Sarah In the spirit of shared responsibility, Giuliana and I are presenting this talk together. We are going to take it in turn to defend our assertion that “Sharing responsibility for ethical research takes more than guidelines” and tell you what we think needs to be done to truly share responsibility for research conduct.
Giuliana In the last few years, a number of significant world firsts have been reported in the research community. In 2005, Eric Poehlman, an American expert in the field of human obesity and ageing, became the first academic researcher to be jailed for falsified data in a grant application. Poehlman published more than 200 journal articles before his career unravelled. A former lab technician accused him of scientific misconduct to which he pleaded guilty. He acknowledged falsifying 17 grant applications to the National Institutes of Health and fabricating data in 10 of his papers between 1992 and 2000. He was ordered to serve a year in a federal prison for using false data to obtain U.S federal research grants. Last year, Hwang Woo-Suk, a South Korean biomedical scientist reported the first success in human somatic cell cloning. Hwang was considered one of the pioneering experts in the field of stem cell research, best known for two articles published in Science in 2004 and 2005, where he reported the spectacular claim that his team had created 11 human embryonic stem cell lines. Following concerns raised by Hwang’s former colleagues and a series of media scandals, an investigation by Seoul National University determined that all 11 of Hwang&apos;s stem cell lines were fabricated. The university announced that Hwang&apos;s Science papers were both fabricated and following the confirmation of scientific misconduct, Science retracted them both. Hwang was &quot;indicted on embezzlement and bioethics law violations linked to faked stem cell research.&quot; All in all 2005 was not a great year for research. In another example, a high profile Norwegian cancer specialist, Jon Sudbø reported in a fast track submission to The Lancet that popular over the counter painkillers (like ipuprofen) reduce the risk of oral cancer in smokers. It was revealed that his Lancet paper was based on fraudulent patient data. Sudbø later acknowledged that he had used fictional data in at least two more papers, published in the New England Journal of Medicine and the Journal of Clinical Oncology. A commission investigating Sudbø revealed that most of his work was based on manipulated and fabricated patient data and found him guilty of fraud.
Sarah Every few years we’re treated to juicy new scandals like these. In the aftermath of such scandals the research community shakes its head, fingers are pointed, guidelines drafted and earnest efforts are made to restore the public’s confidence in science and research. While spectacular examples of scientific fraud or misconduct like those Giuliana has just described may indeed be the work of mavericks and rogues, most examples of poor research conduct are done by your garden variety researcher. In fact, research misconduct is not rare. Given that many Australian researchers do not receive any formal training in research ethics, it seems hardly surprising that some researchers conduct their work in a manner that does not comply with accepted standards. While we support the spirit and intention of both the National Statement on Ethical Conduct in Human Research and the Joint Statement (now known as the Australian Code for the responsible conduct of research ), we suggest that guidelines in themselves do not protect against misconduct. We argue that it is one thing to write clear guidelines on ethical research conduct, it is another to ensure that researchers read, understand and comply with these guidelines. In fact, we argue that non-compliant, or indeed unethical research conduct, is something that we should expect in institutions that fail to train researchers in research ethics.
Giuliana Most of you might be wondering is there really a problem? Most of us have not received any formal training, but we know how to do the right thing. Although Sarah says that misconduct is not rare, there’s some debate on this question In 1987, the editor ofScience stated that “99.9999 % of [scientific] reports are accurate and truthful, …..there is no evidence that the small number of cases of [research misconduct] that have surfaced require fundamental change in procedures that have produced so much good science” More recently the editor of MJA commented on fraudulent research by stating “There is no doubt these events are the tip of the iceberg, as research misconduct is endemic and may well become more prominent as the competitiveness and commercialisation of research escalates”. Earlier this year, an editorial in Nature claimed that“ There is broad agreement within the community on two main points regarding outright scientific fraud: it is rare, and it is serious.”
Sarah Despite speculation in editorials, there is some empirical data that indicates that research misconduct is both serious and commonplace. For example, a large US survey of 6,000 researchers in 2005 found approx 1.5% of researchers admitted to falsification or plagiarism. 7.6% said they had circumvented some requirements of human subject research 12.5% admitted overlooking others use of flawed data; 15.5% said that they changed the design, methodology or results in response to pressure from a funding source;
Another survey in 2000, this time of biostatisticians, found that A quarter were involved in Fraud and Fabrication A third directly involved in projects with misconduct half knew about fraud in medical research
An interesting survey in 2001 with 305 new medical consultants found Over half had observed misconduct The interesting thing about this survey is that 17% said that they had research ethics training. This ethics training may explain participants awareness of misconduct and may explain why over half said that they had observed misconduct. Alternatively, it could suggest that ethics training is a waste of time. Finally, a study published in MJA in 2005 reports on a survey of Australian medical specialists undertaking research. It is reported that 8.6% of respondents had experienced at least one event representing a breach of research integrity :These breaches included • Concealment of relevant findings • Alterations to data or statistics. Delay in publication of findings Failure to publish key findings Selective reporting
Giuliana Some explanations for research misconduct found in the literature are An increasing pressure to publish, increased competition for research dollars, The fact that universities do not have strong surveillance mechanisms to deter research wrongdoing. And that Universities provide limited infrastructure to support ethics codes We suggest that there is a point missing from this list and that is CLICK- the absence of effective education and training. We suggest that the incidence of research misconduct is linked to a lack of training in good research conduct.
Sarah This may look familiar. Currently, researchers are merely required to tick a box on their ethics application to say that they have read the National Statement. Although every researcher who submits an ethics application ticks this box, some colleagues tell me that they tick YES without having actually reading this document. To see if this practice is more widespread than just my colleagues in public health, Giuliana asked researchers who undertake her courses on research ethics two simple questions: Have you ever submitted an application to an ethics committee? Most hands in the room are raised indicating YES Then, have you read the National Statement? Much fewer hands are raised. So our anecdotal accounts suggest that many researchers undertake research without reading the National Statement let alone understanding the ethical principles upon which it is based. In addition, some researchers, including those who have senior positions in research institutes, have never heard of the Australian Code.
Sarah Last week,we sent several of our research colleagues a spoofy survey asking them “What is the Australian Code?”. While the most common answer was in fact the correct one, quite a few participants selected Kevin Andrew’s new values test for immigrants or Australia’s anti-terrorism defense code.
Giuliana The current approach to training researchers relies heavily on a system of apprenticeship and mentorship and assumes that junior researchers will learn good practice through osmosis. The current system also assumes that researchers should simply ‘know through intuition’ how they should behave and when there research actions could have moral implications. We suggest that this system is not only inefficient and problematic but unfair on researchers. Research institutions are neglecting their obligations as educators, and in their duty to protect research participants, by failing to provide explicit and compulsory training in research ethics and good research practice. The current informal approach to educating researchers about ethical conduct in Australia is in contrast to the American system which recognises the importance of compulsory training. Since 1989, you can’t get a grant from the NIH unless you’ve done training in research ethics. Here in Australia, researchers are merely required to sign a form in which they have ticked a box.
&lt;number&gt; Sarah Although the NIH requirements for education and training in ethics sounds great, it didn’t keep Eric Poehlman out of jail. There is lots of research showing that education is not a magic bullet, so there is no reason to expect ethics education to prevent all cases of misconduct. In the Australian Code, education is only one of several initiatives recommended. It also calls for institutions to be more active in providing research ethics education and to have provisions for handling allegations of research misconduct. It also places a greater emphasis on institutional model of research governance and calls for institutions to appoint an adviser on research integrity. It still remains to be seen how institutions will respond to these revised documents. A few institutional models of research governance do exist, including one from Giuliana’s department at Monash University.
The department of epidemiology and preventive medicine at Monash has implemented a research governance framework which is underpinned by these five components One of the key operational ‘governance tools’ adopted by the DEPM is routine random audits of ethics approved research. Another way we ensure that research staff are aware of their responsibilities as set out in the national guidelines is to ensure that every new staff member joining the department receives a compulsory induction and training with me, the Research Governance Co-ordinator. We have also implemented a number of initiatives to try to break down the prevailing view that ethical research is simply a matter of jumping through the ethics committee hoops these include - highlighting research ethics news in a fortnightly newsletter, encouraging researchers to attend the Alfred ethics committee meeting as observers to try to demystify the process …. And instituting a dial e for ethic hotline to me … what we have tried to foster is shared responsibility for ethical research by having an open door collaborative approach to ethical review
&lt;number&gt; Sarah In an MJA paper last year Warwick Anderson, Chris Cordner and Kerry Breen argued that National Statement and the Australian Code are important steps in strengthening research oversight. They said: “We believe that these two draft documents herald a new era in the governance of research involving humans in Australia. At a time when commercial and other pressures on researchers may be increasing the risk of fraud and misconduct, it is crucial that our system for the oversight of research be sufficiently robust to protect participants and maintain community confidence in research.”
Sarah But Unfortunately, the revised National Statement and the Australian Code were not heralded. If our anecdotal accounts accurately reflect the current research environment, these documents remain a well kept secret. This morning, we have argued that researchers can hardly be expected to comply with policies and guidelines in which they are given no formal training. As I have said, it is one thing to write clear and comprehensive guidelines on ethical research conduct, it is another to ensure that researchers read, understand and comply with these guidelines. It is also worth noting that some universities make training in animal research ethics compulsory while they have no corresponding requirement for human research. We believe that research institutions that do not provide compulsory training in research ethics are failing in their obligations to researchers and also to protect research participants.
&lt;number&gt; If we are serious about sharing responsibility and not merely shifting it, and if institutions are to take their responsibilities for research conduct seriously, education is an obvious place to start. If researcher do not receive education and training in responsible research conduct and the requirements of the key national documents, how can they comply?
Sharing responsibility forSharing responsibility for
ethical research takes moreethical research takes more
than guidelinesthan guidelines
Dr Giuliana FuscaldoDr Giuliana Fuscaldo
Dr Sarah RussellDr Sarah Russell
World firsts in research
Researcher jailed for falsified data
Researcher indicted on embezzlement
charges for faking stem cell data
Researcher found guilty of fraud for
fabricating patient data
Myths about research
• Mavericks and rogues
• Rare and surprising
• Guidelines protect against misconduct
Research misconduct: is
there a problem?
Science 1987, “no evidence”
MJA 2006 “tip of the iceberg”
Nature 2007 “rare & serious”
Incidence of Research Misconduct
1.5% falsification or plagiarism.
7.6% circumvented some requirements
12.5% overlooked flawed data
15.5% changed design, method or results
Martinson, Nature (June 2005)
26% involved fraud and fabrication
31% directly involved in projects with
51% knew about fraud in medical research
Ranstam, Control Clinical Trials (2000)
305 new medical consultants:
55.7% observed misconduct
5.7% committed misconduct in the past
18% would commit in future
17% had research ethics training
Geggie, J Med Ethics (2001)
Heightened pressure to publish
Increased competition for research dollars
Lack of strong surveillance mechanisms
Limited infrastructure to support ethics
Absence of education and training
I, the researcher, agree to observe
the principles in the National
Statement on Ethical Conduct in
Research involving Humans published
by the National Health and Medical
Research Council (June 1999)
What is the Australian Code?
a. Australian soccer
b. A new Australian values test for immigrants
c. Dan Brown’s sequel to Da Vinci Code
d. A code for research conduct
e. Australia’s anti-terrorism defense code
f. Dialing code for overseas phone calls
g. Marketing code for prescription drugs
Education in research ethics
• Ad hoc
Institutions to be more active in
providing research ethics education
handling allegations of research misconduct
Greater emphasis on institutional model of
Appoint adviser on research integrity
Risk management plan
Short courses in research practice
Research project audits
Research governance coordinator
We believe that these
two draft documents
herald a new era in the
governance of research.
Anderson, Cordner, Breen 2006
Without education and training, it
is unfair to expect current
researchers to comply with the
key national guidelines
The extent to which
responsibility for research
conduct is shared, or merely
divested from one group to
another, will depend largely on
how research institutions
respond to the guidelines.
Fuscaldo, Monash Bioethics Review, 2007