This document discusses the development of the Ethical Matrix as a decision support framework, using GM fish as a case study. It was developed in the 1990s to help decision-makers explore the ethical issues of agri-food biotechnologies. The authors analyze the concept of "ethical soundness" for ethical frameworks and identify key criteria including inclusion of values at stake, transparency, consideration of multiple viewpoints, inclusion of ethically relevant case details, and inclusion of ethical arguments. They assess how well the Ethical Matrix meets these criteria and conclude it scores relatively highly, though caveats remain about information availability and complexity of ethical decision-making.
MATTHIAS KAISER, KATE MILLAR, ERIK THORSTENSEN, and SANDYTOM.docx
1. MATTHIAS KAISER, KATE MILLAR, ERIK THORSTENSEN,
and SANDY
TOMKINS
DEVELOPING THE ETHICAL MATRIX AS A DECISION
SUPPORT
FRAMEWORK: GM FISH AS A CASE STUDY
(Accepted in revised form October 25, 2006)
ABSTRACT. The Ethical Matrix was developed to help
decision-makers explore the
ethical issues raised by agri-food biotechnologies. Over the
decade since its inception
the Ethical Matrix has been used by a number of organizations
and the philosophical
basis of the framework has been discussed and analyzed
extensively. The role of tools
such as the Ethical Matrix in public policy decision-making has
received increasing
attention. In order to further develop the methodological aspects
of the Ethical
Matrix method, work was carried out to study the potential role
of the Ethical
Matrix as a decision support framework. When considering
which frameworks to
apply when analyzing the ethical dimensions of the application
of agri-food bio-
technologies, it is important to clarify the substantive nature of
2. any prospective
framework. In order to further investigate this issue, reflections
on the neologism
‘‘ethical soundness’’ of an ethical framework are presented
here. This concept is
introduced in order to provide more structured evaluations of a
range of ethical
tools, including ethical frameworks such as the Ethical Matrix.
As well as examining
the philosophical dimensions of the method, theoretical analysis
and literature
studies were combined with stakeholder engagement exercises
and consultations in
order to review the Ethical Matrix from a user perspective. This
work resulted in the
development of an Ethical Matrix Manual, which is intended to
act as a guide for
potential user groups.
KEY WORDS: biotechnology, decision support, Ethical
frameworks, Ethical
Matrix, GM fish
1. INTRODUCTION
One of the first decision-support frameworks to be developed to
explore the
ethical issues raised by agri-food biotechnologies was the
Ethical Matrix,
proposed by Mepham of the University of Nottingham in the
3. mid 1990s.
Since then, the Matrix has been applied to a number of case
studies, such as
bST, xenotransplantation and bioremediation, by Mepham and
his col-
leagues at the University of Nottingham (e.g., Mepham, 1996,
2000, 2001;
Mepham and Tomkins, 2003; Moore, 1996; Millar, 2002) and in
the Food
Journal of Agricultural and Environmental Ethics (2007) 20:65–
80
DOI 10.1007/s10806-006-9023-8 � Springer 2007
Ethics Council, and by others working at several different
institutions (e.g.,
Kaiser and Forsberg, 2001; Kaiser, 2004; Schroeder and Palmer,
2003;
FAO/WHO, 2003; Chadwick et al., 2003). Over the decade since
its incep-
tion, the Ethical Matrix has attracted considerable attention
from specialists
in the field of bioethics, and the philosophical and
methodological basis of
the framework has been discussed and analyzed extensively.
4. Therefore, we
shall not attempt to survey and present all pertinent aspects and
justifica-
tions of the Ethical Matrix in this paper (refer to Mepham et al.,
2006 and
cf. also Forsberg, 2007).
The role of tools such as the Ethical Matrix in public policy
decision-
making has received increasing attention over the last few
years, with a
number of practitioners exploring the use of new and novel
frameworks and
tools, in particular in regard to applied ethics. In order to
further develop the
methodological aspects of the Ethical Matrix method, the
authors have
studied the potential role of the Ethical Matrix as a decision
support frame-
work in the field of biotechnology and food regulation.
Theoretical analysis
and literature studies were combined with stakeholder
engagement exercises
and consultations in order to study various aspects of the
Ethical Matrix
5. from a user perspective. This work resulted in the development
of an Ethical
Matrix Manual (Mepham et al., 2006). The aim of the paper is
to clarify some
general evaluation criteria for the uses of the Ethical Matrix as
a decision
support framework, and to exemplify briefly two participatory
approaches.
2. ETHICAL SOUNDNESS OF THE FRAMEWORKS
When considering which frameworks are appropriate for use
when ana-
lyzing the ethical dimensions of agri-food biotechnologies, it is
important to
clarify the substantive nature of any prospective framework. In
order to
investigate this, we have attempted to present some reflections
on the
neologism ‘‘ethical soundness’’ of an ethical framework. This
concept is
introduced in order to provide more structured evaluations of a
wider range
of ethical frameworks.
1
6. The term ‘‘soundness’’ in this context is adapted from the
philosophical
work on logic. An inference is normally termed ‘‘sound’’ if,
and only if, the
logical form of the argument is valid (i.e., truth preserving) and
all its
premises are true. An axiom system is sound if, and only if, all
the axioms
and theorems are true under all interpretations. Accordingly,
one would say
that an ethical argument is sound if, and only if, the logical
form of the
normative argument is valid (e.g., in a version of deontic logic,
namely, a
1
For a list of several such frameworks see the website of the
project Ethical Bio TA Tools:
http://www.ethicaltools.info/.
MATTHIAS KAISER ET AL.66
logic of normative concepts) and all its premises are either true
or valid (here
in the sense of the German term ‘‘gültig’’; ‘‘normative
rightness’’). It could
7. then be said that a normative system (theory) is sound if, and
only if, all its
axioms and derived theorems are valid under all normative
interpretations.
However, an ethical framework is not to be confused with a
particular
ethical theory. An ethical theory would, ideally, distinguish all
morally right
from all morally wrong or morally neutral actions. A framework
on the
other hand only assists us in reaching a reflected ethical insight
or normative
conclusion. A framework is not composed of statements that
together make
up a normative theory; rather it is a tool on a meta-level, since
it makes use
of a variety of ethical theories and normative arguments. Given
this variety,
the above description of ethical soundness cannot apply to such
a frame-
work, since viewpoints might be included that arise from very
different
theoretical conceptions and that may collide with each other.
Thus, ethical
8. soundness of a framework cannot mean normative validity under
all
interpretations. But a framework is also a practical and
pragmatic tool,
since it should allow us to extract all relevant information for
decision-
making involving ethical issues, without necessarily implying a
unique an-
swer to all issues. Ethical frameworks are not material objects,
or even sets
of statements; rather, they are conceptual or procedural devices,
which are
designed to facilitate explicit ethical decision-making, typically
by a body
consisting of several individuals with varying viewpoints. They
are tools that
are dependent on the competency of users, i.e., as moral
individuals. Given
this definition of an ethical framework, the use of ethical
soundness in this
context is therefore conjectural and non-traditional, and
requires further
analysis. This analysis should take account of the essential
function of
9. ethical frameworks to assist public bodies in making ethically
justified
decisions.
The question then arises, what should be preserved and
accentuated if
one transposes ethical soundness from normative ethical theory
to ethical
frameworks that are developed to aid decision-making. The
intuitive notion
is that a decision support framework works well, i.e., is
ethically sound, if it
allows competent access to all relevant normative
considerations and facts
of an issue, and leaves the users free to draw conclusions based
upon their
own priorities, but informed by insights into alternative
viewpoints.
Frameworks that have an inbuilt bias towards a particular
ethical position
should not be regarded as ‘‘ethically sound.’’ Similarly,
frameworks used
within a given knowledge base that systematically neglect
information that
10. is crucial for certain normative viewpoints, are also not
ethically sound. All
frameworks should ensure that the normative reasoning put
forward by
potential users is transparent to all external reviewers and
evaluators.
GM FISH AS A CASE STUDY 67
Therefore it is proposed that an ethical framework is ethically
sound, if
and only if, its application produces understanding of ethically
relevant con-
siderations in such a way that within a given body of knowledge
and on con-
dition of its competent use no further considerations would
decisively alter the
normative conclusions drawn from the framework by the users.
Such a definition of soundness of an ethical framework in some
way
parallels proposed definitions of, e.g., scientific objectivity (cf.
Føllesdal
et al., 1986, pp. 354–360).
2
It is clear that a definition of this kind with an
11. inbuilt counterfactual clause cannot be checked in any direct
manner as to
whether it applies or not. However, a test of ethical soundness
is to ask
whether certain ideal criteria are sufficiently respected in a
competent use of
a framework, such as the Ethical Matrix. These criteria could
then be seen as
indicators of ethical soundness, in much the same way as one
talks of
indicators of sustainability etc. The indicators would be such
that neglecting
them would weaken the value of the framework as a decision
support tool
and typically lead to different normative conclusions or
different reasons for
given conclusions. It should also be recognized that these
indicators could
be used to evaluate the performance of several alternative
ethical frame-
works (of which the Ethical Matrix is just one).
Thus, in the decision-making context addressed here, i.e., a
context
12. where a decision-maker is faced with competing value claims in
society and
a plurality of ethical theories appealed to by various groups,
several con-
siderations enter the picture that may indicate the ethical
soundness of
frameworks. The main properties of ethically sound
frameworks, as we
tentatively see them, are the following:
(1) Inclusion of values at stake
(2) Transparency
(3) Multiplicity of viewpoints
(4) Exposition of case-relevant ethically-relevant aspects
(5) Inclusion of ethical arguments
2.1. Inclusion of Values at Stake
Moral decisions represent choices between different moral
impacts or
assessments. Therefore, an explicit listing of all the values that
are at stake in
a decision is instrumental for the ethical soundness of the
framework. If a
relevant value is overlooked, the outcome of the moral
13. evaluation will
typically be different.
2
Føllesdal et al. (1986) characterizes scientific objectivity as the
ideal that is reached when a
given scientific claim would not be evaluated differently by
adding more pertinent facts in its
justification.
MATTHIAS KAISER ET AL.68
2.2. Transparency
One of the main challenges of ethical frameworks is to
overcome the
opaqueness of moral decision-making. The challenge is thus
that the process
of decision-making becomes transparent. Transparency is a
precondition for
(a) allowing a wide and inclusive social debate on the issue, and
(b) making
decisions that are socially robust and not immediately
challenged by public
voices on the basis of information gaps. All too often political
actors and
14. decision-makers seem to assume that ethical positions are
simply taken,
without clarification of why and how they are reached and how
they could
be challenged. This opacity leads to instability in moral
evaluation.
3
2.3. Multiplicity of Viewpoints
Democratic societies are by definition pluralist societies, and
this extends
naturally to the sphere of ethics. Any given or automatic
dominance of a
particular ethical viewpoint, be it a utilitarian viewpoint or
Kantian ethics,
etc., would infringe on the rights of those who adhere to
alternative ethical
viewpoints. Not seriously considering other ethical viewpoints
would also be
deeply unjust and run counter to ideals of equity. An ethical
framework
should, therefore, take account of this multiplicity of known
ethical view-
points. To the extent that this is not guaranteed by the
competent use of a
15. framework, the ethical soundness of the framework is
threatened, since
consideration of alternative conceptions may alter the outcome.
2.4. Exposition of Case-specific Ethically Relevant Aspects
Ethical decision-making presupposes that all ethically relevant
aspects of
the issue are adequately accounted for. As well as appropriately
specified
ethical principles, ethically relevant aspects include factual
information, the
inclusion of which potentially contributes to strengthening or
weakening a
particular moral outcome or judgment.
2.5. Inclusion of Ethical Arguments
Frameworks seem to differ in regard to the extent to which they
aspire to
represent ethical argumentation. In ethical theory, the ideal is
that an ethical
position is reached through a reflective argument, based on the
available
3
Even transparent decisions may of course be challenged, but
then disagreements may either
16. point to a lack of specific information that was not duly
considered, or to a simple disagreement
on the weighing of values. Currently we see that a number of
decisions are challenged simply on
the basis of being ‘‘unethical’’ or for presenting the wrong
ethical position. Ethical frameworks
aspire to extend beyond this rhetoric by ensuring the
transparency of the ethical reasoning
behind any given decision.
GM FISH AS A CASE STUDY 69
information and the ethical principles of the theory. This
applies in par-
ticular to situations where different principles run into conflict
and one has
to weigh and balance them. Knowledge of the arguments behind
particular
decisions enables rational critique and debate. Thus, we might
see this
aspect as instrumental for the ethical soundness of a framework.
The concept of ethical soundness was applied to evaluate the
suitability
17. of different candidates to operate as ethical tools in democratic
decision-
making processes. For instance, a committee approach (that
might be
ranked as a procedural decision support framework) might not
easily, or
necessarily, satisfy all requirements for transparency, e.g., in
terms of how
the final recommendation was reached and who discussed what.
However, it
is clearly very difficult to provide a definite characterization of
all possible
frameworks.
Examining the Ethical Matrix, and the process for translating
the prin-
ciples for such a matrix, reveals that the criterion of
transparency seems
optimally to be realized. A judgment formed on the basis of a
Matrix shows
clearly what information was available and which
considerations were
judged to be dominant and how they were weighed. Similarly,
one can say
that the multiplicity of viewpoints is optimally accounted for by
18. the explicit
listing of stakeholder viewpoints. In principle, there is also a
good chance
that an Ethical Matrix will account for all ethically relevant
information and
all ethical arguments. Yet, there are some caveats: these
features are
dependent on the information that is available and included in
the analysis.
Typically, this will depend on the scientific training and ethical
competence
of the users of the framework, such as organizers of a workshop
and the
participants or a committee secretariat. To the extent that all
users are
challenged by information overload, it may be difficult to be at
the cutting
edge of all issues. This may be reflected, for example, in the
quality of the
information included in the Matrix. In spite of this caveat, it
seems that the
probability of including all relevant values at stake would be
high, since this
is a criterion for compiling a list of interest groups. In
19. summary, the Ethical
Matrix would appear to score relatively highly on the indicators
of ethical
soundness.
One of the purposes of conducting an exercise to determine
ethical
soundness is to recognize that not all frameworks score alike
under the five
specified criteria. It appears that no framework could easily
fulfill all the
ethical soundness criteria. This may be due to the following
factors: (i) the
list of conditions may not really be comprehensive for this
purpose; (ii) some
frameworks may consciously be built upon leaving out certain
aspects in
order to optimize other aspects, e.g., playing down ethical
argument in favor
of transparency and multiplicity of viewpoints; (iii) the nature
of ethical
decision-making may be such that one in effect has to choose
between a
MATTHIAS KAISER ET AL.70
20. broad and inclusive framework and an in-depth framework with
detailed
expert arguments; and (iv) different frameworks may be
intended for dif-
ferent stages of the decision making process. In view of such
limitations, one
should be careful to consider the five properties as tentative
indicators for
reviewing the ethical soundness of a framework, and not as
conditions that
together define ethical soundness.
The aim of the above characterization was to clarify further the
needs of
decision-makers with regards to ethical frameworks. While one
may easily
agree that an ethical framework should facilitate the decision-
making pro-
cess, one also needs to pay closer attention to the variety of
possible uses to
which these frameworks can be put.
3. DEVELOPING A USER MANUAL FOR THE ETHICAL
MATRIX
21. When considering the conceptual basis of the Ethical Matrix, as
articulated
by Mepham et al. (2006), it is at its simplest level a checklist of
concerns,
structured around established ethical theory. However, it can
also be used as
a means of promoting structured discussion. The interest
groups, the
weighting of each cell, and even the appropriateness of the
principles may all
be challenged or modified by those using it. At best, it helps
those involved
in making a decision to put themselves in the shoes of others.
At the very
least, it ensures that more than the usual narrow range of
concerns are
raised and considered.
In order to review the needs of potential users of the Ethical
Matrix and
to develop a user manual for the Ethical Matrix, two workshops
were
convened, in each of which the potential use of GM fish was
chosen as the
case study. This case was chosen in order that the exercises
22. could relate
directly to the decision-making process involving the
Norwegian Ethical
Board on the Ethics of Patents. However, it is not the intention
of this
article to present a detailed ethical discussion of the chosen
case study. The
main focus of this article is to discuss a number of structural
features of the
Ethical Matrix approach that are of interest when evaluating it
as a decision
support framework. One workshop was conducted in Edinburgh
with a
group of experts, while a second workshop was conducted in
Oslo with
‘‘lay’’ participants. One of the previously reported strengths of
the Ethical
Matrix is that it can be used by numerous groups and does not
presuppose
that participants should all be knowledgeable stakeholders.
The research team reviewed aspects of the operation of an
expert group
with a group of lay people when using the Ethical Matrix.
However, within
23. a European context there are notable differences in scientific
and political
culture. While some countries seek ethical advice from broadly
composed
GM FISH AS A CASE STUDY 71
and highly qualified expert groups (which can include lay
members), other
countries, notably in Northern Europe, seek to further include
members of
the lay public, in the processes that lead to such advice. The
research team
worked on the assumption that there may not be any general or a
priori
arguments for or against either of these approaches, but that
both require
transparent justification of their ethical assessments.
Building on published material on the Ethical Matrix and the
practical
experiences of the research team, a provisional protocol was
devised as a
basis for the development of a Manual for the framework (see
the diagram
24. in Figure 1 for a summary). This protocol set out a clear
methodology for
potential users. The protocol gave guidance on the application
of the
method and both Research Groups used this protocol in two
workshop
trials. The protocol was then evaluated to determine its
applicability and
was further developed. In order to explore the two
methodological ap-
proaches to the Ethical Matrix that have emerged, the two
research groups
independently applied a top-down approach (TDA), or the
classical form of
the method, and a bottom up approach (BUA) that are described
below.
The Ethical Matrix may be used in several ways and by
different groups of
people, or even by individuals. So organizational requirements
are likely to
be quite different in different circumstances, and to be critically
influenced by
factors that are not directly related to the nature of the Ethical
Matrix as an
25. ethical tool. Such factors not only include financial and time
limitations but
also the degree to which participants in a group exercise are
encouraged to set
the agenda themselves rather than follow a prescribed step-by-
step proce-
dure. With reference to the latter point, the different ways in
which the
Ethical Matrix may be used will be greatly influenced by
whether its use
conforms more to a ‘‘top-down’’ approach than to a ‘‘bottom-
up’’ approach.
4. ETHICAL MATRIX TOP DOWN APPROACH (TDA)
In a TDA, the specifications of the Ethical Matrix principles are
largely set
by the organizers of the workshop, who have acknowledged
expertise in
facilitating bioethical deliberation, and play a prominent role in
structuring
the exercise.
In order to examine whether expert participants found the TDA
Ethical
Matrix approach useful when applied in a participatory setting,
26. a workshop
was organized in September 2005 in the UK. Using the potential
use of GM
salmon in aquaculture as a case study, nine ‘‘expert’’
participants applied the
Ethical Matrix to discuss key issues raised by the use of the GM
technology.
The notion of ‘‘expert status’’ was designated to the
participants on the basis
that they are actively involved with the aquaculture industry, or
biotech-
MATTHIAS KAISER ET AL.72
nology research and development. The group�s expertise
covered areas such
as marine biology; aquaculture industry; fish welfare;
regulation; and
molecular biology, etc. The final selection of participating
experts was done
by the workshop organizers. The final list of participants was
determined by
a combination of considerations, such as interest and
willingness to partic-
ipate, area of expertise, recognized standing in the profession,
27. etc.
DEFINE SUBJECT AREA
* Consideration of the technological claims
* Consideration of key ethical issues associated with
implementing the technology
DEFINE THE ETHICAL MATRIX
* Define the relevant interest groups
* Define the specifications of principles for each of the cells
WORKSHOP OBJECTIVES
* Define the aim of the workshop
* Define the scope of the discussion
* Define the outcomes expected from the workshop
WORKSHOP MATERIALS
* Prepare an introductory presentation
* Define the meeting sessions
* Define the role of the facilitator
* Prepare a briefing paper on the key ethical issues
FEEDBACK FORMS
* Prepare meeting feedback forms to review process and
the methodology
* Prepare SWOT analysis forms for assessing the
methodology
SELECT WORKSHOP PARTICIPANTS
28. * Define the relevant stakeholders
* Determine the relevant areas of expertise
* Ensure that there is a diversity of opinion and interests
represented
PARTICIPANT INVITATION
* Clarify the terms of reference for the workshop
* Clarify the reporting procedure and the role of each
participant
* Send out participant documents including a description of
the method and topic briefing paper
WORKSHOP
* Opening session that defines the methodology, sets out the
aims of the meeting, clarifies the
context of the discussions and clarifies the reporting process for
presenting the results of the
meeting.
* Balanced presentation of experts’ views
* Work through the cells of the matrix in a series of discussion
sessions
* Conclude with an overview session that draws out
participants’ overview of the issues
* Completion of the feedback forms
ANALYSIS OF THE DATA BY FACILITATOR
* Qualitative analysis of the discussion
* Quantitative analysis of data
29. * Qualitative analysis of the feedback forms
* Report on findings
FEEDBACK TO PARTICIPANTS
* Send draft of the workshop data analysis back to participants
to allow
them to check and review the representation of their input
FINAL ANALYSIS AND REPORT
Figure 1. Summary of a generic protocol of the Ethical Matrix.
GM FISH AS A CASE STUDY 73
Participants were sent briefing documents prior to the meeting,
including a
copy of the Ethical Matrix methodology. The workshop was
held over one day
andatthestartof
theevent,participantsweregivenanintroductiontotheEthical
Matrix and the potential issues raised by the case study. During
this process, the
classic TDA Ethical Matrix was used, where the principles are
pre-specified for
each of the interest groups (cf. Table 1). One justification for
using the ‘‘classic’’
30. Ethical Matrix approach was that it had proven useful in many
earlier settings,
and that its form and content are well documented (cf. Mepham,
2005).
The participants used the Ethical Matrix to map out the key
issued
raised. As part of their assessment, they were asked to comment
on the use
of the Ethical Matrix and its potential value. When examining
participants�
views of the Ethical Matrix in relation to the notion of ethical
soundness,
many felt that the strengths of the framework were its inclusion
of a mul-
tiplicity of viewpoints and the discussion of the key (ethical)
arguments.
Participants commented on the value of working through the
pre-defined
Ethical Matrix as it facilitated a structured debate amongst the
group.
When asked to complete a SWOT-analysis (setting out
strengths, weak-
nesses, opportunities, and threats) of the method, common
weaknesses were
described as: the lack of time to discuss each issue and the
31. potential limita-
tions of the knowledge of the participants. Participants noted
the need to
ensure that a broader range of stakeholders are involved in the
discussion,
therefore, the involvement of additional participants with
complementary
backgrounds would have been welcomed by the group. These
potential
limitations should be further explored within the context of
other partici-
patory methods, since many of the limitations identified can
relate to these
methods per se. As part of the written feedback, all participants
believed the
use of the Ethical Matrix helped the process. Although this was
a limited
exercise conducted in a UK setting, the findings from this
workshop appeared
to reinforce the perception that expert groups prefer to work
with a TDA.
5. ETHICAL MATRIX BOTTOM UP APPROACH (BUA)
In a bottom-up approach, the organizers provide less explicit
guidance, and
32. defer to the majority views of the (usually) lay participants in
specifying the
principles and conducting ethical deliberation.
In order to further analyze and develop the BUA Ethical Matrix
method,
a workshop was organized in Oslo (November 2004). The use of
GM
salmon in aquaculture was again chosen as the case for study.
Ten lay
participants were chosen from a sample of 70 (standardized
demographic
balancing was applied) self selecting citizens who had
responded to an
advertisement placed in a public newspaper. The ten
participants were
MATTHIAS KAISER ET AL.74
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.
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GM FISH AS A CASE STUDY 75
chosen on the basis of criteria such as gender, age, variety in
educational
background, and apparent motivation in application.
Participants were sent
briefing documents on the potential use of GM salmon and the
workshop
was conducted in two sessions on two separate days. On the
first day, the
participants were introduced to the case study and during the
second day the
group worked through the issues using the Ethical Matrix.
For this BUA approach, the research group applied a BUA
48. Ethical
Matrix based on the four principles – with well-being specified
separately as
increased benefits and reduced harm, autonomy, and fairness.
The partici-
pants translated these ethical principles into specifications for
the interest
groups and as a result of discussions the principle Autonomy
was modified
and the term Dignity was subsequently used in the Matrix. The
participants
also added additional stakeholders to the original list. Some
participants
argued for the inclusion of ‘‘future generations’’ as a
stakeholder group, but
it was agreed that these considerations could be included under
the Con-
sumer group. Others perceived ‘‘Research and Knowledge
Production’’ to
be an important issue. As a result of this discussion, an
additional stake-
holder group, ‘‘Research Community,’’ was added to the
Matrix. Five
interest groups were, therefore, used in this BUA Matrix. The
49. Ethical Matrix
articulated and agreed to by workshop participants is set out in
Table 2.
It should be noted that the Ethical Matrix method was
introduced to the
participants at the beginning of the discussion. Although,
participants
appreciated the organizers initial presentation of an Ethical
Matrix as a
starting point for their discussions, they claimed that if given
more time,
they might have proposed further changes, both in the list of
ethical prin-
ciples and in the list of stakeholders. Participants stated that the
Matrix
applied during the workshop should be seen as a first
approximation to the
problem, but they also highlighted that it would not necessarily
rank as a
‘‘natural’’ classification scheme. The organizers interpreted this
view as
indicating a level of abstraction in the Ethical Matrix method
that requires
some familiarity with, and knowledge of, ethical assessment
50. procedures.
In terms of outcomes from the workshop, much discussion
centered on
what the principles ‘‘Increased benefits’’ and ‘‘Reduced harm’’
actually re-
ferred to. It was, for instance, not obvious to the participants
that ‘‘Food
safety’’ was a correct specification of reduced harm for
consumers.
On the second day, the participants discussed the potential
ethical
impacts for the defined stakeholders (interest groups). This was
referred to
as specifying the consequence matrix. The organizers proposed
a completed
consequence matrix, but the participants wished to propose their
own
analysis of the issues without assistance.
In terms of feedback from the participants and in view of the
notion of
ethical soundness, some individuals were of the opinion that the
ethical
MATTHIAS KAISER ET AL.76
65. o
w
n
re
se
a
rc
h
‘‘
U
n
d
efi
n
ed
’’
GM FISH AS A CASE STUDY 77
arguments were not fully clarified. This may be a limitation of
the BUA,
where principles are not predefined. Since this workshop was
conducted
with lay participants, it was felt that there should be sufficient
time for a
learning process to occur, in terms of the process and the
subject. Giving
more time for participants to reflect upon their own judgments
could im-
66. prove the process. The evolution of specification of the
different cells and
their contents are dependent upon interpretation, and this
interpretation
depends on the participants� background and preparation. This
may be seen
as a limitation for the use of the BUA approach with lay
participants.
However, the completed cells create compartmentalized data on
the par-
ticipants� views of the issues. The completion of the cells
demanded a fo-
cused debate over how one perceives a decision to affect the
interested
parties. This leads to a debate over values and potential ethical
impacts.
In addition to the comments on the methodology, several
participants
reported that some of their views changed as a result of
conducting the process.
For instance, while they raised ethical concerns with regards to
commercial use
of growth enhanced GM salmon, they also felt that the
development of sterile
GM salmon might reduce the significance of some of the major
67. concerns, since
it might address current concerns relating to wild stock levels.
Thus they found
that they did not fundamentally object to the use of GM
technology in animal
production, but options were dependent on the distribution of
implied benefits.
According to the participants, many of the advantages
demonstrated in
this study were procedural. There is room for further
development of the
methodology as a tool relevant for engaging with lay
participants. Some of
these developments are interrelated, e.g., time and clarity. It is
conceivable
that some more time – or stretching the exercise over a longer
period – could
lead to more reflection on ethical arguments.
CONCLUSIONS
Applying both the TDA and BUA approaches to the case of GM
salmon pro-
vided valuable insights that allowed further development of the
Ethical Manual.
68. The workshops highlighted the fact that, although the Ethical
Matrix does not
emerge as a very simple tool to use as a participatory ethical
framework, it does
show its potential to structure ethical concerns under varying
conditions.
It is not possible to conduct a direct comparison of the
outcomes from the
two workshops, since the participant sample is too small and the
method-
ological approach differed, in terms of preconditions and type
of participant.
However, even with these varying conditions, the two
applications of the
method, TDA and BUA, have allowed the analysis of some
crucial indica-
tors relating to the ethical soundness of decision support
frameworks.
MATTHIAS KAISER ET AL.78
Examining the discourse from the workshops, the participants
were able
to present their ethical reasoning in relation to the technology
that allowed
69. their evaluations to be more transparent, the reference to ethical
values and
argument was made explicit. The use of both methodologies,
TDA and BUA,
allowed individuals to present varying ethical viewpoints, even
to the extent
that they may not have coincided with participants original
viewpoints.
Conducting further participatory events would establish how
comprehensive
the recorded considered ethical viewpoints were in this study.
With regards to
ethically relevant factual information, both groups seemed to
endorse the
view that a broad range of expertise should be involved in the
preparation of
technology evaluation of this nature. This represents a
significant challenge
and responsibility for the organizers of this type of consultation
process.
These trial workshops highlighted that there are further
opportunities to
explore and develop the Ethical Matrix for use as a
participatory tool.
70. However, some interesting outcomes were observed from these
exercises. The
expert group felt that the use of the Ethical Matrix provided a
needed
structure for the discussion, allowing all participants to
contribute and
participate. It was interesting to note that the lay panel, which
at the start of
the process had voiced some skepticism towards biotechnology,
ended up
with a more positive evaluation of the potential use of GM
salmon by the end
of the process. No inherent technophobia seemed dominant in
their evalu-
ation and it seemed as if the close examination of this case
study on the basis
of an Ethical Matrix approach provided an overview that
allowed partici-
pants to distance themselves from preconceived ideas and judge
on the basis
of information and principles that are designed to serve the
common good.
Thus, it is hoped that for both applications, lay and expert, that
the Ethical
71. Matrix may actively contribute to what one may call ethical
discourses.
ACKNOWLEDGMENTS
This work was conducted as part of the EC funded project under
DG Re-
search, FP5, Quality of Life program, ‘‘Ethical Bio TA tools,’’
(QLG6-
CT-2002-02594). The funding and the inspiring collaboration of
all other
consortium members are gratefully acknowledged.
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Functional Foods,
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University Press.
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Millar (2006), Ethical
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MATTHIAS KAISER and ERIK THORSTENSEN
National Committee for Research Ethics in Science and
Technology (NENT)
P.O. Box 522 Sentrum,
Prinsensgate 18
0105, Oslo, Norway
74. E-mail: [email protected]
KATE MILLAR and SANDY TOMKINS
Centre for Applied Bioethics, School of Biosciences,
University of Nottingham, Sutton Bonington Campus
Loughborough, Leics, LE12 5RD, UK
E-mails: [email protected]; [email protected]
MATTHIAS KAISER ET AL.80
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reproduction prohibited without permission.
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80. Toronto,
Ontario, Canada. This work was carried out at the Center for
Tobacco
Research and Intervention, University of Wisconsin Medical
School,
and at the Ontario Tobacco Research Unit.
Corespondence: Brion J. Fox, J.D., University of Wisconsin
Comprehensive Cancer Center, Room 385 WARF Bldg., 610
Walnut
St., Madison, WI 53726, USA. Tel.: + 1 (608) 262-3894; fax: +
1 (608)
262-2425; E-mail: [email protected] u
Review
Tobacco harm reduction: A call to address the
ethical dilemmas
Brion J. Fox, Joanna E. Cohen
[Received 31 July 31, 2001; accepted 18 February 2002]
The 2001 Institute of Medicine report Clearing the Smoke:
Assessing the Science Base for Tobacco Harm
Reduction has helped to focus attention on the scientific basis
for assessing tobacco harm reduction products.
As the tobacco research and policy communities tackle the
challenges of evaluating harm reduction, there are
ethical issues that must also be addressed. There has, however,
been very little writing on the ethics of this field.
In an effort to spur research into answering these ethical
questions, we present two complementary approaches.
First we outline three overarching topics in tobacco harm
reduction that would particularly lend themselves to
study: (a) Is the pursuit of tobacco harm reduction an ethical
81. goal? (b) What are the ethical considerations of
tobacco harm reduction vis-à-vis pharmaceutical companies?
and (c) What are the ethical considerations for
harm reduction vis-à-vis tobacco companies? We then present
one possible framework for analyzing the ethical
issues that accompany particular tobacco harm reduction
strategies. By considering the ethical dilemmas
attendant to tobacco harm reduction in a prospective and
thoughtful manner, we will be better prepared to
handle the challenges that face us individually as researchers
and collectively as a tobacco control
community.
Introduction
In 2001, the Institute of Medicine published a report
assessing the science base for tobacco harm reduction
(Stratton, Shetty, Wallace, & Bondurant, 2001). In that
report, the term harm reduction referred to strategies
that lower tobacco-related mortality and morbidity even
though there continues to be exposure to one or more
tobacco-related toxicants. There are a wide variety of
harm reduction strategies. Some of these strategies
include using nicotine replacement therapies to reduce
smoking, the development of ‘safer’ cigarettes, and the
implementation of behavioral strategies to reduce the
total number of cigarettes a person smokes. The
Institute of Medicine report has helped spur the tobacco
research and policy community to examine more
closely the prospect of developing products and strate-
gies for tobacco harm reduction. This effort comes
bearing a myriad of challenges, including the scientific
difficulties in developing and evaluating new products,
the prospect that individual benefits may be outweighed
by population harms, and the reality that many ideas
83. below three topics that should be the focus of greater
study as the tobacco control community evaluates the
advantages and disadvantages of pursuing a harm
reduction strategy: (a) Is the pursuit of tobacco harm
reduction an ethical goal? (b) What are the ethical
considerations of tobacco harm reduction vis-à-vis
pharmaceutical companies? and (c) What are the ethical
considerations for harm reduction vis-à-vis tobacco
companies? Because of the overarching nature of these
questions, they will not be answered quickly, nor should
they be. These questions should be part of an ongoing
dialogue and series of analyses that encompass the wide
range of interests of the tobacco control community.
Given, however, that there is an immediate need to
understand some of the ethical implications of particular
harm reduction strategies, we also present and discuss an
ethical framework for analyzing proposed harm reduc-
tion strategies.
Should the tobacco control community pursue
tobacco harm reduction?
As the Institute of Medicine report discusses, harm
reduction strategies that have been adopted in fields
other than tobacco control can provide analogies to
possible tobacco harm reduction strategies. For example,
improving the safety of automobiles is analogous to
removing toxicants from tobacco smoke; providing clean
needles through needle exchange programs is analogous
to heating rather than burning tobacco products; and
providing methadone to heroin addicts is analogous to
providing long-term nicotine replacement therapy to
people who are addicted to nicotine. In many cases, these
harm reduction strategies were reported to be successful,
although recently there has been growing criticism of a
harm reduction approach (Erickson, 1999; Mangham,
84. 2001; Mugford, 1992).
Part of the desire to pursue a tobacco harm reduction
strategy is based upon the belief that we will be unable to
achieve our health goals through current efforts to
prevent and treat tobacco use. For example, it is believed
that there remains a significant core of individuals who
are unable to quit, are increasingly recalcitrant or
otherwise impervious to the public health messages (e.g.,
Irvin & Brandon, 2000), and who would benefit from
harm reduction strategies. In addition, even the most
efficacious treatments or prevention programs will not
reach all smokers. In fact, there is a core of smokers,
often poorer, less educated, or suffering from a co-
morbidity such as mental illness, that would dispropor-
tionately benefit from safer products. The difficult
question, however, is whether efforts taken to reach hard
core smokers will overshadow efforts that could help a
larger number of smokers.
The recently published Public Health Service Clinical
Practice Guideline Treating Tobacco Use and Depend-
ence concluded, ‘There is insufficient evidence to
support a recommendation regarding harm reduction
strategies’ (Fiore et al., 2000). The Guideline describes
numerous strategies and approaches for the effective
treatment of tobacco dependence, and speaks of ‘opti-
mism’ for a ‘promising era in the treatment of tobacco
use and dependence’ (Fiore et al., 2000). The report
identifies the failure to systematically implement the
guideline recommendations as the key barrier to increas-
ing quit rates; that is, it may be too soon to give up hope
on treating the great majority of smokers. This is not
because our tools are insufficient, but because we have
been inadequate in adopting and applying the tools. This
85. view was supported by the publication of a prevention
priorities project that identified that adult tobacco
cessation treatment was among the most effective, cost-
effective, yet under-utilized prevention interventions
(Coffield et al., 2001).
Similarly, the Centers for Disease Control and Pre-
vention have identified Best Practices for states devel-
oping programs to reduce tobacco use (Centers for
Disease Control and Prevention, 1999). The neglect of
many states to fully fund programs to promote these
best practices shows another failure to live up to the
full promise of what we can accomplish in reducing
tobacco use. Indeed, the U.S. Surgeon General has
declared that a 50% reduction in youth and adult
smoking could be achieved by applying what we
already know (U.S. Department of Health and Human
Services, 2000).
The concern is that if clinicians and public health
professionals are encouraged to implement harm reduc-
tion strategies, it is possible that this would be done at
the expense of delivering the cessation messages and
developing the prevention programs that we know are
effective. We fail not because current strategies are
ineffective, but because of a lack of commitment to
strategies that we know work. The conundrum thus
posed is whether it is ethical to invest time, energy, and
resources in the development and testing of new harm
reduction strategies when strategies known to be effec-
tive have not been fully implemented. The challenge
remains even if a private company introduces the harm
reduction strategy– i.e., the tobacco control community
will need to decide if it endorses or uses the product.
It is not as simple as saying that we can pursue all
86. approaches simultaneously. One of the difficulties in
persuading clinicians to provide treatment is the con-
founding nature of the multiple messages they receive.
Similarly, it has been shown that with the advent of low
tar and nicotine cigarettes, smokers used the lower-risk
messages to continue their smoking behavior (National
Cancer Institute, 2001). In assessing the potential value
S82 ETHICAL DILEMMAS
of a harm reduction product, there must be some
recognition that there will be a tradeoff for other public
health efforts. On the other hand, there should also be a
recognition that there is nothing foreseeable that suggests
the current approaches will ‘solve’ the problem in the
near future, and eventually some form of harm reduction
product may be necessary.
What are the ethical considerations of harm
reduction with regard to pharmaceutical
companies?
Any consideration of pursuing or recognizing the
legitimacy of tobacco harm reduction raises the specter
of involvement with pharmaceutical companies. These
companies currently market nicotine replacement prod-
ucts and non-nicotine therapies, such as bupropion SR.
These agents have been approved for use as cessation
devices in a number of countries, and have established
the pharmaceutical companies as partners in the effort to
promote tobacco cessation. In the future, these com-
panies may seek to promote these or newly developed
products as harm reduction products, which could put
them at odds with the cessation community.
87. The participation of pharmaceutical companies in the
debate on harm reduction raises challenging ethical
issues. Despite the positive advances that have been
made by the drug industry, they are private corporations
driven by a profit motive. In the pursuit of harm
reduction, this business ethic may conflict with a public
health ethic. There are a number of ways that this conflict
could be realized. For example, the development of
competitive nicotine delivery devices that would replace
cigarette smoking with long-term nicotine maintenance
(Warner, Slade, & Sweanor, 1997) could subject the
pharmaceutical companies to the criticism that they are
simply replacing one addiction with another. Moreover,
if the pharmaceutical industry produces new products
that reduce harm but do not promote cessation, or market
existing products as a complement to smoking that will
reduce overall harm, the presumed beneficence of the
industry may be lost.
There may also be ethical issues with respect to having
researchers collaborate with pharmaceutical companies.
These companies have an economic interest in the
outcomes of studies they fund that may conflict with the
independence that researchers desire. There is an asso-
ciation between positions that are favorable to the
pharmaceutical industry and financial relationships of
the authors with this industry (Stelfox, Chua, O’Rourke,
& Detsky, 1998). There is evidence that proceedings
from pharmaceutical-sponsored symposia tend to have
misleading titles, to use brand names, and to not be peer
reviewed (Bero, Galbraith, & Rennie, 1992). Further,
many contracts between the pharmaceutical industry and
investigators have unacceptable publication clauses, and
a substantial number of articles that are published
include authorship lists that do not meet accepted criteria
88. for authorship (Bodenheimer, 2000). An uncomfortabl e
reality is that pharmaceutical companies and, potentially,
tobacco researchers who receive support from the
pharmaceutical industry, could have a vested interest in
the types of harm reduction strategies explored.
Recent efforts have addressed the publication of data
from sponsored clinical trials (e.g., Davidoff et al., 2001)
and have established guidelines for industry collabora-
tion (Centers for Disease Control and Prevention, 1997).
These efforts provide guidance as to how to conduct
collaborations but do not discuss whether to pursue the
collaboration in the first place. Moreover, because drug
companies are able to invest great resources in the
development of pharmaceutical products, they may be in
a position to control the tobacco harm reduction research
agenda. Drug-free harm reduction strategies, such as
banning smoking in workplaces (Chapman et al., 1999;
Evans, Farrelly, & Montgomery, 1999; Glasgow, Cum-
mings, & Hyland, 1997), may get left out of any serious
discussion of tobacco harm reduction.
A final difficulty is that, although it is possible to get
public money to study pharmaceutical products, the
majority of funds for clinical drug trials in the U.S. is
provided by pharmaceutical companies. Academic medi-
cal centers are now receiving a minority of those funds,
with for-profit contract-research and site-management
organizations the favored providers of clinical trial
services (Bodenheimer, 2000); thus, researchers who
choose to pursue harm reduction products may be
required to work with this industry.
What are the ethical considerations of harm
reduction with regard to tobacco companies?
89. With respect to harm reduction, the greatest incentive for
creating safer products may come from the tobacco
industry itself. Many of the private lawsuits have been
based upon a failure of the industry to create a safer
product, misleading the public into thinking that a
product is safe, or, in the case of public plaintiffs, to not
pursue research into safer products. The industry thus has
incentives, in the form of improved public relations and
the avoidance of future litigation, to create a safer
product. Any company that develops a safer product is
also likely to have a significant market advantage over its
competitors.
Furthermore, the tobacco companies may be best
situated to understand the subtleties of nicotine delivery
and the development of a safer cigarette. Indeed, there
are many industry products that are already being tested
or discussed. As a result of these factors, it is likely that
the tobacco control community will face the prospect of
having to assess a tobacco-industry-produced harm
reduction product. This assessment may include direct
collaboration in the development or testing of such a
product, or responding to the presence of such a produc t
in the market.
There are reasons that the tobacco control community
may be cautious of such a collaboration. It is well
established that the tobacco industry has perverted
NICOTINE & TOBACCO RESEARCH S83
science for its own purposes by creating artificial
controversy, attacking the reputation of tobacco control
90. researchers, and filtering science through lawyers (Bero,
Barnes, Hanauer, Slade, & Glantz, 1995; Saloojee &
Dagli, 2000). Efforts by the tobacco industry to sponsor
forums to discuss scientific issues or promote collabora-
tion have been met with scorn and have been boycotted
by many in tobacco control. Similarly, efforts to enlist
reputable scientists to review or support the work funded
by the industry have been met with derision (Gardiner,
2001).
Distrust of the industry runs so deep that many have
argued that relationships with the tobacco industry are
unacceptable (Shield, 2001), that universities should
refuse money from the tobacco industry (Chapman &
Shatenstein, 2001; Cohen, Ashley, Goldstein, Ferrence,
& Brewster, 1999) and that journal editors should refuse
to publish articles based on research sponsored by the
tobacco industry (King, Yamey, & Smith, 2000). Even
analyses of legal settlements with the industry have been
described as ‘dealing with the Devil’ (Annas, 1997). One
would be hard-pressed to find anything positive about
the past behavior of the tobacco industry that would
warrant faith in moving forward in collaboration with
this industry, and many organizations have specific
policies against collaboration with the tobacco industry
(Cohen, 2001). It is feared that collaboration, complicity,
or acquiescence of the public health community in
tobacco industry efforts could result in increased credi-
bility of the tobacco industry, making it harder to oppos e
industry efforts that are genuinely detrimental to the
public health.
Given the innate distrust of the tobacco industry,
researchers are likely to want to test independently any
products developed by this industry. In addition, there
will be an innate skepticism of industry motives; for
91. example, is the industry using harm reduction as a means
to increase the number of smokers, or to decrease the
number of smokers who quit? This skepticism will also
lead researchers to critically examine the broader
implications of the proposed product. This independent
testing may simply delay rather than answer certain
ethical questions, because independent testing could
result in confirming that the products meet the claims of
the industry.
There are risks to rejecting potential future relation-
ships with the tobacco industry. As the pharmaceutical
companies bear the cost of testing their products, there is
an argument that tobacco companies should bear the cost
of testing their products. In addition, if science is built
upon open discourse, censorship of the industry could
marginalize the tobacco control community. To reject all
future collaborations assumes that the industry is beyond
redemption, which may be a faulty and risky assumption.
For example, the industry’s reputation is extraordinarily
low in the eyes of the public. The result of this has been
a drive for regulation and litigation. If the industry
changes and the tobacco control community is not
prepared to deal with an industry that is not easily
demonized, the tobacco control community may lose its
own credibility.
Before initiating any collaboration with tobacco
companies on harm reduction strategies or tools,
thoughtful analyses will be needed to define the
appropriate scope and nature of the associations. Ethical
considerations will vary depending on the proximity of
the funds to the tobacco industry and the level of
restrictions on the use of the funds. For example, there
seems to be a spectrum of funding risks from clearly
92. inappropriate to acceptable that includes: the sponsorship
of a researcher or student, the direct funding of a research
project, the unrestricted funding to an institution, and the
use of litigation settlement funds for research. Similarly,
significant ethical consideration should be given to
determine how the public health community should react
to industry efforts even if there is no collaboration. Over
time, these reactions may prove to be what changes the
most, should the industry actually reform, even if, for the
immediate future, skepticism is warranted.
A framework for analyzing tobacco harm reduction
strategies
If the tobacco control community can answer the
questions laid out above in a way that supports pursuing
tobacco harm reduction, there will still be a need to
examine the ethics of individual tobacco harm reduction
strategies. We propose an ethical framework under which
such strategies could be analyzed similar to frameworks
produced in other contexts (see for example Kass, 2001).
An ethical framework will not predetermine answers to
all ethical questions, nor will it guarantee that any two
parties using the framework will arrive at the same
outcome. What it can assist with is a rigorous analysis of
the relevant questions that can then lead to an increased
understanding of the principles at stake. Such a frame-
work could also assist in the development of analyses
and standards for scientific conduct, and the develop-
ment of future research questions.
Ethicists have generally agreed upon a series of cross-
cutting principles that can serve as the basis for a
framework for analysis. Among these principles are:
beneficence – the principle of doing good; nonmalefi-
cence – the principle of not doing harm; self-determina-
93. tion – the principle of allowing individuals to make their
own decisions; and justice – the principle of fairness
(Beauchamp & Steinbock, 1999). These principles also
serve as the basis for many of the ethical theories,
including utilitarian, Kantian, and communitarian theo-
ries (Beauchamp & Steinbock, 1999). For our framework
we have chosen to use a utilitarian approach, which
evaluates and balances the likely benefits and burdens of
the proposed strategy. This balancing should be done in
such a manner that it takes into account the cross-cutting
ethical principles as they come to bear on the underlying
question. The framework that follows will account for
many of the ethical questions raised earlier in this
paper.
S84 ETHICAL DILEMMAS
What are the proposed benefits?
A proposed tobacco harm reduction strategy should be
analyzed for its probable real world benefits and should
be examined for efficacy and for effectiveness. Fur-
thermore, care should be taken to understand the true
penetration of the proposed strategy into the market. For
example, promoting nicotine replacement products as a
part of a harm reduction strategy could fail if the
products are not used or are used incorrectly. Similarly,
new products will have limited effect if they are not
purchased and used by consumers because of inadequate
taste or nicotine delivery. Where evidence is suggestive
of a strong potential benefit, one should not necessarily
withhold the strategy in favor of scientific certainty, but
it should be coupled with specific research questions to
be able to promote the long-term analysis of the
94. proposed strategy.
A primary difficulty in assessing effectiveness is that
the time for scientific discovery is lengthy, and the net
epidemiologic effects of new products cannot be known
for years. On the one hand, too cautious a stance may
discourage the development of new products that are
potentially effective in reducing at least some of the risks
of smoking. On the other hand, proposed tobacco harm
reduction strategies should result in more good than
harm, and not simply substitute harms. For example,
much has been written about the failure of low tar
cigarettes as a harm reduction approach. Initially these
products were seen as potentially beneficial for health
because they were supposed to deliver lower levels of tar.
In the end, however, these products were determined to
be no better than conventional products because of the
innate hazards of tobacco products and how smokers
actually used the product, which offset much of the
benefit that could have been realized. Although an ethical
analysis of low tar cigarettes may not have prevented the
mistakes which occurred, a thorough ethical discussion
could have identified the risks and tradeoffs that were
being made, and promoted research to assist in evaluat-
ing the potential risks versus the potential benefits.
What are the possible harms?
Even if a particular harm reduction strategy suggests
great promise, it must be scrutinized for the potential
burdens that accompany it. These burdens could be
inherent in the product or the result of replacing one risk
with another. An historical example of this kind of
burden would be the original Kent micronite filter, which
was found to have high levels of crocidolite asbestos
fibers (Longo, Rigler, & Slade, 1995).
95. Burdens could also arise from secondary conse-
quences accompanying the harm reduction product. For
example, by creating a safer product there could be a
reduced incentive to quit smoking or avoid initiation.
Therefore, a presumed-safer product could have the
perverse effect of creating a greater population-wide
harm if prevalence is increased. The overarching issues
related to opportunity costs discussed above are espe-
cially appropriate to this part of the framework. Sim-
ilarly, certain types of products may remove other
motivations to quit or maintain abstinence. For example,
a product that reduces or eliminates second-hand smoke
could remove the incentive for individuals to quit in
order to protect those around them. It could also serve to
remove incentives for employers, home-owners, or
policymakers to promote smoke-free environments.
Other burdens may be more regulatory in nature. If a
product is developed that escapes definition as a
cigarette, it may avoid taxation, advertising restrictions,
and so forth. Although the solution could be regulatory,
such an outcome should be considered in an ethical
analysis.
Just as the proposed benefits are to some degree
speculative, the proposed burdens will also be a matter of
some prognostication; nevertheless, efforts should be
made to understand the likely harms as well as the gaps
in research that need to be filled to explain the true nature
of the burden. For example, a better understanding of
how individuals process risk messages is important to
understanding the probable impact a reduced risk
product may have on prevalence rates. In addition,
research such as that published recently by Kozlowski
96. and colleagues (Kozlowski, Strasser, Giovino, Erickson,
& Terza, 2001), which provides a model for how one can
balance the reduction in risk of a harm-reducing produc t
against the increased use of that product, can assist in the
calculation of the scope of the burden.
Would the possible benefits and harms be
distributed across the population equitably?
Even if a product appears on balance to be beneficial,
with the probable risks outweighing the burdens, the
proposed product should be analyzed for its implications
for social justice. If there exists a truly beneficial produc t
that significantly reduces the risk of disease related to
smoking, but that product is expensive, there arises a
social justice question. What mechanisms are in place, or
need to be put in place, to make a safer produc t
accessible to all who might need it? This opens an
additional set of problems, however. If no mechanism
exists, should the product be abandoned even if such an
action would prohibit benefit to those who could afford
it? Conversely, it would be awkward at best for the
tobacco control community to argue for increased
availability of a tobacco product, albeit a reduced-risk
one.
There also could be cultural or other barriers to
products that may create a social disparity. For example,
smokeless tobacco, which may be considered a reduced-
harm product, is almost exclusively used by males. The
answers to these and comparable social justice questions
lie outside the scope of this paper; nevertheless, at a
minimum an examination of these questions should be
made prior to the endorsement of a particular tobacco
harm reduction strategy.
97. NICOTINE & TOBACCO RESEARCH S85
What additional benefits and risks accompany the
proposed strategy because of the involvement of
private industry?
A further level of scrutiny that a proposed harm
reduction product or strategy should undergo is whether
the development or promotion of the product involves
the pharmaceutical or tobacco industries. In addition to
the industry analyses proposed above, one must make
transparent any biases or conflicts of interest that could
arise due to industry involvement.
The mere existence of a bias may not be deleterious,
but the proposed analysis would require the disclosure of
all potential biases. Financial disclosures are clearly the
most apparent and have found their way into the
requirements for peer review publications and general
researcher behavior. However, biases can also be experi-
entially based. For example, as discussed above, the
inherent mistrust of the tobacco industry and its motives
runs deep, which itself may cause one to prejudge a
product from the industry. These biases should also be
disclosed when endorsing or criticizing a tobacco harm
reduction strategy.
An example of how industry involvement could create
an ethical dilemma can be seen in the following
hypothetical situation. How should the tobacco control
community react if essentially identical reduced-risk
products arise out of both the pharmaceutical and
tobacco industries? If the products otherwise pass ethical
muster, the tobacco control community may choose to
98. support the pharmaceutical company product because of
the historical burdens that are associated with the
tobacco industry. Alternatively, the tobacco control
community may shy away from endorsing the pharma-
ceutical company product because of an appearance of
impropriety if this company had funded tobacco control
programs or researchers. Silence could result in a
slowing of the dissemination of the proposed product.
Whichever solution individuals choose to follow, their
biases should be disclosed.
Discussion
One potential interpretation of this commentary is that
the tobacco control community should operate under a
single set of ethics. We are not advocating either for or
against this proposition, and we believe this idea should
be thoughtfully examined prior to any recommendation.
One of the strengths of tobacco-related research is that it
represents the coming together of a range of disciplines
and perspectives. It is possible that the forced homoge-
neity of a single set of ethics could eliminate some of the
diversity we currently enjoy.
If we examine the most basic sources of principle that
exist in our discipline, we can see how the issues conflict
as much as they overlap. Clinicians who operate under
the medical model, treating disease one patient at a time,
could value a harm reduction strategy that benefits an
individual much more than do public health profession-
als who are trying to address population-based problems.
Indeed, one could argue that a failure to prescribe a harm
reduction product to a particular patient who could
benefit from its use could be seen as a violation of a
biomedical ethic. Alternatively, one could see that public
99. health workers could consider it unethical to support a
harm reduction product that had a negative effect on the
overall population. Similarly, non-profit organizations
may be driven by a mission to improve health of all
people, whereas for profit corporations are, by definition,
responsible for maximizing profits for their shareholders.
If a commercially viable and individually-beneficial
harm reduction product was available but nevertheless
had a negative net population-based effect, one could not
expect private corporations to shy away from that
product, nor is it ethically clear that they should.
Our position is simply stated: Individuals should, prior
to adopting a stance on a particular harm reduction
strategy, conduct a rigorous ethical analysis such as that
presented in this paper. Moreover, to best protect the
interests of researchers and policymakers, we urge that
ethical studies be embraced as a necessary part of any
larger commitment to pursue harm reduction. These
studies should involve thoughtful analyses of the issues
from a variety of perspectives, including biomedical,
public health, corporate, legal, and policy. We have
presented but one approach for determining the appro-
priateness of harm reduction strategies. We hope that it
stimulates discussion and encourages others to improve
upon the framework.
Acknowledgments and disclosures
Preparation of this manuscript by the first author was supported,
in part,
by the Robert Wood Johnson Foundation program Developin g
Leadership in Reducing Substance Abuse. Dr. Cohen received
funding
from the Canadian Institute of Health Research. The authors
would like
100. to thank Stella Aguinaga Bialous, Mary Jane Ashley, Roberta
Ferrence,
Pam Kaufman, and Kenneth Warner for their helpful comments
on
earlier drafts of this manuscript .
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NICOTINE & TOBACCO RESEARCH S87
March/April 2009 229
he financial fiascos at Enron,
Tyco, WorldCom, Global Cross-
ing, Qwest, HealthSouth, and the vari-
ous hedge fund investments managed
by securities firms that were highly
questionable from an ethical perspec-
tive have received extensive coverage
106. in the media. As these unethical—if not
illegal events unfolded—the pressure
mounted for regulatory agencies such
as the Securities and Exchange Com-
mission to enforce tightened restrictions
and for legislative bodies, including the
U.S. Congress, to prohibit some of the
more deliberate misrepresentations. For
example, the Sarbanes-Oxley Act (2002),
with its Public Companies Accounting
Oversight Board, has made an attempt
to address aspects of this far-reaching
problem. Some of the business profes-
sionals involved in these incidents active-
ly participated in cover-ups, shredding
documentary evidence of their corporate
misconduct (e.g., Arthur Andersen) and
creating an elaborate web of intentional-
ly misleading corporate structures. Some
of these professionals merely looked the
other way as such deceptions occurred in
the workplace. However, when a course
of action has been undertaken, it is often
difficult for subsequent players to effec-
tively challenge the status quo (Demski,
2003). In a 2005–2006 survey devel-
oped by KPMG (an international public
accounting and consulting firm), nearly
75% of the respondents reported that
they had observed misconduct in their
current organization during the previous
12 months (Williams, 2006). During the
same time period, a study by Walker Infor-
mation, as reported in a meta-analysis
by Verschoor (2006), found that 42% of
107. respondents thought their organization’s
senior leaders were unethical. Walker
Information’s study also reported that
25% of the respondents had knowledge
of, or suspected, an ethics violation in the
previous 2 years (Verschoor).
The widespread nature of the recently
publicized scandals suggests that there
has been a deterioration of ethical stan-
dards in the corporate workplace and rais-
es the question of whether regulatory or
legislative actions alone are sufficient to
ensure that the next generation of workers
demonstrate ethical decision making.
Although professional ethics contin-
ues to be a growing concern for busi-
nesses and government in the United
States, interest has surfaced about the
ethics of college students who are
tomorrow’s business leaders. The pres-
ent study focuses on college students’
perceptions of professional ethics and
how these perceptions can be evaluated
using academic situations as surrogates
for business situations.
BACKGROUND
In our research, we used cheating by
students as an indicator of future ethical
Students’ Perceptions of Business Ethics:
Using Cheating as a Surrogate
for Business Situations
108. LYNNETTE S. SMYTH CHARLES O. KRONCKE
GORDON COLLEGE COLLEGE OF MOUNT SAINT JOSEPH
BARNESVILLE, GEORGIA CINCINNATI, OHIO
JAMES R. DAVIS
ANDERSON UNIVERSITY
ANDERSON, SOUTH CAROLINA
TABSTRACT. Today’s college students are entering the
workplace at a time when
ethical issues are under greater scrutiny.
Thus, the authors examined students’ per-
ceptions of varying ethical situations, sam-
pling 786 college students at 3 institutions
(1 public, 1 Baptist affiliated, 1 Catholic
affiliated). The authors used an anonymous
survey and statistically analyzed student
assessment of questionable academic and
business situations. The survey results indi-
cated that (a) nonbusiness majors, on aver-
age, are more ethical than business majors;
(b) female students are more ethical than
male students; and (c) when analyzing the
110. growing number of students.
Much research has been conducted
to examine collegiate cheating by vari-
ous demographic variables other than
academic major. Crown and Spiller
(1998) examined 16 previous studies on
the relation between gender and cheat-
ing, and found mixed statistical results.
Studies that focused on cheating and
the student’s academic year in college
also yielded inconsistent results. Baird
(1980) reported that upperclassmen
cheat less often; Lipson and McGav-
ern (1993) determined that sophomores
cheat the most; and Haines, Diekhoff,
LeBeff, and Clark’s (1986) research
showed no significant difference in
cheating behavior on the basis of aca-
demic classes. Davis and Welton (1991)
found that lower division students have
lower ethical standards than do upper
division students, a difference not found
between upper division students and
graduate students. Similarly, younger
students cheat more than their older
peers (Diekhoff et al., 1996; Graham,
Monday, O’Brien, & Steffen, 1994;
Haines et al.).
It is undoubtable that current trends in
the global business environment (and in
pending legislation) ensure that business
professionals will come under closer
scrutiny in the future and will likely be
expected to hold a higher level of ethi-
111. cal standards than has been the case in
recent years. Rocha and Teixeira (2006)
conducted a large multinational study
on academic cheating and found that
the magnitude of academic fraud is not
constant across countries and that there
is a positive correlation between the
amount of academic fraud in a country
and its level of real-world business cor-
ruption. It is clear that higher education
must give student exposure to ethics a
greater priority, beginning with ethical
decision making in students’ lives in
their academic communities. Cheating
is a form of unethical behavior, and
students who cheat in college today may
soon become professionals engaging in
similar unethical behaviors in the work-
place of tomorrow (Sims, 1993; Smith,
Davy, Rosenberg, & Haight, 2002).
DATA AND METHODOLOGY
To examine the prevalence of unethical
attitudes and behavior in the college envi-
ronment, we examined the issue of cheat-
ing at three institutions: one 2-year public
college and two private 4-year colleges.
Data
During the spring semester of 2006,
we surveyed 786 students regarding
their attitudes toward, and experiences
with, cheating and their perceptions of
112. professional ethics in business. We con-
ducted the survey at three institutions
with enrollments of less than 3,500
students (residential and commuter):
Anderson University, a 4-year private
Baptist-affiliated college in Anderson,
South Carolina; Gordon College, a 2-
year public college of the University
System of Georgia, located in Barnes-
ville, Georgia; and the College of Mount
Saint Joseph, a 4-year Catholic college
in Cincinnati, Ohio. In this article, we
denote these three colleges as Baptist
college, public college, and Catholic
college, respectively.
In an effort to obtain a broad cross-
section of students, we gave surveys dur-
ing classroom time in selected courses
representing the various majors at each
institution to sample approximately
10% of the student body at each institu-
tion. We provided all respondents the
assurances of confidentiality and ano-
nymity, an especially important require-
ment in researching student experiences
with cheating and unethical behavior.
Because of participant requirements,
each student was given the choice of
not participating in the study, and fewer
than 1% declined.
Students were given a set of ques-
tions regarding various aspects of
cheating that included generalized
113. inquiries into how often they cheated
in college, how often they observed
collegiate cheating and its detection by
faculty members, their willingness to
participate in cheating, and their sense
of ethics and acceptability of cheating.
In addition, students were asked to rate
on a 7-point Likert-type scale ranging
from 1 (not dishonest at all) to 7 (very
severe dishonesty) their assessments
of the dishonesty level of a number of
business and academic situations. A
number of demographic variables were
also collected for each respondent to
assess how student attitudes regarding
cheating may differ by demographic
grouping.
Methodology
We analyzed the student responses
in a variety of ways. To investigate the
internal consistency of the surveyed eth-
ical statements, Cronbach’s alpha was
calculated for the 26 statements with a
resulting value of .97. In addition, the
deletion of each statement one at a time
did not significantly increase the value
of alpha. This suggests that the items
measure the same underlying unidimen-
sional construct: ethical perspective.
For much of the analysis, the data
were processed using the chi-square sta-
tistical test for independence and the
corresponding nonparametric Cramer’s
114. V statistic to correct for the possible
influence of sample size. Cramer’s V
tests for the strength of the degree of
association among the variables being
tested, and thus the null hypothesis has
no degree of association. For this analy-
sis and given the large sample size, there
was little difference, if any, between the
p values of the two methods; therefore,
the Cramer’s V statistics were the pri-
mary basis for the conclusions given
for this research project. In addition,
in an effort to assess if business majors
have significantly different perceptions
of unethical behavior compared with
their nonbusiness majors counterparts,
the mean responses of each group were
March/April 2009 231
compared for each statement using a
simple two-tailed independent t test,
with a null hypothesis of equal means
between the two groups. For each state-
ment, the equal variance assumption of
the t test was evaluated using Levene’s F
test statistic; for those cases in which the
equal variance assumption was rejected,
the separate variance formulation was
used to form the t statistic value.
The primary focus of this article is on
two sets of situations, each containing 13
statements for evaluation: ethical situa-
115. tions in the academic environment and
similar situations in a business setting.
The statements can be categorized as
pertaining to lying and deceiving, cheat-
ing, cheating others, stealing, assisting
others in wrongdoing, and contemplat-
ing unethical behavior. It is important to
note that, although these academic and
business situations were paired for this
analysis, they were not paired on the
survey instrument, and thus respondents
considered each situation separately.
RESULTS
General Cheating
From the demographics collected, we
were able to determine that student bod-
ies at the surveyed colleges predomi-
nately comprised full-time students (an
average of 86%). Approximately 40%
of students were business majors. The
gender split was estimated at 57% (56.8)
female students, and 43% (43.1) male
students because 10% (10.1) of respon-
dents did not report their gender. From
the set of questions regarding cheating
in general, we found that 55% of the
respondents reported having cheated in
college at least once, a value that is
in line with two studies: (a) Grimes
(2002), in which 49.8% reported hav-
ing cheated, and (b) Smyth and Davis
(2004), in which 46% of respondents
reported having cheated in college at
