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May a covered entity accept documentation of an external Institutional Review Board's (IRB) waiver of authorization for purposes of reasonably relying on the request as the minimum necessary?


Yes. The HIPAA Privacy Rule explicitly permits a covered entity to reasonably rely on a researcher’s documentation of an Institutional Review Board (IRB) or Privacy Board waiver of authorization pursuant to 45 CFR 164.512(i) that the information requested is the minimum necessary for the research purpose. See 45 CFR 164.514(d)(3)(iii). This is true regardless of whether the documentation is obtained from an external IRB or Privacy Board or from one that is associated with the covered entity.



Date Created: 12/19/2002

Content created by Office for Civil Rights (OCR)
Content last reviewed on July 26, 2013