Biomedical Engineering Reference
In-Depth Information
century but the original text (
Russell and Burch 1959
)
contained these definitions:
l
“We shall use the term 'replacement technique' for any
scientific method employing nonsentient material which
may in the history of experimentation replace methods
which use conscious living vertebrates.”
l
“Reduction means reduction in the numbers of animals
used to obtain information of a given amount and
precision.”
l
“Suppose, for a particular purpose, we cannot use
replacing techniques. Suppose it is agreed that we shall
be using every device of theory and practice to reduce to
a minimum the number of animals we have to employ. It
is at this point that refinement starts, and its object is
simply to reduce to an absolute minimum the amount of
distress imposed on those animals that are still used.”
Russell and Burch (1959)
expand their discussion of
replacement to consider the replacement of “higher” (more
sentient, more evolved) organisms by the use of “lower”
organisms; what they call “Comparative Substitution.” This
concept has been developed in many jurisdictions since the
initial publication of the Three Rs, to legislation and poli-
cies that require justification of the use of nonhuman
primates above other vertebrate species, including dogs and
cats as well as rodents and these developments continue.
Furthermore, within nonhuman primates, any use of great
apes is invariably singled out for further scrutiny.
USA
General Organization of Laws and Policies
United States (US) Federal laws (statutes) are organized
annually into their appropriate subjects (e.g. Agriculture)
and are published as the United States Code (USC) (e.g.
title 42 USC 264). The USC is composed of all federal
statutes of a general and permanent nature, arranged by
subject, and are available in legal libraries. The USC
includes a brief “intent of Congress” for establishing these
statutes plus interpretations from federal and state court
rulings. Newly passed federal statutes are published indi-
vidually as public laws with a unique notation denoting
the Congressional year and chronological number (e.g. PL
89-111). At the end of each calendar year the statutes are
then collated in the USC.
Federal regulations are published in the Code of Federal
Regulations (CFR) (e.g. 21 CFR 71). Federal regulations
are detailed requirements developed by the respective
executive department (e.g. United States Department of
Agriculture (USDA), Department of Health and Human
Services (DHHS)) responsible for enforcing the corre-
sponding statute. The US Congress determines the execu-
tive department to which enforcement and responsibilities
are assigned. Newly written regulations are published in the
Federal Register as proposed rules. Following public
comment, they are then published again in the Federal
Register as final regulations before being incorporated into
the CFR. Enforcement of the law begins only after publi-
cation of the final regulations.
Litigation is a process for challenging laws, regulations,
and executive orders by turning to the courts for a ruling.
Litigation can also be used by one party to force a new
interpretation, challenge a current interpretation, or even as
a means to express a particular viewpoint by delaying
activities. Litigation has been used by a few special interest
groups as a means to express their particular ethical and
political viewpoint,
Nongovernmental Approaches to the
Oversight of the Use of Nonhuman
Primates in Biomedical Research
Both the pace of expansion of the use of nonhuman
primates in biomedical research in rapidly developing
countries, and the increasing internationalization of
research, has meant that national laws, regulation and
policies have not always been developed at a similar pace,
and also cannot address international issues. This has led to
increasing interest in existing nongovernmental systems of
oversight such as accreditation. These systems of oversight
include bodies such as the Association for Assessment and
Accreditation of Laboratory Animal Care International
(AAALAC International), which has developed a key role,
and in some cases the primary role, in harmonizing stan-
dards for animal care and use around the world.
to include the use of nonhuman
primates.
Animal Welfare Act
The Animal Welfare Act (AWA) is the core legislation that
defines the standards for the care and use of animals in
biomedical research in the USA.
Part 1 (Definitions) and part 2 (Regulations) of the
USDA Animal Welfare Act Regulations (AWARs) were
published in the Federal Register (9 CFR 54, 36112, 35183)
and became effective October 30, 1989 (
http://www.aphis.
usda.gov/animal_welfare/awa_info.shtml
). The language
used is very similar to that in Public Health Service (PHS)
Policy (see section “Public health service policy” below) to
ensure congruency between the two federal agencies
having separate oversight of animal research. The Animal
NATIONAL LAWS ON USE OF
NONHUMAN PRIMATES IN
BIOMEDICAL RESEARCH
Countries regulate the use of nonhuman primates in
biomedical research using a wide range of laws, policies,
and systems.
