Washington Update

FASEB Submits Comments to OLAW on Guide Departures

By: Naomi Charalambakis
Thursday, October 14, 2021

On October 5, FASEB submitted comments to the National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW) in response to a Request for Information (RFI) regarding reporting requirements for departures from the “Guide for the Care and Use of Laboratory Animals.” Developed by the National Academies, the Guide serves as a resource for research institutions in developing and managing their animal care programs. FASEB’s response builds on previous recommendations to OLAW as federal agencies seek to reduce administrative burden in animal research, a key aim of the 2016 law, the 21st Century Cures Act.

The process of reporting deviations from recommendations in the Guide represents one of the leading sources of administrative burden because reporting requirements differ for the Guide’s “must,” “should,” and “may” recommendations.  Institutional Animal Care and Use Committees (IACUCs) must approve potential deviations and subsequently report this information either in semiannual reports or directly to OLAW, depending on the nature of the departure. To simplify the reporting process, FASEB recommended OLAW eliminate the requirement to disclose “should” statement departures because “should” statements represent strong but not mandatory recommendations. Eliminating this requirement would allow IACUCs to apply their discretion to update protocols in a way that maximizes animal welfare.

In its response, FASEB emphasized how the complex reporting structure undermines the role of IACUCs and, more importantly, does not enhance animal welfare. Researchers and IACUCs employ multiple mechanisms to ensure the best possible animal care, including post-approval monitoring and routine veterinary check-ups. Additionally, FASEB’s comments highlight how animal research regulations should be consistent with Public Health Service Policy—the set of laws administered by OLAW that establish appropriate standards for animal care and use—which integrates a level of flexibility for institutions and IACUCs to apply regulations according to their individual needs.

Comments on the RFI close November 1. Other strategies to reduce administrative burden are available in FASEB’s report, “Reforming Animal Research Regulations.”