The justification and responsibility of researchers in
the ethical assessment of animal experiments
Author
Lieke Faber
Utrecht University
Department of Biology
Master: Environmental Biology
Specialisation Program: Behavioural Ecology
Supervisor
Dr. Frans Stafleu
Utrecht University
Department of Philosophy – Ethics
Ethics Institute
March 2013
“The use of animals in research should evolve out of a strong sense of ethical self-examination.
Ethical self-examination involves a careful self-analysis of one's own personal and scientific
motives. Moreover, it requires a recognition of animal suffering and a satisfactory working through
of that suffering in terms of one's ethical values.”
John P. Gluck & Steven R. Kubacki (1991)
1
Contents
1. Introduction
3
2. Ethics of animal experiments: an overview
5
2.1. History and legislation of animal experiments in the Netherlands
5
2.2. Ethical theories
7
2.2.1. Consequentialism
7
2.2.2. Deontological ethics
9
2.2.3. Virtue ethics
10
2.3. Conclusion
11
3. My study: Methods
13
3.1. The ethical assessment: what would be in it ideally
13
3.1.1. The importance of the experiment
14
3.1.2. The discomfort of the involved animals
16
3.1.3. The relevance and quality of the experiment
17
3.2. The ethical assessment: what would have to be in it at least
18
3.3. The scoring sheet
19
4. My study: Results
20
5. Analysis
23
6. Discussion
25
7. Conclusion
30
8. References
32
9. Appendix: Recommendations for the DEC Utrecht
34
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1. Introduction
In the Netherlands, animal experiments are being carried out for fundamental research, for
applied research, and for educational purposes. Animal experiments are subjected to strict rules in
the Netherlands. Only institutions with a license may carry out animal experiments on vertebrate
animals and the testing of cosmetics on animals has been prohibited since 1997. All animal
experiments involving vertebrate animals must be approved by an accredited Animal Ethics
Committee (AEC, or, in Dutch: DEC). Only when the DEC approves a research proposal, the
experiment may be carried out. Researchers who are planning to carry out an animal experiment,
need to submit an inquiry form to the DEC. This inquiry form will be reviewed by the DEC on the
importance of the experiment, the welfare of the animals involved and the presence of
alternatives. Ultimately, the DEC will make an ethical assessment in which the importance of the
experiment is being weighed against the suffering of the animals involved in the experiment.
Since the end of 2011, the DEC Utrecht has added a new section to its inquiry form. In this section,
the applicant is being asked to make his/her own ethical assessment of the experiment. This new
section has been added to the inquiry form in order to make the applicant more aware of the
importance of the welfare of the animal in animal experiments and to let the applicant critically
think about the ethical aspects of the animal experiment.
The goal of my study was to determine, based on literature, what should be included in this ethical
assessment and to compare this to what researchers themselves had filled in. I formulated what
ideally should be incorporated in the ethical assessment and what needs to be in it minimally. I
then looked at what researchers themselves had filled in in their own ethical assessment during
the first months after the section was added to the inquiry form. I created a scoring sheet to assess
3
to what extent the ethical justification given by the researchers complies with what minimally
should be in the ethical assessment.
In this report I present the results of my study, after a brief introduction into the ethics of animals
experiments. I will try to explain why there is such a difference between what researchers fill in
themselves and what should be in their own ethical assessment minimally. I will also present a
possible solution for this discrepancy. Finally, I will discuss critically what we may expect from the
DEC and from researchers, where the responsibility for the ethical assessment should be placed
and what role education can or should play in this.
4
2. Ethics of animal experiments: an introduction
2.1 History and legislation of animal experiments in the Netherlands
The western history of animal experiments dates back from long ago, back to the time of the
ancient Greek and Aristotle and the roots of the development of medicines in the third and fourth
centuries BC (Cohen & Loew 1984). Aristotle argued that animals lacked reason (logos), thought
(dianoia), intellect (nous) and belief (doxa) and that all animals were made for the sake of human
beings (Sorabji 1993). The view that humans had no ethical obligations towards animals remained
the predominant view in the following centuries and animal experiments could be carried out with
virtually no moral or legislative restrictions (Rollin 2006). The use of animals for experiments
increased with the discovery of anesthetics and the publication of Darwin’s ‘On the origin of
species’ in 1859 in which he defended the biological similarities between human beings and
animals (Baumans 2004). This increase of animal experiments paralleled the increase of moral
objections against the use of animals for experiments as well as the demand for legislation of
them (Rollin 2006; Baumans 2004; Pereboom et al. 2004).
Although animal cruelty had been prohibited by law in the Netherlands by 1886, in practice
animal experiments were not considered to be in conflict with this law (Pereboom et al. 2004;
Boon, 2004). In 1920 it was stated that the suffering of the animals in the experiment should in
some way be proportional to the goal of the experiment, but it was not until 1977 that
experiments on animals in the Netherlands were clearly restricted and regulated by the Law on
Animal Experiments (in Dutch: the Wet op Dierproeven; from here on referred to as the WoD).
This law states that animal experiments are prohibited unless the importance of the experiment
outweighs the suffering of the involved animals. Since then, the WoD has extended significantly
and in 1985 the Animal Experiments Decree (Dierproevenbesluit; from here on referred to as the
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Db) was added to the WoD. Nowadays, the in 1996 modified WoD and the Db together determine
under which circumstances an animal experiment may be carried out in the Netherlands.
As stated in the WoD, only institutions with a license are allowed to carry out animal
experiments. Researchers at these institutions who are planning to do an animal experiment, have
to submit a research proposal to an accredited Animal Ethics Committee (in Dutch: Dier
Experimenten Commissie; from here on referred to as DEC). The Db mentions 15 points that
should be in this research proposal, including the scientific and social importance of the study, by
whom the scientific quality of the study has been assessed, a motivation for the species and
number of the involved animals, the expected degree, frequency and duration of suffering of the
involved animals and an argumentation in which it needs to be motivated why the question
addressed in the study cannot be answered with less or no animals. The DEC will assess the
research proposal on these 15 points. An animal experiment may only be carried out after
approval of the DEC, or, if the DEC does not approve, after approval of the Central Commission of
Animal Experiment.
Most of the institutions in the Netherlands that are licensed to carry out animal
experiments, have their own DEC; 18 DECs are member of the NVDEC, the Dutch society of DECs.1
The WoD states that a DEC has to have at least seven members with expertise on different
subjects, including animal experiments, alternatives of animals experiments, ethics and the
welfare/protection of laboratory animals. At least three members of the DEC, including the
chairman, should not be employed with the licensed institution. At least two members of the DEC
should not be involved with conducting animal experiments.
Based on the assessment of the 15 points that should be in the research proposal, the DEC
will decide if the importance of the experiment outweighs the suffering of the involved animals
and thus decide if the animal experiment can be judged as ethically acceptable. This ‘ethical
1
Personal communication with the secretary of the NVDEC, the Dutch society of DECs.
6
assessment’ is not easy since there is not one standard, criterion or system to weigh the benefits
of an experiment against the suffering of the involved animals. In fact, the interests involved can
be seen as incomparable or ‘incommensurable’ (Orlans 2002). Swart and Tramper (2009) state
that three ingredients are of importance in determining if an animal experiment can be judged as
ethically acceptable: 1) The ethically relevant facts, 2) moral intuitions, and 3) ethical theories. The
ethically relevant facts can be obtained from the 15 points in the research proposal. Moral
intuitions can serve as a signal function, but they are not well thought out yet. Therefore, ethical
theories are needed that have proven their value in previous ethical problems.
2.2 Ethical theories
In normative ethics, the study of the ethics of our actions, two main types of theories can be
distinguished: consequentialistic theories and deontological theories. In this next section, I will
explain these theories and show how these theories can be used in the ethical assessment of
animal experiments. I will also discuss another type of ethics, known as virtue ethics. This type of
ethics goes beyond the classical normative ethics by broadening the ethics of our actions to the
question of how someone ought to be.
2.2.1 Consequentialism
Consequentialistic theories hold that our moral actions are based on and related to the
consequences they have. The consequences of an action is what determines if the act itself is
moral. According to consequentalistic theories, actions that lead to the most benefits to the
maximum number of involved parties are considered to be ethically right. Utilitarianism is a
consequentialistic theory stating that the ethically right action is the action that maximizes utility.
Representatives of utilitarianism are Jeremy Bentham (1748-1832), John Stuart Mill (1806-1873)
and Peter Singer (1946). Bentham states that it is the greatest happiness of the greatest number
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that is the measure of right and wrong (Bentham 1981) and that happiness should be maximized
and suffering should be minimized (Swart & Tramper 2009). This should not only apply to human
beings, but also to animals, according to Peter Singer (Singer 1975). He states that to value the
interests of humans higher than those of animals is a form of speciesism: a ‘prejudice or bias in
favour of the interests of one’s own species and against those of members of other species’
(Singer 1975).
When we use consequentialistic theories for the ethical assessment of animal experiments,
those experiments that should be judged as ethically acceptable, are the ones in which the
benefits or happiness of the involved parties outweighs the suffering of the involved parties. Both
human beings and animals can be seen as involved parties and the interests of human beings
should not be scored higher than those of animals. Simply said: an animal experiment should be
carried out if the eventual happiness of humans can be scored higher than the suffering of the
involved animals. But how do we score happiness and suffering? In the Netherlands, the estimated
amount of suffering has to be scored in the research proposal. This score can range from 1 to 6, in
which 1 is the lowest amount of suffering and 6 is given to experiments in which animals are
exposed to severe and long lasting pain (Ter Horst 2009). No score is given to the estimated
amount of happiness, or the estimated benefits of the experiment, which makes it hard to
compare this with the amount of suffering. The WoD states that it is forbidden to perform an
experiment in which the animals suffer very severe pain if the experiment is not carried out for
essential needs of human beings. But what are essential needs?
Also, the chance that the experiment will lead to the estimated benefits is hard to determine. How
should that be scored in the ethical assessment? And what is worse: an experiment causing very
severe pain in 5 animals or an experiment with only a little bit of pain in 100 animals? It is clear
that consequentialistic theories are not enough to make a good ethical assessment of the
acceptability of an animal experiment.
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2.2.2 Deontological Ethics
Contrary to consequentialistic theories, deontological theories do not look at the consequences of
an action but at the act itself. According to deontological theories, an action can be considered as
ethically right if it meets up with certain criteria. What these criteria are, differs between
deontological theories. Justice, respect and non-maleficence for example might be criteria with
which an action should comply. Representatives of deontological theories are Immanuel Kant
(1724 – 1804) and W.D. Ross (1877 – 1971). Kant stated that it is the intention with which one
acts that determines if an action is ethically right or wrong (Van Delden 2007). Even when an
action has good consequences, the action is ethically wrong if it is done with bad intentions.
According to Kant moral laws can be identified that apply in every context. With these laws, we
can determine if something is ethically right or wrong. Ross on the other hand argued that context
does matter and that there are several duties with which one should act – for example fidelity,
non-maleficence, self-improvement – and that these duties can sometimes clash with each other.
When they do, it is the context that defines which one of the duties is the weightiest.
When we use deontological ethics for the ethical assessment of animals experiments, experiments
should be considered ethically acceptable if they meet certain criteria. What these criteria are,
should still be specified. Right now, the WoD already specifies some criteria with which an animal
experiment should comply. Respect and acknowledgment for the intrinsic value of the involved
animals is paramount in this law. However, acting with respect for the intrinsic value of an animal
is a vague concept and definitions on the integrity of the animal vary. Rutgers and Heeger (1999)
describe this integrity as the wholeness and completeness of the animal and that to act with
respect for the integrity of an animal is to leave the animal whole, undamaged and intact.
However, they also emphasize that respect for the integrity of the animal does not imply that
‘every infringement of integrity is unacceptable’: the infringement of the integrity might be
justified on other, more weighty, moral grounds.
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According to Musschenga (2009), the integrity of the animal does not seem to play a big role in the
assessment of animal experiments, although it might be of matter in the assessment of the
conditions in which the animals are being held during the study. Musschenga pleads that more
specific and refined concepts are needed in the assessment of the acceptability of animal
experiments. However, he does not discuss what these specific and refined concepts should be.
2.2.3 Virtue Ethics
In virtue ethics it is not about the act itself, nor about the consequences of the act, but about the
person performing the act. Virtue ethics resemble deontological ethics in that there are several
criteria that have to be met to judge something as ethically right. But in deontological ethics, the
focus is on ‘doing’, while in virtue ethics the emphasis is on ‘being’.
In virtue ethics, the criteria that a person should have are called virtues. As in deontological ethics,
there is variation between theories in which criteria, or virtues in this case, are considered to be
morally right. One of the theories in virtue ethics comes from Aristotle (384-322 BC). In his theory,
virtues are things in which someone or something excels. A virtue is a mean of too much and too
little, and each virtue is placed between a corresponding vice of excess and one of deficiency.
According to Aristotle, we are not born with virtues. Virtues have to be practiced, they need to be
aimed for and to be achieved. (Bolt 2007) Examples of virtues are courage, trustworthiness,
compassion, justice, honesty, integrity and responsibility.
When we use virtue ethics in the assessment of the ethical acceptability of an animal
experiment, we should look at which virtues the person that performs the act should have. The
person that performs the animal experiment is the researcher. Which virtues should a performer
of animal experiments have? There is no clear answer to that question. In the Netherlands, people
that work with laboratory animals have done an ‘article 9’ course. The objective of this course is
the careful and responsible use of laboratory animals. Responsibility seems to be an important
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virtue for researchers in animal experiments. Competence is also a virtue a researcher should
have. For an animal experiment to be assessed as ethically acceptable, it needs to be performed
by responsible and competent researchers.
2.3 Conclusion
There are several factors that are of importance in the ethical assessment of an animal
experiment. One should look at the consequences of the animal experiment, at the way the
experiment is being carried out and at the attitude of the researcher. The benefits of the
experiment should outweigh the suffering of the involved animals, the experiment should be done
with respect for the integrity of the involved animals, and the researcher that carries out the
experiment should be competent and have a responsible attitude. Combined, these factors should
determine if an animal experiment should be judged as ethically acceptable. Ethical theories help
us to assess these different factors. A summary of how this assessment can be made, is shown in
figure 1.
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Fig. 1 The ethical assessment of an animal experiment can be made with the combined help of three different ethical
approaches, each with their own emphasis. This figure is made based on the figure of Swart and Tramper (2009).
The ethical assessment of an animal experiment is one of the tasks of a DEC. In the Netherlands,
an animal experiment needs approval of an accredited DEC before it can be carried out. The DEC
consists of members with different backgrounds. Some of them have an expertise that is more
focused on the consequences of an experiment, others focus more on the way an experiment is
carried out. This multidisciplined composition of a DEC promotes a balanced assessment of an
animal experiment.
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3. My study: Methods
The responsibility for the ethical assessment of an animal experiment is mainly placed with the
DECs. Since the end of 2011, the DEC Utrecht has added a new section to its inquiry form in which
the applicant is being asked to make his own ethical assessment of the animal study he is planning
to conduct. With this, the DEC Utrecht places part of the responsibility back to the researcher. In
this ‘own ethical assessment’, the DEC Utrecht asks the researcher to point out why he thinks that
the importance of the experiment outweighs the inevitable suffering of the animals.
For my study, I compared the justification of researchers in their own ethical assessment with
what should be in it. Based on literature, I first decided what would have to be in this ethical
assessment ideally. I then brought this back to what would have to be in it minimally. I created a
scoring sheet based on what has to be in it minimally to compare this to what researchers actually
had filled in themselves. I looked at 128 inquiry forms that were sent to the DEC Utrecht between
January 11 and March 28 of 2012 and copied what applicants had filled in at the ‘own ethical
assessment’ section.
3.1 The ethical assessment: what would be in it ideally
From the previous chapter we can already tell that it is not easy to judge if an animal experiment
can be considered ethically acceptable. There are multiple factors involved and there is not one
straightforward rule that can be applied in the ethical assessment. Therefore, the argumentation
or justification that is given in the assessment is of great importance. What should be in this
justification? What kind of arguments should be given? A couple of papers have been published on
the ethical justification of animal experiments and on how to weigh the involved costs and
benefits. Although these papers sometimes differ in the weight that should be given to the
13
involved factors, there is a consensus on which factors play a role in the justification. In this
section I will point out these factors and discuss which arguments should ideally be given in the
ethical assessment of an animal experiment.
3.1.1 The importance of the experiment
In order to make a good ethical assessment, the importance of the experiment needs to be clearly
pointed out. Not only should the goal of the experiment be mentioned, but also how important
this goal is. In other words: the importance of the experiment needs to be quantified. How do you
weigh the importance of an experiment? Which arguments should be given?
First of all, the type of interest that is served by the experiment should be mentioned. Different
types of interests can be distinguished (Stafleu et al. 1999; Kostomitsopoulos & Durašević 2010;
Vorstenbosch et al. 1999; Wet op Dierproeven; Orlans 1997) and can be distributed over three
types of interest: Health interest, knowledge/education interest, and welfare/economical interest.
The aim of an experiment can serve only one type of these interests, or more. Then arguments
need to be given to discuss to what extent the experiment serves these interests. Per type of
interest, I will discuss which things are relevant in order to quantify the importance of the
experiment.
Health
Many animal experiments are being carried out for medical reasons for either human beings or for
other animals. However, some diseases are much more serious than others. To determine the
importance of the study for health interests, a number of factors need to be pointed out (Stafleu
et al. 1999; Vorstenbosch et al. 1999; Kostomitsopoulos & Durašević 2010). One of these factors is
the morbidity of the disease: the rate of incidence. The more people or animals suffering from the
disease, the higher the importance. Mortality is another factor that is of importance. How many
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people or animals actually die because of the disease? There are more people suffering from
asthma than from HIV, but the mortality is higher for the latter. The amount of suffering that is
involved with the disease is another important factor. The last factor that should be discussed is to
what extent the experiment improves the current situation of available medicines and therapies.
An experiment that contributes to the development of a new medicine when there is no medicine
available yet, is of more importance than an experiment that only leads to a slight improvement of
an already available medicine.
Knowledge/Education
In research we can distinguish between studies done for applied purposes and studies done for
fundamental purposes. Fundamental research is being done for the gain of knowledge. However,
the gain of knowledge can also be an applied purpose in case of education. Animal experiments
are used for both fundamental research and for education. Because it is the gain of knowledge
that is the aim of animal experiments for both fundamental research and education, I put the
interests of both types of experiments under the same type of interest. Which factors are of
importance in quantifying the importance of animal experiments done for this type of interest?
The factor that seems to be of most importance is the extent to which the experiment contributes
to the existing scientific knowledge (Kostomitsopoulos & Durašević 2010; Stafleu et al. 1999), or as
Stafleu et al. (1999) describe it: “the potential growth of knowledge”. The originality of the
approach is another factor that is mentioned (Stafleu et al. 1999; Orlans 1997).
Economic
Although the WoD does not mention economic interests as a purpose for which an animal
experiment may be carried out, in practice many experiments do serve economic interests to
some extent. The aim of some experiments might in certain cases be formulated as serving one of
15
the other types of interests, while in fact the main benefit or goal of the experiment is of
economic nature. When addressing this type of interests, it should be pointed out to what extent
the experiment contributes to the national economy, to employment and to human welfare
(Stafleu et al 1999).
3.1.2 The discomfort of the involved animals
So at one side of the equation we have the importance of the experiment, or in other words: the
benefits of the experiment. Classically, this is being weighed against the discomfort of the involved
animals, or in other words: the costs of the experiment. Quantifying the discomfort of the involved
animals seems to be easier than quantifying the importance of the experiment. A scale has been
developed to quantify the discomfort of the involved animals. This scale is being used in the
inquiry forms of the DECs and ranges from 1 to 6 in which 6 is the highest possible amount of
discomfort (Ter Horst 2009). However, there is not a clear standard for deciding exactly what kind
of discomfort should be given which score, although the scoring model proposed by Stafleu et al.
(1999) does help and give examples. As in the quantification of the importance of the experiment,
there are several factors involved in the quantification of the discomfort of the involved animals
(Ter Horst 2009; Stafleu et al. 1999; Porter 1992; Orlans 1997). One of these factors is the amount
of discomfort, ranging from none or minimal to severe and very severe. But the duration of this
discomfort also plays a role. It is hard to judge whether the amount of discomfort or the duration
of it is of more importance. The same accounts for the third factor: the number of animals
involved in the experiment. Because it is hard to decide which of these factors is of more
importance, it is best to discuss them all in the ethical assessment. The type of animals that is
involved could also play a role in the ethical assessment. The WoD forbids animal experiments on
chimpanzees, bonobos, orangutans and gorillas. According to Porter (1992), animals with high
consciousness and intelligence should get a higher score in the quantification of the discomfort
16
than less complex animals and Stafleu et al (1999) also suggest that different scores should be
given to different categories of species. However, whether the discomfort of the involved animals
should be judged differently for different species is still subject of debate.
3.1.3 The relevance and quality of the experiment
Solely looking at the benefits and costs of the animal experiment is a very consequentialistic
approach and should not be the only things that are considered in the ethical assessment. One
should also consider the experiment itself and the way in which it is carried out. The relevance and
the quality of the experiment should be weighed and taken into account in the ethical assessment
of the experiment. There is much less emphasis on this subject in the literature and papers differ
in which factors are being considered as important.
In determining the quality of the experiment, the three R’s are of importance. The three R’s
stand for Refinement, Reduction and Replacement and are proposed by Russell and Burch (1959).
Refinement refers to the minimizing of the discomfort of the involved animals. Reduction refers to
the reduction of the number of animals involved in the experiment. Replacement refers to the use
of alternatives in the experiment: non-animal models or animals that are less complex and/or
conscious (yet again, whether complexity or degree of consciousness/intelligence of animals
should play a role is debatable). In the ethical assessment it should become clear that attention
has been paid to the three R’s. This is one of the factors that determines the quality of the
experiment. Another factor is the quality of the research group (Stafleu et al 1999), which is
influenced by the experience of the research group, the experience of the researchers that carry
out the experiment and if previous pilot studies were followed up by full studies (Theune & De
Cock Buning 1993). The necessity or relevance of the animal experiment is also of importance
(Kostomitsopoulos & Durašević 2010; Stafleu et al 1999; Swart 2009). It should be pointed out that
17
what the experiments leads to (e.g. knowledge, medication) is not yet available and that this
experiment is the best way and only way to achieve this.
Another relevant factor that has been mentioned in several papers is the potential of the
experiment to achieve the objective; the chance that the aim of the experiment is indeed being
achieved (Stafleu et al 1999; Porter 1992; Orlans 1997; Swart 2009). The aim of an experiment
might be to develop a medicine to cure cancer, which makes the experiment highly relevant, but
the chance that this aim is indeed being achieved might be very low. This is something that can be
hard to estimate, but there are a number of factors one could look at that play a role in
determining the chance that the aim of the experiment is being achieved. One of these factors is
the way in which the experiment is being carried out, which should already be discussed when
addressing the quality of the experiment. Another factor that determines the chance that the aim
of the experiment is being achieved is to what extent the results of the experiment can be applied
in ‘the real world’: in real patients for example. How far is the experiment in the process of theory
to practice? To what extent can the results from this animal experiment be translated to
application of these results to human patients?
3.2 The ethical assessment: what would have to be in it at least
In the previous section I discussed the factors that are of importance in the ethical assessment of
an animal experiment. I used three different categories to discuss these factors: The importance of
the study, the discomfort of the involved animals and the relevance and quality of the experiment.
Ideally, the justification of researchers in their own ethical assessment of the animal experiment
would discuss all these factors. However, such a justification would be very extended and detailed
and although all factors play a role, some factors might play a bigger role than others. Therefore I
narrowed that what would ideally be in the ethical assessment to what should have to be in it at
least. For this, I used the three different categories mentioned in the previous section of this
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chapter. I determined that what has to be in the ethical assessment of the animal experiment
minimally is a justification of the experiment in which it has to be discussed why the importance of
the experiment outweighs the discomfort of the involved animals in which arguments need to be
given from all of the following categories:
-
The importance of the study
-
The discomfort of the involved animals
-
The relevance and/or quality of the experiment
3.3 The scoring sheet
For determining to what extent the ethical assessments given by the researchers complies with
what should be in it minimally, I created a scoring sheet. I used this scoring sheet to score the
argumentation given in the ethical assessments of the researchers. For each copied ethical
assessment (n=128), I scored which categories were represented in the argumentation. The
scoring sheet I used was this:
1. Quantification of the importance of the study: yes/no
e.g.: Morbidity, mortality, potential growth of knowledge, originality of approach
2. Quantification of the discomfort of the involved animals: yes/no
e.g.: Amount and duration of suffering, number of animals involved, species
3. The relevance and/or quality of the experiment: yes/no
e.g.: Attention for 3 R’s, necessity, chance the aim is being achieved
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4. My study: results
Of the 128 ethical assessments that were filled in by the researchers in the inquiry form of the DEC
Utrecht between January 11 and March 28 of 2012, there were three that the DEC Utrecht judged
as fully insufficient. To these applicants the DEC Utrecht sent an example of what the ‘own ethical
assessment’ should look like:
“Unfortunately, the outcome of surgical treatment of CPSS's is still unsatisfying. Therefore,
alternative (non-surgical) treatments should be improved in order to reduce the symptom’s
occurring in CPSS’s and ensure a good life quality for the dogs who are not operated or in
which the surgical treatment was not optimal. The degree of suffering for the dogs being
used for this experiment is very low. On the other hand, the scientific and social benefit of
this study is significant. We will only perform the experiment in vivo (dogs) if we observe
that Phenylacetate and benzoate are effective in vitro. This reduces the amount of dogs
used for experiments. Further evaluation of the efficacy of these drugs is unfortunately only
possible in vivo. Taken together all the above mentioned factors (degree of animal
suffering, reduction in the amount of dogs used and the scientific benefit) we believe this
experiment could be considered as ethically justified”.
This example complies with all of the three criteria; this ethical assessment includes a justification
in which arguments are being given about the quantification of the importance of the experiment
(outcome of surgical treatment is still unsatisfying), the quantification of the discomfort of the
involved animals (very low) and the quality and relevance of the experiment (reduction in the
amount of animals used; only possible in vivo).
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Of the 128 ethical assessments only 5% complied with all of the three criteria. 41% of the ethical
assessments gave arguments from only one category in the justification and 43% from two
categories. 20% of the ethical assessments did not comply with any of the criteria (fig. 2).
Fig. 2. The number of criteria that are met in the ethical assessments (n=128).
In a bit more than half of the ethical assessments (50.8%) a justification was given in which the
importance of the experiment was quantified. 35.9% of the ethical assessments had a justification
in which the discomfort of the animals was quantified. 38.3% of the assessments discussed the
quality and/or relevance of the study in their justification. (Fig. 3)
21
Fig. 3 The number and amount of ethical assessments that meets to each of the categories separately (n=128).
22
5. Analysis
What is striking in the results is that only a very small amount of the researchers’ own ethical
assessments comply with all of the three criteria of what should be in the ethical assessment
minimally. Based on these criteria, only 5% of the ethical assessments should have been approved.
Often, the researchers did mention “the importance of the study” or “the discomfort of the
animals”, but they did not quantify these aspects. How could this be explained? In the inquiry
form the researcher is being asked to estimate the expected amount of suffering for the involved
animals, to specify the importance of the aim of the study and answer questions concerning
reduction, refinement and replacement. So all the aspects that need to be quantified in the three
criteria for what should be in the ethical assessment minimally, already need to be pointed out
somewhere else in the inquiry form. This might have the effect that the researchers feel less
inclined to explicitly mention these aspects again in the own ethical assessment.
In the ethical assessments of the researchers, most of the arguments that were given fell into the
category ‘Quantification of the importance of the study’. This is in line with the results in the
dissertation of dr. Frans Stafleu about the ethical acceptability of animal experiments as judged by
researchers (1994). He found that human interest is the most important factor influencing the
judgment of researchers of the ethical acceptability of animal experiments.
The example that was sent by the DEC to the researchers that had given an ethical assessment
that was judged by the DEC as fully insufficient did comply with all of the three criteria. However,
this example would ideally address the quantification of the importance of the aim of the study to
a greater extent. Currently, the only quantification of the importance of the aim of the study in
this example is that “the outcome of surgical treatment of CPSS's is still unsatisfying”. To better
23
serve as a good example of the own ethical assessment, the example would, for instance, also
address the incidence of CPSS’s and the amount of suffering that is involved with CPSS’s.
24
6. Discussion
All of the aspects that should be in the ‘own ethical assessment’ minimally already need to be
addressed somewhere else in the inquiry form. To what extent then is the ‘own ethical
assessment’ an addition to the previous inquiry form of the DEC Utrecht? The added value of the
own ethical assessment is that researchers have to combine the aspects and weigh them
themselves. This promotes the researchers’ awareness of the ethics of their study and it makes an
appeal to the responsibility of the researchers. From a virtue ethical point of view, we expect
researchers to be competent and to have a responsible attitude. The addition of the ‘own ethical
assessment’ contributes to that. In chapter 2.3 a figure was shown of the different factors involved
in the ethical assessment of an animal experiment and which ethical theories emphasize on which
factors. The previous inquiry form focused mostly on the two right-hand sided factors and ethical
theories; with the own ethical assessment the new inquiry form includes the researcher and what
we expect from him based from virtue ethical theories as well (fig. 4). Also, the ‘own ethical
assessment’ creates scope for the personal view of the researcher. This part of the inquiry form is
therefore a section that is really something of the researcher himself.
25
Fig. 4 The previous inquiry form of the DEC Utrecht was focused mainly on the two right hand sided aspects. With the
addition of the ‘own ethical assessment’ the researcher and the from virtue ethics’ expected responsible attitude of
the researcher is included as well.
Ultimately, it is the DEC that decides if an animal experiment can be considered as ethically
acceptable. So in the end, the responsibility for the ethical assessment lays with the DEC. But with
the addition of the ‘own ethical assessment’, the responsibility is being partly placed back with the
researcher. Because the researcher is one of the factors that should play a role in the ultimate
ethical assessment of the DEC, the addition of the ‘own ethical assessment’ to the inquiry form
leads to a more complete assessment of the DEC.
Right now, most of the ethical assessment given by the researchers do not comply with
what should be in them minimally. How could this be improved? What might help is to implement
directions in the inquiry form for what should be filled in at the section of the ‘own ethical
assessment’. In the online inquiry form of the DEC Utrecht a red question mark sign can be seen
26
next to some sections of the form. When the applicant clicks on this question mark sign a textbox
pops up with a clarification of the section. As for the ‘own ethical assessment’ section, the text
that pops up in the textbox of the question mark is exactly the same as the text that is already in
the section itself (fig. 5). The text states that the researcher needs to clarify why he thinks that the
importance of the aim of the study outweighs the inevitable suffering of the animals.
Fig. 5 The section with the ‘own ethical assessment’ (in Dutch: eigen ethische afweging) in the online inquiry form of
the DEC Utrecht. A) The text that is in the section of the ‘own ethical assessment’. B) The text that is in the textbox
that shows up when the applicant clicks on the red question mark sign. These texts are exactly the same.
Instead of the text that is currently in the textbox, more clear directions for what should be in the
ethical assessment could be implemented. The three criteria that need to be met minimally could
be given. Even examples of aspects that could be pointed out per criterion could be implemented.
An example of what could be in the textbox that pops up when the applicant clicks on the question
mark sign is:
27
Justify why the importance of the experiment outweighs the discomfort of the involved
animals whereby arguments need to be given from all of the following categories:
-
Quantification of the importance of the study
e.g.: Morbidity, mortality, potential growth of knowledge, originality of approach
-
Quantification of the discomfort of the involved animals
e.g.: Amount and duration of suffering, number of animals involved, species
-
The relevance and/or quality of the experiment
e.g.: Attention for 3 R’s, necessity, chance the aim is being achieved
Although all of the three criteria need to be addresses separately in the inquiry form in which most
of the aspects of the criteria need to be discussed, the chance that the aim of the study is being
achieved does not have to be pointed out. In the ethical assessment of the researchers, there was
only one that mentioned this aspect in the justification of the animal experiment. I think that the
chance that the aim of the study is being achieved is highly relevant in the ethical assessment. I
suggest that this aspect should either become a mandatory part of the ‘own ethical assessment’ or
that it gets implemented in the inquiry form as a separate section. This section could be included
in the part of the inquiry form in which the researcher also has to discuss the background of the
study, the aim/hypothesis of the study, the importance of the study and in which the own ethical
assessment needs to be given.
The DEC Utrecht is not the only DEC that has an inquiry form in which the researcher needs to give
an ‘own ethical assessment’. Other DECs in the Netherlands that have this section in their inquiry
form are the DECs of the Vrije Universiteit Amsterdam, the Rijksuniversiteit Groningen, the
Maastricht University and the Biomedical Primate Research Centre. How many ethical
assessments are judged as insufficient differs between DECs: one DEC states that in only a few
28
cases the DEC asks the applicant to give a clarification of the filled in ethical assessments (but that
this does not mean that the remainder of the own ethical assessments are sufficient); another DEC
estimates the amount of insufficiently filled in ethical assessments as 5-10% and yet another DEC
as 20%. Clear directions for what researchers should fill in in this section seem to be missing in the
inquiry forms of the other DECs as well.
We expect researchers to have a responsible attitude and to take responsibility for the ethical
assessment of their animal experiments. But how do they get this responsible attitude? As
Aristotle stated in his virtue ethical theory, we are not born with virtues. Virtues need to be
achieved. How could a virtue like responsibility be achieved? I think that universities could and
should play a role in this. Researchers that want to perform an animal experiment need to have an
article 9 certificate in the Netherlands. This article 9 course, or ‘laboratory animals’ course, is
aimed at a considerate and responsible use of laboratory animals in biomedical research. Ethics is
part of this course. Students of research masters often carry out animal experiments for their
internships. Not all of these students need to have this article 9 certificate. Right now, bioethics is
not a mandatory course for biomedical oriented studies at the Utrecht University. I think this
needs to change and that bioethics should become a mandatory course in the biomedical oriented
research masters. Research masters aim to educate researchers-to-be. These researchers should
be educated in the ethical aspects of research and to be taught how to make a sound ethical
assessment of studies that they plan to perform.
29
7. Conclusion
In the ethical assessment of animal experiments both the experiment itself, the consequences of
the experiment and the researcher that carries out the experiment should play a role. As for the
consequences the importance of the aim of the study should outweigh the suffering of the
involved animals. The experiment should be of high quality and attention needs to be given to the
3 R’s: Refinement, Reduction and Replacement. The researcher that carries out the animal
experiment needs to be competent and responsible.
By adding a section to the inquiry form in which the researcher has to make his own ethical
assessment of the animal experiment, the DEC Utrecht appeals on the responsibility of the
researcher.
The own ethical assessment of the researcher should minimally include a quantification of the
importance of the experiment, a quantification of the suffering of the involved animals, and
arguments about the relevance and quality of the study.
Most of the ethical assessments that were filled in by the researchers did not comply with what
minimally should be in it. This discrepancy could be decreased by implementing a ‘manual’ for the
own ethical assessment in the inquiry form.
The example of the DEC Utrecht that is being sent to researchers that gave an unsatisfying ethical
assessment complies with what minimally should be in the own ethical assessment, but the
example would ideally address the quantification of the importance of the experiment to a greater
extent.
The chance that the aim of the study is being achieved is a relevant factor for the ethical
assessment of an animal experiment. I suggest that this aspect is being implemented in the inquiry
form.
30
The ‘own ethical assessment’ is a good addition to the previous inquiry form. It promotes
awareness of and responsibility for the ethical implications of animal experiments. This
responsibility is something we should expect from the researcher from a virtue ethical
perspective. However, a responsible attitude needs to be developed. Universities could play a part
in this by implementing bioethics as a mandatory course in biomedical oriented research masters.
31
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van Delden, J.J.M. (eds), Van Gorcum, the Netherlands. 93-102.
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Singer, P. A. D. 1975. Animal liberation: A new ethics for our treatment of animals. New York
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Appendix: Recommendations for the DEC Utrecht
The DEC Utrecht has added the ‘own ethical assessment’ section to its inquiry form in order to
make the applicant more aware of the importance of animal welfare in animal experiments and to
let the applicant critically think about the ethical aspects of the animal experiment. However, clear
directions for what should be in this new section are missing. This might explain why most of the
ethical assessments of the applicants do not comply with what minimally should be discussed in
this section. Based on my study I would like to make some recommendations to the DEC Utrecht.
1. Short manual for the applicant under question mark sign
Applicants can click on a red ‘question mark’ in the inquiry form in order to get more information
about a section. Right now, as for the section in which the own ethical assessment needs to be
given, the text in the textbox that appears when the applicant clicks on the question mark is
exactly the same as the text that is already visible in the section itself (fig. 5, page 27). I
recommend that the DEC Utrecht uses the textbox that appears under the question mark to give
clear directions on what the applicant should discuss in the ‘own ethical assessment’. The DEC
Utrecht could give the three criteria that need to be discussed minimally in this textbox. An
example of the text that could be used in the textbox under the question mark is:
Justify why the importance of the experiment outweighs the discomfort of the involved
animals whereby arguments need to be given from all of the following categories:
-
Quantification of the importance of the study
e.g.: Morbidity, mortality, potential growth of knowledge, originality of approach
-
Quantification of the discomfort of the involved animals
34
e.g.: Amount and duration of suffering, number of animals involved, species
-
The relevance and/or quality of the experiment
e.g.: Attention for 3 R’s, necessity, chance the aim is being achieved
I expect that more - if not most – of the own ethical assessments will comply with what minimally
should be in this section when this textbox is being added to the inquiry form. This text gives clear
directions for what is expected from the applicant without ‘giving away’ too much: the applicant
still needs to make his own assessment and critically think about the ethics of the experiment
himself.
2. Judgment of the ‘own ethical assessments’
To determine if the own ethical assessment of the applicant should be judged as sufficient, the
DEC Utrecht could use the same three criteria as I used in my study for what minimally should be
in it. These are the same criteria as I suggested to implement in the textbox under the question
mark: the own ethical assessment should include a justification of the animal experiment in which
the importance of the study and the discomfort of the involved animals should be quantified and
the relevance and quality of the experiment should be discussed.
3. Improvement of the example sent by the DEC Utrecht
The example that is sent by the DEC Utrecht to applicants of whom the ‘own ethical assessment’ is
insufficient, does comply with what minimally should be in the own ethical assessment. However,
the example would ideally address the quantification of the importance of the experiment to a
greater extent. Right now, the importance of the experiment is only quantified by stating that
35
“…the outcome of surgical treatment of CPSS’s is still unsatisfying”. This could be improved by also
addressing the incidence or the amount of suffering involved with CPSS’s in the example.
4. New section in the inquiry form: chance that aim of the study is being achieved
Most of the aspects that need to be discussed in the own ethical assessment, also have to be
addressed in other sections in the inquiry form: the three R’s, the discomfort of the animals, the
aim of the study, the importance of the study. However, the chance that the aim of the study is
being achieved with the experiment does not have to be discussed in another section of the
inquiry form. I think that this aspect is important for the ethical assessment of an animal
experiment and that this should be addressed somewhere in the inquiry form. I recommend that a
new section is added to the inquiry form in which the applicant should discuss what the chance is
that the aim of the study is being achieved with this experiment. This section could be
implemented in part A, point 5, in which the applicant also needs to address the importance of the
study, the goal/hypothesis, the background of the study and the own ethical assessment.
36