Abstract

The institutional review board (IRB) is a federally mandated group instituted by the U.S. government to protect the rights and welfare of human subjects engaged in clinical research. Research involving human subjects, whether living individuals, data, or specimens, requires IRB approval and oversight prior to implementation. Investigators must conduct research in accordance with federal regulations, state and local laws, relevant policies and procedures, and ethical principles. IRBs provide oversight by reviewing and monitoring research to ensure research is conducted in a scientific, safe, and ethical manner and in compliance with research regulations. This chapter describes the role and purpose of the IRB in protecting the rights and welfare of human subjects in research in the United States, reviews federal regulatory standards relevant to IRB oversight, discusses research involving special populations, and comments on the non-research functions of the IRB.