Regulations Governing Research in the U.S.

Federal Laws, Budget Constraints Ensure Animals are used Prudently:

One of the most widely held misconceptions of animal research is that no regulatory system exists to protect the welfare of laboratory animals. It is common to hear animal rights activists claiming that scientists can do "anything they want" to laboratory animals without justification. Activists also imply that there is an endless supply of research dollars, and that scientists can qualify for funding simply by contriving an animal experiment that has not been tried in the past.

Actually, many factors prevent the unnecessary suffering of laboratory animals and the appropriation of money for frivolous research. What follows are some of the major restraints:

A federal law, the Animal Welfare Act, sets forth standards for the care and treatment of laboratory animals, including housing, feeding, cleanliness, ventilation and veterinary care. (Currently, AWA regulations do not cover rats and mice bred specifically for research.)

All facilities using laboratory animals covered under the AWA must register with and be inspected by the United States Department of Agriculture's enforcement arm, the Animal and Plant Health Inspection Service (APHIS). It is the responsibility of APHIS--through random, unannounced inspections--to ensure that institutions are complying with all USDA regulations.

The AWA also mandates the use of anesthesia or painkilling drugs for potentially painful procedures and for postoperative care unless the research precludes it. Some pain is inflicted in certain procedures and cannot be alleviated. For example, in research on pain relief for cancer patients, the animals endure some discomfort and distress.

The Animal Welfare Act also requires that each institution establish an Institutional Animal Care and Use Committee (IACUC), which is responsible for evaluating the total animal care program, as well as for scrutinizing all proposed animal experiments. The committee must include at least one person who is unaffiliated with the institution and one veterinarian. Researchers proposing a procedure must explain to the committee in writing the number of animals they plan to use, why a certain species is necessary, and what steps will be taken to prevent unnecessary suffering. The committee has the power to reject any research proposal and stop ongoing projects if it believes USDA standards are not being met.

Researchers seeking funds from the U.S. government must follow its rules regarding animal welfare. All institutions receiving grants from the U.S. Public Health Service (PHS) must adhere to its animal welfare assurance Policy. Under the terms of the Policy, not only must institutions adhere to the AWA, they also must follow the detailed recommendations on animal care and treatment that are contained in a book called the Guide for the Care and Use of Laboratory Animals. The PHS policy covers all animals, including rats and mice, and has several key elements.

One is that each institution must document that it has an animal care committee to review the use and care of animals in research. (Usually, this same committee satisfies the Animal Welfare Act requirement mentioned earlier.)

Another is that institutions must file (and update annually) Animal Welfare Assurances with the NIH office. The Animal Welfare Assurance includes:

1. documentation of institutional commitment
2. description of the animal care and use program
3. implementation procedures

The written assurance must be provided up front if the institution wants a PHS grant. NIH will even suspend or revoke PHS grants or contracts if an institution does not remain in compliance. The burden of proof and documentation is always on the research institution.

Intense competition for research funds deters projects that are not essential. Animal rights activists often claim that researchers can get funding simply by changing one variable of an experiment that already has taken place. As a 1990 publication by the Medical Research Modernization Committee (MRMC) put it, "Animal research is publishable. It is easy to take a well-defined animal model, change a variable, and obtain 'new' and 'interesting' findings which are readily published. In the 'publish or perish' world of academic science, this is a B incentive to perform animal research."

In reality, there is little basis for the charges that animal researchers can secure grant money for meritless projects. First of all, competition for grant money is fiercer than ever; for the past few years, only one of four applications has received PHS funding. Further, some duplication--or more accurately, replication--of research is necessary to validate scientific findings and eliminate fraud or error. This requires some experimentation that may deviate in only minor ways from previous work and, therefore, may appear to be duplicative.