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
Number of Individuals Affected by Disclosure ________________________________________________________________ |
Date or Date Range of Disclosure ________________________________________________________________ |
Research Sponsor Name ________________________________________________________________ |
Research Sponsor Address ________________________________________________________________ |
Research Sponsor Telephone ________________________________________________________________ |
Recipient Researcher Name ________________________________________________________________ |
Recipient Researcher Address ________________________________________________________________ ________________________________________________________________ |
Recipient Researcher Telephone ________________________________________________________________ |
Name of Research Protocol or Activity ________________________________________________________________ |
Description of Research Protocol or Activity ________________________________________________________________ ________________________________________________________________ |
Purpose of the Research ________________________________________________________________ ________________________________________________________________ |
Criteria for Selection of Particular Records ________________________________________________________________ ________________________________________________________________ |
Description of PHI Disclosed ________________________________________________________________ ________________________________________________________________ |
Purpose of Disclosure (may attach a copy of Institutional Review Board research approval) ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ |