How eConsent Is Changing The Informed Consent Process For Clinical Trial Sponsors And Participants

Informed consent — providing a potential participant with enough information about a study to allow for an informed decision about their participation — is a critical step for enrolling patients in clinical trials. The process is a vital one revolving around participant education and communication, and one that is highly controlled through local, country-specific, and global regulations.

While informed consent form (ICF) signatures traditionally have been collected on paper at a physical site, today’s digital approach — electronic consent (eConsent) — offers more than high-tech signature collection. It provides an upgrade to patient education and communication as well, empowering participants in new ways. Moreover, eConsent can democratize clinical trial access, allowing researchers to recruit broader and more diverse participant groups through entirely remote consenting processes. This broader and less burdensome access also can increase the speed of recruitment and reduce drop-out rates.

In addition, when the eConsent solution is part of a larger platform for decentralized clinical trials (DCTs), it can facilitate automated workflows to further reduce both trial site and patient burden. Plus, as part of an interactive multimedia experience, eConsent offers the opportunity to present information in new and interesting ways to aid in reaching participants with various learning styles.

While the eConsent experience offers a number of opportunities for enhanced communication, it’s important to recognize that it is not a replacement for discussions between clinical trial site staff and trial participants. This discussion, facilitated by the consent documents, will always remain the bedrock of the informed consent process.