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.

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.