Laws, Regulations and Federal Policies Governing Animal Research
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 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:
Federal law safeguards the
welfare of laboratory animals
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:
- Documentation of institutional commitment
- Description of the animal care and use program
- 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 strong 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.
More information
|
