Oversight
and Regulation
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 opponents
of animal research claiming that scientists can do "anything
they want" to laboratory animals without justification.
It is also implied that there is an endless supply of research
dollars, and that scientists can qualify for funding simply by
contriving an animal research project that has not been tried
in the past.
Actually, many factors prevent the unnecessary use of laboratory
animals and the appropriation of money for frivolous research.
What follows are some of the major restraints:
I. National Institutes of Health (NIH) and the “Peer Review” process
Even prior to beginning their research, UCSF scientists must
undergo a rigorous process, known as “peer-review,” to
obtain approval for funding from organizations such as the National
Institutes of Health (NIH).
Applications for support from the National Institutes of Health
(NIH) are evaluated initially by peer review groups composed
of scientists from the extramural research community. The objective
of the initial peer review is to evaluate and rate the scientific
and technical merit of the proposed research or research training.
The Office of Extramural Research (OER) manages the development
and implementation of policies and procedures that pertain to
peer-review conducted in all components of the NIH.
First Review: Scientific Review Groups (SRGs)
Peer review of
applications submitted to the NIH takes place in multiple steps.
The initial step of the peer review process, the evaluation of
scientific and technical merit, takes place in Scientific Review
Groups (SRGs) that are managed by the Center for Scientific Review
or by the individual institutes within the NIH. The group or
panel, established according to scientific disciplines or medical
specialties, may consist of as many as 16 to 20 members who are
primarily non-federal scientists with expertise in various disciplines
and areas of research.
The primary requirement for serving on an SRG is competence
as an independent investigator in a scientific discipline. Other
factors such as respect among peers and quality of research accomplished
are also important. The reviewers study each application individually
before the meeting; and for each application, some reviewers
are assigned to prepare written critiques. Those projects deemed
most competitive, approximately the upper half, are fully discussed
and given a priority score based on the scientific merits of
the project.
Second Review: National Advisory Boards or Councils
The second
level of the peer review process is conducted by the NIH National
Advisory Boards or Councils. This panel of 12-18 members consists
of scientists and laypersons chosen from their interest in matters
related to health and disease. Council members review the applications
against a broad background of considerations including relevance,
program goals, and available funds of the institute; they also
consider the appropriateness of the scientific review conducted
previously by the SRG.
Funding the highest quality research
Because of the magnitude,
diversity and complexity of the NIH mission, the NIH draws
on a national pool of scientists actively engaged in research
for advice on the selection of the most promising research
projects for support. These scientists review and rate applications
for grants and proposals for contracts and attend review meetings
at the NIH to discuss and make final recommendations on those
applications.
In Fiscal Year 2004, over 40,000 applications for research projects
were reviewed. Only the very best – the top 24 percent – were
funded.
Opponents of animal research often claim that researchers can
get funding simply by changing one variable of a previous research
protocol. A 1990 publication by the Medical Research Modernization
Committee (MRMC), a group opposed to the use of animals in research,
said: "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 merit less projects. First
of all, competition for grant money is fiercer than ever; for
the past few years, only one of four applications has received
Public Health Service funding. Further, some duplication – or
more accurately, replication – of research is necessary
to validate scientific findings and eliminate fraud or error.
This requires some research that may deviate in only minor ways
from previous work and, therefore, may appear to be duplicative.
II. Animal Welfare Act (AWA) and the U.S. Department of Agriculture
(USDA)
A federal law, the Animal Welfare Act, sets 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. These are regulated by the Public Health Policy
enforced by the Office of Laboratory Animal Welfare (OLAW) of
the NIH). 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 regular, unannounced inspections – to
ensure that institutions are complying with all USDA regulations.
The AWA also mandates specific criteria regarding the use of
animals in research that includes the quality of veterinary care,
surgical procedures, and 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.
III. Institutional Animal Care and Use Committee (IACUC)
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 research. The
committee must include at least one person who is unaffiliated
with the institution and one veterinarian. Researchers proposing
a procedure must submit a written protocol and justify the use
of animals, provide information on their search for alternatives
to the use of animals, explain to the committee the number of
animals they plan to use and justify the numbers proposed,, explain
why a certain species is necessary, outline the research procedures
involved and what steps will be taken to prevent unnecessary
pain or distress, including the use of analgesics (pain killers)
after procedures. The committee has the power to reject any research
proposal that does not meet its requirements and stop ongoing
projects if it believes USDA standards are not being met.
Every proposed research study involving animals at UCSF must
undergo an in-depth scientific review through the 16-member UCSF
Institutional Animal Care and Use Committee, which determines
whether the study may be conducted. Each protocol is approved
for a three-year period after which it must be renewed in its
entirety with a new application submitted to the UCSF Institutional
Animal Care and Use Committee. Furthermore, based on the requirements
of the Animal Welfare Act (AWA), each year (i.e. the second & third
year of a new protocol), the principal investigator must submit
an “annual review” or “continuing review,” a
mandatory request for re-approval that includes a progress report
for the continuation of the protocol.
IV. Animal Welfare Assurance Policy & NRC Guide for the
Care and Use of Laboratory Animals
UCSF adheres to all applicable federal and state laws and regulations,
as well as University of California policies, governing the use
of animals in research. These include the U.S. Public Health
Service (PHS) Policy on Humane Care and Use of Laboratory Animals,
the U.S. Department of Agriculture (USDA) Animal Welfare Act
(AWA) Regulations regarding the care and use of animals in a
research setting and its pertinent policies and the National
Research Council’s Guide for Care and Use of Laboratory
Animals.
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 vertebrate 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. (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.
V. Association for Assessment and Accreditation of Laboratory
Animal Care International (AAALAC)
UCSF has achieved a highly regarded laboratory animal care and
use accreditation from the independent Association for Assessment
and Accreditation of Laboratory Animal Care International (AAALAC).
The accreditation is given to organizations exhibiting the highest
standards for the humane treatment of animals in research.
The voluntary accreditation involved an extensive internal review
by UCSF officials, submittal of a detailed animal care and use
program description and supporting documentation, followed by
an on-site review by AAALAC evaluators, who are animal care and
use professionals and researchers around the globe. The AAALAC
assessors reviewed the internal reports, USDA reports, visited
facilities and interviewed researchers using animals in research
and conducted their own comprehensive assessment prior to granting
full accreditation to UCSF.
The assessment included all aspects of UCSF’s animal care
and use program, including procedures used and overall performance.
The basic components that were evaluated included institutional
policies, animal husbandry, veterinary care and the physical
plant.
AAALAC is not a regulatory body and does not make or enforce
regulations. Instead, it uses widely accepted guidelines and
best practices, such as the “Guide for the Care and Use
of Laboratory Animals” (NRC 1996) and other resources in
determining the status of animal care and use programs at institutions
seeking accreditation.
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