The document is a formal submission of comments from three leading organizations—the Association of American Medical Colleges (AAMC), the Council on Governmental Relations (COGR), and the National Association for Biomedical Research (NABR)—in response to an NIH Request for Information (RFI) regarding the clarification of reporting requirements for departures from the Guide for the Care and Use of Laboratory Animals. The associations emphasize the critical role of animal research in advancing science and medicine and express support for regulatory reforms that protect animal welfare while also reducing unnecessary administrative burdens on researchers and institutions. Drawing on Congressional intent as articulated in the 21st Century Cures Act, the associations argue that current NIH efforts, while useful, do not go far enough and call for more comprehensive reform to streamline regulations without compromising animal welfare or research integrity.
The letter’s primary recommendations include urging NIH and OLAW to avoid treating the Guide as a regulatory document, instead recognizing its intended purpose as a flexible reference, particularly regarding “should” statements, which are recommendations rather than obligatory requirements. The authors advocate for institutional flexibility and the use of professional judgment in adopting alternative strategies for animal care, and recommend that such alternatives not be classified or reported as departures or deviations from the Guide. They offer detailed critiques of specific language within the RFI, suggesting modifications to ensure consistency with both the spirit and letter of relevant policies and the Guide itself. The letter concludes by highlighting the necessity of aligning regulatory requirements with the goal of eliminating inefficiencies, thereby enabling responsible, self-regulated, science-based animal research. The associations reaffirm their commitment to ethical research and request further engagement to address these concerns.
