A social autopsy of the TGN1412 clinical trial: Northwick park, Research Ethics Committees and the normalisation of deviance
SpeakersDr Adam Hedgecoe, Senior Lecturer, Sociology, University of Sussex
VenueUniversity of Exeter,Egenis,Byrne House,St Germans Road,Exeter, EX4 4PJRoom no: GF7, Byrne House
Time: 3:30 - 5:00 PMA social autopsy of the TGN1412 clinical trial: Northwick park, Research Ethics Committees and the normalisation of deviance
This paper draws on a detailed historical and ethnographic study of the UK research ethics committee (REC) system, as well as interviews with people involved in assessing and running the TGN1412 trial at Northwick Park in Match 2006 which resulted in serious harm to 6 healthy volunteers. While there has been a formal investigation into the events at Northwick Park - the so-called 'Duff report - there has been no public examination of the role of the Brent Medical Ethics Committee, the REC which gave ethics approval to the trial. This paper sets the Brent committee's decision within the culture and system of UK RECs, and shows how a number of features - the undermining of scientific expertise on RECs, the changing nature of pharmaceutical companies, the attendance of applicants at REC meetings and the working relationships that develop between researchers and RECs - lead to a context that encouraged the ethical approval of a risky, and ultimately harmful, clinical trial.