Dale William E
Animal Care Quality Assurance, Animal Sciences Research Center, University of Missouri, Columbia, MO 65211, USA.
ILAR J. 2008;49(4):393-401. doi: 10.1093/ilar.49.4.393.
Postapproval monitoring (PAM) of research animal use is becoming increasingly common, and the compliance office plays a leading supportive role for the institutional animal care and use committee (IACUC) in implementing PAM at many institutions. Several other groups--higher administration, veterinary and husbandry staff, scientific staff, and occupational health and safety--are important participants in the process, and the compliance office should strive to work collegially with them as a team that facilitates research while meeting compliance requirements. Maintaining a cooperative and open attitude and developing an interest in the science will enhance the research staff's trust in both the compliance office and the PAM program. Resources required by the compliance office to oversee PAM include adequate physical facilities, funding, personnel, and time. Of these, appropriately trained quality assurance coordinators who have the requisite interpersonal and communication skills to interact constructively with researchers are vitally important. Education is key to minimizing the possibility of postapproval noncompliance, and the director of the compliance office, together with the quality assurance coordinators, should assume responsibility for teaching the IACUC, research staff, and higher administration about compliance requirements as well as correct practices and improved techniques. Postapproval noncompliance will occur despite even the best-run PAM program, and adequate documentation and communication will be necessary to address it. The compliance office, on behalf of the IACUC, should assume a primary role in facilitating the institutional response to noncompliance.
对实验动物使用的批准后监测（PAM）正变得越来越普遍，在许多机构实施PAM的过程中，合规办公室对机构动物护理和使用委员会（IACUC）发挥着主要的支持作用。其他几个群体——高层管理人员、兽医和饲养人员、科研人员以及职业健康与安全人员——都是这一过程中的重要参与者，合规办公室应努力与他们合作，作为一个团队共同促进研究，同时满足合规要求。保持合作和开放的态度并对科学产生兴趣，将增强研究人员对合规办公室和PAM计划的信任。合规办公室监督PAM所需的资源包括充足的物理设施、资金、人员和时间。其中，经过适当培训、具备与研究人员进行建设性互动所需人际和沟通技能的质量保证协调员至关重要。教育是将批准后违规可能性降至最低的关键，合规办公室主任应与质量保证协调员一起，负责向IACUC、研究人员和高层管理人员传授合规要求以及正确的做法和改进的技术。即使是运行最好的PAM计划也会出现批准后违规情况，因此需要有充分的文件记录和沟通来处理。合规办公室应代表IACUC，在促进机构对违规行为的应对方面发挥主要作用。
