Future of Clinical Research

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?

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