Patient Perspectives On eConsent

The evolution of the informed consent process in clinical research has transformed from a mere signature on a document to an integral educational and acknowledgment tool. Before participating in clinical trials, potential participants engage in a comprehensive informed consent process, culminating in the decision to sign the Informed Consent Form (ICF). This pivotal document serves as the fulcrum, documenting participants' understanding and acknowledgment of the information shared during the consent process.

Over time, the consent form transitioned from a concluding step to the essence of the entire process. In September 2013, the FDA's guidance on eSource marked a significant shift. Initially, eConsents were digital replicas of paper documents, introducing a learning curve for participants and research sites. However, advancements in technology led to more user-friendly interfaces, revolutionizing the eConsent process.

With digital tools, the eConsent process addressed the challenges of information dissemination, explanation, and recall. Participants were no longer confined to static paper or digital scans but could interact meaningfully with their consent documentation. This transformation not only streamlined the consent process but also enhanced accessibility, marking a paradigm shift in the integration of technology to meet the evolving needs of clinical research participants.

While the process does have its own set of unique challenges, discover how future iterations of eConsent will provide value to stakeholders and ease burdens for all involved in clinical research by accessing the white paper below.