FASEB Comments on OLAW’s Semiannual Animal Program Reviews

By: Naomi Charalambakis
Wednesday, July 13, 2022
On July 12, FASEB submitted comments in response to the National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW) Request for Information (RFI) (NOT-OD-22-114) seeking input on flexibilities for conducting semiannual animal program reviews. NIH OLAW oversees compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, the policy that covers all vertebrate species in NIH-supported research. PHS Policy Section IV.B.1.-2 requires the Institutional Animal Care and Use Committee (IACUC) to review the grantee institution’s program for the humane care and use of animals in research twice a year. As part of OLAW’s efforts to reduce the administrative burden in animal research, the office offers a broad range of flexibilities for IACUCs to help conduct these reviews.

Recognizing that the program review requirement is burdensome for IACUCs, FASEB’s response extends appreciation for the availability of the seven outlined flexibilities. Additionally, FASEB offers specific feedback for the third flexibility regarding standard operating procedures (SOPs).  While we appreciate OLAW’s specification that SOPs do not need to be reviewed every six months but at least once every three years, FASEB’s comments emphasize that SOP review is particularly time-consuming for larger institutions whose SOPs can be thousands of pages long.

To address this, FASEB recommends OLAW rephrase the flexibility to include language that permits institutions to review SOPs that are unrelated to animal welfare on a more flexible, as-needed basis. This is particularly important given that nonanimal welfare related issues (e.g., equipment maintenance, painting schedules, etc.) fall outside the scope of the IACUC’s expertise yet consume a considerable amount of time to review. Providing IACUCs additional flexibility to review nonanimal welfare related SOPs on a schedule based on their institution’s individual needs will further lessen their administrative burden and enable them to focus efforts towards ensuring optimal animal care.

More information about the semiannual program review, including a downloadable checklist, is available on OLAW’s website.