United States should dramatically retool animal research rules, groups say

For years, scientists and universities have complained about the patchwork of U.S. regulations governing the welfare of animals used in research. Studies involving rabbits and larger mammals, for example, are overseen chiefly by the U.S. Department of Agriculture (USDA) in Washington, D.C. Federally funded studies of rats, mice, and birds are subject to different rules and a different overseer, the National Institutes of Health (NIH) in Bethesda, Maryland. Many privately funded animal studies, meanwhile, get relatively little federal oversight. “It’s a crazy quilt,” says Ross McKinney, chief science officer for the Association of American Medical Colleges (AAMC) in Washington, D.C.

Now, AAMC and three allied groups are pushing for sweeping changes to animal research rules. In a report released this week, the groups call for moving all oversight to a single, unnamed agency, conducting less frequent lab inspections, and giving researchers greater say in crafting new rules. The changes would ensure “that we’re protecting the research animals,” McKinney says. “But we want to do so in a way that’s consistent, coherent, and effective.”

The political climate is ripe for reform, with a new law calling for federal officials to streamline regulation of animal research and a White House that dislikes regulations. But many of the recommendations aren’t sitting well with groups concerned about animal research. “It’s clear this would negatively impact animal welfare,” says Kathleen Conlee, vice president of animal research issues at The Humane Society of the United States in Washington, D.C. The changes would water down government oversight, the critics charge, and give researchers too much say over how their work is regulated.

Congress launched the debate last year by passing the 21st Century Cures Act, which aims to accelerate biomedical research. One provision calls on the NIH director to work with USDA and the U.S. Food and Drug Administration in Silver Spring, Maryland, to find ways to reduce the “administrative burden” on U.S. researchers and institutions that use animals. More than 800,000 animals were used in 2016, according to USDA, including cats, rabbits, and primates. (That number does not include millions of rats, mice, and birds that are not tracked by the government.)

Under current rules, “We spend a lot of time documenting,” says Sally Thompson-Iritani, who oversees animal research at the University of Washington in Seattle and took part in a workshop that led to the report. She ticks off examples: A university committee must inspect animal facilities every 6 months, a process that takes 4 months at her university. USDA requires the university to review testing protocols every year, whereas NIH says every 3 years. To avoid violating either rule, everything gets an annual review. Researchers must submit testing protocols long before they get grants, then complete more paperwork if the protocols change. And, she says, scientists chafe at rules requiring them to check the literature for less invasive alternatives.

The report calls for easing many of the requirements. It seeks facility inspections by universities just once a year, for instance, and protocol reviews every 3 years. It also proposes that Congress amend the Animal Welfare Act to do away with annual site inspections by government officials, and instead focus inspections on facilities with problematic track records. And in a bid to cut paperwork, it urges exempting some kinds of experiments from full reviews by university committees, and doing away with literature searches for alternatives to testing. The goal, says Thompson-Iritani, “is getting scientists back to the bench doing their research, and animal care specialists getting back to their animals.”

Even some critics of the recommendations agree the current system could be more coherent. But they worry that the proposed changes would allow researchers to default to the least strict options. Conlee argues that, rather than doing away with the literature searches for alternatives, officials should be pushing for a more comprehensive look. And she dismisses calls to reduce inspections. “We don’t want fewer eyeballs on the institutions,” Conlee says. “If anything, there should be more.”

Critics are also wary of the report’s call for the White House to create a new advisory panel made up of animal researchers. It would scrutinize a broad array of reports and proposed rules from regulators before they are made public or finalized. That suggests researchers are “trying to stifle transparency, and make sure that their interests are met and not the animals’,” Conlee says.

Research groups, however, say they are simply trying to create mechanisms for better collaboration. “You could save a lot of people, both in government and in the research community, a lot of time,” says J. R. Haywood, a physiologist and assistant vice president of regulatory affairs at Michigan State University in East Lansing.

Patricia Brown, head of NIH’s Office of Laboratory Animal Welfare, says the agency will be talking with all sides as it moves to comply with Congress’s call to explore ways of cutting red tape. The agency faces a December 2018 deadline for its recommendations.

*Correction, 26 October, 4:30 p.m.: An earlier version of this article incorrectly stated which office Patricia Brown leads. It is the Office of Laboratory Animal Welfare.