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Module 1: Lesson 1
Principle 2: Informed Consent Fundamentals
Understand informed consent as an ethical cornerstone requiring voluntary, informed decision-making, including requirements for legally acceptable representatives and assent.
Consent is a conversation, not a signature
There is a document that sits at the heart of every clinical trial, often running to a dozen pages or more, filled with technical language and legal provisions. It describes risks, procedures, alternatives, and rights. It ends with a signature line. And too often, the entire informed consent process is reduced to obtaining that signature.
This is a fundamental misunderstanding of what consent means.
Informed consent is not a form. It is not a signature. It is not a legal requirement to be checked off before enrollment can proceed. It is, instead, a conversation, a process, an ongoing relationship between the research team and each participant. The form documents that process, but it does not constitute it.
I have watched consent discussions that honored the spirit of this principle and others that violated it while technically satisfying every regulatory checkbox. The difference is profound. In one, a potential participant leaves with genuine understanding and freely chosen commitment. In the other, they leave with a signed document but no real comprehension of what they have agreed to do.
ICH E6(R3) Principle 2 establishes informed consent as an integral feature of ethical trial conduct. This lesson examines that principle and its four sub-principles, which together describe what genuine consent requires.
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