E-Consent—a guide to maintain recruitment in clinical trials during the COVID-19 pandemic

Abstract

Background The COVID-19 pandemic has posed daunting challenges when conducting clinical research. Adopting new technologies such as remote electronic consent (e-Consent) can help overcome them. However, guidelines for e-Consent implementation in ongoing clinical trials are currently lacking. The NeuroSAFE PROOF trial is a randomized clinical trial evaluating the role of frozen section analysis during RARP for prostate cancer. In response to the COVID-19 crisis, recruitment was halted, and a remote e-Consent solution was designed. The aim of this paper is to describe the process of implementation, impact on recruitment rate, and patients’ experience using e-Consent. Methods A substantial amendment of the protocol granted the creation of a remote e-Consent framework based on the REDCap environment, following the structure and content of the already approved paper consent form. Although e-Consent obviated the need for in-person meeting, there was nonetheless counselling sessions performed interactively online. This new pathway offered continuous support to patients through remote consultations. The whole process was judged to be compliant with regulatory requirements before implementation. Results Before the first recruitment suspension, NeuroSAFE PROOF was recruiting an average of 9 patients per month. After e-Consent implementation, 63 new patients (4/month) have been enrolled despite a second lockdown, none of whom would have been recruited using the old methods given restrictions on face-to-face consultations. Patients have given positive feedback on the use of the platform. Limited troubleshooting has been required after implementation. Conclusion Remote e-Consent-based recruitment was critical for the continuation of the NeuroSAFE PROOF trial during the COVID-19 pandemic. The described pathway complies with ethical and regulatory guidelines for informed consent, while minimizing face-to-face interactions that increase the risk of COVID-19 transmission. This guide will help researchers integrate e-Consent to ongoing or planned clinical trials while uncertainty about the course of the pandemic continues. Trial registration NeuroSAFE PROOF trial NCT03317990. Registered on 23 October 2017. Regional Ethics Committee reference 17/LO/1978.

Informing a European guidance framework on electronic informed consent in clinical research: a qualitative study

“…eIC applications are often highly configurable. For example, they can be used in a fully remote setting or a combination of eIC elements and obtaining the participants’ wet-ink signature can be employed [ 24 – 27 ]. To avoid misconceptions of what eIC could exactly entail, it is advisable to address these specific types of eIC in a European guidance framework.…”

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

“…This is particularly important in rare diseases, where numbers of eligible patients are limited. We have no direct feedback from participants about eConsent, though evidence available elsewhere suggests it may be acceptable, at least in principle, including in the speci c context of the REDCap eConsent module [4,10,[16][17][18].…”

An evaluation of the implementation, adoption, and uptake of a model of remote e-consent within the PRE-DX study

“…Many potential bene ts to the use of e-consent have been suggested (5,11), including increasing the diversity and reach of the research (12) and reducing the environmental impact from the study (5). The National Institute for Health Research have previously set-out guidelines on carbon reduction in health research (13); if more trials were to successfully transition to remote and paperless methods of consent this could contribute to reducing the environmental impact of clinical trials.…”