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ETICA ÎN EXPERIMENTAREA PE ANIMALE

Article in Revista Românǎ de Bioeticǎ · January 2010

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 Romanian Journal of Bioethics, Vol. 8, No. 3, July – September 2010

THE ETHICS OF ANIMALS TESTING

Bogdan Marinescu*
Cristin Coman**
Abstract
The progress of medical science could not have been developed to the actual stage without
involving laboratory animals. The research in this field depends sometime on the work with
laboratory animals. It is impossible to do research using laboratory animals and not to create a
minimum discomfort to them. The necessity of reducing the animals distress appeared at the
same time with the necessity of their use, but today this is a major issue, and the proof is the big
amount of money available to the studies on the improvement this process. Researchers make
studies to find the methods to replace the in vivo techniques or to improve them, in order to
produce less suffering on animals. At the same time of these studies, a new institution has been
established, with the aim to evaluate and certify the experiments. This aim may be achieved by
dividing the animal testing into the following three stages: pre-experimental, experimental and
post-experimental. The goal of all these efforts is to replace the use of animals, to reduce their
use in experiments and, when they are still used, to be treated as human as possible.

Key words: ethics, experiment, animal,”human’’, welfare.

Introduction stabile populations in the natural

The human beings have various
relationships with animals. We enjoy
them as our pets or when we see them in
their natural environment, in zoos or in
natural wild parks. In some cultures,
certain animals have religious
significations and are treated with a
special consideration. Nevertheless, we
breed extensively animals for food and
clothes. We use animals at work,
transport or sports. We hunt them or we
fish them. We make interventions by
various methods in order to preserve
ecosystems or we kill them when they
come in conflict with the human
population. For example, rodents like
mice and rats, flies, mosquitoes; all these
are considered pests and thus
exterminated. The examples above show
that the relationship between man and
animal is different, according to the
benefits the animals bring to man. This
material is focusing on ethical aspects
raised from animal use in a particular
area: fundamental and applied scientific
research. Animal testing was, is, and will

* DVM, CS, INCD „Victor Babe ” Bucharest, Romania, mg_bogdan@yahoo.com

** DVM, PhD, CS III, INCDMI „Cantacuzino” Bucharest, Romania, comancristin@yahoo.com

197
be an important stage for the medical and
biological research [5]. There are no
complete alternatives to the research on
animals, but we have instruments which
can guide and train us, instruments that
we can improve, about the approach we
should have when doing research on
animals. Animal testing is used in
various institutions, such as territorial
laboratories for the environment control
and the protection, the laboratories in
drugs factories, the central and local
human and veterinary diagnose
laboratories, the research institutes and
academic area, which include study
subjects like biology, human medicine,
pharmacology, dentistry, veterinary
medicine, zootechnics, environment
protection.
To provide a simple definition,
animal testing is the application of a
research idea, by specific techniques, on
a number of animals, in a time interval,
in a specific area, which ends with one or
more conclusions. (Fig.1. Animal testing
stages).
The ethics of animal testing is
reflected in the ethics applied to the
following stages: the experimental
design, the hosting unit for the test and
the use of results. We may conclude that
the ethics of animal testing is divided
into three phases: pre-experimental,
experimental and post-experimental.
The use of the term “human”
in animal testing
How we can best define the term
“human” in the context of animals used
in experiments? In most of the
documents on animal testing, the term
“human” is defined as “the animals
treated in the same way like a human
198
being” with respect and care for their
welfare. But, people often treat people
worst that they treat the animals. The
gain of any kind of social, economic,
political or muscular power position
often leads to abuses of power and the
treatment of people in a manner that the
abusing people themselves wouldn’t like
to be treated. The term “human” in
relation to animal testing is used in
various contexts: “human use”, “human
crime”, “human end” and “human care”.
Presently, this term involves an idealist
vision and there is still a long way to go
until a clear definition is established. The
American and Community legislation
refers to the “human care” of the animals
used in experiments, but don’t offer a
clear definition of term “human”. Being
unclearly defined clear, the term
“human” has no value and led to
misinterpretations when used in the laws
on animal welfare. As researchers and
testers on animals, we find it very
difficult to define what the “human” use
in animal testing means. We cut the ears
of the animals in order to mark them, we
cut their tails for genetic analysis, we
induce burns, we make them subject
experimental infections or to the action
of chemicals and, in the end, we kill
them. None of these seems to comply
with term “human”, but we are not in the
position to judge and to decide on this
thing. If we make all these “inhuman”
things to the animals, the ethical
evaluation of all the experimental
projects for the reduction of the pain and
distress of animals, becomes compulsory
for making peace with ourselves and for
the consciousness of all persons involved
in animal testing.
 Documentation

IDEEA

Control Testing planning

Organization

Animals and
materials entry

Pilot study

Animal test in progress

Research unit involving laboratory animals

Unit area Condition of Condition of Testing Unit specific Personnel

accommodati environment specific procedures
on procedures

Data exit, process

and assessment

Result report, publication,

dissemination

Fig. 1. The stages of the experiments on animals

The pre-experimental ethics that transform the idea in an experimental

The pre-experimental ethics refers to design. There are sufficient tools that
shaping the experiment design. This should be taken into account during this
stage directly depends on the personnel stage: the national legislation, the

199
European directives, guidelines,
organizations, publications, etc. A
compulsory filter to be observed when
drafting a “human” experimental design
is the “Principles of 3 R’s” stated by
Russell and Burch – Replacement,
Reduction and Refinement [6]. The
European Union regulates by law that the
researcher involved in a project using the
tests on vertebrate animals should make
sure that the goals of the studies cannot
be achieved through alternative methods.
This is the Replacement principle and it
is the first to apply when establishing a
work plan. The replacement could be
achieved by in vitro techniques,
mathematics models, computerized
models, the use of inferior species on the
evolution scale, like insects, fungus and
bacteria [7]. The larger the number of
animals used in experiments, the bigger
the sufferance and the higher the costs.
This is why we should apply the
Reduction principle. This concept
provides the application of any strategy
in order to use a smaller number of
animals to achieve enough data from the
proposed study or the maximum
information from the tested animal,
limiting thus the need for using
additional animals without any prejudice
to the welfare of the tested animals [7].
The Reduction principle should not
be used to an extent that generates
intense individual suffering. The
experiments with a well designed
framework can be made on a smaller
number of animals, without reducing the
scientific outcomes. The pilot studies
must be applied whenever possible. The
advantages of the pilot studies are: they
verify the validity of the assumption of
an experimental design using a smaller
number of animals, it enables the
improvement of the work protocol before
they are included in the large scale study,
it can generate the development of new
200
techniques and procedures, and it can
help the researcher to understand the
intensity of the animal suffering in the
respective study [3]. The selection of the
species influences the number of the
animals used in the study; a species
similar to the one used for testing a
product should prevent the need for
repeating the studies in the future on
other animals; the selection of a well
defined species could reduce the number
of tested animals, because a smaller
species could increase the number of
animals necessary to the experiment due
to certain limits (the amount of blood for
sampling). The use of genetically
modified animals or of animals with no
pathological germs presumes
experiments conducted on a smaller
number of animals. The number of
animals can also be reduced by using the
same animals in other experiments but in
compliance with Article 10 from the
Ordinance no. 37/30.01.2002 “An animal
can only be used once in an experiment
that produces pain and intense suffering”
[4]. The reduction can be achieved
directly by lowering the number of
animals per test or indirectly by
performing fewer tests (e.g. – the
increase of the product sampling
implicitly reduces the number of tests
performed). The avoidance of experiment
repetition leads to the reduction of the
animal number used. There are two
aspects we must take into consideration
here: duplication and replication. The
duplication refers to the repetition of an
experiment, without being necessary,
such as the case of non-informed
researchers who, for various reasons,
have no access to data on the
experiments made by other researchers.
The replication refers to a repeated
experiment necessary for the validation
of data by the researchers. The use of
animals for educational purposes
involves replication in order to prove
already known principles, or to train in or
learn new techniques. A strategy that
could be applied is given by the
possibility of using the same animal at
the time zero by the researchers or later,
by cryopreservation of various organs,
tissue or cells. The Refinement principle
refers to the changes to the
accommodation conditions and
experimental procedures in order to
minimize the pain and stress and to
promote the welfare of the animals used
in research from birth to their death. The
implementation of the refinement
concept should be done for the entire life
of laboratory animals, not only during the
experiment. Beside the promotion of
animal welfare, the refinement brings
benefits on the rise of the quality of
scientific research. For example, the pain,
stress and discomfort generate
physiological changes that increase the
variability of the research results and
implicitly decrease their validity. The
Refinement could be applied at the level
of each procedure involving the direct
work with laboratory animals. Table no.
1 presents the frequently used techniques
in the research on animals, with
minimum and compulsory conditions that
must be observed [2].

Table no. 1. Procedures frequently used in research and minimum compulsory conditions [2]
Procedure Minimum compulsory conditions

Identification - use of painless and permanent methods, if possible

Handling and - performed to produce less stress, but safe for the researcher
manipulation
Drug administration - following the indications on species for: route of administration,
maximum volume, the frequency of administration, the size of
needles
- asepsis
- bleeding - following the indications on species for: place for bleeding,
maximum volume, frequency, the time between bleedings, flow,
the necessity of anesthesia
- asepsis
- biological samples - following the indications on species for: volume, frequency, the
necessity of anesthesia
- proceeded with less stress and pain
- asepsis
- anesthesia - made for painful procedures
- the method is selected depending on the species in order to
produce less pain and rapid effects
- following the doses and route of administration specific to the
species
- generates fewer secondary effects, assures the recovery without
complications and the minimum interference with the goal of the
research
- surgical procedures - asepsis, anesthesia, pain control, post-surgery assistance,

201
 -health condition - exact and frequent monitoring
monitoring

- establishment of the - decided exactly and very well justified

experiment endpoint

- euthanasia - specifications on the species and age

- generates the quick loss of consciences
- the death should be noticed after the application of the procedure

The experimental ethics variations, this being the reason for

The experimental ethics is
represented by a number of factors that
involve the research unit for laboratory
animals, factors that must be coordinated
to provide the animals’ welfare
throughout their entire period, from the
entry to the exit from the unit: the source
of animals, the existing spaces,
accommodation conditions, microclimate
conditions, the personnel and the specific
operation procedures. The animals must
be supplied by an authorized unit, and
accompanied by health certificates. They
shall be transported in special, safe,
comfortable vehicles with specific
microclimate conditions. During the
transportation, the animals shall benefit
from obligatory water, while the need for
feeding is determined depending on the
duration of the transportation. It is
compulsory to enable the animals’
adjustment to the climate conditions in
the quarantine rooms at the destination
place, depending on the species. The unit
rooms must assure the workflow under
the following compulsory conditions:
quarantine rooms, accommodation rooms
for the experiments, experimental room,
sanitary adjacent rooms, storage areas for
food, materials, equipments, cleaning,
staff, storage of clean equipment, for
euthanasia, necropsy, and waste disposal
rooms. The environment conditions
affect the biological behavior producing
which they should be fitted with
temperature, humidity, air, noise, light,
vibration control, etc. The environment
condition requirements are provided by
law. The water and food provided to
animals must comply with the biological
requirements; the necessary quantity of
food varies depending on the species,
age, etc. The accommodation and caring
should be done, as much as possible, as
in the natural environment of the species.
The animals should be accommodated in
special equipments and they must benefit
from minimum territory limits
established by law. “The success of the
3Rs principle implementation strictly
depends on the education and the
continuous training of the staff involved
in animal testing” [1]. The scientific
activity using laboratory animals has a
higher value when it involves the
cooperation between researchers,
doctors, veterinaries, technicians, the
maintenance personnel, professors,
students, etc. Each of them must be
properly trained in the work with lab
animals. The continuous study and
training is necessary in order to:
minimize the pain and stress induced to
the animals, acquire theoretical and
practical knowledge, provide safety for
the staff, leading to satisfactory scientific
expectations. The increase of scientific
quality can only be achieved when the

202
activities run in the unit rely on
procedures, the staff is trained and
responsible, and when there is a strict
evidence of the records [3].
The post experimental ethics
It is known that the progress is
closely related to the research
contribution. Another critical phase in the
experimental development is data
collection, processing and dissemination.
At the end of the study, the researchers
should extract as many data as possible
and this data should be processed
objectively, regardless the congruence
with the scientific expectations.
The results must reflect the
experiment reality even if they are
contrary to the expectations, because they
can serve as starting point for other ideas,
and if the assumption is not real, then the
future studies are performed without
great expectations. The results must be
reliable, reproductive and multipliable.
Their dissemination is compulsory
regardless the conclusions. Regardless
the form of dissemination used, the
material must contain the following data
about animals: (species, line, stem,
source, type, number, age, sex, weight,
clinical health), the experimental
protocol design (procedures used,
duration, equipment used), analysis
methods (including the statical methods).
An accurate study design is useless if the
results have not been processed
objectively and disseminated.
The effect of the animals’ welfare
on the scientific research results
The ideal situation in the studies
conducted on animals, is to preserve the
physiological condition of animals, in
order to avoid the interference of
undesirable factors in their response [8].
The studies on animals without solid
grounds lead to incorrect conclusions.
203
Due to the complexity of the behavioral
and physiological requirements,
associated to the existing stress and pain,
there is a major risk of collecting and
interpreting the data in a wrong manner.
The physiological and behavioral
disturbances generated by the non-
compliance with the welfare concept can
be caused by the maneuvers during the
experiment or by spontaneous stressors
related to the daily social and
environmental conditions. When these
effects occur accidentally and are not
caused by the experiment design, the
causal factors should be eliminated or
minimized. If the animals’ welfare is
compromised, the consequences may
include: great variability of the results,
the necessity to increase the number of
animals, incomplete data, data that can’t
be analyzed and not reliable, results that
can’t be applied in other situations and
the impossibility to publish them. The
maintenance of the animal welfare, the
identification, the control and the
elimination of the factors that affect the
physiological and behavioral
disturbances reflect a good scientific
practice.
Regulatory Bodies
The need for limiting the animal
suffering in order to achieve quality
scientific results led to the establishment
of regulatory bodies called the Ethics
Committees. The role of these
committees is to control the
implementation of ethics in the field of
animal testing through the examination
of the experiment design, using as
instrument of work the possibility to
accept or reject the development of the
study. There are many committees
worldwide, of which some at institutional
level, some at a superior organization
level, but each of them individually
organized, aiming at the same: the ethical
 justification for using animals. The work
methods vary from one to another but
there are some common steps in the
evaluation such as: the justification of the
protocol, species selected, number of
animals, stress, pain, discomfort, staff
training, surgical procedure, euthanasia,
accommodation and care facilities. There
is a tendency, at the European level, to
standardize the functionality of the ethics
committees. The European Federation for
the Association of Science of Lab
animals (FELASA) published the
“Principles and practice in the ethical
revision for animal experimentation in
Europe”. Regardless its name, a
regulatory body that evaluates the animal
testing is compulsory for assuring the
implementation of the ethics concept in
animal testing and its structure should
include members from various
professional categories (doctors,
researchers, neutral persons, persons
from animal protection associations,
lawyers, philosophers, priests) whose
opinions should neutral in respect of the
institutions conducting studies on
animals.
Conclusions
The assessment of the ethical level of
an experiment should be performed
separately from its three stages: pre-
experimental, experimental, and post-
experimental. The elaboration of the
experiment design should focus on the
provision of alternatives methods to the
experiments run on animals in all the
stages of the principle stated by Russell
and Burch: Replacement, Reduction, and
Refinement. The experimental ethics is a
compulsory condition for assuring a good
scientific practice. The existence of a
regulatory body providing consultancy
and evaluation of the experiment design
becomes compulsory for the control of
how the concept of animal testing ethics
is being implemented.

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