The IACUC at Great Eastern University (GEU) is commended for developing and promoting a robust Quality Assurance (QA) program. QA programs are able to assess the animal care program through direct engagement and evaluation with active researchers. A successful QA program employs qualified and educated evaluators who are knowledgeable on animal welfare and common research techniques. This allows the evaluator to have a “find it, fix it” mentality when noting easily correctable items. During a Post-Approval Monitoring (PAM) visit, the QA personnel should be able to assess and advise on topics such as: handling techniques, injection techniques, asepsis, needle and suture size and material, and anesthetic refinement. Their recommendations can either lead to improvements in laboratory procedures, and/or may necessitate a protocol amendment to further refine the research plan. QA programs such as this can be a majorly impactful portion of an animal care program.
Although having a skillful QA team is important, ultimately the responsibility for ensuring and empowering the QA program rests with the IACUC. In providing this oversight, the IACUC must make it clear what the outcomes of a PAM session could be. The IACUC at GEU cited Footnote 8 of the PHS Policy1, stating it allowed them flexibility to “fix” issues discovered during a PAM visit. However, Footnote 8 of the PHS Policy allows flexibility in institutions for how they conduct semi-annual inspections and program reviews (i.e., allowing consultants to perform these reviews). It is not, in these authors’ opinions, intended to allow staff members or individual IACUC members to “fix” potential non-compliance issues discovered during a PAM visit. It is, therefore, imperative that the IACUC outlines those items that may be corrected on site, those that may necessitate a protocol amendment, and finally those situations that clearly uncover protocol non-compliance. Non-compliance is something that must be reported to the IACUC for detailed evaluation at a convened meeting. The National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW) has provided guidance (NOT-OD-05-034) with examples on what constitutes reportable non-compliance2. The IACUC and the QA Program at GEU would do well to reference this notice in determining not only what is non-compliance, but also what should likely be reported as serious non-compliance to OLAW, if applicable.
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