The importance of informational items in a PIL for RCTs
Research type
Research Study
IRAS ID
181413
Contact name
Seonaidh Cotton
Contact email
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
This project aims to identify and assess which pieces of information different trial stakeholder groups rank as the most important, and the reasons for this when considering taking part in a hypothetical phase III randomised controlled trial.
Trial stakeholders in this study refer to Adults age 18 and over with decisional capacity or research nurses who may be involved in seeking informed consent from participants in clinical trials.
Participants will be invited to attend a one-to-one face to face interview. During the interview participants will be asked to rank a set of statements (information items that are included in patient information leaflets) in terms of the importance of these items from their perspective, and place these onto a response grid (from most to least importance),this is called card-sorting . Whilst participants are placing the statements on the grid they will also be encouraged to provide an explanation of why each statement have been placed in certain areas of the grid.
Interviews will last for no more than 1 hour and full consent will be sought.
REC name
London - Bromley Research Ethics Committee
REC reference
15/LO/1221
Date of REC Opinion
3 Jul 2015
REC opinion
Favourable Opinion