Postapproval Monitoring and the Role of the Compliance Office

Abstract

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.