What is 21 Code of Federal Regulations Part 56 (21 CFR 56)?
The legislation known as 21 Code of Federal Regulations Part 56 governs IRBs that review 21 CFR 56 outlines the organization, personnel, functions, operations and the administrative actions for non-compliance of any IRB responsible for reviewing clinical investigations regulated by the Food and Drug Administration (FDA), including applications for research or marketing permits for products regulated by the FDA. This document outlines the IRB’s organization, personnel, functions and operations, as well as specifying administrative actions for non-compliance. The OHRP website provides a link to the full text of 21 Code of Federal Regulations Part 56 at http://www.hhs.gov/ohrp/international/index.html#NatlPol.
