Ted Palys and John Lowman of the School of Criminology, Simon Fraser University, find that the second edition of Canada's Tri-Council Policy Statement (TCPS2), released in December 2010, offers significant improvements over the first edition of 1998.
[Ted Palys and John Lowman, "What's Been Did and What's Been Hid: Reflections on TCPS2," 18 January 2011].
On the positive side, they find that "The section that has been one of our primary foci over the years – the policy's provisions regarding privacy and confidentiality – has improved to the point where it is respectful of different epistemological and moral perspectives, offers protections for research participants, and reminds both researchers and the institutions in which they work of their duties and obligations. To that extent, TCPS2 represents an exemplary policy that other nations can emulate."
While they would have liked the document to offer better legal advice, they appreciate the ethical advice it gives to researchers and institutions about their duty to honor pledges of confidentiality.
They also applaud TCPS2's new Chapter 10 on qualitative research, provided it is correctly employed: To the extent that Chapter 10 elaborates principles that differentiate qualitative from quantitative and/or experimental research designs – for example, it allows an emergent research design, and authorizes researchers to avoid the legalistic relationship implied by a signed consent form – it will force REBs to be more sensitive to the protocols of qualitative methods. To the extent that it adequately captures qualitative approaches, it may serve as an example of the sort of experience and expertise that is required on REBs that review qualitative research. However, if REB members use the chapter on qualitative methods as a "Coles Notes" course enabling them to claim that they have developed that expertise, we will all be in trouble.
Palys and Lowman are less sanguine about TCPS2's efforts to combat "the inappropriate imposition of biomedical practices and solutions that may make sense in relation to biomedical/experimental research, but would be epistemologically inappropriate and sometimes unethical in a more qualitative field-based context."
Though senior university officials, such as vice presidents for research, are prohibited from attending REB meetings, their appointees can and do. How does this prevent conflict of interest?
REB "community members" are supposed to represent the perspective of research participants, but they are never recruited from the ranks of homeless persons, intravenous drug users, drug dealers, sex workers, and prisoners studied by criminologists.
TCPS fails to give adequate "guidance about when establishing multiple REBs would be desirable," so that qualitative researchers may still find themselves at the mercy of quantitative, medical researchers who do not understand the work they are reviewing.
Still, they end on a hopeful note. While TCPS2 is flawed, it is an improvement over TCPS1. And the three councils that created the policy statement can continue to collect feedback, eventually leading to an even better TCPS3.
I share their cautious optimism. The final version does include some troubling language. In their comments on an earlier draft, Palys and Lowman noted that it could promote "ethics creep" by "broadening the concept of 'welfare' to include not only the individual research participant but also everything of concern in that person's life world." The final TCPS 2 does just that, stating that the welfare of groups can also be affected by research. Groups may benefit from the knowledge gained from the research, but they may also suffer from stigmatization, discrimination or damage to reputation. Engagement during the design process with groups whose welfare may be affected by the research can help to clarify the potential impact of the research and indicate where any negative impact on welfare can be minimized. Researchers must also consider the risks and potential benefits of their research and the knowledge it might generate for the welfare of society as a whole.
On the other hand, chapter 10 does take pains to explain to REBs how qualitative researchers work, and the differences between their ethics and methods and those of biomedical researchers. REBs, it cautions, should accept projects that focus on just a few people, or people more powerful than the researchers. They can expect some researchers to produce "research that is critical of settings and systems, or the power of those being studied." Consent may be "dynamic, negotiated, and ongoing," rather than spelled out in advance. While some qualitative researchers may offer confidentiality, others (including oral historians) show "respect for the participant's contribution . . . by identifying the individual in research publications, or other means of dissemination of the results from the research." REBs should not expect fixed protocols, since "Specific questions or other elements of data collection may be difficult to anticipate, identify and articulate fully in the research proposal in advance of the project's implementation."
In short, TCPS2 calls on REBs to evaluate qualitative research in ways wholly unlike the ways they evaluate quantitative, biomedical research.
Whether that will happen is another question. Canadian researchers have told me that in practice, university REBs ignore the TCPS in favor of American-style ethical imperialism.
Nor has the Panel on Research Ethics explained why we need REB review of qualitative research in the first place. Forcing every project to go through the REB is a massive burden, even if the REB finds the right clause in TCPS2 that will allow the project to proceed as designed. If qualitative researchers had an established record of abusing research participants, and if REBs had an established record of preventing such abuses, that would be one thing. But in the absence of such evidence, I don't see why all of this is necessary.
Still, so far as recognition of ethical and methodological pluralism goes, I am inclined to regard TCPS2 as the state of the art. More sophisticated than the Belmont Report or equivalent documents in the United Kingdom or Australia, it suggests what can happen when social scientists are allowed to participate in discussions of research ethics, and when government bodies revise their guidance in light of experience.