This policy describes what the IRB requires when: 1) a DUHS Investigator conducts research external to Duke, 2) a DUHS Investigator is Principal Investigator of a multi-site research project, 3) a DUHS Investigator oversees an operations or coordinating center for multi-site research, 4) a DUHS Investigator oversees a statistical center for multi-site research. The policy also discusses IRB reliance agreements.