The costs of animal research: origins and options.

Animal-based research comprises almost half of the portfolio of the National Institutes of Health (NIH). It is vital to the biomedical community but is encountering unprecedented challenges to its continued success. These challenges are related to technological advances in science and to specific aspects of the regulatory climate and costs of animal research. These are not abstract issues for the individual scientist. The costs for animal research may determine in which institution a scientist pursues his/her research and with whom he/she can, or cannot, collaborate. The National Allergy and Infectious Disease Advisory Council outlined many of these challenges in a resolution forwarded to NIH Director Varmus in February 1996. As scientists who deal with this issue daily, we highlight the origins and the potential solutions. Much current animal-based research focuses on basic biological mechanisms or host-agent interactions and requires specific pathogen free, genetically uniform rodents, especially mice. Many are designer animals that offer a unique opportunity to understand the function of specific genes or to create rodent models that are susceptible to human pathogens. Animals with induced mutations may be unusually susceptible to infectious agents including some previously considered inconsequential. These designer rodents require intensive health monitoring and more sophisticated husbandry; as a result expenses for equipment and specialized animal care have increased significantly. Historically, the NIH supported the infrastructure of animal resource programs as an essential component that protected federal investments in biomedical research. This support included grants to train veterinarians in specialties central to animal-based studies: research skills, laboratory animal medicine, and comparative pathology. Training grants now preclude substantive clinical training leaving a potential deficit in clinical support that can only be met by highly skilled professionals. Federal support for animal diagnostic laboratories (microbiology, virology, and pathology) also has been discontinued. Ironically, this has occurred as the need for diagnostic support to protect the health of designer animals has escalated. The animal diagnostic laboratories represented a financial partnership between the federal funding agencies and the biomedical community. As financial demands on institutions have increased, they find it difficult to fund these essential programs alone, despite their critical importance in support of animal health. An additional hidden cost has resulted from the growth of organismal approaches to molecular genetics, especially utilizing the achievements of the Human Genome Project. This growth also has brought many scientists with little or no background in animal research to animal-based studies. These individuals often require training by animal resource staff and veterinarians to prepare them to perform animal experimentation appropriately and to comply with regulations governing animal welfare. Animal welfare is a vital concern for the public and the scientific community; as a result, animal experimentation is heavily regulated. Regulatory agencies require extensive documentation of virtually all activities that involve animal use, entailing additional effort from investigators, administrators, and animal resource staff. Animal resource staff spend many hours reviewing required animal care protocols for institutional animal care and use committees, counseling and training scientists and their staff, providing veterinary medical care, monitoring compliance, and dealing with a myriad of details, inspections, and reports required by regulatory and accrediting agencies. Although regulations continue to proliferate, the cost: benefit ratio has not been adequately assessed scientifically, ethically, or financially by society, legislators, and regulatory agencies. Probably the single most damaging action to affect the cost of animal research was the federal government’s decision to consider research animal resource programs as “specialized facilities.” This action required that all the costs of operating such facilities must be excluded from the institution’s indirect cost recovery agreement and instead should be fully recovered from users. The rationale underlying this approach appears flawed, because other types of regulated research, for example, that using radioactive isotopes, are not treated in this fashion. Federal negotiators have implemented the “specialized facility” rule inconsistently in apparently comparable institutions. When it is applied, the direct costs of animal research soar—often more than doubling ([1][1]). Coupled with the federal government’s increasing efforts to drive down the recovery of the indirect costs of research, the effect on an animal care program can be devastating. Ongoing efforts by the National Center for Research Resources (NCRR) to standardize the methodology for allocating costs of animal use are an important step as are the ongoing discussions with the Office of Management and Budget (OMB) that seek to redress this targeting of animal research. The draft for cost analysis and rate setting is available for comment until 12 May 1997 ( ). We have responsibilities for the oversight of laboratory animal programs in major research institutions. As investigative scientists we applaud the opportunities presented by animal research; as research animal program and animal facility administrators, we strive to find ways to achieve them. We cannot do this alone. We seek partnership with fellow scientists who use research animals, institutional leadership, an informed public, and the federal government. To remove penalties from animal research and benefit animal welfare, we recommend that the revised standards of cost allocation by OMB be adopted promptly and that the designation as “specialized facilities” be removed from animal resource programs. Requiring institutions to allocate animal care costs comparably would create a level playing field; institutions could bench mark their costs and identify areas to improve efficiency based on local conditions. To further enhance animal welfare, we recommend that increasing funds be allocated to support animal health infrastructure especially for specialized animal populations. We know of no national forum to exchange views or seek workable and timely solutions. A workshop planned by the NCRR is an important step in this direction. However, we believe that it is important that the scientific community be aware of the obstacles to continued productive animal-based research and join in overcoming them. 1. [↵][2]Federal Register 60 , 7107 (1997). [1]: #ref-1 [2]: #xref-ref-1-1 "View reference 1 in text"