There are three main aspects to informed consent: firstly, to engage in a comprehensive discussion with the patient about the characteristics, goals, and procedures of the study with an emphasis on voluntary participation and option to withdraw from the study at any time; secondly, to allow the patient to use this information to make an informed decision; and finally, to ensure the patients’ decision is accurately documented [13]. These objectives are all addressed via the remote web-based methods that we have detailed in this paper. At the time of writing, this was the first study to describe the use of remote e-Consent in prostate cancer research. Our data demonstrate a significant uptake in patient recruitment after remote e-Consent implementation, which has allowed the continuation of our trial while complying with the government guidelines and simultaneously minimizing infection risk for patients and researchers.

Early in the pandemic, a survey revealed that only 14% of oncology-focused European research institutions continued to enrol, with the focus being critical interventions for cancer patients [14]. Institutions were forced to implement criteria to decide which trials could continue, for example, Marcum et. al. reported that 29 of 130 active trials were cancelled at their centre [15]. A similar fate was expected to befall our trial. However, this was prevented by modification of the protocol via the described changes. Importantly, NeuroSAFE PROOF was the first trial focused on oncological surgery to reopen recruitment after a 3-month halt during the first UK lockdown. Full trial protocol will be published according to the CONSERVE recommendations [16].

Furthermore, cancer research budgets within the UK have been drastically cut over the last 2 years, as charities have struggled to fundraise, and government budgets have been diverted [17]. Strategies such as E-consent can decrease the costs associated with clinical trials and may be key when determining funding allocation in the upcoming years. This was the case for our study when trial personnel were redeployed to frontline clinical services. However, due to the straightforward nature of the platform and lack of need for paperwork, one person can consent multiple patients and simultaneously monitor their responses in real-time. The trial was therefore able to continue with minimal staffing. Furthermore, no further costs to the project budget were incurred by the implementation of the platform as it used resources already available to the sponsor (UCL).

Our trial has been transformed from in-person to almost entirely remote conduct. Patients are now only required to travel to the hospital for surgery and postoperative catheter removal. E-consent, remote collection of PROMs, and virtual consultations have allowed for this shift to occur without the quality of clinical care or research standards being compromised. The uptake of technological platforms is particularly challenging in the older cohort of patients [18]. However, our transition to online consent was relatively seamless, indicating that REDCap is a user-friendly platform and therefore a strong alternative to paper consent forms, particularly for those shielding during the pandemic.

Before the COVID-19 crisis, most e-Consent platforms relied on the use of an in-clinic electronic device [11]. Haussen et. al described the process of setting up an e-Consent platform using smartphones to communicate with legal representatives to authorize treatment for patients suffering from acute stroke [19]. This process was favoured amongst the representatives and even shortened trial enrollment time in comparison to paper consent methods. The smartphones provided adequate Internet connection and trial personnel were readily available to resolve any troubleshooting issues [20]. However, face-to-face interaction poses an increased risk of COVID-19 transmission [21] and requires setting aside time for device disinfection in between patients [22]. Not only does our platform eliminate the risk of COVID-19 transmission but also allow patients to digest provided information in their own time. Patients are then able to utilize telehealth platforms to communicate any questions or concerns surrounding the consent form, directly with the research team. In addition, such platforms will potentially broaden the patient demographic of research trials such as NeuroSAFE [23]. Patients who may not have the means to travel back and forth to the clinic, who are unable to drive due to disability, or who have caregiver responsibilities will all be able to utilize this platform to provide informed consent without leaving the confines of their homes. REDCap-based e-Consent utilizes these advantageous factors in confluence to overcome a multitude of challenges encountered with paper consent and, as a result, may lead to a definitive switch from paper-based to online consent forms in the UK, irrespective of the COVID-19 pandemic (Table 1).

Table 1 Advantages and disadvantages of e-Consent

Other e-Consent platforms have demonstrated a vast array of additional advantages that can be utilized to optimize clinical trial recruitment rates. An example is the Research Permissions Management System (RPMS), developed in South Carolina [24]. This tool not only simplified the patient recruitment process but also matched patient to trials most tailored to them. Part of the RPMS consent was a section that allowed patients to opt-in to being contacted for future research. The ability to swiftly track patients who are willing to participate in clinical trials, without having to search through paper records, will inevitably facilitate the recruitment process for future studies.

A study by Naeim et al. has also shown video-based remote e-Consent to be useful in the obtainment of consent for biospecimen collection [25]. Patients are often uneasy about the relinquishment of bodily fluids and tissue samples for research. The reasons for this may include a lack of understanding of the research process or a lack of knowledge regarding where samples will be stored. Given the importance of biospecimen studies in answering current and future translational research questions, we utilized this knowledge to incorporate an optional separate section for biospecimen collection consent within our platform, to which patients generally agreed. Lastly, physicians and researchers have also used e-Consent to gain permission to access electronic health records for both clinical care and data-sharing between institutions [26]. This will enhance collaborative research and has the advantage of being a dynamic process, in which patients can easily opt-out or request re-consent.

There are several limitations to our study. Patients may have mixed preferences towards e-Consent [27]. Elderly patients are less familiar with the use of electronic devices and tend to be more sceptical about the trustworthiness of electronic records [28]. Since the average age of our cohort is younger than in other prostate cancer studies, owing to our inclusion criteria, we acknowledge that this could be one of the reasons for our success in using this platform. In addition, our cohort was exclusively male. There is no current research to indicate whether there is a difference in gender preferences towards online consent methods. The best approach for future studies would be to integrate both remote and in-person consent of female and male patients, maximizing opportunities to observe differences in outcomes amongst patients with different backgrounds.

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