Online Issues

Journal Vol 49 (4)

Avoiding an Overzealous Approach: A Perspective on Regulatory Burden

J.R. Haywood and Molly Greene

J.R. Haywood, PhD, is Chair of the Department of Pharmacology and Toxicology and Assistant Vice President for Regulatory Affairs in the Office of the Vice President for Research and Graduate Studies; and Molly Greene, BA, CPIA, is IACUC Advisor in the Office of the Vice President for Research and Graduate Studies, both at Michigan State University in East Lansing.

Address correspondence and reprint requests to Dr. J.R. Haywood, Chair, Department of Pharmacology and Toxicology, B440 Life Sciences Building, Michigan State University, East Lansing, MI 48824-1317 or email haywoo12@msu.edu.

Abstract

The authors discuss the impact of regulatory burden on the research enterprise, with emphasis on animal care and use programs. They identify three sources of regulatory burden: specific requirements in law and regulation, interpretive requirements or "guidance" by regulatory agencies, and self-imposed regulatory burden resulting from institutional interpretations. Attempting to minimize the risks of noncompliance through the overzealous application of "requirements" does not necessarily benefit the animals. Balancing risks associated with animal research and burden in a successful program requires clear and consistent communication among all stakeholders—the institutional leadership, institutional animal care and use committee (IACUC), attending veterinarian and staff, and scientists. An evaluation tool is provided for institutions to assess their approach to required and voluntary activities in their animal care program. Drawing on the knowledge and experience gained in a combined 40 years of serving on, managing, training, and evaluating animal care programs, the authors conclude that institutions must thoughtfully balance their research and compliance needs to successfully maintain their institutional goals. They stress that a culture of compliance based on knowledge of the regulations, dedication to quality animal care, reasoned use of science-based performance standards, and the judicious application of professional judgment is the foundation for facilitation of research in the context of animal welfare and regulatory compliance.

Key Words: compliance; institutional animal care and use committee (IACUC); regulations; regulatory burden; risk assessment