e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidence

Mitchell, E. J.; Appelbe, D.; Bravery, A.; Culliford, L.; Evans, H.; Farrin, A. J.; Gillies, K.; Hood, K.; Love, S. B.; Sydes, M. R.; Williamson, P. R.; Wakefield, N.

Abstract

Background: During the COVID-19 pandemic, in-person healthcare visits were reduced. Consequently, trial teams needed to consider implementing remote methods for conducting clinical trials, including e-Consent. Although some clinical trials may have implemented e-Consent prior to the pandemic, anecdotes of uptake for this method increased within academic-led trials. When the increased use of this process emerged, representatives from several large academic clinical trial groups within the UK collaborated to discuss ways in which trialists can learn from one another when implementing e-Consent. Methods: A survey of UKCRC-registered Clinical Trials Units (CTUs) was undertaken in April–June 2021 to understand the implementation of and their views on the use of e-Consent and experiences from the perspectives of systems programmers and quality assurance staff on the use of e-Consent. CTUs not using e-Consent were asked to provide any reasons/barriers (including no suitable trials) and any plans for implementing it in the future. Two events for trialists and patient and public involvement (PPI) representatives were then held to disseminate findings, foster discussion, share experiences and aid in the identification of areas that the academic CTU community felt required more research. Results: Thirty-four (64%) of 53 CTUs responded to the survey, with good geographical representation across the UK. Twenty-one (62%) of the responding CTUs had implemented e-Consent in at least one of their trials, across different types of trials, including CTIMPs (Clinical Trial of Investigational Medicinal Product), ATIMPs (Advanced Therapy Medicinal Products) and non-CTIMPs. One hundred ninety-seven participants attended the two workshops for wide-ranging discussions. Conclusion: e-Consent is increasingly used in academic-led trials, yet uncertainties remain amongst trialists, patients and members of the public. Uncertainties include a lack of formal, practical guidance and a lack of evidence to demonstrate optimal or appropriate methods to use. We strongly encourage trialists to continue to share their own experiences of the implementation of e-Consent.

Citation

Mitchell, E. J., Appelbe, D., Bravery, A., Culliford, L., Evans, H., Farrin, A. J., Gillies, K., Hood, K., Love, S. B., Sydes, M. R., Williamson, P. R., & Wakefield, N. (2023). e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidence. Trials, 24(1), Article 657. https://doi.org/10.1186/s13063-023-07656-8

• Journal Article Type: Article
• Acceptance Date: Sep 15, 2023
• Online Publication Date: Oct 10, 2023
• Publication Date: 2023
• Deposit Date: Jul 11, 2024
• Publicly Available Date: Jul 12, 2024
• Journal: Trials
• Electronic ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 24
• Issue: 1
• Article Number: 657
• DOI: https://doi.org/10.1186/s13063-023-07656-8
• Keywords: e-Consent, Consent, Clinical trial
• Public URL: https://nottingham-repository.worktribe.com/output/25954056
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07656-8