Clinical Research Glossary

Institutional Review Board (IRB) Institutional Review Board (IRB)

CDISC

A team of people who review studies to protect the rights and welfare of study participants.

Example of Institutional Review Board (IRB) in a sentence

Participants can only enroll in a study after an IRB reviews and approves the study protocol.

More Info

An IRB must approve a research study before it starts. The IRB uses rules and regulations to make sure the research is ethical and the participants who enroll are protected. An IRB is sometimes also called an Ethics Committee.

The IRB members are not part of the study team. They are separate and conduct an independent review. IRB members come from different backgrounds and have medical, scientific, and non-scientific experience.

IRBs were created in the 1970s to respond to unethical research. They protect the rights and welfare of participants.

Other info to think about when joining a study

You may see the term “institutional review board” in the consent form in a section about which group approved the study.

You may also hear members of the study team talk about the IRB and getting the IRB’s approval before any study activities can take place.

The contact information of the IRB that is overseeing a study should be included in the consent form. You can reach out to the IRB if you have any concerns or complaints about your experience being in a research study.

 

Version 3.0 September 2025

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