Good Clinical Practice (GCP)
Full course · ICH E6(R3) Principles
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This lesson is part of a complete GCP track — 2 courses, quizzes, a final exam, and a free verifiable credential. The optional $29 PDF certificate is recognized by 18+ trial sponsors.
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Understand the requirement for independent ethical review by an IRB/IEC, including prior approval, continuing review, composition requirements, and procedural safeguards.
Consider the position of a prospective research participant. They are being asked to take an investigational product whose full safety profile remains unknown. They are being asked to undergo procedures that may offer no direct benefit. They are being asked to trust that strangers in white coats have designed a study that will not harm them.
Now consider what stands between that vulnerable individual and potential exploitation: an independent group of qualified people who have reviewed every aspect of the trial before a single participant can be approached. This is the Institutional Review Board (IRB) in the United States, or the Independent Ethics Committee (IEC) in most other jurisdictions. Different names, but the same essential function. They are the gatekeepers of ethical research.
ICH E6(R3) Principle 3 codifies this requirement for independent review. It is not a bureaucratic formality. It is the structural safeguard that ensures no investigator, however well-intentioned, operates without external oversight. The history of research ethics, as you learned in Module 1, is littered with examples of investigators who believed their work was ethical while harming participants. Independent review exists precisely because good intentions are not sufficient protection.
This lesson examines what Principle 3 requires, how IRBs and IECs must be composed to ensure genuine independence, what documents they must review, and how they must conduct their oversight responsibilities.
What you will learn5 objectives
By the end of this lesson, you will be able to:
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