An evaluation of the process of informed consent: views from research participants and staff

Rachel K. Crowley,Prasanth Sukumar,Lydia O’ Sullivan,Peter Doran,Laura Feeney,Eilish McAuliffe

doi:10.1186/s13063-021-05493-1

Abstract

BackgroundThe process of informed consent for enrolment to a clinical research study can be complex for both participants and research staff. Challenges include respecting the potential participant’s autonomy and information needs while simultaneously providing adequate information to enable an informed decision. Qualitative research with small sample sizes has added to our understanding of these challenges. However, there is value in garnering the perspectives of research participants and staff across larger samples to explore the impact of contextual factors (time spent, the timing of the discussion and the setting), on the informed consent process.MethodsResearch staff and research participants from Ireland and the UK were invited to complete an anonymous survey by post or online (research participants) and online (research staff). The surveys aimed to quantify the perceptions of research participants and staff regarding some contextual factors about the process of informed consent. The survey, which contained 14 and 16 multiple choice questions for research participants and staff respectively, was analysed using descriptive statistics. Both surveys included one optional, open-ended question, which were analysed thematically.ResultsResearch participants (169) and research staff (115) completed the survey. Research participants were predominantly positive about the informed consent process but highlighted the importance of having sufficient time and the value of providing follow-up once the study concludes, e.g. providing results to participants. Most staff (74.4%) staff reported that they felt very confident or confident facilitating informed consent discussions, but 63% felt information leaflets were too long and/or complicated, 56% were concerned about whether participants had understood complex information and 40% felt that time constraints were a barrier. A dominant theme from the open-ended responses to the staff survey was the importance of adequate time and resources.ConclusionsResearch participants in this study were overwhelmingly positive about their experience of the informed consent process. However, research staff expressed concern about how much participants have understood and studies of patient comprehension of research study information would seem to confirm these fears. This study highlights the importance of allocating adequate time to informed consent discussions, and research staff could consider using Teach Back techniques.Trial RegistrationNot applicable

Highlights

The process of informed consent for enrolment to a clinical research study can be complex for both participants and research staff
While researchers agree that maintaining participant autonomy and supporting their decision-making is important, much debate remains on how the informed consent process can be measured and optimised [6]
Few or no studies have sought to quantify how clinical research participants and staff experience the process of consent and the importance of contextual factors such as the time spent, the setting of the informed consent discussion and the timing at which the participant is approached. Given this gap in our understanding, the aim of this study is to describe how participants and research staff experience the informed consent process and the contextual factors that contribute to their satisfaction with the process

Summary

Introduction

The process of informed consent for enrolment to a clinical research study can be complex for both participants and research staff. While the Participant Information Leaflet (PIL) provides a record of the information disclosed and the informed consent form (ICF) records the participants’ written decision to take part, it is recognised that informed consent is a process [4, 5], rather than a single event enabled solely by paper or electronic documents. This process involves the researcher approaching the prospective participant, providing some initial information about the research study, and as this information is processed, responding to questions and adjusting the level of information to fit the needs of the individual. While researchers agree that maintaining participant autonomy and supporting their decision-making is important, much debate remains on how the informed consent process can be measured and optimised [6]

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