FASEB Comments on OLAW RFI Regarding Noncompliance Guidance

By: Naomi Charalambakis
Wednesday, May 10, 2023
On May 2, FASEB submitted comments to National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW) in response to the Request for Information (RFI) on prompt reporting of noncompliance. As the agency continues to implement the 21st Century Cures Act and identify ways to reduce administrative burden for animal researchers, the RFI sought to collect feedback on ways to clarify reporting requirements. The current guidance was last updated in 2005.

OLAW proposed updates to two sections of the current guidance: “Information to be Reported” and “Additional Examples of Situations Not Normally Reported.” In its comments, FASEB expressed support for the proposed change to eliminate Public Health Service award numbers on noncompliance reports because this information does not directly impact animal welfare or Institutional Animal Care and Use Committee (IACUC) functions. However, FASEB urged OLAW not to separate National Science Foundation award numbers from this change, as outlined in the RFI. Independent rules could cause confusion for investigators, especially those who may be funded by multiple agencies. 

Regarding changes to the “Additional Examples of Situations Not Normally Reported” section, FASEB appreciated the range of situations included in OLAW’s proposed list, as many of these instances frequently occur and do not compromise animal welfare. Nonetheless, FASEB recommended modifying the example related to animal injury due to social housing. Given the frequency of animal injury and separation that occurs with incompatible animals—particularly in rodents—FASEB suggested adjusting the example to state that housing-related injuries are only reportable if there is no IACUC-approved protocol or standard operating procedure in place. Deferring to local IACUC expertise ensures research proceeds continuously while optimizing animal welfare according to each species’ needs. 

View NIH OLAW’s progress to update animal research guidance and reduce administrative burden here.