Lay Persons Involvement and Public
Interest. Ethical Assessment in Animal
Ethics Committees in Sweden.
The Swedish Transition Process of the
EU Directive 2010/63/EU with Regard to
Harm-Benefit Analysis in Animal Ethics
Committees
Helena Röcklinsberg
Dept. of Animal Environment and Health, Swedish University of Agricultural Sciences, Uppsala, Sweden
Summary
The Messerli Research Institute asked me to give a presentation of the Swedish situation with regard to the implementation
of the Directive 2010/63/EU, for which I’m most grateful. Given that the administrative and legal transition process is
not of primary interest as relatively small changes were made in Swedish legislation, the focus here will rather be on a
few issues which are typical for Sweden and relevant for the application of the Directive: lay person involvement in the
ethical assessment, i.e. the decision-making process in the ethical review, as prescribed by the Swedish Animal Welfare
Act (SFS 1988:534). In Sweden, a system of Animal Ethics Committees (AECs) was initiated in 1976, fully established in
1979 and located at a number of civil courts, i.e., not governed by or located at universities or other research facilities.
Since then it has been mandatory to apply for permission for all research including animals. The AECs included lay
persons from the beginning. In 1989, however, today’s system of half of the committee members being lay persons and
the other half representing science came into force. During the first 19 years, decisions were advisory, as decisions on
approval or rejection didn’t become legally binding before 1998. The regulation for the composition of the AECs has
not changed due to the implementation of the EU Directive, but differs from the ones of many other EU Member States.
Half the committee members are lay persons, but have a difficult task to ensure “public perspectives” in the ethical
assessment. In this regard, I briefly discuss the role of transparency as laid down in the Swedish legislation and relate
this to recent studies on decision-making in Swedish AECs, arguing for improved structure of discussion in order to
ensure lay persons’/society’s views are included in the assessment process.
Key words: decision-making, hierarchies, open discourse, public involvement, transparency
1 The Swedish Animal Welfare Act before
the Directive
Sweden has a tradition, dating back to 1979, of involving lay
persons in committees on animal experiments. The ideal for these
committees was to be “consensus-making decision forums” in
the assessment process of applications. Already in the first animal
ethics committees, laymen were members in equal numbers as researchers (including animal care takers), motivated by a number
of arguments. Firstly, it was argued that this would initiate dialogue as a basis for consensus and improve decisions by taking a
range of perspectives into account. Secondly, animal experiments
were perceived as a significant moral issue which required public
responsibility both for present and arising discussions. Thirdly,
ALTEX Proceedings 4(1), 2015
it was on the political agenda to create a transparent assessment
process, although this idea had been subject to heated debates
ever since the beginning of the last century until the 1944 legislation, Sweden’s first Animal Welfare Act (replaced the 1857
“cruelty to animals act”), was settled (Borgström, 2009).
Today, there are seven AECs, located at the civil courts of
main university towns. Their decisions on whether to approve
or reject an application have been legally binding since 1998.
The Swedish legislation regarding the assessment procedure as
described in the Swedish Animal Welfare Act SFS 1988:534,
section 21, (Government of Sweden (1988:534) before the Directive (EU, 2010) came into force read as follows:
1) The use of animals in animal experiments shall be approved
from an ethical perspective by an ethical committee on ani45
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mal experiments before the activity commences.
2) When examining a case the committee shall weigh the importance of the experiment against the suffering of the animal.
3) The committee may only approve an animal experiment application if such use can be considered important in the public
interest and the conditions set out in section 19, points 1-3 are
fulfilled.
4) The Government or the authority designated by the Government may issue further regulations concerning such approval,
as well as regulations providing for exemption from the requirement for approval. Act (2007:362)”.
Hence, the core task of the committee is to carry out a classical
utilitarian cost-benefit analysis. Parallel claims to consider the
importance of the research (potential human benefit) compared
to the mental and physical suffering inflicted on animals and,
thus, to decide whether the expected human benefits justify the
expected animal suffering in each application can be found in
Preamble 38, 39 and Article 36, 38, 40 of Directive 2010/63/EU
(EU, 2010). There are, however, differences regarding both the
composition and the task of the committees between the “plain”
Directive and Sweden’s implementation as incorporated in existing legislation and regulation.
2 Elements of transparency and lay person
participation in the Swedish Animal Welfare Act
and the Directive
Committee members are appointed by the Board of Agriculture, the committees are agency subordinated under the Board
of Agriculture, but their decisions are independent. According
to the principle of public access to official documents, i.e. SFS
2009:400 (Government of Sweden, 2009), all applications sent to
the committee become open documents (unless there are strong
reasons to make an exception). A further element of openness is
the requirement that applications shall be written in a language
understandable also for non-scientists, since half of the committee are lay persons. Hence, the new EU requirement for a “nontechnical” summary (EU, 2010, Preamble 41, Article 43) did
generally not evoke reactions in Sweden. Relating this to the task
of the AEC, i.e., the assessment procedure, it is interesting to note
that the Swedish Animal Welfare Act from 1988 state that “The
committee may only approve an animal experiment application if
such use can be considered important in the public interest and
the conditions set out in section 19, points 1-3 are fulfilled.” (italics mine) (SFS 1988:534 §21; Government of Sweden 1988:534
section 21). (Chapter 19 §1-3 is described below). This is explained in a more detailed administrative provision: the AEC
shall make sure that “an application is sufficiently assessed and
given an overall investigation” (SJVFS, 2008). After the implementation of the Directive, the AWA is not changed, but in the
new detailed administrative provision (SJVFS (2012) this aspect
is not further explained. However, taking the legislative claim
seriously, this is a difficult task.
Ideally, each AEC should then assess what “public interest”
means in relation to each application, whereby the role of the
AEC’s lay members is to reflect or represent these public views
46
(Röcklinsberg, 2010). Although Sweden has this tradition of
openness to and inclusion of public views, it is a remarkably
strong claim to, at least in principle, give public or common interests an overriding role in the assessment process.
Regarding the requirements of assessing an experiment, the
implementation of the new Directive brought about some new
wordings in the more detailed regulations (SJVFS, 2012). After
stating that the Swedish Animal Welfare Act shall be obeyed, this
wording follows: “An AEC shall analyze suffering and benefit
from an ethical point of view, balancing animal suffering against
expected benefit of the experiment for humans, animals or the
environment” (SJVFS, 2012, Chapter 7, §25 (my translation)).
Thereafter, the above mentioned section 19 §1-3 AWA is referred
to, which describes limitations for approval. “Animal experiments may only be carried out provided that
1. the purpose of the activity cannot be accomplished by any other satisfactory method that does not entail the use of animals;
2. as few animals as possible are used;
3. the activity is designed in a way that does not inflict greater
suffering than absolutely necessary on the animals; and
4. no animals other than the animals bred for the purpose are
used in the activity.” (my translation)
Hence, already before the implementation of Directive 2010/63/
EU the Swedish AECs had to assess a number of rather demanding claims: no alternative methods are available; the principles
of the 3Rs (reduction, replacement, and refinement) have been
properly applied; no undue suffering is inflicted on the animals;
and, the actual research is in line with common or public interests. (Parallel claims can be found in the EU Directive 2010/63/
EU cf. EU, 2010, Preamble 10, 11, 12, Article 38).
The detailed wording in the Swedish Animal Welfare Act
(Government of Sweden, 1988) and more detailed regulations
(SJVFS, 2012) can be interpreted as a high demand on AECs to
ensure a balance between interests – research, animal welfare,
public view. There are, however, studies indicating that there are
good reasons to doubt that such detailed examinations are carried
out. Some Swedish studies indicate a number of difficulties in the
assessment process. One is that the potential value of the research
is considered more important than animal suffering. Another one
is that discussions on ethical issues in AECs in Sweden are often very limited (Borgström, 2009; Ideland, 2009; Nordgren and
Röcklinsberg, 2005; Persson, 2009), which might be due to a tacit
agreement of not questioning status quo (Holmberg and Ideland
2012). A recent interview study by Tjärnström (2013) showed
perceived difficulty in performing an ethical analysis. “More efforts are needed in order to make sure that what the legislators
initially intended is comprehended, but also in fact what is executed in practice. The utilitarian analysis that constitutes the basis of the ethical evaluation is in practice problematic at best and
impossible at worst. Different interpretations cause confusion
and frustration for many committee members in today’s evaluation process.” (Tjärnström, 2013, p. 46). The main topic of this
study was the committee members’ view on the role of empathy
in decision-making in Swedish AECs. It showed an ambivalence
regarding how to bridge the gap between the perceived importance of empathy (to understand the animals) and the necessity
not to be emotional in order to be rational. Others had a wider
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understanding of rationality, but chose not to show emotions in
order to increase the chances to be listened to (Tjärnström, 2013;
Tjärnström and Röcklinsberg, submitted). Hence, the differences
between the characteristics of a rational decision-making process
are considered a further difficulty in ethical evaluation. A similar
tendency was observed in an interview study on the communication in AECs by Edström (2011). She showed that committee
members have the feeling that there is a stronger focus on the
research protocol/design than on a proper ethical harm-benefit
analysis, that there are rather limited discussions of benefits, that
the gathered knowledge of the committee is not deep enough to
contribute to improvements, and that applications are often difficult to understand for lay persons, who, due to a lack of experience in animal research, have difficulties visualizing the steps in
a research protocol.
According to the presented studies, it is apparent that instead of
such a wider ethical balance discussions often strongly focus on
details which might provide refinement to a certain extent (e.g.,
small changes of the number of animals used or technicalities); in
many committees, excessive amounts of time are spent on clarifications of aims, medical discussions and on the wording of the
protocol (that, according to the law, should be understandable to
laymen and researchers from other fields but often is not). As
a consequence, a number of core claims defined in the 3Rs are
not met. E.g., it is hardly ever ensured or investigated in depth
whether there are alternative methods applicable (replacement)
or if the aim of the lowest possible level of animal suffering
(reduction) is fulfilled. This is partly due to lacking analysis of
animal welfare parameters related to restrictions caused by the
actual experiment. In a Swedish study of applications regarding
the use of genetically modified mice, both researchers and committees showed unawareness of the relevance of distinguishing
between clinical symptoms caused by an experiment, on the one
hand, and by a genetic modification, on the other hand. Hence,
the well-being of the animal at different stages of an experiment
cannot be assessed and thereby not be balanced against potential
benefit (Nordgren and Röcklinsberg, 2005).
A study by a Swedish ethnologist, Malin Ideland, shows the
importance of defining concepts. According to her interviews,
there are disparate definitions of ethics and diverging perceptions
of the reason to undertake an ethical assessment among Swedish
committee members. Three main perceptions were mapped: in
the name of science, in the name of patients or in the name of animals (Ideland, 2009). In the committee discussions, she further
noted that scientists’ views are generally given precedence over
lay persons’. International studies indicate a similar phenomenon
(Schuppli et al., 2004; Kolar and Ruhdel, 2005). A Finnish discourse analysis of AEC showed that a narrow understanding of
the issue at stake is used and that scientists’ arguments are given
highest weight (Lehto and Hirsjärvi, 2011). It seems that the focus in the ethical assessment process is on what is already common practice in a certain committee, i.e., following its traditions
(Holmberg and Ideland, 2012) rather than always carrying out a
new weighing process.
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3 Gap between the legislator’s ideal and reality –
new formats needed
It seems fair to conclude that ideals for both the aim and the process set by legislation are difficult to fulfill. The presented studies
show difficulties in transforming the once politically expressed
ideal of each AEC being a “consensus-making decision forum”
in full transparency to the public. Although consensus might be
achieved without a proper discussion, this was not intended: The
idea was a lively discussion where integrated lay persons would
guarantee a wide range of perspectives. Understood in this way,
it is a task for all members, but taking social hierarchies connected to, e.g., education level and specific competence into account,
it is obvious that it is more of a challenge for lay persons. In order
to make sure that the lay persons’ views are taken seriously and
that they represent “a public view”, not only an understandable
language in the applications is required, but also an open and
respectful discussion atmosphere, as well as the genuine effort of
all committee members to take this “public view” into account.
Only if this is provided, the required ethical analysis or weighing
can be carried out. Hence, one important feature for improvement
is to pay attention to the inherent structure of the way discussions
are performed (Tjärnström and Röcklinsberg, 2014).
There might be a structural dilemma in committees involving
experts and lay persons when striving for an open discussion and
consensus decisions. Expert knowledge is needed to analyze an
issue, but may not per se override the lay persons’ ethical views
and perceptions, as they are experts in a certain field of research,
but not in ethics (see also Hedlund, 2007). If public interests are
to be taken into consideration, they need to be discussed and
that’s where lay persons’ views on criteria for important research
need to be taken into equal consideration as researchers’ criteria.
Overcoming hierarchies in each AEC, creating an open discourse
along the lines of, e.g., Benhabib (1992) or Habermas (1990)
seems a crucial point in order to consider the lay persons’ skills
and ethical awareness – a prerequisite to make sure that all approved applications are “considered important in the public interest”, which in turn is relevant from a democratic point of view
(Röcklinsberg, 2010).
Taken together, these studies indicate at least three points of
insufficiency in the assessment process of Swedish AECs. 1) The
scope of the cost-benefit analysis is often narrow – also in Sweden in spite of political and structural aims for including broader citizen perspectives on animal research; 2) the committee’s
balancing processes seems to rest on more nuanced information
about potential human benefits than on the animal conditions
and suffering; 3) it was shown that the most demanding of the
3Rs, replacement, is hardly ever taken into consideration, but
refinement and/or reduction is used at times. If this is a correct
mapping of the ethical assessment process, one can see a risk of
ethical aspects coming close to a narrow balancing of potential
human benefits against an unclear or non-described picture of
actual animal welfare interests. A further complexity of this difficulty is the question which ethical aspects and which perception
of “animals” is taken into account, whether concepts like integrity and inherent value are considered relevant (Gjerris and Gamborg, 2010; Röcklinsberg et al., 2014). Approaching these issues
47
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by acquiring increased ethical competence among committee
members (Kuhlau, 2013), an open discourse in terms of “interactive universalism” where each partner is prepared to take on the
views of the others for a moment, as well as to see the discussion
as an ongoing process (Benhabib, 1992), and striving for respect
for each participant and for each argument, independent of social
status of the speaker, each participant’s right to introduce a statement and to question the other’s statements, and all this without
risk for any kind of coercion (Habermas, 1990) would help to
create a respectful discussion atmosphere enabling learning and
a more thorough ethical balancing of harm and benefits. This, in
sum, would increase the possibilities to live up to the legislation’s
request for an ethical weighing of costs and benefits based on taking public interest into account.
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Correspondence to
Helena Röcklinsberg, PhD
Dept. of Animal Environment and Health, Box 7068
Swedish University of Agricultural Sciences
75007 Uppsala, Sweden
e-mail: [email protected]
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