Groups Urge Streamlining Animal Research Oversight

Cover of the Reforming Animal Research Regulations: Workshop Recommendations to Reduce Regulatory Burden report Prominent research organizations recently issued recommendations for promoting greater efficiency in the oversight of animal research. Reforming Animal Research Regulations was based upon an April 17, 2017 workshop convened by the Federation of American Societies for Experimental Biology, Association of American Medical Colleges, Council on Governmental Relations, and the National Association of Biomedical Research. The goal of the workshop was to “provide actionable recommendations for promoting regulatory efficiency, animal welfare, and sound science.” Participants included research scientists, laboratory animal veterinarians, institutional officials responsible for research compliance, and science policy experts. The report reflects their consensus on best approaches to improve upon conflicting, outdated, or ineffective oversight policies.

The report includes numerous recommendations for simplifying regulations and policies issued by the National Institutes of Health (NIH) and the U.S. Department of Agriculture (USDA), which are the primary federal agencies involved in the oversight of federally-funded biomedical research. It also contains several recommendations for dealing with regulatory processes that are directed towards the White House and its Office of Management and Budget (OMB). Other recommendations that would require changes to current law are directed towards Congress.

Reforming Animal Research Regulations recommends that both NIH and USDA establish a risk-based process for reviewing animal research protocols, similar to the one in place for reviewing research protocols involving human subjects. The goal of this change is to expedite Institutional Animal Care and Use Committees (IACUC) review of studies involving low-risk, noninvasive, or minimally invasive procedures.

The report points out that the Guide for the Care and Use of Laboratory Animals “is not a regulatory document” and urges NIH’s Office of Laboratory Animal Welfare (OLAW) to “use the Guide as it was intended, namely, ‘to assist institutions in caring for and using laboratory animals in ways judged to be professionally and humanely appropriate.’” The report notes that the Guide “allows facilities to produce welfare outcomes for animals in diverse and innovative ways by permitting alternative strategies to ‘should’ statements upon approval by the IACUC.” Accordingly, the report recommends that OLAW revise its policies to state that IACUC-approved alternatives to “should” statements in the Guide will no longer be “deemed departures or deviations” from acceptable practice.

The report calls upon the USDA to revise the language of its Animal Care Policy #12 regarding literature searches. It points out that the Animal Welfare Regulations gives the IACUC the responsibility of ensuring that the principal investigator has “considered alternatives to procedures that may cause more than momentary or slight distress or pain,” and that the regulations only require that the investigator provide “a written narrative description of the methods and sources” used. The report also urges USDA to revise its Animal Care Policy #14 to permit multiple survival surgeries at the discretion of the IACUC when justifiable for scientific and animal welfare reasons. This change reflects the intent of the language in both the Animal Welfare Act and the Animal Welfare Regulations. In addition to reducing regulatory burden, this change would also enable researchers to reduce the total number of animals needed for research.

Perhaps the most sweeping recommendation asks the White House and OMB to explore the possibility of “[harmonizing] existing federal requirements for those species currently covered by USDA and those covered by the Public Health Service Policy on Humane Care and Use of Laboratory Animals to conform to the least burdensome standard while maintaining animal welfare.” The report also recommends that OMB consider requiring at least a 60-day comment period when federal agencies issue “interpretive rules” such as policies, guidance documents, or frequently asked-questions.