I am a full-time PhD student at Cardiff Law School. I am a qualified American lawyer in the state of California as well as an English Solicitor. I have worked for large law firms in both Los Angeles and London, and my primary interest lies in medical law and policy.

Fraud in Research

Introduction
Research fraud has been around a long time; probably as long as there has been biomedical research. High-profile cases show that in history, scientists were no more obedient to conscience and self-discipline than they are now. It is still unproven but suspected that the work of Robert Millikan on the electron and that of Sir Cyril Burt on the genetic factor in IQ rating was blighted by manipulated data.[1] We close our eyes to the possibility that what we rely on could be comprised of false data and purposeful design of the "right" result. We would like to believe that biomedical research is self-regulating, and therefore that results are in fact reliable.

Chameleon, thy name is Misconduct
Clinical misconduct and fraud in research takes on numerous forms and is therefore widespread. The term “misconduct” encompasses many things, including commonly, “frank fabrication of data, issues to do with failure to obtain the informed consent of participants, plagiarism, duplicate, and redundant, publication.”[2] Misconduct can disguise itself as a pretty gift; researchers receive gifts, incentives, kickbacks or inducements from manufacturers, and they provide payment or nice presents to research subjects as inducement to participate in research. Misconduct is also manipulation of information in the form of delayed or non-publication of journal articles, gift and ghost authorship and borrowing of names in order to increase likelihood of publication.

Research misconduct is a long-standing international problem, but has only recently come to light with such vibrancy because people affected by medical misconduct have more access to information than they previously did, and because the media has become an enthusiastic spokesman for the public watchdog. People are more aware of their rights and whether they are victims of misconduct. Losing secrecy in medical research is not necessarily a bad development. The majority of medical staff have traditionally patronised patients, and coerced them into behaving in certain ways simply by controlling the information that they give their patients. Doctors are now required to be open about their practices, and particularly in research, where there is naturally an element of uncertainty, researchers may be held accountable for patients’ choice to participate in a trial. It is simply safer to have nothing to hide.

There is no internationally accepted definition of fraud in research. The US Commission of Research Integrity adopted the term “research misconduct” and identified three specific types of misconduct: misappropriation, interference and misrepresentation.[3] The UK Medical Research Council (MRC) has also adopted the term “misconduct”, but a further definition has recently been promulgated by the Joint Consensus Conference on Misconduct in Biomedical Research: “Behaviour by a researcher, intentional or not, that falls short of good ethical and scientific standards.” The earlier MRC definition may be easier to understand, simply because it excludes honest error. These are all brave attempts at catching the wide spectrum of things that fall under the umbrella of research misconduct, but none are specific enough to allow those working in the field to identify questionable practices with certainty.

References
[1] Ankier SI, Dishonesty, Misconduct and Fraud in Clinical Research, The Journal of International Medical Research, 2002, 30: 357-365.

[2] Sheikh A, Publication ethics and the research assessment exercise, Journal of Medical Ethics, Vo. 26(6), [ ] 2002, pp. 422-426 at 422

[3] Commission on Research Integrity, Integrity and Misconduct in Research, Washington: DHHS, 1996