eConsent

Electronic consent (eConsent) provides many advantages over traditional paper-based consent methods however despite MHRA/HRA guidance on the legal and ethical requirements for seeking and documenting eConsent, there is no recognised system within the UK academic clinical trials network for the implementation of eConsent.

The REDCap (Research Electronic Data Capture) system provides a clear framework for eConsent however experience in implementing eConsent in REDCap is limited in the UK.

Norwich CTU received funding in 2021 from the National Institute for Health Research (NIHR) CTU Support Funding scheme to provide training and develop a guidance document to assist the adoption of eConsent via REDCap (NIHR135418).

The training, publicised via the UKCRC mailing list and during the dissemination webinar for the joint UKCRC, TMRP and UKTMN eConsent research project, took place between 14th and 28th February 2022 and included two webinars and one online workshop. These were well attended with 364 registrations, converting to approximately 230 attendees across the three weeks. Feedback on the sessions was highly positive with 98% of respondents reporting that they were satisfied / very satisfied with the training.

The guidance document, completed in May 2022, includes the following topics:

• General information on eConsent

• General information on REDCap

• Gathering Requirements for an eConsent System

• Implementing the Different parts of an eConsent System

• Useful Tools in REDCap for eConsent

• Keeping Information Secure

• Example eConsent System Structures in REDCap

• Other Common Issues and where to get help