Guidance for Industry: Institutional Review Board Review of Stand-Alone Health Insurance Portability and Accountability Act Authorizations; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations," dated October 21, 2003. The guidance document provides clarification for institutional review boards (IRBs) of their responsibilities for reviewing and approving stand-alone authorizations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. A stand-alone HIPAA authorization is a document used to obtain permission from an individual for a covered entity to use and/or disclose the individual's identifiable health information for a research study and that is not combined with an informed consent document to participate in the research itself. This guidance is intended to encourage IRBs to permit enrollment of subjects in clinical investigations without the IRB's prior review and/or approval of stand- alone HIPAA authorizations, even under circumstances in which the IRB's written procedures require such review and/or approval. Because FDA has determined that prior public participation is not feasible or appropriate, this guidance document will be implemented upo