Fraud and Misconduct

1. Introduction

Fraud is often coupled with misconduct and the two are certainly related; fraud by definition is misconduct, but not all misconduct is fraud. Fraud always contains intent whilst misconduct covers a wide range of activities, from carelessness, right through to deliberate deception.

The word misconduct is used differently in English. Therefore, there are different definitions. According to the UK Medical Research Council and the Wellcome Foundation, misconduct is defined as:

‘The fabrication, falsification, plagiarism or deception in proposing, carrying out or reporting results of research or deliberate, dangerous or negligent deviations from accepted practices in carrying out research.'

Alternatively, the Joint Consensus Conference, Edinburgh, (1999) defined it as:

‘Behaviour by a researcher, intentional or not, that falls short of good ethical and scientific standards.’

In contrast, a definition of clinical research fraud is clearer:

‘The generation of false data with the intent to deceive.’

Sponsors of clinical trials and doctors participating in clinical trials (investigators) put a lot of emphasis on planning, performing and evaluating clinical trials. This is to ensure that the trial results in:
  • Trustworthy data.
  • Clear results and treatment recommendations.
The data are generated by the investigators who enrol the participants into the trial they perform the measurements and observations. Findings are documented in Case Report Forms (CRFs) prepared by the sponsor. The Good Clinical Practice (GCP) standard defines the conditions that sponsors and investigators have to apply to ensure good quality data. Auditing the trial performance at the investigator’s site ensures that the trial is carried out properly. However, some investigators may decide to falsify or even invent data.

This topic explains the following:
The conduct of most clinical research is honest and adheres to ethical principles. Occasionally the sponsor or organiser of a clinical research project may be faced with data which are questionable, such data may or may not be fraudulent.

Fraud should not occur at all. However, we do not live in an ideal world… Crimes do happen everywhere. The following three examples of fraud from different regions in the world demonstrate what happens when fraud is committed.