AAMC, FASEB, COGR, and NABR Announce Groundbreaking New Report on Regulatory Burden

The 21st Century Cures Act instructs the National Institutes of Health (NIH) Director to work with the Food & Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) to identify ways the government can reduce regulatory burden on researchers. A new set of recommendations introduced today proposes changes to federal regulations, policies, and guidelines governing the use of animals in research. Directed to federal agencies involved in the oversight of federally funded animal research – primarily the NIH and the USDA – the recommendations aim to address the numerous conflicting, outdated, or ineffective regulations that do not improve animal welfare. The proposed changes would ensure that standards of care in animal research are maintained and would have the practical effect of promoting efficiency among researchers.

Today's report grew out of an April 2017 workshop convened by the Federation of American Societies for Experimental Biology (FASEB), the Association of American Medical Colleges (AAMC), the Council on Governmental Relations (COGR), and the National Association of Biomedical Research (NABR). The workshop participants sought to identify federal requirements that demand significant administrative effort but do not enhance animal welfare.

There have been numerous reports dating back nearly two decades that highlight the negative impact overly burdensome regulations have on biomedical research in the United States, and federal research dollars are being stretched more each day.

“The U.S. has long been a world leader in biomedical research and development. If we wish to remain competitive in a global research landscape, we must find ways to decrease burden on investigators,” said NABR President Matthew R. Bailey. “Scientists and the teams who support them shouldn't be spending nearly half their time filling out paperwork or attempting to comply with multiple requirements that each aim to accomplish the same goal in different ways. These recommendations examine ways in which efficiencies can be realized while maintaining the highest standards for animal welfare.”

The use of animals in research continues to be vital to understanding human and animal disease, and researchers take their commitment to the humane care and use of research animals seriously. The sponsoring organizations hope this report will aid federal agencies and Congress in reducing the significant inefficiencies in the animal research oversight process