (at http://www.hrppc-pphrc.ca/english/communiquejuly182008.html) the Sponsors’ Table indicated that its four priorities were (a) to recognize the Tri-Council Policy Statement as Canada’s basic policy framework and to create a subcommittee to discuss further governance issues; (b) to work on a strategy for better education about research ethics; (c) to launch a pilot voluntary accreditation system; and (d) to emphasize and develop the notion of “proportionate review.” While the exact implications of this will only become apparent over time, it seems clear that the Sponsors’ Table has chosen at present not to implement some of the more controversial directions that were stated in or implied by the Moving Ahead report, such as the replacement of the TCPS by a large and expensive new bureaucratic structure.
Next steps
For CPSA members concerned about research ethics issues the most important upcoming development will be the call for consultations on the revised Tri-Council Policy Statement in the fall of 2008. It will also be important to monitor developments at the Sponsors’ Table. The Sponsors’ Table subcommittee reports that will set out proposals for implementing the priorities listed above are scheduled to be completed in June 2009 so it is unlikely that there will be significant public developments before then.
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