Regulation and Review of Animal Research
Eric Sandgren, VMD,Ph.D., Director, UW–Madison Animal Care and Use Program
The Animal Welfare Act (a federal law) and associated Animal Welfare Regulations and Policies define legal standards that must be met by organizations using animals in research. The “Guide for the Care and Use of Laboratory Animals”, published by The National Academy of Sciences, sets guidelines that must be followed by organizations receiving Public Health Service funds.
The United States Department of Agriculture (USDA) enforces the Animal Welfare Act and Regulations and Policies. They are required to make unannounced visits to every registered facility at least once each year. They are required to follow up on all complaints they receive about animal care. The National Institutes of Health Office of Laboratory Animal Welfare (OLAW) monitors compliance with the “Guide”. They require each organization receiving Public Health Service funds to prepare and submit an Assurance, which describes that organization’s plan for meeting requirements of the “Guide”. The UW–Madison Assurance is 20 pages long (plus attachments).
The Association for the Assessment and Accreditation of Laboratory Animal Care, International (AAALAC) is a private, voluntary organization that evaluates in person how well an animal care and use program meets and exceeds criteria of the “Guide”. Accreditation indicates programmatic excellence. At UW–Madison, the College of Agriculture and Life Sciences, Graduate School, School of Medicine and Public Health, and Veterinary School are fully accredited.
An Institutional Official (IO) must be appointed who will take responsibility for the proper composition and functioning of the organization’s animal program and for compliance with all laws and Public Health Service policy. The IO for UW–Madisonn is Professor William Mellon, Associate Dean for Research Policy.
The Institutional Animal Care and Use Committee (IACUC) has primary oversight of animal care and use. IACUC membership must include at least one scientist with expertise in experiment design, one veterinarian experienced in care of research animals, and one unaffiliated member who is not associated with the organization (a lay public member). The IACUC must review and approve each proposed animal use before it can begin, and performs a comprehensive review of the organization’s animal program twice a year. Committee disapproval of protocols or findings of program deficiencies cannot be overruled by anyone. UW–Madison has 6 IACUC with a total of 57 voting members and voting alternates. 31 are faculty, 12 hold staff appointments, 8 are veterinarians, and 6 are unaffiliated members. The Chair of one committee is a Bioethicist.
Review of the Program of Animal Care and Use:
The animal program includes buildings, animal environment and management, personnel qualifications and training, occupational health of program staff, veterinary medical care, the IACUC, and the IO. The program is reviewed by at least three groups. USDA veterinarian visits registered organizations at least once each year, and review in person all aspects of program composition and functioning. OLAW examines and must approve an organization’s Assurance, which includes a comprehensive program description. It also performs occasional site visits. Each IACUC must review the animal program twice a year (we use an 8 page review guide document). IACUC-accredited units also are evaluated in person once every 3 years. Any of these groups can identify program deficiencies, which must be corrected by the organization. Failure to correct deficiencies can lead to closing of specific facilities or suspension of specific studies, fines, loss of accreditation, loss of research funding, or suspension of all animal activities.
Review of Proposed Animal Use:
Overall distribution of research funding is determined by the public, through direct giving to charitable organizations that fund research or through elected representatives who set priorities for federal funding agencies. Each specific proposed use of animals in research, teaching, or outreach must be reviewed and approved at two levels before that use can begin.
Funding agencies typically perform proposal review in two areas. Scientific review by a panel of 12 or more scientists ensures that the study being proposed constitutes outstanding science, and that animal use is necessary to accomplish the goals of the study. Specific review is focused on proposed use of animals. For example, the current “Vertebrate Animals” section of an NIH application requests the following information:
- a description of animal use to include species, strain, ages, sex, number, and concise but complete description of proposed procedures;
- explicit justification for animal use and choice of species and number;
- a general description of veterinary care, to include veterinary staff availability, their schedule of animal monitoring, additional monitoring relevant to proposed procedures, and indicators for veterinary intervention to alleviate discomfort, distress, or pain;
- detailed description of procedures to minimize discomfort, distress, pain, and injury;
- description, rationale for, and justification of methods of euthanasia. This section receives both scientific and administrative review at NIH. Proposal funding depends on appropriate answers to these questions.
An IACUC must evaluate and approve each proposed use of animals. Investigators prepare a protocol that outlines the study, describes its importance and significance, outlines all experimental procedures the animals will experience, and describes how pain and distress will be minimized and/or treated. At UW–Madison, most protocols that are reviewed go back to the investigator for additions or clarifications. The study can be started only after final approval is received. Ethical considerations are built in to each protocol review, as described in another document. UW–Madison has over 1000 active protocols.
Oversight and Compliance:
As for program and protocol review, oversight occurs at many levels. USDA veterinary inspectors always examine compliance. IACUC’s 3-year site visits include evaluation of compliance. At the local campus level, many individuals monitor compliance. Ongoing research occurs in the daily presence of animal care staff, research staff, veterinarians and veterinary technicians, and also IACUC committee members on semiannual facility inspections. All have access to approved animal care and use protocols. Systems are in place so that each member of the animal program team can ask questions or report concerns at any time. There are 3 program staff members who perform random or targeted spot-checks of animal studies and animal facilities across campus. Problems, including non-compliance, are addressed and must be corrected by IACUCs and/or University administration.