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Accountability in Research
Ethics, Integrity and Policy
Volume 26, 2019 - Issue 8
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Articles

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

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Figures & data

Table 1. This table displays the results of general items. They include the items on the left side, the valuations above, and a summation of the values for the 14 AUP forms we analyzed on the right. General items posed address the logic of the 3Rs, such as ordering (1.5) and their clear articulation (1.1, 1.2, 1.3, 1.4, 1.6), as well as issues beyond the 3Rs that are nonetheless crucial for ethics evaluation, such as the social value of research (1.7), Purpose of Animal Use (1.8) and Category of Invasiveness (1.9). For the second item (1.2), asking if there is dedicated 3Rs section, forms that have a section with a concentration of 3Rs related questions and resources was considered sufficient for a “Yes.” Likewise for the items concerning subsections (1.4) and the order of subsections (1.5).

Table 2. This table addresses items related to database searches for 3Rs alternatives, including keywords used for the search and the results. Items are listed on the left side, and the 3Rs category that we applied the items to appear above. Four numbers displayed in the represent the number of “Yes (in 3Rs section),” “Yes (other section),” “No” and “Other” values respectively.

Table 3. This table displays the results of Replacement-specific items. Items are listed on the left side, and the 14 forms are classified on the basis of whether they addressed the item in a specific 3Rs section, addressed the item in a different section, did not address the item, or had questions that might on some readings be thought (albeit ambiguously) to address the item, which are counted as “Other.” Items address Replacement definitions (3.1) and examples (3.2) as well as Replacement-specific issues such as the justification of the animal model (3.3), possible alternatives (3.4), and the reasons for their rejection (3.5). Any form that asks the researcher generally to justify their choice of animal or species in relation to their goal and/or in the context of Replacement, satisfies the justification item (3.3). For the fourth Replacement item (3.4), identifying rejected Replacement alternatives, any form that asks researchers whether they “considered” alternatives fails to satisfy this item but is counted as “Other.” Questions asking “how” researchers considered alternatives, while better than those asking “whether” they have, are still considered too vague and count as “Other.” The reasoning behind this choice is described in more detail in the body of the text.

Table 4. displays the results of Reduction-specific items. Items are listed on the left side, and the 14 forms are classified on the basis of whether they addressed the item in a specific 3Rs section, addressed the item in a different section, did not address the item, or had questions that might on some readings be thought (albeit ambiguously) to address the item, which are counted as “Other.” Items address reduction definitions (4.1) and examples (4.2) as well as items that clearly address reduction specific requirements, such as the search for opportunities to share data (4.5) and tissue samples (4.7) and re-use animals (4.6). For the third item (4.3), which addresses the calculation showing that the fewest animals required for statistically significant results has been proposed, any form that did not ask for specific calculations to this end did not satisfy this item. With respect to the items addressing opportunities to re-use animals (4.6), any form that mentions animal re-use in the context of either sourcing animals or what happens after research is satisfies this.

Table 5. This table displays the results of Refinement-specific items. Items are listed on the left side, and the 14 forms are classified on the basis of whether they addressed the item in a specific 3Rs section, addressed the item in a different section, did not address the item, or had questions that might on some readings be thought (albeit ambiguously) to address the item, which are counted as “Other.” Items address Refinement definitions (5.1) and examples (5.2) as well as items that clearly address Refinement specific requirements, such as plans for mitigating pain and distress (5.4) and deviations from SOPs (5.5). Regarding the fourth item, which asks how the researcher plans to mitigate pain and distress (5.4), any form that asks which refinements are going to be included or that asks anything substantially similar to this will satisfy this item.