Facilitating the Research Process: Limiting Regulatory Burden and Leveraging Performance Standards

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.…”

The Role of IACUCs in Responsible Animal Research

“…However, this can sometimes make it difficult to balance compliance with responsible research practices and the burden this compliance may pose to the IACUC and researchers. When this burden becomes disproportionately high, it can affect productivity in research and add to institutional expenses [39].…”