ETHICS IN MEDICINE

Research misconduct: time for a re-think?

K. J. Breen
Department of Forensic Medicine, Monash University, Melbourne, Victoria, Australia

Key words Abstract

research misconduct, scientic misconduct,
incidence, whistleblower, sanctions.
Correspondence
Kerry J. Breen, Department of Forensic
Medicine, Monash University, 5783 Kavanagh
Street, Southbank, Vic. 3006, Australia.
Email: kerry.breen@bigpond.com
Received 28 December 2015; accepted
12 March 2016.
doi:10.1111/imj.13075
The incidence of research misconduct appears to be increasing, drawing attention in
the general media and academic literature. Concerns have been expressed about proba-
ble under-reporting, harms arising, lack of an agreed international denition, welfare
of whistleblowers and the adequacy of the investigation processes and any subsequent
sanctions. A fully satisfactory approach to prevention, detection, investigation and adju-
dication has yet to emerge. While the denition of research misconduct contained in
the Australian Code for the Responsible Conduct of Research is comprehensive, universities
and other research institutions at times struggle in their task of investigating and adju-
dicating allegations of research misconduct. A more centralised, independent process of
oversight and monitoring of this role played by the universities and institutions would
help support those institutions and help maintain community condence in the
research endeavour.

The problem of research misconduct (also known as sci-
entic misconduct) refuses to go away. Indeed, it is prob-
ably increasing, although due to under-reporting, things
might be even worse than most people think.1 Concerns
over research misconduct, as expressed recently in the
general media and the academic literature, include not
only its apparent rising incidence but also the lack of an
internationally agreed denition, likely under-reporting,
the harmful consequences of this form of misconduct,
the role of the pressure on researchers to publish, the
option of criminalising research misconduct, the difcul-
ties that institutions have in dealing with allegations and
the often unsatisfactory application of sanctions for
proven misconduct.26 Despite the efforts of several
developed nations to address these concerns, no single
satisfactory approach has emerged. Australia has made
some progress with the extension of whistleblower legis-
lation to most jurisdictions, a revised 2007 Code for the
Responsible Conduct of Research7 currently under review
which contains a comprehensive denition of research
misconduct, and the formation of the Australian
Research Integrity Committee. However, these changes
alone are unlikely to reduce the incidence of misconduct
Funding: None.
Conict of interest: None.
Disclosure: The author is a member of the Australian Research
Integrity Committee of the National Health and Medical
Research Council and the Australian Research Council. The
views expressed are personal ones.
or provide better systems for handling allegations and
creating deterrents. In this paper, these concerns are
enlarged upon and associated issues commented upon.
This leads to a suggested new approach for Australia that
could address many of the concerns.
Why the denition of research
misconduct is important
In the USA, the longstanding agreed denition of
research misconduct is conned to fabrication, falsica-
tion and plagiarism.8 A proposed extended denition
that added the words or other practices that seriously
deviate from those that are commonly accepted by the
scientic community for proposing, conducting or
reporting research was rejected after intense lobbying
by American scientists.8 Resnik et al. note that this nar-
row denition omits the following additional categories
of research misconduct: unethical authorship, unethical
publication practices, conict of interest mismanage-
ment, unethical peer review, misconduct related to mis-
conduct investigations, poor record keeping, other
deception and human or animal research violations.9
Other published examples of research misconduct
include putting patients in danger (via poor study design,
inadequate research oversight, ignoring adverse events
or failing to adhere to the approved protocol), forging
consent forms and accepting condentiality clauses
regarding publication of ndings.10

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Through the weight that the US carries in interna-
tional affairs and in medical research in particular, the
narrow US denition has been adopted by many other
countries. This has probably delayed the development of
an internationally agreed more encompassing denition.
Such a denition should include research conduct that
endangers humans, animals and the environment and
conduct that bypasses or ignores ethically approved
research proposals. The current denition in the
Australian Code for the Responsible Conduct of Research gen-
erally meets this need.7 This denition is accompanied
by a detailed list of examples of what may constitute
research misconduct.
A clear denition is an essential component of natural
justice for any person against whom an allegation is
made, particularly where career, reputation and liveli-
hood may be at risk.8 People cannot have misconduct
alleged against them if the type of conduct alleged is not
clearly envisaged in the denition in operation at the
time of the alleged behaviour. Any denition should
ensure that simple human errors or mistakes made, for
example, by trainee researchers (without ill intent) are
not accidentally pushed into a formal assessment proc-
ess. One means of achieving this has been to qualify
research misconduct as intentional or knowing or reck-
less.8 In addition, the absence of an agreed international
denition makes it difcult to compare incidence data
from different countries and may make problematic the
assessment of allegations of research misconduct arising
from international collaborative research.8
How is research misconduct brought
to light?
There has been very little published on this question. Those
who have expressed opinions have suggested that the most
frequent source of reporting is through whistleblowers11
(who therefore deserve to be valued and must be better
supported, as discussed below) and have also noted that
academic journal editors and the peer reviewers acting for
those journals may not be well-placed to contribute to
reporting.12 Independent monitoring of research, as occurs
for most drug company-sponsored clinical trials, does play
a role.13 Random or routine auditing of other types of
research is underutilised because of the costs involved.14
Incidence: under-reporting
Studies of the incidence of research misconduct are gen-
erally less than ideal. Some studies are based on the
reports of institutions or of central data agencies, but
nearly all reports identify the likelihood that the data are
incomplete. The most frequently quoted data have been
2016 Royal Australasian College of Physicians
Research misconduct
based on self-reporting by researchers of their own beha-
viour or the observed behaviour of others.4,6,15,16 As
described by Roberts and St John, self-reporting by ques-
tionnaire of socially unacceptable behaviour typically
leads to underestimates, but there are methods to control
for this effect. Using such methods, they reported the
estimated prevalence of plagiarism in a group of UK bio-
science academics as 4.2%, roughly double the previous
reports. In the study, they also examined types of mis-
conduct that were less frowned upon; for example, for
inappropriate authorship, they found a prevalence of at
least 68%. They commented that their study and other
studies suggest that known cases of research misconduct
are just the tip-of-the-iceberg.1
The relevance of research papers that
are retracted
Research misconduct is believed to underpin more than
half of the papers retracted by academic journals.17 As
the number of retracted articles has jumped sharply,3
this may be additional evidence that research miscon-
duct is increasing. Fake or manipulated peer review has
become another reason for papers to be retracted.18 The
Retraction Watch website (http://retractionwatch.com/)
is a valuable source of information about retractions.
Why is there under-reporting?
The Australian Code for the Responsible Conduct of Research7
states that anyone who forms a reasonable suspicion
that research misconduct has occurred must act in a
timely manner in accordance with the institutions pol-
icy, but full compliance is unlikely. Reluctance to report
is understandable, not only because whistleblowers fare
badly in Australia (as elsewhere) but also because in
many instances, the potential reporter may feel uncer-
tain that she or he possesses sufcient information to
justify making a report. In most countries, anonymous
reporting is not encouraged as anonymity is difcult to
maintain if an inquiry is instituted. Examination of cases
that have become public in Australia suggests that the
person who nally raises allegations often does so
because of feeling aggrieved by their experience.
In very few countries is there a legal or contractual
obligation to report the research misconduct experiences
of universities and similar institutions, and thus, central
data collection does not take place. Even where an obli-
gation does exist, reporting may be tardy or incom-
plete.19 In Australia, most institutions have policies of
requesting that all parties to research misconduct inquir-
ies keep condential their knowledge of any inquiry and
its outcome. Institutions in receipt of funding from the
729
Breen
National Health and Medical Research Council
(NHMRC) and the Australian Research Council (ARC)
are obliged to notify the relevant funding agency of seri-
ous misconduct allegations and ndings.
Why do some researchers engage
in research misconduct?
Systematic studies of the motives of researchers who
admit to or are found guilty of research misconduct are
non-existent, and understanding of this issue is based on
inference and on occasional admissions of those found
guilty. Riis who has studied research misconduct in
depth gives a list of possible motives and other factors,
including those general to all competitive human beha-
viour, such as desire for fame, prestige, money, position
and travel paid for by others, and those specic to com-
petitive science, including pressure to publish, bad
authorship practices and inadequate mentoring.20 Other
commentators have made similar observations.3,10,15,21
Of this list, pressure to publish and the related subversive
inuence of publication metrics are major factors that
are probably increasing in importance.22,23
The consequences of research
misconduct
It is unusual to be able to point to direct immediate harm
to research participants as a result of research miscon-
duct, although death and serious harm to participants do
occur.10 The harm or potential harm takes a number of
forms more often, including harm to future patients
because of the publication of false ndings that have
been used to promote the use of medications or to ques-
tion the safety of vaccines.2426 It also includes undermin-
ing public condence in the research process, wasting
resources, collateral damage to whistleblowers and inno-
cent colleagues and harm to institutional reputations.
The perils of whistleblowing
A whistleblower can be dened as a person who calls
attention to wrongdoing, usually from within an organi-
sation.27 It is common knowledge that many
whistleblowers are damaged in the process of raising
allegations,28 despite the efforts of governments to legis-
late to protect them and despite the existence of
voluntary groups offering support (for example,
Whistleblowers Australia http://www.whistleblowers.
org.au/). Some have suggested calling them complai-
nants, but even this term is stigmatising.11 It seems that
societys general stigmatisation of whistleblowers (read-
ers might reect on the stigma of tell-tales and dobbers Australian Code for the Responsible Conduct of Research7
730
in their childhood) colours the manner in which institu-
tions handle their staff who have the courage to come
forward. If this is to change, institutions need clear poli-
cies that recognise the centrality of whistleblowers in the
maintenance of research integrity and put in place pro-
cesses that provide genuine support and protection from
reprisal. This should include careful selection of senior
support staff (research integrity advisors under the
Australian Code) who should be provided with training in
this difcult task.29 A good starting point for a person tak-
ing on this role would be to read the 1995 US report on
the consequences for whistleblowers.30
The US study referred to above also examined the
negative experiences of researchers accused of miscon-
duct but later exonerated; this possibility also needs to be
kept in mind by research integrity advisors.
Prevention
Many authors have pointed out that education alone is
very unlikely to prevent intentional misconduct.8,29,31 As
Riis has written, most who engage in such practice
know very well about the consequences of such beha-
viour, but think they are too smart to get detected.24
However, education of new researchers is clearly desira-
ble if only to protect novices from accidental or uninten-
tional breaches of codes of research conduct. If the risk
of detection was increased by more intensive use of audit
and monitoring, or if the level of sanctions was
increased, deterrence might have some impact. General
deterrence, as discussed below, implies the need to make
public any ndings of serious research misconduct.
How research misconduct is currently
dealt with
In virtually every developed nation, universities (and
other institutions where research is conducted including
research institutes and hospitals) continue to insist on
handling allegations of misconduct internally, initiating
investigation of allegations, conducting hearings into
them and then applying sanctions. For more serious alle-
gations, external experts may be added to or may fully
constitute panels of inquiry, but even then, the investi-
gation that precedes the inquiry and later decisions
about sanctions or penalties, if research misconduct is
proven, remain with the university. This power is one
that is ercely guarded by the universities, even though
it seems to do more harm than good to their reputation
at times. In Australia, the process is often built into the
terms of employment of university staff by agreements
reached through enterprise bargaining. The 2007
2016 Royal Australasian College of Physicians

urged universities to align those staff agreements with
Part B of the Code, but so far, little has changed. As a
result, universities may be constrained to comply with
enterprise bargaining agreements with implications for
the precise roles of external panels and for what infor-
mation can be released publicly.
In several countries, recognition of the weaknesses of
decentralised processes has led to some form of national
oversight or overlay of accountability. In the USA, this
takes the form of the Ofce of Research Integrity (ORI)
(https://ori.hhs.gov/) and in the UK, the Research Integrity
Ofce (http://ukrio.org/), although the latter has no regu-
latory powers and acts only in an advisory role.32 In
Australia, the NHMRC and ARC established the Australian
Research Integrity Committee in 2011 (https://www.
nhmrc.gov.au/research/responsible-conduct-research/
australian-research-integrity-committee). The Commit-
tees role is limited to review whether an institution has
followed the procedures laid down in the Australian Code
for the Responsible Conduct of Research, and any review
depends on the receipt of a complaint/request for review.
Denmark appears to be the only country that has taken
the handling of research misconduct out of the hands of
universities through the establishment of the Danish
Committees on Scientic Dishonesty (http://ufm.dk/en/
research-and-innovation/councils-and-commissions/
the-danish-committees-on-scientic-dishonesty).32
The investigation/inquiry process and
its problems
Theoretically, and in practice, there are inherent weak-
nesses in giving universities the power to receive, inves-
tigate, prosecute and adjudicate allegations of serious
research misconduct.32,33 These weaknesses include the
infrequency of dealing with serious allegations that can
result in lack of experience and corporate knowledge.
Problems arise in the initial assessment and investigation
of allegations, where lack of experience can lead to fail-
ure to secure relevant evidence. Other weaknesses
include inherent conicts of interest and bias that are
difcult to avoid other than where an inquiry panel con-
sists mostly or completely of external members. Inquiry
panels (tribunals) made up of senior scientists may also
be inexperienced in this task, with little or no knowledge
of administrative law as it applies to tribunals.34 Panel
members have other commitments and are often busy,
so delays are inevitable. The dispersion of the inquiry
process across the nation means that panels have little
access to precedents. Although the Australian Code
recommends the participation of a legally qualied coun-
sel to assist a panel, this recommendation is not always
followed, and where it is followed, the use made of
2016 Royal Australasian College of Physicians
Research misconduct
counsel is quite variable. In Australia, the inquiry panels
task is to decide, after hearing all the evidence, if specic
allegations of misconduct are proven (on the balance of
probabilities). The panel is usually not asked to advise
whether proven allegations actually constitute research
misconduct and is not asked to advise on or determine
sanctions. These tasks are allocated to the Vice Chancel-
lor/Chief Executive Ofcer or his or her delegate.
Sanctions
In disciplinary procedures, sanctions generally have sev-
eral purposes. The primary purpose is protection of the
community, hence the emphasis on sanction rather than
penalty, although, of course, severe sanctions may have
punitive effects.34,35 Sanctions also are deemed to carry
both specic deterrence and general deterrence. Specic
deterrence is directed at the perpetrator of the research
misconduct; general deterrence is directed at other
researchers. In Australia, as research misconduct hear-
ings are closed, and ndings rarely become public, gen-
eral deterrence cannot apply.
Can we do better? Where to look for
guidance? The medical misconduct
analogy
This traditional system of how research misconduct alle-
gations are handled contrasts markedly with how allega-
tions of medical misconduct by medical practitioners
(and misconduct by other registered health profes-
sionals) are handled. In the latter system, here and in
many other countries, investigations are centralised with
the national medical board, and allegations of miscon-
duct are dealt with by two levels of hearings. For less
serious matters (where a doctors registration is not at
risk), hearings are closed, less formal and conducted by
peers supplemented by a community member, and legal
representation is not permitted. More serious matters are
referred to an administrative tribunal, chaired by a
legally trained person and made up of professional peers.
Tribunal hearings are open and more formal; legal repre-
sentation is allowed, and outcomes are made public.
While always stressful for the doctor, the system does
allow public condence to be maintained. In contrast, in
the research misconduct hearing system, if a researcher
is found guilty of serious research misconduct, he or she
may be dismissed, but there is no public record, and the
researcher may readily continue their career elsewhere.
As public and political awareness of research misconduct
and its possible harmful consequences grows, it is easy to
imagine that demands will build for centralised and
independent handling of allegations of more serious
731
Breen

research misconduct. Far-sighted university administra-
tors may see advantages in such a change.
Double jeopardy
It is unusual in the USA and Australia for medical practi-
tioners found to have engaged in research misconduct to
be referred to a medical tribunal. Sydney obstetrician, Dr
William McBride, is a notable exception.36 This is partly
explicable in the USA because of the narrow denition of
research misconduct. This contrasts markedly with expe-
rience in the UK where, for many years, the General
Medical Council (GMC) frequently conducted hearings
into allegations of research misconduct by medical practi-
tioners engaged in clinical trials. This difference may be
explained by steps taken by the pharmaceutical industry
to employ competent investigators whose tasks included
the provision of a brief of evidence to the GMC.37
Should some forms of research
misconduct be criminalised?
The answer to this question is that some forms of
research misconduct are already criminalised in several
countries, most often on the grounds of major fraud.3840
However, that such debate is now taking place about the
option of serious research misconduct being dealt with
under criminal law4143 should be seen as a warning that
the current processes for handling research misconduct
are seen by many as unsatisfactory.
Ways forward
Short of adopting the medical misconduct model, two
options for changing how research misconduct is dealt
with in Australia might appeal. Both represent a move
away, to a lesser or greater degree, from the independence
of the university and are likely to be resisted. The rst
option is the US model, involving a central authority, the
ORI (https://ori.hhs.gov/), with the powers to demand full
accountability of universities/institutions and to intervene
if not satised with the actions of an institution. While the
US ORI powers are restricted to research misconduct
involving federally funded research, this is little different
from the application of the Australian Code to institutions
in receipt of funding from the NHMRC and the ARC. The
second is the Danish model (http://ufm.dk/en/research-
and-innovation/councils-and-commissions/the-danish-
committees-on-scientic-dishonesty) involving centra-
lised investigation and assessment by an independent
agency.44 Both models publish their ndings, although
this is done anonymously in Denmark. Given Australias
geography, the US model is likely to be the more cost
effective and has the advantage of long US experience,
albeit an experience that has been handicapped by a nar-
row denition of research misconduct. Vaux has made a
similar recommendation and has described in more detail
additional potential roles for such an ofce.45 Without
data on how many instances of serious research miscon-
duct are dealt with by Australian institutions each year, it
is difcult to plan for or decide such issues. If either sys-
tem were to be directly funded by taxpayers, this could
be an additional attraction for universities that are cur-
rently required to fund their inquiries. Australias institu-
tions should welcome such a change.
There are additional reasons why our institutions
should embrace such a change. It would demonstrate
their willingness to be fully transparent as to how
research misconduct is handled. It would also enhance
the reputation of the sector while maintaining public
condence in the research endeavour. It would reduce
the problem of apparent conicts of interest. Through
deterrence, it may contribute to reducing the occurrence
of research misconduct. In the UK, universities have
been criticised for their apparent reluctance and/or tardi-
ness to comply with an agreement that annual returns
on research misconduct be made public, perhaps because
of fear of harming their reputation.19 Public accountabil-
ity through an ORI should have the opposite effect and
help maintain reputations.
In the absence of such changes, there are two other
steps that universities must seriously consider. There
must be better support for, and recognition of,
whistleblowers, and to reduce incentives for misconduct,
more effort must be made to move away from the mis-
use and overuse of publication metrics.22,23,46
Acknowledgements
Professor Warwick Anderson kindly critiqued a draft of
the manuscript.

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