E-Consent – an innovative solution to maintain recruitment momentum in clinical trials during the COVID-19 pandemic

ABSTRACT

Introduction & Objectives: The NeuroSAFE PROOF trial is an ongoing randomized clinical trial evaluating the role of frozen section analysis during robot assisted radical prostatectomy for localized prostate cancer. In response to the COVID-19 crisis, recruitment was halted, and a remote e-Consent solution was designed. The aim of this is to describe the implementation, impact on recruitment rate and patient’s experience using e-Consent. Materials & Methods: To replace in person consent. An email-based PDF Auto-Archiver feature was created within the Research Electronic Data Capture (REDCap®) environment, following the structure and content of the already approved paper consent. Each question was included as a binary (yes/no) field. An electronic signature field allows the participant to sign the document using a mouse, stylus, or their finger. The signature is captured and appended as a PNG image with a timestamp. This allows research staff to review and electronically co-sign and lock the document. This new tool was approved by the Health Research Authority, Research Ethics Committee, Trial Management Group and Sponsor. Owing to the process collecting patient identifiable data, the platform resides within the REDCap service being hosted behind a Data Safe Haven, which conforms to National Health Service Data Security & Protection Toolkit, General Data Protection Regulation and ISO 27001 Information Security standards. Results: Before recruitment suspension, the trial was recruiting an average of 9 patients per month, with an increasing trend. (Figure 1) After e- Consent implementation in June 2020, 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. The use of this pathway eliminates the need to travel and, therefore, the resultant cost and potential risk of infection, while allowing patients to read and understand information in their own time before providing consent. (Figure Presented) Conclusions: Guidelines for e-Consent implementation are currently lacking. We present the first description of its use for prostate cancer research. This innovation was critical to resume recruitment for the NeuroSAFE PROOF trial and will be essential for planning future research.