Instructions: Use this form to track disclosures to an individual or entity outside of [Covered Entity] of protected health information (PHI) for purposes of research where individual participant HIPAA authorization is not obtained. For example, this form must be used when PHI is disclosed:
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Preparatory to research
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Pursuant to an Institutional Review Board waiver of HIPAA authorization
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Number of Individuals Affected by Disclosure ________________________________________________________________ |
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Date or Date Range of Disclosure ________________________________________________________________ |
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Research Sponsor Name ________________________________________________________________ |
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Research Sponsor Address ________________________________________________________________ |
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Research Sponsor Telephone ________________________________________________________________ |
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Recipient Researcher Name ________________________________________________________________ |
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Recipient Researcher Address ________________________________________________________________ ________________________________________________________________ |
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Recipient Researcher Telephone ________________________________________________________________ |
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Name of Research Protocol or Activity ________________________________________________________________ |
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Description of Research Protocol or Activity ________________________________________________________________ ________________________________________________________________ |
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Purpose of the Research ________________________________________________________________ ________________________________________________________________ |
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Criteria for Selection of Particular Records ________________________________________________________________ ________________________________________________________________ |
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Description of PHI Disclosed ________________________________________________________________ ________________________________________________________________ |
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Purpose of Disclosure (may attach a copy of Institutional Review Board research approval) ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ |