The document is a joint response from the Association of American Universities (AAU), the Association of Public and Land-grant Universities (APLU), and the Council on Governmental Relations (COGR) to the United States Department of Agriculture’s (USDA) 2016 Request for Information regarding the identification and reduction of regulatory burdens. The letter addresses the administrative challenges faced by research institutions, particularly the increasing regulatory workload associated with federally funded research. Citing various reports and surveys, including the Federal Demonstration Partnership’s finding that administrative requirements can consume up to 42% of a principal investigator’s research time, the letter highlights the disproportionate administrative workload in areas such as animal research, while recognizing the importance of appropriate regulations for ensuring safety and compliance.
The co-signing organizations recommend several measures to streamline USDA regulations without compromising the welfare of research subjects. Key suggestions include aligning USDA requirements for continuing review of animal research protocols with the triennial review standard set by the Public Health Service, limiting annual reviews to research involving higher risk (Category E), and adopting a risk-based, tiered approach to oversight, similarly utilized in human subjects research. They also propose less frequent, risk-based inspections for compliant institutions and express concerns over current inspection practices, including inconsistencies and excessive scrutiny of IACUC-approved protocols. The letter further advocates for alternatives to the mandated literature search for animal model alternatives, citing its high administrative cost and limited utility. The organizations emphasize their willingness to collaborate with the USDA to explore solutions that achieve regulatory compliance and animal welfare while reducing unnecessary administrative burdens.
