Posted 8th November 2022
In recent years, Electronic Informed Consent or eConsent, has been increasingly adopted for improved interaction between researcher and participant in the medical industry, specifically within clinical trials.
During the pandemic, we facilitated the creation of eConsent platforms throughout the healthcare industry, to bridge the gap between research staff working from home and patients requiring access to questionnaire forms for COVID-19. Our eConsent platforms were also expanded to incorporate clinical research trials for the various COVID-19 vaccines that are now readily available. These platforms are still very much in use and assisting researchers with new vaccines and treatments worldwide.
In this blog we take a look at the application and benefits of eConsent.
The medical industry describes eConsent as a digital consent process that potential study participants undergo prior to enrolment as well as throughout the study to confirm their comprehension.
Participants can drop out of a clinical trial for various reasons from personal events or concerns about transportation, to worries about side effects. However, research from The Center for Information and Study on Clinical Research Participation (CISCRP) suggests that failure to understand informed consent documents has a direct connection to a failure to see a trial through.
After talking with our current customers about their paper consent processes, we established that eConsent saved over one hour of paperwork time per consent. Before eConsent, our healthcare providers described the clinical trial process as a lengthy one that involved scanning paper eConsent forms into medical records, then filing the paper forms in huge cabinets.
With eConsent, the process is simple. Electronic forms are sent out and then stored instantly and securely once completed, within an eConsent program or online study binder.
eConsent also makes it easier to update consent forms. The central site can change a form and immediately have those changes show up within the eConsent platform across their entire site network. This allows staff to spend more time interacting with participants and less time printing or copying new versions of forms.
Information compiled in an e-Consent format is tracked automatically. Participants receive immediate updates, and auditors have access to that data at any point, not just on-site. e-Consent forms reduce participant errors, such as inputting the wrong date.
According to a Quorum report, from 2011 to 2016, the FDA reported 214 inspectional observations related to the mandate to obtain informed consent, the failure to adequately document informed consent and the failure to maintain documents evidencing informed consent. Approximately 95 percent of those observations would be eliminated with an e-Consent format versus a paper format. These benefits would allow trials to meet and even exceed regulatory standards.
4 . The system needs to comply with institutional review boards, quality assurance guidelines and regulatory standards. Such a system should prioritise risk reduction for regulatory audits and, therefore, incorporate tools including real-time enrolment statistics and traceable electronic signatures.
The healthcare market has shifted to ensure products have a patient-centric approach, and that directive now includes clinical trials. Investing in e-Consent is fast becoming a necessity for most providers. Compared to traditional methods, adopting a unified platform that enables e-Consent will always streamline studies, while saving time and significantly reducing costs.
If you are considering adopting an eConsent platform, please contact us to discuss your requirements.
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