Avoiding an Overzealous Approach: A Perspective on Regulatory Burden

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.

Reforming Science: Structural Reforms

“…American scientists are increasingly burdened with regulations and administrative responsibilities that touch all aspects of research (20). Although some regulation is clearly necessary, there is a point at which the costs exceed the benefits.…”

Assessing the satisfaction and burden within an academic animal care and use program

“…The perception of burden of IACUC processes may be influenced by a variety of factors, such as the requirements for institutional training and safety requirements and the lack of user‐friendly software for completing other requirements. Numerous reports caution that compliance requirements, beyond that required by regulations and standards or any interpretive guidance by the regulatory agencies, adds a self‐imposed regulatory burden that can be costly in time and resources (12, 13, 17). With reductions in federal support and clinical revenue (23), most academic institutions are under budgetary pressure to increase efficiencies.…”

“…Although regulation and standards governing animal care and use is immutable, institutions have some flexibility in determining the processes instituted to achieve regulatory compliance (11)(12)(13). There are 2 approaches to regulatory compliance on each extreme, with a spectrum between these extremes that determines the nature of the processes adopted.…”

A Sample Postapproval Monitoring Program in Academia

“…The specific regulatory requirements and regulatory basis for PAM activity are discussed elsewhere in this issue (Bayne and Garnett 2008;Haywood and Greene 2008). Even so, considered against the backdrop of increasing scientific complexity and depth of regulations as well as selfimposed institutional policies, the responsibility of academic IACUCs to ensure adherence to all regulatory requirements is frequently challenging.…”