Twenty years ago, this scenario was unimaginable. Consent happened in person, at the study site, on paper. Today, technology has fundamentally changed what is possible. But possibility does not automatically translate to compliance. The ethical and regulatory requirements for informed consent remain unchanged; what has evolved is the recognition that these requirements can be met through multiple technological approaches.

ICH E6(R3) takes a deliberately technology-neutral stance. Where earlier guidance might have specified paper documents and wet-ink signatures, the current guideline acknowledges that valid consent can be obtained through various media, provided the essential requirements are met. This lesson examines what those requirements are and how to implement technology-enabled consent that satisfies both the letter and spirit of GCP.

Twenty years ago, this scenario was unimaginable. Consent happened in person, at the study site, on paper. Today, technology has fundamentally changed what is possible. But possibility does not automatically translate to compliance. The ethical and regulatory requirements for informed consent remain unchanged; what has evolved is the recognition that these requirements can be met through multiple technological approaches.

ICH E6(R3) takes a deliberately technology-neutral stance. Where earlier guidance might have specified paper documents and wet-ink signatures, the current guideline acknowledges that valid consent can be obtained through various media, provided the essential requirements are met. This lesson examines what those requirements are and how to implement technology-enabled consent that satisfies both the letter and spirit of GCP.