Research Policy Analysis and Coordination
Institutional Review Boards
An Institutional Review Board (IRB) is an administrative committee designated to provide ethical and regulatory oversight of research that involves human subjects. IRBs exist to protect the rights, safety, and welfare of human subjects involved in research projects, consistent with ethical principles and federal, state and local regulations. For human subject research conducted internationally, additional local regulations and international standards apply and are overseen by ethics committees in respective countries.
IRBs are enacted under federal regulation, specifically 45 CFR 46, and are regulated by the Office for Human Research Protections (OHRP) within the U.S. Department of Health & Human Services (HHS). There are additional requirements for IRBs overseeing clinical trials of drugs involved in new drug applications from the Food and Drug Administration (21 CFR 56.111) and for studies supported by the Department of Defense.
IRBs operate within Human Research Protection Programs on all UC campuses and the Lawrence Berkeley National Laboratory.