Online Issues

Journal Vol 49 (4)

Program Oversight Enhancements (POE): The Big PAM

Aaron Plante and Mary Lou James

Aaron Plante, MLAS, MJ, is an IACUC Compliance Specialist at Wyeth Research in Collegeville, Pennsylvania. Mary Lou James, BA, LATG, is a consultant in regulatory compliance and research animal welfare in St. Louis, Missouri.

Address correspondence and reprint requests to Mr. Aaron Plante, IACUC Compliance Specialist, Wyeth Research, 500 Arcola Road, Collegeville, PA 19426 or email plantea@wyeth.com.

Abstract

Federal animal welfare regulations and policies require compliance during animal research. But the methods used to oversee, assess, and ascertain compliance are left in the hands of the research institution and its institutional animal care and use committee (IACUC). Differences in institutional cultures, research goals, individuals responsible for animal care and use activities and oversight, and availability of financial and personnel resources have given rise to a variety of institution-specific mechanisms for ensuring compliance with the federal requirements and specifically with IACUC-approved animal research activities. In recent years one such mechanism, postapproval monitoring (PAM), has risen in popularity. An often cited topic in animal welfare–related conferences and periodicals, it is well on its way to becoming a compliance standard. However, it is but one mechanism for ensuring postapproval compliance and is not required by the federal animal welfare regulations. In this article we describe alternative mechanisms for ensuring compliance with IACUC-approved animal research through the use of program oversight enhancements (POE) in the context of an institution's animal care and use program. We present these enhancements in a way that allows readers to pick and choose those of interest. While these methods may not be feasible at all institutions, adopting even a few should improve a program's ability to ensure compliance with approved animal research and reduce the need for an aggressive and formal postapproval monitoring process.

Key Words: compliance; institutional animal care and use committee (IACUC); institutional official; postapproval compliance; program oversight enhancements; postapproval monitoring (PAM)