Institutional Review Board

OSIRIS
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AAHRPP

Health Insurance Portability and Accountability Act (HIPAA)

Request for Waiver

Guidance Document (PDF)

Guidance for Requests for Waiver of HIPAA Authorization and Federal Policy Informed Consent Requirements Associated with (1) Identification and Recruitment of Research Participants and (2) Conduct of Retrospective Research Studies Involving the Use of Medical Record Information

Scenario 1 (PDF):

Model Request for Waiver of Informed Consent to Use Medical Record Information (PHI) to Identify Potential Research Subjects: Researcher Who Accesses and Uses Medical Record Information for the Purpose is Involved Directly in Providing Health Care to the Respective Patients.

Scenario 2 (PDF):

Model Request for Waiver of the HIPAA Authorization Requirement for the Sharing of Contact Information (i.e., Linked to Study-Specific Health Information [subject's medical diagnosis or condition]) for the Purpose of Recruiting Potential Research Subjects

Scenario 3 (PDF):

Model Request for a Waiver of the Requirements to Obtain HIPAA Authorization/Informed Consent to Access, Record, and Use Protected Health Information/ Patient Medical Record Information for a Retrospective Research Study: Investigator(s) Who Access and Use Such Information for Research are Involved Directly in Providing Health Care to the Respective Patients.