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European Pharmaceutical Contractor

False Evidence

Evidence is emerging, according to some opinions, that misconduct in scientific research is increasing. The US Office of Research Integrity (ORI) found that the number of cases they are handling has reached record levels (1). Retractions of papers in scientific journals are on the rise and have increased tenfold in the last few decades, according to a report by iThenticate (2). Scientific misconduct has been found to be the leading cause of retraction in nearly 80 per cent of cases (3).

In June 2013, pharmaceutical giant GSK announced that it was retracting a paper written by scientists at its China research centre and published in Nature Medicine in 2010 (4). The retraction followed an investigation by GSK that “established that certain data in the paper were indeed misrepresented”.

Scientific misconduct extends to clinical research. There have been some high-profile cases such as that of UK researcher, Andrew Wakefield, for his infamous paper in the Lancet linking autism with the Mumps, Measles and Rubella (MMR) vaccine (5). Another notorious example was that of Jon Sudbø, a Norwegian researcher who committed research fraud in oncology by fabricating the data of 900 fictitious patients.

Defining the Problem

Research misconduct can be defined in a number of ways. Definitions can often be very subjective because they are dependent on opinions or knowledge of a person’s intentions.

The UK Research Integrity Office (UKRIO) is an independent body which offers advice and guidance to universities, other research organisations and individual researchers about the conduct of research. It defines misconduct in research as including, but not limited to:

● Fabrication
● Falsification
● Misrepresentation of data and/or interests and/or involvement
● Plagiarism
● Failures to follow accepted procedures or to exercise due care in carrying out responsibilities for avoiding unreasonable risk or harm to:
– humans
– animals used in research
– the environment
– the proper handling of privileged or private information on individuals collected during the research (6)

A somewhat contentious addition to this set of definitions was offered by the British Medical Association (BMA) in June 2013 when it voted for the “selective non-publication of unflattering trial data” to be considered research misconduct. The BMA reasoned that if evidence is distorted by results being withheld, then informed decisions cannot be made about which treatments are best for patients.

Why is Misconduct Growing?

The iThenticate 2012 report theorises that one reason for the growth in research misconduct might be the growing pressure to publish, particularly in prestigious journals (2). Falsified, fraudulent research data, paraphrasing and plagiarism have all increased over recent years. The precise incidence of misconduct can be hard to quantify, but a report in 2012 published by the British Medical Journal revealed that one in seven UK-based scientists and doctors have witnessed colleagues intentionally fabricate or alter data for publication purposes (7). In the US, things are not much better; the Office of Research Integrity recently reported that it is handling record levels of allegations of misconduct (8).

One reason for the apparent upturn in misconduct may be an increase in reporting. Many organisations now have research integrity groups of their own in place with formalised approaches and processes for the reporting of misconduct, which include the protection of whistleblowers. Plagiarism is easier to identify due to the sophisticated software that is now available.

Types of Misconduct

Misconduct manifests itself in various ways. A consensus view is that there is deliberate intent associated with the act of misconduct. Fraud – defined as falsification or fabrication of data – is a clear example of a deliberate intent to deceive. Purposely not following recognised procedures, such as clinical trial protocols, is another example – and is particularly reckless and callous if patients’ wellbeing and rights are compromised. Deception of patients when seeking consent for research is certainly misconduct. An associate of mine attended what she imagined to be a routine, standard clinic, only to discover – after some questioning about the procedures – that she was to be enrolled into a clinical trial.

Plagiarism, the presentation of others’ work as one’s own, while perhaps not as sinister, is still a blight, and does nothing for the public perception of clinical research when it is exposed.

The reasons behind misconduct are many and varied. Financial gain; pressure to publish or attain a promotion; the urge to achieve fame; or the climate of research competition for funding may all be contributory factors (9).

Any individual or group in any clinical research is capable of misconduct. Many incidences seem to be perpetrated by individuals, which is unsurprising given the motivation for committing these offences. Honest mistakes, differences in the interpretation of data and scientific disputes are not considered to be misconduct. However, reckless behaviour, such as failure to exercise due care without regard to research subject safety or the integrity of the data, could be classed as misconduct under the UKRIO definition.

Lack of Awareness

Is misconduct sometimes due to ignorance of what is good practice, or a lack of awareness of the consequences? Sometimes, people involved in research may not be aware that what they are doing is misconduct, or may be unaware or disinterested in the consequences of their actions. This was apparent in the case of my associate. It became clear after she had discussed her perceptions with the research staff that they were unaware of the need to state very clearly, during the consent process, that the patients were being invited to participate in research.

Another example came from one of my previous working lives: I was a clinical research monitor and came across an investigator who had a very loose interpretation of what could be deemed timely data entry. On a monitoring visit, I discovered that he had not entered data about a patient either in the medical notes or case report forum. When I asked him to explain, he said he had conducted the visit but had the results ‘in his head’. After a discussion about how unreliable this method of data entry was, and the potential impact on patients and on the trial, we agreed that in future he should enter the results in the patient records at the time he did the observations. This is an example of the fine line between having a cavalier attitude and misconduct.

A common example is when investigator site staff backdate a subject’s signature on a consent form because the subject did not date the form at the time of consent. This is often due to unconscious ignorance of the correct procedure for rectifying this omission.

Widespread Impact

Depending on the nature of the misconduct, the impact on patients can be widespread and potentially devastating. The fraud perpetrated by Andrew Wakefield during his research on the MMR vaccine caused many parents to leave their children unprotected. During a measles outbreak in Wales in the winter of 2012, a survey conducted by NHS Wales revealed that the vast majority of confirmed cases were individuals who had never been vaccinated with MMR.

For the individuals who are found guilty of misconduct, it is often a career-ending experience. The range of possible consequences include criminal prosecution, loss of employment and action by the regulatory authorities, such as debarment by the Food and Drug Administration.

The reputations of organisations, such as academic institutions or pharmaceutical companies, associated with fraudulent practices or individuals can be severely damaged, and there can be financial consequences such as withdrawal of funding or a drop in share price. In addition, public confidence in research can be undermined if a case of misconduct reaches the national press and gains widespread coverage in the news.

Education and Training

The success in tackling misconduct relies on early detection of suspected cases and a thorough, objective investigation carried out in a professional way so that the innocent are protected, and the guilty are suitably punished or admonished. Successful detection relies on a number of factors including whistleblowing from peers and co-workers, thorough monitoring from sponsors, and robust inspections and enforcement of regulations from national and local authorities.

The best method of tackling misconduct is to prevent it happening in the first place. It is human nature that if people believe there is a good chance they will be caught the majority of potential miscreants will be sufficiently deterred. Just as in any community, there will always be a core of researchers who will perpetrate acts of misconduct, irrespective of the chances of being caught and the severity of the penalties.

Some examples of misconduct can be put down to ignorance of what is good practice, and lack of awareness of the potential consequences for patients and the integrity of the research. Proper supervision, training and competence assessment of people who work in clinical research in all capacities should not only cover what is good, ethical research practice but also deal with misconduct, its definition and how to avoid it.

Unawareness of what misconduct is can be no defence, and clinical research professionals should be competent and confident in the reporting of misconduct if they suspect it. Each organisation should ensure that its staff know how to follow their specific procedures for reporting suspected misconduct so that they are assured that their concerns are dealt with seriously and discretely. Misconduct through ignorance can no longer be an excuse.

References

1. Hicks J, Ethics training in science, The Scientist Magazine, May 2013. Visit: www.the-scientist.com/?articles. view/articleno/35543/title/opinion-- ethics-training-in-science
2. The true costs of research misconduct. Visit: www.ethics.elsevier.com/pdf/ ithenticate-misconductreport-2012.pdf
3. Fang FC et al, Misconduct accounts for the majority of retracted scientific publications, PNAS 109(42), 2012
4. Liu X et al, Crucial role of interleukin-7 in T helper type 17 survival and expansion in autoimmune disease, Nature Medicine 16: pp191-197, 2010
5. General Medical Council’s Fitness to Practice Panel Hearing, January 2010
6. The UKRIO Code of Practice for Research, September 2009. Visit: www.ukrio.org/wp-content/uploads/ UKRIO-code-of-practice-forresearch. pdf
7. Tavare A, Scientific misconduct is worryingly prevalent in the UK, shows BMJ survey, BMJ Group, January 2012. Visit: www.bmj.com/content/344/ bmj.e377
8. Office of Research Integrity Annual Report 2011. Visit: http://ori.dhhs. gov/images/ddblock/ori_annual_ report_2011.pdf
9. Illingworth R, Fraud and other misconduct in biomedical research, Neurocirugía 16: pp297-300

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Martin Robinson PhD is Principal Director of the International Academy of Clinical Research (IAoCR). He leads a team providing independently accredited training courses for clinical research professionals, including project management, clinical research associate and good clinical practice training. Martin has over 15 years of international experience in training and education in clinical research. His past career highlights include working in organisational development for Dovetail, and in training and development for the Institute of Clinical Research. Previously, he worked for Covance where he had a number of roles in training and development, and project management.
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