Research fraud

There has been much published on the incidence, detection and prosecution of publication fraud, rather less on fraud and misconduct in clinical research, but we should be equally concerned about research fraud. The Consensus Conference on Misconduct in Biomedical Research convened by the Faculty of Pharmaceutical Medicine and the Royal College of Physicians of Edinburgh in 1999 defined research misconduct as behavior by a researcher, intentional or not, that falls short of good ethical and scientific standards . Frank Wells, co-founder of MedicoLegal Investigations Ltd., the only specialist research fraud investigation company in Europe, prefers the generation of false data with the intention to deceive . 

Carelessness is common, research fraud less so, but both are almost impossible to quantify. The US Food... 

It is tempting to use the words fraud and misconduct almost interchangeably, but in most cases, they can be differentiated. In broad terms, research fraud is defined as wilful behavior that breaches the principles of good practice in research. Fraud must have an element of deliberate action true fraud is not an accidental act. 

There are many types of research fraud, and this list is not exhaustive, but it is useful to consider the various categories. 

Forged consent forms are one of the most common types of research fraud. A monitor from a Contract Research Organization (CRO) took the trouble to lay out all the patient consent forms at one site side by side. She noticed that the patients signatures looked similar to each other and some of the letters... 

It is perhaps fear of being shown to be wrong that holds many back from making allegations of research fraud. The term of whistleblower does not have a good connotation and is being widely replaced by such euphemisms as Open-Practice Policy . It is in an attempt to minimize risk both to those who report suspected fraud and to those... 

What is being done about handling research fraud ... 

The FDA plays a major part in the prevention and detection of research fraud and misconduct. The FDA carries out two different types of reviews. Study-orientated audits are conducted on clinical trial data itself, in order to ensure patient eligibility, and investigator-orientated inspections can be carried out either routinely or because a sponsor has concerns. If the inspectors have reason to believe that a site has not complied with regulatory requirements or has engaged in fraudulent activity - for which the definition in the Federal Code is very similar to that of the Wellcome Trust - they have the power to disqualify the investigator from taking part in further research, or severely restrict his activities. Such findings are widely publicized both within and outside the United States on the so-called Black List . 

Although European countries take research fraud and misconduct seriously, most have no official sanctions in research fraud. The first research misconduct committees in the Nordic countries date from the early 1990s. Their roles may be both preventive and investigative, but they do not, for the most part, allow sanctions to be taken that remains in the hands of the institutions. 

First was the National Research Ethics Council of Finland, founded in 1991, under the auspices of the Department of Education. It does not itself investigate research fraud, but produces guidelines for the prevention, handling and investigation of... 

WHAT IS BEING DONE ABOUT HANDLING RESEARCH FRAUD ... 

The principle medical body in France established a group of experts in 1999, the Delegation a l Integrite Scientifique, to focus on both the prevention of research fraud and the sanctions to be taken against individuals or institutions, although there have been few official reports of fraud. There are detailed sequential procedures to be followed, and much use has been made of the experiences of other countries. 

In the United Kingdom, a Joint Consensus Conference on Misconduct in Biomedical Research was held in Edinburgh in 1999 with all major stakeholders and interested parties represented. The panel s main conclusion was that a national panel should be established - with public representation -to provide advice and assistance on request . The suggestions for the remit of this panel included the development of models of good practice, assistance with investigation of alleged misconduct and the collection and publication of information on incidents of research fraud and misconduct. It was only in 2004 that a National Panel for Research Integrity... 

In general, the role of national bodies involved in the investigation of research fraud and misconduct is merely to advise and support the relevant institutions, but it is for those institutions themselves to decide whether to take action against those found to have acted dishonestly. The situation in the United States is somewhat different the FDA can order the closure of institutions and circulates the names of wrongdoers on their Black List . The ORI can recommend the withdrawal of Federal funding, and the French authorities, too, can take direct action. 

The system for dealing with doctors suspected of research crime in the United Kingdom revolves around the GMC, which stated in 1992 that their disciplinary committee would take a very serious view of proven clinical research fraud. Since 1990, 26 doctors accused of research fraud have been reported to the GMC, all but 1 being found guilty. The penalties imposed ranged from erasure from the Medical Register, to admonishment and limitation of future research. The GMC can only investigate suspected fraud or misconduct after a formal... 

Research fraud is a reality, but in the past, healthcare professionals and academia have sometimes chosen to turn a blind eye, and pharmaceutical companies tacitly condoned it by choosing not to investigate fully and to bring prosecutions. The climate now is changing, driven by all those parties, but medical research is still vulnerable in the absence of any effective mechanism to combat and detect fraud. 

Three elements are necessary to improve the situation. There must be official bodies in each country with real powers to investigate and prosecute clinical research fraud. There must be a widespread and unequivocal acceptance that failure to act on suspicions of fraud is itself serious misconduct. And finally there must be an... 

Most clinical researchers, like most members of the public, are honest. However, to pretend that clinical research fraud and misconduct do not exist is to allow bad medicine, bad science and, above all, abuse of patients. 

Dyer C (1997) Consultant struck off over research fraud. Br Med J 2X5 205. 

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