What is an IRB?
An Institutional Review Board (IRB) — sometimes called an Independent Ethics Committee (IEC) outside the US — is an independent committee that reviews and approves every clinical trial before it can enroll participants in the United States. The IRB's job is to protect the rights and welfare of human research participants. By federal regulation (45 CFR 46 and 21 CFR 56), an IRB must include at least five members with diverse backgrounds: scientists, non-scientists, and at least one community member unaffiliated with the institution running the study. The IRB reviews the protocol, the informed consent document, the investigator's qualifications, the recruitment materials, and the risk-benefit analysis. It can approve, require changes, suspend, or terminate any study at any time. IRBs also conduct continuing review at least annually, and they investigate any complaints from participants. Every research site QualifiedStudies works with operates under IRB approval — it's a non-negotiable requirement for joining our network.