A National Panel for Research Integrity: a proposed blueprint for the prevention and investigation of misconduct in biomedical research*

Abstract

Biomedical researchers in the UK have made major contributions to disease prevention and patient care through the publication of a large quantity of research evidence in peer-reviewed journals. Isolated (but well publicized) instances of deliberate misconduct (fraud) in clinical research by doctors in the UK have been reported to, and dealt with by, the General Medical Council (GMC) as part of its procedures for professional misconduct [1]. The UK has not yet developed systematic procedures for identification and investigation of suspected deliberate misconduct in biomedical research, unlike other countries such as the US and Denmark [2]. Whilst increasingly publicized and requiring joint attention by the medical profession, and by its colleagues in the biomedical sciences (over whom the GMC has no jurisdiction), such isolated instances of deliberate misconduct probably have little lasting effect on the scientific basis of medical practice [3]. In contrast, it has been suggested that ‘almost certainly far more direct harm to patients results from the inept efforts of poorly trained researchers than ever results from deliberate deception’ [3]. Hence there is a need to address not only deliberate research misconduct, but also to address non-intentional behaviour by researchers which falls short of good ethical and scientific standards. In a recent international survey of biostatisticians, who routinely work closely with physicians and scientists in many branches of medical research and therefore have an unique insight into data, 51% of the 37% who responded knew about fraudulent projects (e.g. fabrication and falsification of data, deceptive reporting of results, suppression of data and deceptive design or analysis) [4]. A recent consensus statement developed at a UK Consensus Conference on Misconduct in Biomedical Research organized by the Royal College of Physicians of Edinburgh defined research misconduct as ‘behaviour by a researcher, intentional or not, that falls short of good ethical and scientific standards’ [2]. It proposed that representatives of both of the Royal Colleges of Physicians of Edinburgh and London, the Royal College of Physicians and Surgeons of Glasgow and their joint Faculty of Pharmaceutical Medicine meet to consider the establishment and remit of a national panel for good research practice. We therefore established our joint working group to address these issues. At a series of meetings we have developed a blueprint for such a panel, which we now publish to inform people of developments and to invite public debate. We have also had discussions with the UK government (Departments of