Research Integrity

January 1, 2013

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-01-01-2013, Volume 22, Issue 1

Standard operating procedures need to be in place for the handling of suspected research misconduct.

Human nature being what it is, in any environment there is always the possibility that someone has done something wrong. In the context of clinical research such wrongdoing might be some aspect of research misconduct such as fabrication of data, falsification of results, plagiarism, or piracy. If the misconduct is carried out with the intent to deceive, that's fraud.

Frank Wells

I've been fraud-busting for over two decades now, and although the most obvious cases have almost disappeared, research fraud still exists. Breaches of good clinical practice occur all the time, but so long as they are not intentional, only sloppy, they will most likely be picked up by the vigilant monitor or the astute auditor. Unfortunately, where the deception really is intentional, the fraudster will go out of his way (in my experience always "his" not "her") to cover his tracks—we do not know what we do not know. So although I'm confident that research fraud is not rife, it still exists and those of us with the interests of research integrity at heart must do all we can to minimize it and not become complacent.

People often accuse me of using platitudes, but I stick to my firm conviction that "once a fraudster, always a fraudster," because time and again I come across multiple instances of fraud committed by the same person. So it makes sense never, ever, to use again as a researcher anyone who has demonstrated any degree of research misconduct. However, sponsors sometimes wish for research to be led by a known specialist in that particular field, and the temptation to acquiesce to such a wish if the potential investigator is known to have committed research misconduct must be resisted.

Everyone who is involved in clinical research should have a set of standard operating procedures in place for the handling of suspected research misconduct. Furthermore, they should be familiar with how such a procedure operates and should ensure that it remains up-to-date. Because such misconduct is not rife, the need to use this procedure may not often arise, but when it does, it should be used without delay. In my extensive experience, academic departments and universities are singularly ill-prepared or are unwilling to invoke the procedure they have in place and are much more likely to sweep any irregularity under the carpet. But it is incredibly irresponsible and potentially dangerous to do that, as the rogue investigator who fabricates or fantasizes will be liable to go on repeating his misdemeanours if he is not stopped. Furthermore, whistle-blowers who have identified where research is being corrupted are, even now, more likely to be told to shut up than to be commended for exposing the shortcomings of the suspect investigator.

Integrity must therefore be maintained at all costs. However, I'm well aware that honesty in the conduct of research can be difficult to maintain, especially when time is running out, some of the figures are missing, the analysis proves nothing at all, and there is no more money for the project. But reporting that the outcome of the research is inconclusive or that the results are negative is important in itself as well as being honest. Such information can well save time and money if it is reported that certain processes don't work, so that that particular dead-end can be avoided in the future.

I hope the readers will agree with me that the utmost vigour is needed to apply a policy that minimizes the incidence of research misconduct; because it is in the ultimate interest of all involved, and especially patients, that this is done and that the integrity of future research can be safeguarded.

Frank Wells Retired Pharmaceutical Physician Lead Advisor on Integrity Fraud and Misconduct to the Health Research Authority E-mail:

download issueDownload Issue : Applied Clinical Trials-01-01-2013

Related Content:

A Closing Thought | FDA