Lessons learnt from the implementation of electronic consent (eConsent) and its use across a large portfolio of trials in a UK academic clinical trials unit

TL;DR

This paper discusses the use of electronic consent in clinical trials, showing how it has been successfully implemented in over 35 studies involving nearly 12,000 participants.

Contribution

The paper provides insights into the practical implementation and benefits of eConsent across a large portfolio of clinical trials in a UK academic unit.

Findings

eConsent was used in 35 studies with nearly 12,000 participants over six years.

Most studies used eConsent for documentation and some used multimedia for participant information.

Remote eConsent reduced paper use and carbon footprint in most studies.

Abstract

The use of electronic consent (eConsent) in clinical research studies is on the increase and has been since 2019. eConsent itself can be multi-faceted, encompassing documentation of the consent process, delivering information to the potential participant via the use of different media, and even facilitating a check of the participants’ understanding of the research before they enter a study. Some researchers and research teams have embraced the use of the different aspects of eConsent, whilst other groups/teams are hesitant to employ the methodology until it has been proven and fits better with workflows and patient pathways.

We report on how eConsent has been utilised in 35 studies from a large academic clinical trials unit in the UK, with nearly 12,000 participants being consented using this methodology via the REDCap data collection system over a 6-year period. The studies utilising eConsent have all made use of the documentation facet of eConsent, with some studies also making use of different media to provide information to the potential participant. The use of these methods has been adopted by the majority of our open studies and all but one of the research delivery teams across the whole CTU portfolio. To facilitate some of the processes that need to be implemented, two external modules have been written for REDCap to make the process easier. Many of our studies also make use of the facility to enable remote eConsent (i.e. where the potential participant and researcher are not physically in the same place), and very few studies in our portfolio now require paper consent forms as either an alternative option or as a backup in case the electronic systems are not available. This has resulted in a reduction in the amount of paper that needs to be provided, resulting in a decrease in the carbon footprint of the studies.

We have successfully utilised eConsent techniques to receive informed consent from nearly 12,000 participants in a multitude of clinical trials recruiting individuals from age 8 to 80. Half of these trials also used eConsent to facilitate both the documentation and the discussion around the consent process. Where remote eConsent has been used, techniques have been employed to make the process easier on the participant and the researcher, whilst not detracting from the two-way conversation that is important for the consent process.

The online version contains supplementary material available at 10.1186/s13063-026-09445-5.

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