Journal Article

Approaches and experiences implementing remote, electronic consent at the Leeds Clinical Trials Research Unit

Swoboda, Peter P, Taylor, Chris, Wheeler, Ian, Dennett, Joanna, Bishop, Liam, Hartley, Suzanne, Graca, Sandra, Greenwood, John P, McKigney, Niamh, Moreau, Lauren, Collier, Howard, Gilberts, Rachael, Barrett, Adam, Farrin, Amanda J, Cragg, William J

2024

Overview

Background Use of electronic methods to support informed consent (‘eConsent’) is increasingly popular in clinical research. This commentary reports the approach taken to implement electronic consent methods and subsequent experiences from a range of studies at the Leeds Clinical Trials Research Unit (CTRU), a large clinical trials unit in the UK. Main text We implemented a remote eConsent process using the REDCap platform. The process can be used in trials of investigational medicinal products and other intervention types or research designs. Our standard eConsent system focuses on documenting informed consent, with other aspects of consent (e.g. providing information to potential participants and a recruiter discussing the study with each potential participant) occurring outside the system, though trial teams can use electronic methods for these activities where they have ethical approval. Our overall process includes a verbal consent step prior to confidential information being entered onto REDCap and an identity verification step in line with regulator guidance. We considered the regulatory requirements around the system’s generation of source documents, how to ensure data protection standards were upheld and how to monitor informed consent within the system. We present four eConsent case studies from the CTRU: two randomised clinical trials and two other health research studies. These illustrate the ways eConsent can be implemented, and lessons learned, including about differences in uptake. Conclusions We successfully implemented a remote eConsent process at the CTRU across multiple studies. Our case studies highlight benefits of study participants being able to give consent without having to be present at the study site. This may better align with patient preferences and trial site needs and therefore improve recruitment and resilience against external shocks (such as pandemics). Variation in uptake of eConsent may be influenced more by site-level factors than patient preferences, which may not align well with the aspiration towards patient-centred research. Our current process has some limitations, including the provision of all consent-related text in more than one language, and scalability of implementing more than one consent form version at a time. We consider how enhancements in CTRU processes, or external developments, might affect our approach.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Aerospace industry / Backup software / Biomedicine / Case studies / Clinical trials / Clinical Trials as Topic - ethics / Clinical Trials as Topic - methods / Commentary / Confidentiality / Consent Forms / COVID-19 / Design / eConsent / Electronic consent / England / Health Sciences / Humans / Informed Consent / Informed consent (Medical law) / Medical research / Medicine / Medicine & Public Health / Medicine, Experimental / Methods / Pandemics / Patients / Product development / Randomized Controlled Trials as Topic - ethics / Randomized Controlled Trials as Topic - methods / Regulatory compliance / Remote consent / Research Design / Research Subjects - psychology / Statistics for Life Sciences / Technology application / The use of electronic consent (e-Consent) in randomised trials