Use of Electronic Consent and Navigating the Ethical and Governance Issues: Experience from the NightLife study

Background: UK Government COVID-19 restrictions have necessitated rethinking the conduct of healthcare research. Obtaining informed, written consent remains a necessity that requires adaptation to accommodate the virtual environment. Here we report the experience of implementing electronic consent as part of the NightLife study. NightLife is a randomised controlled trial assessing the effectiveness of thrice weekly, extended, in-centre nocturnal haemodialysis. Continuation of the qualitative workstream during the COVID-19 pandemic resulted in the implementation of electronic consent where face-to-face consent was unfeasible. Methods: As electronic consent was not part of the original study design, the proposal to use DocuSign to obtain electronic consent was discussed with the Trial Management Group (TMG), patient representatives and study Sponsor;a substantial protocol amendment was submitted. The study team liaised with the University's Information Governance (IG) and IT Risk and Continuity departments to mitigate potential data protection issues. A data protection impact assessment was completed to outline the data handling, management and storage arrangements. The functionality and practicality of the DocuSign portal was trialled and the Database Development team confirmed it integrated well with the clinical study database. Results: The substantial protocol amendment was reviewed by the Research Ethics Committee, Health Research Authority and Confidentiality Advisory Group and received regulatory approvals less than three weeks after submission. As part of capacity and capability assessments at participating centres, approval was sought from local Privacy and Data Protection Officers with no issues identified. Conclusions: Implementation of DocuSign as an electronic consent platform highlighted the importance of early and effective dialogue with the TMG, patient representatives, Sponsor, IG and Data Protection departments. While advantageous in the COVID-19 climate, face-to-face consent is still favoured and will recommence once restrictions are lifted. Integrating electronic consent is feasible from an ethical and governance perspective and represents an alternative for other studies that now require virtual engagement.