Biomedical Engineering Reference
In-Depth Information
medicine, primatology, and biomedical research. These
standards are influential in advancing leading improve-
ments in nonhuman primate care and use.
Research, and Training (
Interagency Research Advisory
Committee, 1985
)(
http://fmp-8.cit.nih.gov/oacu/guidepi/
references/2govprinciple.pdf
). Because the federal princi-
ples also appear in the PHS Policy (2002) and the Guide for
the Care and Use of Laboratory Animals (2011), institu-
tions that are required to conform with either or both of
those documents must also adhere to these principles.
Standards
Especially when working in international cooperative
projects or with nongovernmental organizations, a wider
range of standards may apply, or be useful in the absence of
appropriate national legislation.
The Guide for the Care and Use of Laboratory
Animals
The Guide for the Care and Use of Laboratory Animals,
a report prepared by the US National Academies' Institute
for Laboratory Animal Research, has undergone seven
revisions since its initial publication in 1963, pre-dating
passage of the Laboratory Animal Welfare Act, and was
revised in 2011 as the 8th edition. The Guide is used
internationally as one standard for quality animal care and
use programs. It is the reference used by AAALAC Inter-
national in its accreditation assessments and the PHS Policy
requires Assured institutions to conform with Guide
recommendations. The Guide is written by an expert
committee who receives input from the public and scientific
community. The draft report is reviewed by other experts in
the field and a formal response to reviewers' comments is
then undertaken by the committee. Recommendations of
the Guide are based on published data, scientific principles,
and expert opinion and experience. The Guide places
strong emphasis on performance standards, which describe
desired outcomes by providing criteria to assess those
outcomes without dictating the precise methods to achieve
the outcomes. The Guide extensively addresses topics
specific to nonhuman primate care and use, including
behavioral management, personal protective equipment,
training as an alternative to restraint, housing requirements,
clinical records, etc.
Council for International Organizations of
Medical Sciences
The International Guiding Principles for Biomedical
Research Involving Animals (
http://www.cioms.ch/
publications/guidelines/1985_texts_of_guidelines.htm
) were
developed in 1985 by the Council for International Orga-
nizations of Medical Sciences. CIOMS is an international,
nongovernmental, nonprofit organization established
jointly by the World Health Organization (WHO) and the
United Nations in 1949 as a framework for the ethical
conduct of human and animal research, especially in rela-
tion to drug and device studies. The Guiding Principles are
under revision but topics covered include animal acquisi-
tion, transportation, housing, environmental conditions,
nutrition, the provision of veterinary care, the maintenance
of records, euthanasia, the monitoring of animal care and
use, the implementation of the Three Rs, and the training of
investigators and others in animal care and use. There are
no specific provisions relating to the use of nonhuman
primates, but as the Guiding Principles are broad perfor-
mance standards it should be expected that modern stan-
dards of care, use, with ethical oversight would imply
continuing concordance with these Principles.
US Government Principles
In 1983 the Interagency Primate Steering Committee
(IPSC), at the time the only federal interagency committee
engaged in the review of issues involving research animals,
was asked to represent the USA at a meeting of the Council
of Europe. It quickly became evident that representation on
the committee needed to be expanded; this recognized need
became the impetus to the IPSC to be broadened into the
Interagency Research Advisory Committee (IRAC). The
IRAC's primary concerns are the “conservation, use, care
and welfare of research animals” and its main responsi-
bilities are “information exchange, program coordination,
and contribution to policy development.” In 1985, IRAC
published the nine principles to be taken into consideration
by federal agencies that develop requirements for testing,
research, or training procedures involving vertebrate
animals, known as the US Government Principles for the
Utilization and Care of Vertebrate Animals Used in Testing,
International Primatological Society Guidelines
for the Acquisition, Care and Breeding of
Nonhuman Primates
The IPS International Guidelines for the Acquisition, Care
and Breeding of Nonhuman Primates (
http://www.inter
nationalprimatologicalsociety.org/docs/IPS_International_
Guidelines_for_the_Acquisition_Care_and_Breeding_of_
Nonhuman_Primates_Second_Edition_2007.pdf
), published
as the 2nd edition in 2007, represent one of the more
detailed guidance documents and set of collated informa-
tion. Subjects addressed include acquisition, transport, staff
training, health control, staff safety, care and husbandry
that are specific to nonhuman primates. They serve as a
useful source of information, especially where less
common species are used, where national legislation is
absent or local guidance not available.
