“Administrative burden” is one of those phrases that always gets a reaction from the research ethics community. Although we strive daily to balance regulatory compliance, research integrity, and scientific progress, we often have investigators wanting a system with less regulatory strain. On September 22, 2016, PRIM&R provided a great resource to help identify and critically evaluate areas for improvement and move forward in that quest for balance by hosting the webinar Reducing Self-Imposed Regulatory Burden in your Animal Care and Use Program.
Speakers John Bradfield, senior director at AAALAC International, and Jennifer Perkins, director of the office of animal research oversight at UCLA, focused primarily on institutional rather than agency sources of regulatory impact, but noted that regulatory agencies tend to issue performance-based standards, leaving institutions to determine how to implement them. Often the result is excessive burden from over- or misinterpretation. Other global sources of self-imposed burden include risk aversion, “more-is-better” mindsets, universal application of all regulations, and overestimation of the benefits of policies and practices.
Perkins identified protocol review as a specific area of self-imposed burden and challenged attendees to critically review protocol forms and initial submission approval rates to find causes of unnecessary burden to both the IACUC and investigators. As a relative rookie in IACUC administration, I was particularly thankful for another simple but impactful recommendation: utilizing a standard review form for IACUC members to more consistently evaluate protocols.
On the topic of regulatory interpretation and dealing with noncompliance, Bradfield emphasized that self-imposed burden might be minimized by building in flexibility to protocols, avoiding a “police” mentality, and avoiding an overgeneralization of approaches for handling specific acts of noncompliance. Great examples of how to do this are empowering oversight personnel to help investigators address and correct honest mistakes “on-the-spot”, as well as using the Veterinary Verification and Consultation (VVC) process to quickly and easily allow PIs to make adjustments in protocols.
We can reduce self-imposed burden in our internal policies and procedures by capitalizing on expertise and familiarity with the regulations and by avoiding the mentality that an animal care and use program that exceeds the regulations is guaranteed to be a great one. Global application of all regulations to all vertebrate species without question is not required and may not actually improve animal welfare.
Finally, a simplified institutional compliance structure can alleviate self-imposed burden. For example, although the regulations mandate ongoing oversight of animal activities (post-approval monitoring), a formal program is not required. Additionally, administrative coordination of compliance committees (like IACUC and IBC), divisions, and facilities can greatly diminish institutional and investigator burden.
The webinar concluded with the take-home message that every policy, guideline, practice, and procedure we use in animal care and use programs comes at a cost, and those costs should be critically assessed before implementation. The impact on animal welfare, investigators, institutional research missions, and scientific conduct are key considerations to balance against the potential for noncompliance. Finding this balance is critical to maintaining an efficient animal care and use program that excels at ensuring ethical conduct while minimizing the burdens of compliance.
Mandy King is a Research Compliance Coordinator in the Office of Sponsored Projects Administration at Southern Illinois University and a member of PRIM&R’s Webinar Blog Squad.
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