Thursday, January 22, 2009

Canada Considers a New TCPS

The Research Ethics Blog alerted me to the relase of the Draft 2nd Edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS), Canada's manifesto of research ethics. The document is strong in its recognition of critical inquiry. But it is weak in establishing mechanisms to meet its stated goals of proportionate review and reasoned decision-making. It fails to address some of the key concerns in the 2004 report, Giving Voice to the Spectrum, and threatens to leave social scientists not much better off than they are today.

Valuing Critical Inquiry

The new draft recognizes differences among the various activities that go by the name "research." Like the Belmont Report, it offers three core principles: concern for welfare, respect for autonomy, and respect for the equal moral status of all humans. Unlike Belmont (and particularly unlike 45 CFR 46), it recognizes that

these principles are not absolute. They may, at times, conflict. They do not apply in all circumstances, to all types of research, as is set out in the following chapters. How they apply and the weight to be accorded to each one will depend on the nature and context of the research being undertaken. (2)

Such insight is elaborated in sections on social research. In particular, the draft Statement embraces "critical inquiry," in passages longer and stronger than those in the existing Statement:

Research based on critical inquiry – focusing, for example, on public policy issues, modern history, or literary or artistic criticism – may involve interaction with living individuals, notably through interviews. Where the aim of the researchers is to engage in a critical examination of a body of artistic work, a public policy, other comparable types of work, the role of the REB should be limited to ensuring that researchers conduct their work respecting the professional standards of their discipline(s) or field(s) of research. The need to ensure freedom of inquiry and to protect the ability of researchers to criticize the work (or organization, political party, corporate enterprise, etc.) they are examining takes precedence over the need to protect individual parties from harm. (9)

Alas, the authors of the draft are inconsistent in their understanding of the role of critical inquiry. They write,

In certain areas of research in the social sciences and humanities, such as political science, economics or modern history (including biographies) . . . the purpose of the research may be to cast a critical eye on organizations, political institutions, or systems or individuals in public life. The outcome of these types of research may harm the reputation of public figures or institutions in politics, business, labour, the arts, or other walks of life. Such harm may, however, be an unavoidable outcome of research that seeks to shed light on or to critically assess the work of a public figure or institution. Where the purpose of the research is to advance knowledge about the workings, for example, of a public office or a public figure, the risk–benefit analysis by the REB should focus on whether the approach they have adopted respects the professional standards of the researcher’s discipline or fields of research. Just as a bruise is an unavoidable risk of research that requires a needle-stick, so harm to reputation is an unavoidable risk of certain types of social science inquiry, and it must be treated as such. (14)

That's fine until the last sentence, which suggests that the authors don't understand critical inquiry at all. A bruise is an unfortunate byproduct of a needle-stick. A harm to reputation is often the deliberate objective of critical inquiry. The trick, William Potter, is not minding that it hurts.

Seeking Proportionality

The draft Statement concedes that too much review can be a bad thing, stating that

The scope and intensity of ethics review should be proportionate to the level of risk involved. When those involved in the review of research tailor their level of scrutiny to the level of risk, they reduce unnecessary impediments and facilitate the progress of worthwhile and ethical research. This is the crux of proportionality, and it is a message that recurs throughout this Policy.

It is equally important that ethics review be appropriate to the disciplines, fields of research and methodologies of the research being reviewed. This means that REBs must understand the discipline and methodology under review and be able to assess the research on its own terms. (5)

To give researchers a fair shot, the Statement insists that "at least two members should have the relevant knowledge and expertise to understand the content area and methodology of the proposed or ongoing research, and to assess the risks and benefits that may be associated with the research," and that it seek ad hoc advisors when necessary. (58) It even requires "an established mechanism and procedure in place for entertaining appeals" (69), even permitting ad hoc appeals board, something forbidden by the existing statement.

Unfortunately, the draft does little to ensure "a proportionate approach to ethics review" or even to consider what that means. There's nothing in the statement to suggest that ethics boards are uniquely suited to uphold ethical standards, or that they are necessary for all kinds of human subjects research. So why must all research pass through an REB? While the idea of proportionality recurs throughout the document, when we get to its actual application (p. 63) we find only two levels of review: delegated REB review of minimal-risk research, and full REB review of everything else. A two-speed transmission is not very proportionate.

Giving Voice to the Spectrum called for "different approaches to ethics review that would allow REB blanket approval of programs of research based on the overall ethics strategy of the researcher (or team of researchers), within specified parameters" as well as "exemptions from review for social science and humanities research that involves standard practice in the discipline involved." (6)

Along these lines, a more proportionate system would allow for several levels of review, e.g.,

1. No review--for activities even a middle-schooler can do (e.g., conversations with family members)
2. Researcher certification--for activities where the key thing is to be sure the researcher is familiar with professional standards. The draft itself suggests that this is appropriate for much interview research.
3. Departmental committee review.
4. Delegated review.
5. Full board review.
6. Full board review plus outside consultation--for the riskiest research.

Another problem with proportionality is its dependence on the threshold of "minimal risk," which doesn't map well onto the type of critical inquiry that the policy seems to endorse. As noted above, the draft states that "where the aim of the researchers is to engage in a critical examination . . . the role of the REB should be limited to ensuring that researchers conduct their work respecting the professional standards of their discipline(s) or field(s) of research." That would seem to imply that the intent of the research, as well as its level of risk, should determine the level of review.

Ignoring Evidence?

Another big concern is that the document makes no requirement that REBs base their decisions on empirical reality. Giving Voice to the Spectrum called for "a shift in onus where, in order to require changes to a research proposal, an REB would be obliged to explain what identifiable harm has not been addressed, and how their proposed solution will ameliorate the problem." (6) That has not happened.

Article 6.13 of the draft provides that "the research ethics board shall function impartially, provide a fair hearing to those involved and provide reasoned and appropriately documented opinions and decisions." But what does "appropriately documented" mean here?

The 2005 TCPS also required "reasoned and well-documented decisions" (Article 1.9). But much conflict between REBs and researchers takes place when they cannot agree on what is meant by reasoned and documented. For example, when Tony Porter wanted to do some interviews about the governance of research ethics, his REB demanded that it be allowed to scrutinize the questions in advance, looking for some mysterious risk. Would such behavior count as a fair hearing with reasoned and appropriately documented opinions and decisions? Are boards empowered to dream up fantastic risks? Or should the standard be higher, demanding that ethics boards operate according to scholarly standards, and document the risks that they attribute to a project?

Again, compared to the Belmont Report, the ethics sections of this new TCPS are relatively nuanced, reflecting long thought and the input of a great many scholars. I'd like to see American universities list the TCPS as the "statement of principles" on their Federalwide Assurances. (See The Dormant Right to Ethical Self-Determination".) But by assuming the need for board review, and by failing to set standards for board decision-making, the draft leaves research vulnerable to the "unnecessary impediments" it seeks to eliminate.

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