Principles and Approaches in Ethics Assessment

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Principles and Approaches in Ethics Assessment

Research Integrity

Author: Göran Collste, Linköping University

June 2015

Annex 1.b
Ethical Assessment of Research and Innovation: A Comparative Analysis of Practices
and Institutions in the EU and selected other countries
Deliverable 1.1

This deliverable and the work described in it is part of the project


Stakeholders Acting Together on the Ethical Impact Assessment of Research and Innovation -
SATORI - which received funding from the European Commission’s Seventh Framework
Programme (FP7/2007-2013) under grant agreement n° 612231
Research Integrity

Contents
1 Introduction ......................................................................................................................... 3
2 Description: Scientific Misconduct and Scientific Fraud ................................................... 3
3 Norms for Good Research Practice. Legislation, regulation, national and international
frameworks ................................................................................................................................. 6
4 Investigating Scientific Misconduct.................................................................................... 8
5 How common is Scientific Misconduct? ............................................................................ 8
6 Explanation of Scientific Misconduct ................................................................................. 9
7 References ........................................................................................................................... 9

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Research Integrity

1 Introduction
Scientific research is a conscious and systematic approach to acquire knowledge, based on
theories, methods and standards that have been developed through the history of scientific
disciplines. The terms “research integrity” and “good research practice” refer to ideals for how
research ought to be performed.
In the 1940s the American sociologist Robert Merton proposed norms for scientific research
that have influenced the discussion on research integrity since then. According to Merton good
research should not be secret or anyone’s property but requires instead openness and publicity.
Merton uses the term communism/communalism for this norm. The second norm, according to
Merton, is universalism, which means that the only relevant criteria for assessing research are
the scientific criteria. The position or characteristic of the researcher has no relevance. Thirdly,
disinterestedness means that the main motive driving the researcher should be the quest for
knowledge, not for example economic gain or fame. Finally, the researcher should always be
open for questioning the result. Merton calls this “organized scepticism”. This norm coheres
with Karl Popper’s famous demarcation line between research and other activities; falsification,
i.e. the constant efforts to falsify one’s result in order to get closer to the truth.1 Merton’s norms
for research are summarized in the acronym CUDOS.2 Although the exact meaning and
implication of Merton’s criteria can be discussed, they imply an ideal for scientific work and
deviations from this ideal can be seen as misconduct in research.
Merton’s CUDOS norms are well-known examples of ideals and norms for science. These
norms could be seen as the basis for professional ethics of researchers. Scientific misconduct
and fraud are deviation from the ideals of science and good research practice. In the following
we first conceptualise the area of scientific misconduct. Then we present some norms,
guidelines and codes of scientific integrity. In the next section we argue that scientific
misconduct is a real problem that must be taken seriously by the research community and finally
we discuss how scientific misconduct is investigated, how common it is and how it can be
explained.

2 Description: Scientific Misconduct and Scientific Fraud


Scientific misconduct and scientific fraud imply that the researcher, intentionally or by
carelessness, deviates from the ideals of research. There are various forms of scientific
misconduct and there is an on-going discussion of how to delimit the concept. In a narrow
sense, scientific misconduct implies falsification, fabrication and plagiarism. Falsification
means that the researcher manipulates research materials and equipment or omits or changes
data or results, fabrication means that the researcher makes up data or results and plagiarism

1
Popper, Karl, The Logic of Scientific Discovery, Routledge, London, 1959.
2
Merton, Robert, The Sociology of Science, University of Chicago Press, Chicago, 1973.

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that the researcher uses other researchers’ texts, ideas, etc., without given proper recognition.3
In combination, falsification, fabrication and plagiarism form the acronym FFP.
So far, the conceptualisation in this area is rather ambiguous. The narrow definition of scientific
misconduct has been questioned for excluding problematic activities related to research. “Ghost
writing” is one example of problematic research practice that is not covered by FFP. Ghost
writing means that famous scholars in a field of research put their names on publications that
others have produced in order to facilitate the publication. This has for example been practiced
by drug companies in order to speed up the marketing of their products.4 Another questionable
research practice is the so called salami-publications. In order to get more publications a
researcher splits up a research finding in a number of publishable units. The motive behind is
to get as many publications as possible. A third questionable research practice is when a
company reveals or delays the reporting of research findings for the reasons that the publication
is not in the interest of the company. Should also ghost-writing, salami-publication and
revealing or delaying publication be considered as scientific misconduct?
Defining scientific misconduct (and similar phenomena) can have different points of departure.
One can start from cases of misconduct that have been investigated and prosecuted. From a
number of cases one can deduce views on how to understand misconduct. Another starting point
is ideal definitions of science and research. On the basis of views on what characterises
exemplary scientific work, for example Merton’s CUDOS norms or ideals found in codes of
scientific integrity, The European Code of Conduct for Research Integrity (ESF) and the
Singapore Statement (see below), one can identify different kinds of deviations from the ideals.
From this point of departure, ghost-writing, salami-publications and the delay of research
findings are certainly instances of scientific misconduct.
The conceptual work of defining scientific misconduct must adhere to philosophical standards,
such as clarity and precision. The aim of this conceptual work is to stipulate useful definitions
in the area of scientific misconduct, much needed by committees that are investigating cases.
One should also note that scientific misconduct varies according to degree and intention.
Sloppiness and carelessness leading to false results can be seen as milder forms of misconduct,
while fabrication and falsification are graver forms. A careless researcher may have no intention
to deceive on the one side, while a fraudulent researcher who fabricates results might do this
intentionally. The degrees of misconduct and intentions are well illustrated in the graph below.5

3
The Swedish Research Council’s expert group on ethics, Good Research Practice, 2011.
https://publikationer.vr.se/produkt/good-research-practice/
4
Saul, Stephanie, “Ghostwriters Used in Vioxx Studies, Article Says”, New York Times, 15 April 2008.
http://www.nytimes.com/2008/04/15/business/15cnd-vioxx.html?hp%3Cbr%20/%3E&_r=0
5
Nylenna, Magne and Sigmund Simonsen, “Scientific misconduct: a new approach to prevention”, The Lancet,
Volume 367, No. 9526, 10 June 2006, pp. 1882–1884.

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There are reasons to believe that deviation from good research practice is not uncommon, and
even increasing in a time characterised of academic competition and publication stress.
Examples of grave and highlighted cases of scientific fraud are the British Doctor Andrew
Wakefield’s studies linking vaccines and autism,6 the Korean Woo Suk Wang’s research of
human cloning,7 the Norwegian cancer researcher Jon Sudbö’s findings of new medicines8 and
the Japanese researcher Haruko Obokata’s fabrication of STAP-cells (stimulus-triggered
acquisition of pluripotency).9 These three examples were all cases of fabrication and
falsification. In recent years two German ministers, the minister of defence Karl-Theodor zu
Guttenberg and the minister of education Annette Schavan, have been forced to step down from
their political positions due to allegations of having plagiarised their PhD-theses.10
From the figure above, one can conclude that there are numerous different kinds of scientific
misconduct and deviations from good research practice. It is also clear that there is a grey zone
between bad research and misconduct and it can sometimes be difficult to make clear if a
particular case is just an instance of bad research or of misconduct.
There are different reasons why scientific misconduct is challenging. The first reason relates to
human existence. The quest for knowledge is a basic human drive. Already the new-born child
is eager to learn about the world around him or her. Curiosity and desire to learn is an integral
part of human nature and a basic human value. It is a precondition for human and social
development. Science can be seen as a way to organise the quest for knowledge and the
systematic endeavour to get new knowledge in order to get a better understanding of the world

6
http://www.bmj.com/content/342/bmj.c7452
7
https://embrybros.wordpress.com/2011/04/08/375/
8
http://jnci.oxfordjournals.org/content/98/6/374.long
9
http://www.japantimes.co.jp/tag/haruko-obokata/
10
Kulish, Nicholas and Chris Cottrell, “German Fascination With Degrees Claims Latest Victim: Education
Minister”, New York Times, 9 Feb. 2013. http://www.nytimes.com/2013/02/10/world/europe/german-education-
chief-quits-in-scandal-reflecting-fascination-with-titles.html?pagewanted=all&_r=0

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around us. As a consequence, scientific misconduct violates and undermines a basic value of
human life.
Second, research, and in particular the natural, technical and medical sciences, results in new
products that in different ways can aid and help humans. Technical research is a condition for
new power plants, bridges etc. and medical research for new medicines and treatments. But if
the research is not done in a proper way, it might result in deficient products. Then the safety
of power plants and bridges and the effects of the medicines and treatments will be challenged.
For example, as a consequence of Andrew Wakefield’s false report that triple vaccine could
cause autism, many parents decided not to vaccine their children, which later led to diseases
and deaths. The Norwegian cancer researcher Jon Sudbö’s fraudulent research led to ineffective
drugs against mouth cancer.
Third, the central aim of science is to provide new knowledge and a better understanding of the
world. This aim is undermined by scientific misconduct, since it leads to false views and
misunderstandings. This is all the more serious because research is a cumulative process and
scientists depend on others’ findings. False research results will then lead to further false results.
Fourth, science is to a large extent funded by public means. When cases of scientific misconduct
are revealed in the media, this will undermine public trust in science. As a consequence,
taxpayers’ readiness to contribute to research may diminish.
Finally, scientific misconduct means breaking the important moral norms not to lie and not to
steal. Fraudulent researchers who falsify or fabricate their results are lying to the public and
researchers who plagiarise others’ results steal from scientists who have followed the standards
for good research practice.

3 Norms for Good Research Practice. Legislation, regulation, national and


international frameworks
The ethical discussion on scientific integrity relates both to norms and rules for good research
practice and to scientific virtues. Norms and rules for good research practice are formulated in
national and international codes of conduct.

A recent study shows that national guidelines of scientific integrity vary in Europe and
globally.11 12 European countries lacked guidelines. The following table shows the situation
for some of the SATORI target countries regarding national guidelines:

11
Godecharle, S, Nemery B, Dierickx, K, Guidance on Research integrity: no union in Europe, Lancet 2013,
381:1097-98.

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Countries having Countries having Countries that do Countries where


a national a national not have a no guideline could
framework to deal framework (or national be identified or
with research equivalent) to deal framework to deal analysed
integrity or with research with research
misconduct, integrity integrity or
established by law or misconduct, not misconduct
established by law
Austria x
France x
Germany x
Netherlands x
Poland x
Serbia x
Spain x
UK x
Table 1: National guidelines of scientific integrity for SATORI target countries

Some guidelines limit scientific misconduct to fabrication, falsification and plagiarism while
others include also other forms of misconduct. Some guidelines include intention to deceive in
the definition of misconduct, others leave it open if scientific misconduct requires an intention
to deceive. In conclusion, the authors plea for harmonisation of European guidelines on research
integrity. 12

In parallel to the increase of EU-funded research and the globalisation of research cooperation
one can notice an increased European and global interest in research integrity. This
development is illustrated by some recent international codes of conduct. The European Science
Foundation (ESF) and ALLEA (All European Academies) formulated in 2011 The European
Code of Conduct for Research Integrity. The Code starts with the following principles of
scientific integrity: honesty in communication, reliability in performing research, objectivity,
impartiality and independence, openness and accessibility, duty of care, fairness in providing
references and giving credit, and responsibility for the scientists and researchers of the future.
The Code contains a number of guiding principles for good research practice and recommends
principles for investigating research misconduct. The new Horizon 2020 EU funding
programme is also emphasising the importance of research integrity in a more forceful way
then the previous programmes did.13

The Singapore statement on Research Integrity was declared by the second global conference
in research integrity held in Singapore in 2010. It states the following principles for research:
“Honesty in all aspects of research, Accountability in the conduct of research, Professional
courtesy and fairness in working with others, Good stewardship of research on behalf of others”
and then 14 principles of responsibility for the researcher.14

The national, European and global codes contain principles for good research practice.
However, research integrity can also be seen from a virtue ethics perspective. Then the focus is
on the character of the researcher. In line with Alasdair MacIntyre’s theory of virtue ethics,
research can be seen as a “practice” with some internal values and virtues).15 Good research is

12
ibid
13
http://europa.eu/rapid/press-release_SPEECH-15-5243_en.htm
14
Singapore Statement on Research Integrity 2010
15
MacIntyre, Alasdair, After Virtue, a study in moral theory, Duckworth, London, 1981.

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characterised by virtues like honesty, truthfulness, openness, integrity and accuracy. Virtues of
how to act as a researcher are, at least ideally, acquired through doctoral education and collegial
discussions, research seminars etc.

4 Investigating Scientific Misconduct


Ways and procedures for investigating scientific misconduct vary. Some countries have a
central, national board for investigating misconduct while others have decentralised systems in
which the universities are responsible for investigating alleged cases.16
Normally, after an accusation is made, the responsible body appoints experts working in the
same scientific field as the accused researcher and a commission to investigate the alleged case
of misconduct. The experts’ report then forms the basis for the body’s decision.
Accusations of misconduct are very serious matters and can undermine a researcher’s
reputation even when they are groundless. Therefore it is of utmost importance to observe
maximum confidentiality during an investigation.
There is an on-going discussion of whether scientific misconduct should be put to trial as a
legal offence or as an ethical matter. One argument for legal regulations is that it would better
ensure the security and confidentiality of persons accused for misconduct and procedural
justice. On the other hand, while scientific misconduct is a violation of the professional ethics
of researchers, it should be dealt with as primarily an ethical offence.

5 How common is Scientific Misconduct?


It is very difficult to estimate the frequency of scientific misconduct. First, any estimation of
course depends on how scientific misconduct is delimited and defined. Are only intended
falsification, fabrication and plagiarism included or should also sloppiness and deviation from
good research practice be considered?
A study by Fanelli in 2009 gives perhaps a hint of the frequency of scientific misconduct.
According to Fanelli, who made a meta-analysis of 21 surveys of the prevalence of misconduct,
2-3% of scientists admitted having falsified and fabricated research results themselves, but 14%
responded that they knew of colleagues who had fabricated and falsified. When asked about
doing other questionable research, 34% admitted that they had done it themselves and 72%
believed that colleagues had done it.17
Ferric et al. reported to the US National Academy of Sciences in 2012 that in the period 1975-
2012, 67.5% of retraced scientific publications were retraced due to misconduct. Out of these,

16
Godecharle, S., B. Nemery, K. Dierickx, “Guidance on Research integrity: no union in Europe”, Lancet 2013,
381, pp. 1097-98.
17
Fanelli, D., “How Many Scientists Fabricate and Falsify Research? A Systematic Review and Meta-Analysis of
Survey Data”, PLoS ONE 4(5), e5738, 2009. doi:10.1371/journal.pone.0005738

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40% were retracted due to falsification or fabrication, 14% due to double publication and 10%
due to plagiarism).18

6 Explanation of Scientific Misconduct


Research is increasingly becoming competitive. This may lead to a larger number of new
scientific results, but the flip side is that incentives to fraudulence or deviation from good
research practice also increases. The salami-method is an example of this development. This
way of multiplying publications was unknown a few decades ago. The salami-method may not
be an example of grave scientific misconduct but the practice is questionable with respect to
good scientific practice and the ideals of science. The ideal is to publish research results in the
most appropriate and relevant way with respect to the knowledge gained, not to divide the
results in parts because of external pressure.
What are then the motives behind scientific misconduct? The following factors have been
pointed at in the discussion on misconduct: fame, university positions, rivalry, the race for
patents, and, as a consequence, funds. In the humanities or social sciences, ideology can be a
motive, i.e. when a researcher wants to prove a political or ideological view with the help of
falsifying or fabricating his or her scientific results.
There seems to be a positive correlation between private sponsorship and biased research.
Sismondo concludes in his investigation of the impact of sponsorship in pharmaceutical
research: “Results are clear: Pharmaceutical company sponsorship is strongly associated with
results that favour the sponsors' interests.” 19

7 References

ESF and ALLEA, The European Code of Conduct for Research Integrity, March 2011.
http://www.esf.org/fileadmin/Public_documents/Publications/Code_Conduct_ResearchIntegri
ty.pdf
Fanelli, D., “How Many Scientists Fabricate and Falsify Research? A Systematic Review and
eta-Analysis of Survey Data”, PLoS ONE 4(5): e5738, 2009.
doi:10.1371/journal.pone.0005738
Fang, Ferric C., R. Grant Steen, and Arturo Casadevall, “Misconduct accounts for the majority
of retracted scientific publications”, Proceedings of the National Academy of Sciences,
September 2012.

Godecharle, S., B. Nemery, K. Dierickx, “Guidance on Research integrity: no union in Europe”,


Lancet 2013, 381, pp. 1097-98.

18
Fang, Ferric C., R. Grant Steen, and Arturo Casadevall, “Misconduct accounts for the majority of retracted
scientific publications”, Proceedings of the National Academy of Sciences, September 2012.
19
Sismondo, Sergio, “Pharmaceutical Company Funding and its Consequences: A Qualitative Systematic
Review”, Contemporary Clinical Trials, Vol. 29, 8, 2008, pp. 109-113.

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Kulish, Nicholas, and Cottrell Chris, “German Fascination With Degrees Claims Latest Victim:
Education Minister”, New York Times, 9 Feb. 2013,
http://www.nytimes.com/2013/02/10/world/europe/german-education-chief-quits-in-scandal-
reflecting-fascination-with-titles.html?pagewanted=all&_r=0
MacIntyre, Alasdair, After Virtue, a study in moral theory, Duckworth, London, 1981.
Merton, Robert, The Sociology of Science, University of Chicago Press, Chicago, 1973.
Nylenna, Magne and Sigmund Simonsen, “Scientific misconduct: a new approach to
prevention”, The Lancet, Volume 367, No. 9526, 10 June 2006, pp.1882–1884.
Popper, Karl, The Logic of Scientific Discovery, Routledge, London, 1959.
Saul, Stephanie, “Ghostwriters Used in Vioxx Studies, Article Says”, New York Times, 15
April 2008. http://www.nytimes.com/2008/04/15/business/15cnd-
vioxx.html?hp%3Cbr%20/%3E&_r=0
Sismondo, Sergio, “Pharmaceutical Company Funding and its Consequences: A Qualitative
Systematic Review”, Contemporary Clinical Trials, Vol. 29, 8, 2008, pp. 109-113.
The Second World Conference in Research Integrity in Singapore 2010, Singapore Statement
on Research Integrity. http://www.singaporestatement.org/index.html
The Swedish Research Council’s expert group on ethics, Good Research Practice, 2011.
https://publikationer.vr.se/produkt/good-research-practice/

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