Institutional Review Board — What It Means in Clinical Trials
Plain English Definition
An Institutional Review Board (IRB) is the full name for the ethics committee that oversees clinical research at hospitals and universities. The IRB reviews every aspect of a trial — including the treatment plan, consent process, and data protections — to ensure the study is ethical and that participants are not exposed to unnecessary risk.
Why It Matters
The IRB must approve any changes to a trial protocol, including safety updates. They also review reports of adverse events. Their oversight continues throughout the entire trial, not just at the beginning.
Example
A trial document might state: "Protocol amendments must be submitted to and approved by the Institutional Review Board before implementation."
Need help understanding eligibility criteria?
How to Read Eligibility Criteria →