Government sets up inquiry into ventilation trial

Obstacles to gaining ethical approval for a multi-centre study of family support

“…The NHS research governance framework was established to ensure that approved research is of high scientific quality, sufficiently managed, accountable, and complies with ethical standards. The establishment of such a framework grew partly as a response to publicity concerning alleged misconduct in research (Jones, 1999;Redfern, 2001). For instance, the Griffiths report into research with pre-term infants in North Staffordshire recommended that the procedures for conducting all clinical research should be restructured (NHS Executive West Midlands Regional Office, 2000).…”

Scandals, Ethics, and Regulatory Change in Biomedical Research

“…The focus for this discussion is the so called "Griffiths report" (Jones 1999) This pattern remains true for the case of more recent changes in the ethics review system such as the European Clinical Trials Directive (Hedgecoe et al 2006) and disasters such as the TGN1412 clinical trial (Hedgecoe 2014). This insight flows directly from the methodological approach adopted in this paper, suggesting that claims about the drivers for regulatory change need to be based on research--whether it is archival, interview based or ethnographic--that opens up the "black box" of policy decision making.…”

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

“…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.…”