Clinical and Biological Research Fraud in the UK
A group of leading figures from the medical Royal Colleges[1] has today published a blueprint, for open debate with the government and other stakeholders, for the establishment of a National Panel which would identify and investigate suspected cases of fraud and misconduct in clinical and biological research studies.
The blueprint, published in the medical journal Proceedings of the Royal College of Physicians of Edinburgh[2], proposes that a government-funded ‘National Panel for Research Integrity’ (NPRI) (with widespread representation from medical, public, charitable, academic, and pharmaceutical organisations) should be established so as to bring the UK in line with other international countries, such as the US and Denmark, where procedures have already been introduced for dealing with this type of research fraud[3]. The blueprint was developed during a period in which a recent international survey of biostatisticians found that 51% of respondents knew of fraudulent research projects including fabrication and falsification of data, deceptive reporting of results, suppression of data, and deceptive design and analysis[4].
It is anticipated that the creation of the NPRI would close the ‘loophole’ by which the General Medical Council (GMC) has jurisdiction to investigate suspected cases of deliberate research misconduct by doctors, but not by others involved in the biomedical sciences (clinical research studies and activities involving patients and human volunteers; research on biological material; and publications of biomedical research or clinical audit projects). In addition to proposing the establishment of the NPRI the blueprint contains details of its objectives (the promotion of best practice in biomedical research through the education of researchers and supervisors, the development and maintenance of standards and audit, and the development of a co-ordinating function for allegations or suspicions of misconduct) and also provides details of its status, composition/representation, and possible procedures which could be followed in investigating suspected cases of misconduct[5].
The publication of the blueprint follows a sustained period of development during which the Colleges, and other stakeholders, have addressed this area of activity in the UK in order to ensure that public and professional confidence in UK clinical and biological research activities can be maintained and justified. In 1999 the Colleges and their Faculty of Pharmaceutical Medicine[6] held a Joint Consensus Conference on Biomedical Research, at the Royal College of Physicians of Edinburgh, which was supported by the General Medical Council (GMC), the Medical Research Council (MRC), the British Medical Association (BMA), the Chief Scientist’s Office, the Association of British Pharmaceutical Industry (ABPI) and a number of leading medical charities[7]. The conference produced a consensus statement recommending that a national panel should be established and the Colleges were charged with developing the initial blueprint which has now been completed.
Prof Gordon Lowe, a Member of the writing group, and representing the Royal College of Physicians of Edinburgh, said,
“The medical Royal Colleges have developed debate around this subject, and this blueprint is the first stage in developing a model for a system which would allow health professionals and the public alike to have full confidence in the quality and standard of biomedical research in the UK.
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