What do potential participants want to know about low risk interventional research? A feasibility study of electronic information provision and a randomised controlled trial of an Interactive Information Sheet (IIS)

[摘要] This PhD considered provision of information to potential research participants. It gathered data on the types and detail of information potential participants accessed, and determined the feasibility of electronic information provision. A systematic review found limited empirical evidence to suggest what information potential participants want when making a participation decision. An Information Provision study was designed and embedded in an existing piece of low risk interventional research. This had three components; a feasibility study of electronic communication; a RCT of an Interactive Information Sheet (IIS); an observational study that recorded information accessed by potential participants. Results suggest electronic communication did not affect consent rate (although study was not powered to detect this) and understanding and satisfaction were unaffected by level or mode of information provision. Traditional participation information sheets (PIS) may only satisfy 11.4% participants, undersupply 9.1% and oversupply 79.5%. Participants were often unable to accurately recall what information they had accessed. In conclusion, the majority of potential participants to this study would have been satisfied with a streamlined PIS. An IIS could provide additional tailored information to those who require it, with standardised verbal information provision at consent interviews ensuring consent is given in accordance with GCP guidelines.

[发布机构] University:University of Birmingham;Department:School of Health and Population Sciences

[关键词] R Medicine;RA Public aspects of medicine