Guides
eConsent regulations: What changed under FDA, ICH E6(R3), Part 11 and global regulations
Electronic informed consent, or eConsent, is no longer a novel approach to clinical research. Regulators around the world increasingly recognize electronic, remote and technology-enabled approaches to informed consent as part of modern clinical trial conduct.
But the regulatory environment has changed significantly.
The most important development is not a single new eConsent regulation. Instead, updates to Good Clinical Practice, electronic systems guidance and national clinical trial frameworks are changing how sponsors can design, document and manage informed consent.
ICH E6(R3) is central to that change. FDA issued E6(R3) as final guidance in September 2025, describing the revision as a modernization of GCP that embraces innovation in trial design, conduct and technology while emphasizing quality by design, participant protection and risk-based approaches. FDA subsequently withdrew its E6(R2) guidance in April 2026.
At the same time, regulatory developments in the United States, European Union, United Kingdom and Canada are providing clearer frameworks for electronic records, remote interactions and alternative ways of documenting consent.
For sponsors, CROs and clinical trial sites, the question is therefore changing. It is no longer simply, "Can informed consent be electronic?"
Increasingly, the question is: How can electronic informed consent be implemented in a way that protects participants, supports understanding, verifies identity where required, preserves reliable records and meets the requirements of every jurisdiction involved in a trial?
Back to Basics: What is a decentralized clinical trial?
In a decentralized clinical trial, part or all of the protocol occurs away from the primary study site. Instead of patients traveling, often repeatedly, to a central site for enrollment, consent, data collection or symptom monitoring, they can participate in telehealth visits from their homes, often using familiar technologies, like smartphones, tablets and wearables to transmit pertinent information. Even medications and devices can increasingly be delivered directly to a patient’s home, and a home visit from a health care professional can be arranged if necessary.
Back to basics: How digital and decentralized clinical trials enable trial diversity
The advancement of decentralized clinical trials (DCTs) allows patients to participate without having to travel to a trial site, removing many barriers that may have hindered people of diverse backgrounds from participating.
Back to basics: How hybrid and decentralized technologies impact each phase of the clinical research journey
Clinical trials require volunteers to assess medical products like devices, vaccines, or medications for efficacy and safety. For health equity to be achieved, it’s imperative that clinical trials include people from diverse backgrounds so as to represent the global population of patients using the products.
Back to Basics: Remote patient monitoring
Remote patient monitoring programs and technologies are becoming increasingly popular, backed by growing clinical evidence showing numerous benefits to patients and providers. While remote patient monitoring (RPM) isn’t new, it’s evolving quickly due to the regulatory push to expand access to care during the COVID-19 pandemic. Coupled with the fact that the digital health market is poised to more than double by 2026, providers and patients have a greater ability to track vitals between visits, and both centralized and decentralized clinical trials rely on remote data collection now more than ever. While there is tremendous potential upside, some barriers and risks are inherent in this digital process. Human-centered design and strategic implementation can ensure that RPM in clinical trials is both beneficial and cost effective.