Animal Subjects

(source: Responsible Conduct of Research Education Committee. (2007). Resources. Retrieved July 15, 2007, from http://www.rcrec.org/resources.htm)

Major biomedical research institutions, professional societies, and research scientists have a shared understanding of the tremendous value gained from studies using animal subjects. Similarly, polls of the general public repeatedly show support for biomedical research, and an acceptance of the need to perform studies using animals. However, this support is tempered by widespread misunderstanding about the nature of the research, as well as an impassioned opposition to any use of animals by some vocal action groups.

Most, but not all, researchers recognize the need to employ animal subjects responsibly. Yet some investigators perform studies that deviate from approved protocol, some provide inadequate care or feeding for animal subjects, and some leave animals poorly attended during recovery from anesthesia and surgery. None of these lapses is acceptable, and while it is hoped that they happen only rarely, they can occur at the hands of a poorly trained or inexperienced investigator.

Investigators who are irresponsible risk not just their own research project, but also the reasearch of others at the same institution. Potentially, they also risk the public's willingness to support or allow research with animal subjects.

Principles

There is no presumption that animals may be sacrificed for research. Animals should only be harmed if there is a legitimate scientific advantage to doing so, and even then, the harm should be as little as possible.

  • Replacement. When possible, conscious animals should be replaced with insentient material in research, and higher animals should be replaced with lower ones.
  • Reduction. Where it is without a loss of significance or precision, fewer animals should be used.
  • Refinement. Procedures should be designed so as to minimize the incidence and severity of harm to the animal subjects.

The scientific enterprise and the integrity of research depend on the responsible, humane treatment of animal subjects. An experimental design that results in pain and suffering often decreases, if not eliminates, the scientific value of the experiment. Furthermore, irresponsible or inhumane treatment of animals harms the reputation of scientific institutions, endangers funding, and threatens the public image of research.

Rules and Regulations

The use of animal subjects is covered by numerous regulations. Although many federal agencies have relevant regulatory controls, the two most important for biomedical research are the Public Health Service (PHS) and the United States Department of Agriculture (USDA). Institutions are given the responsibility to implement federal regulations primarily through the Institutional Animal Care and Use Committee (IACUC). The roles of these federal agencies and the institutional committee are summarized below.

Public Health Service

The Health Research Extension Act of 1985 ('Animals in Research') is the legislative basis for PHS policy on use of animal subjects. The policy covers uses of living vertebrate animals for any PHS-supported research, research training, and biological testing. PHS agencies include the National Institute of Health, the Centers for Disease Control and Prevention, and the Food and Drug Administration, as well as several others.

United States Department of Agriculture

Animal Welfare Regulations, and specifically the Animal Welfare Act (AWA), are implemented by the Animal and Plant Health Inspection Service (APHIS) of the USDA. The AWA covers the sale, handling, transport, and use of warm-blooded, vertebrate animals. At present, birds, rats and mice that are bred for research, but not those that are wild are specifically exempted from the Animal Welfare Regulations. The AWA incorporates a variety of requirements designed to promote animal welfare. These include minimization of pain and distress, consideration of alternative procedures, definitions of institutional responsibilities, and the establishment of IACUCs. In addition, institutions, businesses, or individuals covered under the AWA must be licensed or registered with APHIS. Facilities are inspected on an unannounced basis. If deficiencies are not corrected by the subsequent inspection, consequences could include fines, or the suspension or revocation of licensing to use animals.

Institutional Animal Care and Use Committee

Although institutions are subject to federal oversight and inspection, the daily responsibility for complying with federal regulations is largely the responsibility of the IACUC. Under PHS policy, institutions are granted the provisional responsibility for self-regulation after approval of an Animal Welfare Assurance by the Office of Laboratory Animal Welfare (OLAW). If the institution fails to meet its regulatory responsibilities, then OLAW can restrict or withdraw the assurance.

Guidelines

The PHS, USDA and IACUCs are the key components of a regulatory environment that promotes the principles described above. However, the ultimate responsibility for the ethical and legal use of animals in research rests with those who conduct the research. The following are guidelines for responsible conduct of such research:

  • Comply with regulations. This begins with the assumption that no procedure or study should be performed that is not explicitly part of an approved protocol.
  • Critically evaluate the use of animals. The responsibile use of animals requires that individuals give thoughtful consideration to what defines an acceptable use of animals. Factors to be considered include new understandings of the science involved, potential benefits of the use of animals, and possible alternative methods of study. A prerequisite for the responsible use of animals is a realistic examination of the intended and likely benefits of that use.
  • Protect animal welfare. The decision to use animals in research and teaching carries a responsibility for the welfare of those animals. That responsibility includes, but is not limited to: ensuring the use of appropriate and adequate anesthesia and analgesia; providing of appropriate feeding, care and protection from infection, pain or suffering; selecting humane methods for euthanasia; and obtaining adequate training to fulfill responsibilities for animal welfare.

If significant violations of animal use regulations are observed, then those observations should be reported to the appropriate people in the institution. This obligation is certainly for the sake of the animals, but it also helps to protect the integrity of the research, the status of the institution, and the institution's privilege for self-regulation.