Response to Protocol Review Scenario: Change to ensure compliance

I agree with the statement that “noncompliance is noncompliance,” which is why I feel that Great Eastern University's IACUC should change the protocol form to list animal strains instead of species alone. Noncompliance is a serious offense and should be avoided at all costs. Although the change may be perceived as extraneous work by the researchers now, it could help to ensure that investigators maintain protocol compliance. Protocol noncompliance may still occur, but it is within the IACUC's purview to put in place a method to safeguard investigators by minimizing the potential for noncompliance. By specifying animal strains and strain numbers, researchers will give the IACUC the information it needs to conduct a thorough review of proposed activities. The provision of this information also allows less opportunity for errors in procurement and animal use, thus lessening the chances for inadvertent noncompliance.

The Animal Welfare Act regulations¹ (AWARs, §2.31.e.1; §2.31.e.2), the Public Health Service Policy on Humane Care and Use of Laboratory Animals² (IV.D.1.b) and the Guide for the Care and Use of Laboratory Animals³ (the Guide) state that IACUC proposals should include a rationale for involving animals, identification of the animal species involved and its appropriateness for the proposed use and the approximate number of animals to be used. Additionally, §2.31.e.3 of the AWARs¹ requires that IACUC proposals include “a complete description of the proposed use of the animals.” Although the regulations do not specifically state that the IACUC must review and approve the use of a particular strain, these provisions implicitly require investigators to fully address their animal construct as it relates to the proposed experimental design.

The Guide³ states that “while the responsibility for scientific merit review normally lies outside the IACUC, the committee members should evaluate scientific elements of the protocol as they relate to the welfare and use of the animals.” Phenotypic assessment is necessary because it directly relates to the research outcomes and must be scientifically justified. Particularly, strain variances can pose the potential for genetically based developmental problems or leave an animal more susceptible to disease. Use of strains with these sorts of characteristics requires an outlined plan for addressing the potential pain and distress that might result from the phenotypic features. Researchers should consult the literature available for assistance in selecting the appropriate animal species and strain, as well as the appropriate control animals. Initial selection of an incorrect strain for the desired research can result in the unnecessary or inappropriate use of animals; therefore, it is critical for the IACUC to assess the proposed phenotype.

Inclusion of the animal strain is a requirement for Department of Defense proposals, as outlined in its Standard Animal Use Protocol Format⁴, and its presence as part of the protocol form positively contributes to the concept of best practices within an animal care and use program. IACUCs that strive to be proactive rather than reactive should seriously consider the potential benefits of including strain and number specifications as part of the protocol form.

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