December 15, 2017

 

 Groups seek combined oversight of research animals

Posted Nov. 29, 2017

Four organizations in research and human medicine support combining federal oversight over research animals.

In an Oct. 23 report, "Reforming animal regulations: workshop recommendations to reduce regulatory burden," the Federation of American Societies for Experimental Biology, Association of American Medical Colleges, and Council on Governmental Relations—with support from the National Association for Biomedical Research—propose combining and editing federal regulations, policies, and guidelines in ways they claim will reduce stress on organizations conducting research yet maintain animal welfare.

"Researchers take their commitment to the humane care and use of research animals very seriously, but there are numerous conflicting, outdated, or ineffective regulations that do not improve animal welfare," the document states.

A provision in the 21st Century Cures Act, signed into law Dec. 13, 2016, states that the Department of Health and Human Services and the National Institutes of Health "must review and revise policies, including policies on conflicts of interest and laboratory animals, to reduce the administrative burden on researchers while maintaining the integrity and credibility of research findings." The proposal published in October indicates that law provides an opportunity to pursue changes.

The Department of Agriculture enforces standards for treatment of certain animals by dealers, research facilities, and exhibitors. The NIH, through the Office of Laboratory Animal Welfare, oversees care of vertebrates in research, teaching, and testing activities funded by the Public Health Service.

October's report indicates regulations from the agencies are inconsistent or duplicative. Complying with all oversight requirements in federally funded research requires vast administrative effort, it states.

The organizations propose clarifying that guidance documents lack legal and regulatory force as well as reducing the reporting requirements for times when practices deviate from guidance. They also suggest considering the risks to animals and past regulatory compliance when determining what protocol reviews and inspections are needed.

The proposal is available as a PDF document at http://jav.ma/researchanimals.