Deadline Extended for TCPS Comments

John Lowman kindly alerts me that Canada's Interagency Advisory Panel on Research Ethics has extended the deadline for comments on the draft second edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS). Comments will now be accepted through 30 June 2009, though the PRE encourages comments by March 31, since the next round of revision will begin in April.

An official announcement of the deadline extension is online at the PRE's French-language website. I could not find an English-language version on the PRE website, but the University of Western Ontario has posted one.

A form for online comments, and instructions for submitting comments by mail, fax, or e-mail, is online.

I have sent in a version of the comments posted on this blog. As I prefaced my comments to the PRE, I write as a non-Canadian. But the regulation of research ethics is an international endeavor. Just as TCPS draws heavily from the Belmont Report and 45 CFR 46, so can we expect TCPS to influence American policy and guidance. I therefore consider myself to have some stake in the outcome of the TCPS revision.

Canadian Criminologists Decry TCPS Draft

Back in January, I mentioned the release of the Draft 2nd Edition of the Tri‐Council Policy Statement: Ethical Conduct for Research Involving Humans, prepared by Canada's Interagency Advisory Panel on Research Ethics, or PRE.

Ted Palys and John Lowman of the School of Criminology, Simon Fraser University, kindly alerted me to their critique of the draft, or TCPS-2, as they term it. (They even more kindly cited this blog in their work.) They find that TCPS-2 "poses a significant threat to academic freedom in Canada." (3)

Their 20-page critique, "One Step Forward, Two Steps Back: Draft TCPS-2’s Assault on Academic Freedom," is all meat and no fat, and I recommend that it be read in its entirety. But here are a few salient points.

1. TCPS-2 Tells Researchers Not to Fight Subpoenas

TCPS 2 states that "researchers may face situations where they experience a tension between the requirements of law and the guidance of ethical principles. In such situations, researchers should do their best to uphold ethical principles while complying with the law." (p. 17, lines 598-602).

Palys and Lowman note that such advice yields what they consider to be the wrong answer to the only recent incident involving a Canadian social researcher who came into conflict with the courts: Russell Ogden's studies of assisted suicide. Palys and Lowman have written about that case at length, and they applaud Ogden's refusal to testify about information given to him after he promised confidentiality.

While I understand the authors' wish that TCPS-2 include room for such principled stances, I had some trouble following their critique on this point. The authors warn that "because it implies that when there is a conflict law must always prevail, Draft TCPS‐2 embodies a doctrine that represents a significant threat to academic freedom." (5) But they go on to note,

Of the hundreds of thousands of studies in Canada over the past few decades that collected personal information about one or more participants, we are aware of only one researcher who has ever received a subpoena from a third party seeking the disclosure of confidential research information, and he has received three. Three subpoenas in the history of all types of research in Canada. How many times was the subpoenaed researcher ordered to disclose information? Not one. (10)

If subpoenas for confidential information are rarely issued and never enforced, how can a requirement that researchers submit to the law be "a significant threat to academic freedom"?

Perhaps there are situations other than defending confidential information from subpoenas that would put social researchers in conflict with laws, but they are not detailed in the critique. If the policy fails only Russell Ogden, it is certainly a threat to his academic freedom, but a minor threat to academic freedom in Canada in general.

2. TCPS-2 Requires "Anticipating That Which Cannot be Anticipated"

Palys and Lowman complain that "Draft TCPS‐2 sets researchers an impossible task by requiring them to anticipate the unanticipated by requiring them to inform participants what they will do if they make incidental findings." (12)

For example, the TCPS-2 section on informed consent notes that

it is not always possible to anticipate with any specificity the nature of the incidental findings that may surface in the course of research. It is therefore not possible to inform prospective participants in anything but the most general terms of what the research may reveal, beyond the realm of the research question itself.

So, for example, social science researchers embarking on questions of a personal nature should inform prospective participants of the legal obligations they are under to reveal information concerning certain types of abuse. (p. 37, lines 909-916)

The two parts of this quotation contradict each other; the first requires only the "most general" warnings, while the second demands warnings "concerning certain types of abuse" that must be revealed.

Palys and Lowman explain how this contradiction could play out:

Consider what could happen if a Muslim student submitted an application to an REB [research ethics board] to interview other Muslim students about their encounters with non‐Muslims in Canada. Can the REB argue that these university‐age Muslims fit the demographic profile for possible terrorist activity? Can they require the student to put in a caution that, if her subjects tell her anything about terrorist involvements, she will feel obliged to report this to an authority? Criminologists at SFU [Simon Fraser University] sometimes encountered precisely this kind of problem when REB members, none of whom had any experience doing criminological research, sometimes brought outlandish stereotypes to the review process. (14)

Or,

Take, for example, the possibility of “incidentally finding” child abuse in research about coaching children’s sports. At the time of securing consent, the draft policy requires a researcher to say something like the following to each coach: “Even though my research is about coaching and I will treat what you say as confidential, if you tell me about situations where you abuse children, I will have to report you.”

Notwithstanding the way this approach appears to violate the principle of respect for participants — it treats all persons who have any contact with children as possible abusers — the ironic ethical consequence of treating informed consent as an absolute value rather than balancing it with other ethical principles is the harm‐perpetuating consequence of Draft TCPS‐ 2’s imposed limitation on confidentiality. If the researcher declares that he/she will report all incidents of child abuse, the chances are that any child abuser would not divulge that piece of information, with the result that the abuse continues. As abuse is not the focus of the research, an alternative ethical approach would be to say nothing. That way the researcher maintains respect for the participants’ integrity unless there is some concrete reason to do otherwise and would allow him/her to deal with the ethical dilemma of “incidental discovery” of child abuse at the point of discovering it unwittingly. (14)

Palys and Lowman are highlighting a structural problem in the TCPS-2: its assumption that prior review of a project can highlight the most significant ethical dilemmas. Ethics boards may make sense for lab experiments, but the PRE offers no reason to believe that they serve fieldwork. This brings us to the third point:

3. TCPS-2 Lacks a Factual Basis

Palys and Lowman note that

At least REBs have to justify their decisions. By contrast, Draft TCPS‐2 too often imposes “right answers” that do not reflect the diversity of the research enterprise, and offers no explanation for its recommended changes. To facilitate feedback, PRE should have provided an annotated draft. Because of its failure to do so the first time around, PRE should produce an annotated second draft TCPS‐2 explaining why it is recommending certain changes and inviting a second round of commentary . . . Can PRE provide any examples of incidental findings in social science research that resulted in a researcher violating confidentiality? If it cannot, why does Draft TCPS‐2 not walk its own talk by considering the degree of risk that is driving its approach to incidental findings? (15)

Worse still, while offering doubtful solutions to problems that may not exist, TCPS-2 fails to offer solutions to a problem that has been relatively well-documented: abuse of power by by research ethics boards. Palys and Lowman write that the Social Sciences and Humanities Research Ethics Special Working Committee's 2004 report, Giving Voice to the Spectrum,

reported many examples of social science researchers facing REB ethics creep and experiencing infringements of academic freedom as a result of REB activity that had little or nothing to do with ethics. Why does Draft TCPS‐2 spend considerable time outlining putative limitations to confidentiality for threats that have never occurred while doing nothing about REB policy violations and infringement of academic freedom that SSHWC documented? (17)

Though TCPS-2 provides some appeals, "the proposed appeal process also is highly inequitable: an REB can say 'no' in five minutes, while the appeal process can take a year or more, during which time the REB continues to function — and may continue to contravene policy — while the researcher is unable to proceed."

Unlike the authors of TCPS-2, who may have been presenting hypothetical harms, Palys and Lowman write from their own experience and that of their students.

In raising these questions, Palys and Lowman point to a much larger problem with TCPS-2 and its analogues in other nations: a lack of empirical investigation. TCPS-2 makes vague gestures toward empirical grounding, as when it claims that "history offers unfortunate examples where participants in research have been needlessly and at times profoundly harmed by research." (p. 1, lines 21-22) Maybe so, but good historians cite their sources, and the authors of TCPS-2 have not.

Sound policy relies on sound research. As Palys and Lowman note, there is nothing in the TCPS-2 to
suggest that its authors are sufficiently familiar with the real problems faced by social scientists to offer real solutions. They complain,

PRE’s strategy is that of an ethics deity imposing its own “right answers” rather than fulfilling its mandate to educate, promote discussion, respect disciplinary and methodological diversity, build consensus, and cultivate a culture of research ethics in Canada. (21)

If PRE is a deity, it is not omniscient. Let us hope it is not omnipotent either.