Adam Hedgecoe, Cesagen, Cardiff University
Location: Ground Floor Lecture Theatre, Institute of Human Genetics, Centre for Life.
Time/Date: 10th March 2010, 13:00 - 14:00
Research misconduct as organizational deviance: local knowledge, meeting people and the TGN1412 trial S
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.
Published: 22nd January 2010