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Investigating allegations of research misconduct: the vital need for due processCommentary: Response from members of the Griffiths inquiry

BMJ 2000; 321 doi: (Published 23 September 2000) Cite this as: BMJ 2000;321:752

Investigating allegations of research misconduct: the vital need for due process

  1. Edmund Hey, retired paediatricianb,
  2. Iain Chalmers, director (
  1. a UK Cochrane Centre, Summertown Pavilion, Middle Way, Oxford OX2 7LG
  2. b Newcastle upon Tyne
  3. a NHS Executive, West Midlands Regional Office, Birmingham B16 9PA
  4. b NHS Executive, South East Regional Office, London W2 3QR
  5. c Association of Community Health Councils for England and Wales, London N5 1PB
  1. Correspondence to: I Chalmers
  • Accepted 25 August 2000

On 27 February 1999 the BMJ carried a news item reporting that the government had set up an inquiry into a controlled trial of neonatal ventilatory support undertaken at the North Staffordshire Hospital, in Stoke on Trent, from 1990 to 1993.1 The trial was designed to assess whether continuous negative extrathoracic pressure (CNEP) ventilation could reduce the need for, and problems associated with, tracheal intubation and positive pressure ventilation.

Summary points

We believe that almost every statement made about the design, conduct, and reporting of the neonatal continuous negative extrathoracic pressure (CNEP) trial in the Griffiths report was ill informed, misguided, or factually wrong. Errors include:

A false assertion that the trial's design had not been subjected to external peer review

A failure to understand the trial's statistical design, as evinced by their erroneous belief that Professor Southall was single handedly responsible for its size and shape

A failure to recognise the expertise of the nurses involved in the study

A false statement that some of the consent forms could not be found

A false statement that it was not possible to be sure who had completed some of these forms

A false statement that there was no way of checking that consent had been obtained properly

An inaccurate statement that the process of consent was not managed consistently and that no system of management or documentation was in place to prove that it was

A false assertion that parents were not given clear opportunities to withdraw their child from the study at any time

A failure to take sufficiently into account evidence showing that parental recall of events in the newborn period can be fallible

An overreliance on the evidence of the small group of parents who asked to testify to the panel at the expense of contemporaneous evidence from …

Correspondence to: R Griffiths

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