Background
Concerns about the process of consenting trial participants were highlighted by the TGN1412 trial incident in 2006. The reports into TGN1412 by the Expert Scientific Group and the Royal Statistical Society both criticised the quality of the information provided to participants.
Concerned by these findings, the University of Leeds commissioned research, which was undertaken by Luto, to find out if participants could find and understand the information in patient information sheets and consent forms.
Poor quality patient information impacts at all levels. Insurers say most claims by participants cite a misunderstanding of the PIS and consent form. Quite apart from the morality of producing information that patients can actually understand, better informed patients can make better decisions and those that do consent are likely to demonstrate improved adherence.
