18 - The prevention and management of fraud and misconduct: the role of the LREC

Summary

Introduction

In an ideal world, fraud or even misconduct in clinical research would not exist; but we do not live in such a world. Accepting, therefore, that they can happen, research ethics committees – particularly local committees – have important roles to play in trying to prevent their occurrence and, if either does occur, to assist in their investigation.

Fraud is much less common than carelessness, though its incidence is difficult to quantify. Nevertheless some element of fraud in clinical trials has been variously estimated (Horton, 1996; Wells, 2001)at between 0.1 and 1% of research projects. As justification for this estimate, there are about 3000 sponsored clinical trials taking place at any one time in the United Kingdom. If the higher figure is assumed, this means that 30 studies may be currently being conducted that could include fraudulent or inaccurately compiled data. Even one case of fraud or other misconduct is one too many. Fraud is likely to exploit patients, deceive the sponsor and may skew the scientific database. Reports of proven cases of fraud in biomedical research are usually greeted with dismay and an element of surprise. Society expects doctors conducting research to be honest and honourable as well as competent – as, indeed, the vast majority of them are.

Definition of research misconduct

At a consensus conference held under the auspices of the Royal College of Physicians in Edinburgh in 1999, a number of definitions of misconduct were discussed. Research misconduct was viewed as including fabrication, falsification and/or suppression of data and plagiarism, as well as unintentional action that undermines the scientific value of the work.