The cost of self‐imposed regulatory burden in animal research

Abstract

U.S. federal regulations and standards governing the care and use of research animals enacted in the mid- to late 1980s, while having positive effects on the welfare and quality of the animals, have resulted in dramatic increases in overall research costs. In addition to the expenses of housing and caring for animals according to the standards, establishing the requisite internal compliance bureaucracies has markedly driven up costs, in both institutional monetary expenditures and lost research effort. However, many institutions are increasing these costs even further through additional self-imposed regulatory burden, typically characterized by overly complex compliance organizations and unnecessary policies and procedures. We discuss the sources of this self-imposed burden and recommend strategies for avoiding it while preserving an appropriate focus on animal well-being and research success.

Postapproval Monitoring Practices at Biomedical Research Facilities

“…12 Another interesting finding was that during this current era of concern regarding 'regulatory burden,' there were generally few differences between the IACUC-approval mechanisms and PAM programs between USDA-regulated species and mice and rats. 18,19 As previously discussed, 81% of responding institutions used the same scoring system for potential pain/distress in mice and rats, despite the unregulated status of Mus musculus or Rattus norviegicus. We noted the practice as an encouraging sign that institutions were generally using similar ethical considerations for the welfare of mice and rats as for 'higher-order' species.…”

“…3 Researchers are commonly concerned about regulatory creep and the perception of an increasing regulatory burden. 18,19 One reason why governing standards avoid being prescriptive and have thus far empowered institutions to establish their own customized PAM programs that suit their research portfolios has been to limit unnecessary self-imposed regulatory burden by research institutions. 4,9,19,22 An institution's ability to customize the PAM program to appropriately balance regulatory burden with compliance, in combination with a strong PAM program's ability to mitigate noncompliance before it becomes a major regulatory issue, makes PAM a valuable tool for the IACUC to use in efforts to decrease self-imposed regulatory burden.…”

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.…”

“…However, each of these processes needs to be examined so the cumulative burden can be minimized. Any additional time beyond what is required to maintain compliance, whether before or after IACUC approval of a protocol, decreases the time that investigators can devote to their research efforts (17).…”

“…There are 2 approaches to regulatory compliance on each extreme, with a spectrum between these extremes that determines the nature of the processes adopted. One approach is to increase oversight beyond what is required from a regulatory standpoint, which may reduce risk for the institution but will increase costs and add burden to the investigators (9, 14–17). The alternative approach is to apply minimal regulatory oversight, within compliance boundaries, which will bring cost saving and less burden but may increase risk.…”