Informed consent (IC) is an accepted ethical and legal prerequisite for research participation yet there is no standard method of assessing patient understanding for informed consent. In the context of informed consent for clinical trial participation, the quality of informed consent is determined by what information is provided and how it is presented (disclosure); and by the quality of patient understanding that arises (understanding) [Sreenivasan et al. 2013 Lad et al. 2014, Richardson et al 2013]. Much attention is paid to monitoring written disclosure, with scrutiny of patient information leaflets (PILs) by ethics committees and review boards. Less attention is paid to monitoring spoken information or patient understanding as evidenced during recruitment and informed consent discussions, the content of which is largely at the discretion of individual recruiters and not routinely monitored [Cohn et al. 2011]. The Participatory and Informed Consent (PIC) (Wade et al. 2017) measure was developed for application to recruitment discussions, to evaluate recruiter information provision and evidence of patient understanding. The goal is to encourage recruiters to use a tailored approach, which will make information inclusive for currently excluded groups. How effective it is in evaluating understanding for informed consent has yet to be tested.
Aims and objectives
- What current tools or methods exist for evaluating and measuring participant understanding for informed consent to take part in research and what is evidence of effectiveness in measuring participant understanding is there for these measures?
- How effectively does the Participatory Informed Consent (PIC) tool (Wade et al, 2017) evaluate and measure understanding for informed consent to take part in trials research as compared with existing tools or methods and as evidenced in patient interviews?
- Given findings from one and two above how can the PIC tool or best comparator be optimised for measuring participant understanding for informed consent as evidenced during recruitment discussions?
This will be a mixed methods PhD and include a systematic review.
A systematic review of the literature will identify what tools / methods exist for evaluating understanding for informed consent in research. These will include quantitative or qualitative approaches and will apply to the recruitment discussion or measure self-reported participant recall of information following this discussion. Described tools will be evaluated for the quality of their validity and reliability data.
The PIC measure and one or more alternative measures of participant understanding for informed consent (identified in the SR above) will be applied to up 90 audio recorded recruitment discussions sampled from at least 3 different trials, with validity and reliability scores calculated and compared. Recruitment consultation data will also undergo analysis using content, thematic and some elements of conversation analysis to provide a qualitative comparison for comparison with the quantitative evaluation. Interviews with patients taking part in these discussions will explore what patients have understood from conversations. Interview data will be analysed using content and thematic analysis to compare evidence and scope of understanding against the respective PIC/other measure score in each case.
Findings will be used to modify the PIC/other tool and identify implications for application in practice to promote understanding for informed consent in all potential participants.
How to apply for this project
This project will be based in Bristol Medical School - Population Health Sciences in the Faculty of Health Sciences at the University of Bristol.
Please visit the Faculty of Health Sciences website for details of how to apply