External IRBs

Duke University Health System (DUHS) may rely on an external IRB, meaning the IRB of another institution or organization, or an independent (commercial) IRB, for review and approval of human research if such reliance benefits DUHS, its investigators, and/or its research participants. Examples of when such reliance may be considered include:  research in which DUHS as an institution has a conflicting interest; multi-site research in which DUHS employees are involved in minimal risk study activities only; Phase II, III or IV multi-site, industry-initiated, industry-sponsored research; and federally sponsored research for which a federally sponsored central IRB is duly constituted, or for federally sponsored research requiring the use of a central IRB.  This policy outlines requirements for Duke investigators when using an external IRB as the IRB-of-record for a study.