The TransCelerate eConsent Initiative aims to create general awareness and enable broad, voluntary implementation of eConsent. The eConsent Initiative has developed practical guidance and tools describing potential implementation considerations and eConsent components.
Use of eConsent may help improve patients’ understanding of study objectives and design, increase regulatory compliance, and reduce quality risks. Data from eConsent pilots suggest that patients prefer multimedia content and on-demand access to consent tools via the web or mobile device over the traditional paper process. Successful adoption of eConsent may empower patients and the families that care for them to proceed through a clinical study better informed.
The eConsent Initiative has collaborated with patients and sites, health authorities (HAs) and institutional review boards (IRBs)/independent ethics committees (IECs), and clinical research organizations (CROs) to develop The eConsent Implementation Guidance and tools.
Below interactively explore components of our eConsent Implementation Guidance, supporting tools and resources.