Both the Animal Welfare Act (AWA) and its policies1 and the eighth edition of the Guide for the Care and Use of Laboratory Animals (the Guide)2 have the inherent intention for an animal research institution to self-govern and regulate its animal care and use program (Program). An IACUC is, within the scope of federal guidelines and regulations, required to create its own regulations, the Program's regulations. The extent of this self-regulation is determined by the committee, its members and the Institutional Official.

The IACUC, as per AWA and the Guide, is not required to approve Standard Operating Procedures (SOPs) in the animal facility. In this respect, Koul's opinion is right. But the IACUC can approve SOPs, if it decides that this task is part of its duty as the overseer of the Program.

Covelli is correct that the IACUC is responsible for overseeing not just research protocols but the whole Program. The Guide defines the Program as “the activities conducted by and at an institution that have a direct impact on the well-being of animals...”2. Animal husbandry and any SOPs detailing animal care and management are part of the Program and thus within the scope and responsibilities of the IACUC.

Given the previous information, the IACUC has the authority to create a policy requiring committee approval of any SOP in the animal facility. Koul is wrong and Covelli is right, as long as he has the committee's support. Covelli cannot unilaterally decide that the IACUC is required to approve the SOPs; the whole committee should approve such a policy. It is also true that the IACUC will not be held accountable by regulatory entities such as USDA, OLAW or AAALAC International for approving any SOPs; it is not a written regulation.

On the other hand, I feel it is important for animal research facilities to have an organizational 'culture' that emphasizes animal care and welfare; this goes hand in hand with trusting their hiring process and the animal care professionals they hired. A self-created policy that requires the IACUC to review all facility SOPs before implementation could put animal care and welfare at risk, because of the bureaucracy and time involved with IACUC approval of a modification to an SOP. We know that this happens; a facility manager, veterinarian or other staff member might make decisions that deviate from SOPs in order to assure animal welfare or accommodate an unforeseen situation. There must be a process to allow for such short-term decisions.

The NIH looked into this matter some time ago, concluding that if regulations become excessive, the work culture may change to circumvent the spirit of the law rather than trying to comply with it. This issue plagues larger organizations, resulting in less compliance with increased regulation.

Finally, IACUCs are required to inspect their facilities and review their Program Description at least twice per year; these inspections (adding reports and complaints from users or care staff) are very good opportunities for the committees to identify adverse situations and reevaluate how things are done, thus triggering SOP reevaluations.

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