he National Institutes of Health recently began seeking public input on revising laboratory animal research policies and regulations, a review mandated by the 21st Century Cures Act.
In coordination with the Food and Drug Administration and the Department of Agriculture, the agency is looking for ways to reduce the administrative burden researchers face, while protecting lab animals and maintaining the integrity of research results.
Public Responsibility in Medicine and Research, the nonprofit organization that I lead, along with other biomedical research stakeholders, agree that review and reform of federal policies for lab animal research in the U.S. are long overdue. But in this era of enthusiasm for deregulation, federal decision-makers must remember the important role that oversight plays in ensuring the humane care and use of lab animals. Here are four ways in which the government can ensure policy changes do not weaken animal welfare standards.
There should be one consolidated federal body for animal research oversight. The government should place all animal research oversight within a single federal entity that would put forth one set of guidance documents and regulations. This echoes a report released last year following an animal research regulations workshop, which representatives from my organization attended, organized by the Federation of American Societies for Experimental Biology (FASEB), the Association of American Medical Colleges, the Council on Government Relations, and the National Association for Biomedical Research.
This approach is likely to secure greater buy-in from the scientific community than the present system of separate but overlapping and redundant regulations that do not necessarily translate to better animal welfare. Currently, the NIH’s Office of Laboratory Animal Welfare oversees all NIH-funded research through the Public Health Service Policy; that policy covers all species of animals used in research funded by a Public Health Service agency. The USDA, in turn, administers the Animal Welfare Act and associated regulations; these federal regulations apply to any facility, regardless of funding source, conducting research with “regulated” animals, which do not include mice, rats, and birds. This means that the treatment of mice and rats — the largest group of laboratory animals by far — is subject to federal oversight and welfare standards only if the research is conducted or funded by Public Health Service agencies. The fact that funding source determines whether a species receives certain welfare considerations is ethically arbitrary and unjustified, and a consolidation of oversight could address this gap.
Policies should enforce the role of institutional review committees and veterinarians. New regulations should recognize and support the important role that Institutional Animal Care and Use Committees and attending veterinarians play in the oversight of animal research. Both the Animal Welfare Act and Public Health Service Policy require institutions conducting animal research to have a standing ethics committee charged with reviewing proposed research activities involving animals, overseeing an institution’s overall animal care and use program, and monitoring compliance with relevant regulation and policy, among other responsibilities. New federal policy should clarify that the committees and attending vets have ultimate authority for ensuring the ethical care and use of animals at the institutional level, and for determining whether the anticipated benefits of the particular research study justify the proposed use of laboratory animals, a balancing exercise that should always occur before research begins.
Any new federal advisory body should solicit a diversity of perspectives. The FASEB report recommends the government consult with experts from federally funded animal research institutions, including researchers, veterinarians, and Institutional Animal Care and Use Committee members, during its review of animal research regulations and policies. The report also proposes a similarly constituted group to permanently advise the government on regulatory burden issues in animal research. Public Responsibility in Medicine and Research agrees with these proposals, but further suggests that any advisory entities include independent animal welfare experts, ethicists, and nonscientists. The inclusion of these perspectives is essential to securing public support of animal research.
Any new federal oversight body should have the independence and authority to ensure the ethical conduct of research with animals. Level of effort and funding for the ethical conduct and oversight of animal research varies institution by institution. Furthermore, institutions and investigators are under pressure to secure funding and accelerate science — demands that are sometimes at odds with the ethical conduct of research. The FASEB report recommends that regular government inspections be eliminated in favor of an approach whereby frequency of inspections is determined by compliance history. Public Responsibility in Medicine and Research is concerned that if this specific recommendation is adopted, some institutions — including those with previously exemplary animal care and use programs that for one reason or another decline — may not receive appropriate oversight. To mitigate this risk, any new federal entity must have the legal authority and resources from Congress to effectively encourage and enforce compliance with animal welfare policies. It must also be functionally and financially independent from any agency that conducts or funds research.
The NIH is accepting public comment until June 12, and it will issue its recommendations this December. The time is right for thoughtful reform. We urge federal decision-makers and the research community not to let legitimate and important concerns about administrative burdens obscure the crucial role that regulations can play in promoting the ethical and humane use of lab research animals.
Elisa A. Hurley, Ph.D., is the executive director of Public Responsibility in Medicine and Research.