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Module 1: Lesson 1
Decentralized and Technology-Enabled Consent
Implement electronic and remote consent processes that maintain ethical rigor while leveraging technology to enhance participant understanding and accessibility.
Consent can happen anywhere
A participant sits in her living room in rural Montana, 200 miles from the nearest academic medical center. On her tablet, a video explains how a new diabetes medication works differently from standard treatment. Interactive diagrams let her explore what the study visits will involve. When she has questions, she types them into a chat window, and within minutes, a coordinator responds. After watching a summary video and correctly answering comprehension questions, she reviews the consent document on screen, asks a few more questions via video call, and applies her electronic signature.
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.
What you will learn
By the end of this lesson, you will be able to:
Good Clinical Practice (GCP)
Full course · ICH E6(R3) Principles