Breaking barriers to ethical research: An analysis of the effectiveness of nonhuman animal research approval in Canada

ABSTRACT

In Canada, all institutions that conduct publicly funded, animal-based research are expected to comply with the standards of the Canadian Council on Animal Care (CCAC). The CCAC promotes the use of animal alternatives, and uses the “3Rs” principles of Replacement, Reduction, and Refinement as a guiding ethical framework. To ensure these standards are strictly enforced, internal ethics committees at each institution are tasked with creating “Animal Use Protocol” (AUP) forms to be filled out by researchers and evaluated by the committees.

In this paper, we assess AUP forms from Canada’s top research universities to identify the extent to which they conform to, or advance, the 3Rs framework. Our results show various deficiencies that call into question the quality of information elicited by these forms. To remedy this, we recommend that the CCAC assume responsibility for creating a standardized 3Rs section to be used on all AUP forms. In addition, proposal forms and experimental results for all research at CCAC-certified institutions should be digitized and uploaded into a national database. We argue that this would offer higher quality information for researchers at the experimental design stage, while strengthening the CCAC’s mandate to be accountable to the Canadian public.

KEYWORDS:

• 3Rs framework
• Canadian Council on Animal Care
• research ethics
• nonhuman animal subjects
• public policy

Acknowledgments

The authors would like to thank Vaughan Black, Andrew Fenton, Paul Locke, an anonymous reviewer, and an audience at the Canadian Society for the History and Philosophy of Science meeting in 2019 for their helpful feedback. We also gratefully acknowledge support from the Social Sciences and Humanities Research Council of Canada, the Canada Research Chair in Bioethics and Philosophy and the Canada Research Chair in Environment, Culture and Values.

Disclosure statement

No potential conflict of interest was reported by the authors.

Notes

1. See Hughes (2003) for criticism.

2. This one exception came into effect in June 2019 with the passage of the Ending the Captivity of Whales and Dolphins Act. Now in order to conduct research on cetaceans in captivity a license must be sought from the province (Ending the Captivity of Whales and Dolphins Act, 2019).

3. We note that it is not at all clear on the face of it what might be meant by “less sentient.” The CCAC defines it as follows: “animals that current expert peer advice and interpretation of scientific evidence indicate have a significantly lower potential for pain perception, such as some invertebrates” (CCAC 2019e). Unfortunately, the care they show on this point is not universally exercised. When it comes to the use of the term “animal” they equivocate between a broad meaning, the biological taxon, and a narrower one, sentient animals. This is problematic as it muddies some issues, for instance, questions around what counts as Absolute versus Relative Replacement. Russell and Burch (1959) clearly limit their discussion to sentient animals, which at the time they took to include all vertebrates (6).

4. This would have the salutary side effect of pressing researchers to consider the 3Rs during the first step of the research approval process when they are applying for funding.

5. Our point here is, in effect, about the logical relationship between research with scientific merit and research that is ethical. It is possible that research that has considerable scientific merit might fail to be ethical, because the costs to the research subjects outweigh the epistemic benefits. It is not possible that research without scientific merit could be ethical as there is nothing to weigh against the costs (barring, of course, external considerations about things like the benefit to research assistants of having work). The question of whether scientific merit alone, often thought of as “knowledge for knowledge’s sake,” should outweigh most ethical considerations is actually a controversial one. Although we acknowledge the difficulty of weighing epistemic goods against other considerations, we do note that it is uncontroversial in human-based research that costs to research subjects are given primacy of place when evaluating research proposals.

6. The U15 comprises the University of Alberta, University of British Columbia, University of Calgary, Dalhousie University, Université Laval, University of Manitoba, McGill University, McMaster University, Université de Montréal, University of Ottawa, Queen’s University, University of Saskatchewan, University of Toronto, University of Waterloo, and Western University.

7. Given that the survey was conducted nearly a decade ago, it may be the case that efforts to promote awareness of 3Rs principles has reduced the number of researchers who are unable to provide accurate descriptions for each of the Rs. However, when AUP forms are created in a way that presupposes a level of competence that may not always exist there is a danger that the 3Rs will not be properly addressed.

8. The National Institutes of Health (U.S.) RePORT database is similar to the tool that we recommend creating (RePORT 2019).

9. The database PROSPERO (2019) uses a similar method to remedy the problem of publication bias across a wide range of disciplines. While it has been well-received, registration is not mandatory (Stewart, Moher, and Shekelle 2012).

10. The Netherlands is developing The Interspecies Database (2019), which serves a related purpose.

11. Frasch (2016) expresses similar concerns about the transparency and accountability for animal-based research in the US.

Additional information

Funding

This work was supported by the Canada Research Chair in Bioethics and Philosophy, the Canada Research Chair in Environment, Culture and Values; and the Social Sciences and Humanities Research Council of Canada [430-2016-00828].