In the Vancouver Olympics, Canada is tied for the most gold medals as of this writing. Will Canada also “own the podium” when it comes to providing a clear and effective voice for ethical human research?
Recall that, in a previous post, I mentioned that Canada was presently undertaking a major overhaul of its main research ethics policy- the Tricouncil Policy Statement. After issuing an intital draft, the panel charged with revising the document (PRE) released a second draft. In a few days, the comment period closes for this second draft. The policy will then be revised again and finalized.
I will be submitting comments on the new version, along with my research collaborators. Here are a few important problems that carry over from the previous version:
1) The draft, like the old version, does not quite get the foundations for research ethics right. As a consequence, principles like respect for persons or justice are made subservient to beneficence. This is not an obscure philosophical point: it sends a message to investigators and research ethics committees that these other principles matter less.
2) The application of justice in studies involving economically or socially disadvantaged populations is somewhat muddled. The draft defines justice in terms of what it is not, or what researchers should not do, rather than providing an affirmative description of what justice entails. Consider what it would mean if the application of “respect for persons” merely meant that researchers should avoid enrolling patients who did not consent, or that researchers should refrain from studies if risks are unacceptable.
3) The language on undue inducement has problems: The TCPS language implies that concerns about undue inducement arise out of a concern for risk (see point 1 above). It doesn’t. It is unethical to pay individuals to override certain moral commitments (in government, we call this bribery), even in the absence of risk to the individual.
4) The chapter on clinical trials sends conflicting messages, and seems to imply that it is ok for doctors and institutions to put patients at medical disadvantage by enrolling them in research. Hard to imagine, if this is accepted, how conscientious doctors could ever participate in research, much less refer their patients to studies. Of particular concern, the chapter on clinical trials seems like it is trying to accommodate the unethical standards established by the International Council on Harmonization’s Good Clinical Practice.
I hope the panel can correct these (and other) flaws, while preserving the many qualities contained in the proposed revisions. (photo credit: pmorgan 2004)
@Manual{stream2010-71,
title = {Canada Human Research Ethics Policies: Take 2},
journal = {STREAM research},
author = {Jonathan Kimmelman},
address = {Montreal, Canada},
date = 2010,
month = feb,
day = 26,
url = {https://www.translationalethics.com/2010/02/26/canada-human-research-ethics-policies-take-2/}
}
MLA
Jonathan Kimmelman. "Canada Human Research Ethics Policies: Take 2" Web blog post. STREAM research. 26 Feb 2010. Web. 11 Feb 2025. <https://www.translationalethics.com/2010/02/26/canada-human-research-ethics-policies-take-2/>
APA
Jonathan Kimmelman. (2010, Feb 26). Canada Human Research Ethics Policies: Take 2 [Web log post]. Retrieved from https://www.translationalethics.com/2010/02/26/canada-human-research-ethics-policies-take-2/
Since it’s issuance in 1998, Canada’s Tricouncil Policy Statement (Canada’s policy on the ethics of human research) has had an influence on the practice of research ethics that has outsized Canada’s population. The three research councils– CIHR, NSERC, and SSHRC– are presently revising the Tricouncil, and a few days ago, a revised draft was presented on the CIHR web site.
There is much to commend the newest version. There are also a number of disappointments. I won’t dwell on these here, however. Instead, I will focus on Tricouncil’s revised language on phase 1 and gene transfer research.
The revised Tricouncil contains a definition of phase 1 that, in my view, is somewhat outmoded and not much of an improvement on the old version. Both emphasize the role of phase 1 in toxicity and dose determination, but do not encompass the many other purposes to which phase 1 trials are put (e.g. for deciding whether to pursue phase 2, for gathering evidence of biological effects, etc.). On the other hand, the new Tricouncil requires prospective registration of all trials– including phase 1. And it contains a lengthy discussion of “therapeutic misconception,” which it defines as “the tendency of trial participants to believe that the primary intention of research tests and interventions is to provide a therapeutic benefit to the patient-participant.” The document urges research ethics boards and researchers to “emphasize which specific elements of a clinical study are required for research purposes, as well as the differences between research and the standard clinical care they might otherwise receive.” Bravo.
The new Tricouncil also, for the most part, replaces the old language of “gene therapy” with the more neutral “gene transfer.” In a section on “Gene Transfer,” the new draft warns about therapeutic misconception. It shrinks from any ethical statement on germline modification by deferrinng to Canada’s Assisted Human Reproduction Act. The remainder of the text notes the irreversibility of genetic alterations (not quite accurate), the potentially latent nature of gene transfer risks (a point I agree with), and states that research and ethical debate is evolving rapidly (a point I mostly agree with). Somewhat disappointingly, there is no mention of the need for centralized, transparent, or specialized review of such protocols.
On balance, these two sets of modifications are pretty good, though rather than anticipate the issues that are likely to arise in the next 5-10 years while this draft is in force, I worry a little that instead the draft represents a policy that I and others wish we might have had in the previous 5-10 years. Onwards and upwards! (photo credit: Studiolit 2006)
@Manual{stream2008-118,
title = {Northern Lights? Canada and the New Tricouncil Draft},
journal = {STREAM research},
author = {Jonathan Kimmelman},
address = {Montreal, Canada},
date = 2008,
month = dec,
day = 8,
url = {https://www.translationalethics.com/2008/12/08/northern-lights-canada-and-the-new-tricouncil-draft/}
}
MLA
Jonathan Kimmelman. "Northern Lights? Canada and the New Tricouncil Draft" Web blog post. STREAM research. 08 Dec 2008. Web. 11 Feb 2025. <https://www.translationalethics.com/2008/12/08/northern-lights-canada-and-the-new-tricouncil-draft/>
APA
Jonathan Kimmelman. (2008, Dec 08). Northern Lights? Canada and the New Tricouncil Draft [Web log post]. Retrieved from https://www.translationalethics.com/2008/12/08/northern-lights-canada-and-the-new-tricouncil-draft/
In the Vancouver Olympics, Canada is tied for the most gold medals as of this writing. Will Canada also “own the podium” when it comes to providing a clear and effective voice for ethical human research?
