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Templates

Templates are for viewing purposes only.

The list of templates used by the TRICARE Management Activity (TMA) Privacy Board facilitates appropriate Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule reviews and documentation. If and when one of these templates is required, the TMA Privacy Board will email the appropriate template to the Principal Investigator (PI) and Government Sponsor for completion.

Required Representations for Research on Decedent’s Information

If the researcher intends to conduct research that is solely on the protected health information (PHI) of decedents, the PI may submit this template to document the required representations, as outlined above, that are necessary for compliance with the HIPAA Privacy Rule and Department of Defense (DoD) Health Information Privacy Regulation (DoD 6025.18-R).

Required Representations for Review Preparatory to Research

If the researcher intends to conduct a review of PHI to prepare for a research protocol or for similar purposes preparatory to research (e.g., for recruitment or screening purposes) and agrees not to remove the PHI from TMA, the PI may submit this template to document the required representations, as outlined above, that are necessary for compliance with the HIPAA Privacy Rule and DoD 6025.18-R.

Research Authorization Review

If the researcher intends to obtain HIPAA Authorizations, also known as “Authorizations,” from research participants to comply with the HIPAA Privacy Rule, the PI must submit to the TMA Privacy Board a copy of the blank Authorization(s) to be used in the project and the completed Research Authorization Review. The TMA Privacy Board will conduct a review to determine that all core elements and required statements are provided in the Authorization(s) as required by the HIPAA Privacy Rule and DoD 6025.18-R.

Principal Investigator Certification

If a Research Authorization Review template and an Authorization are approved by the TMA Privacy Board, a PI will be required to sign a Principal Investigator Certification. Among other requirements, the certification ensures that the PI will maintain, electronically and/or in hard copy, the signed Authorization for each research participant whose PHI is used or disclosed in the project, and will provide any and/or all of the signed Authorizations to TMA immediately upon request.

TMA Privacy Board Application for a Waiver of Authorization or an Altered Authorization

If the researcher has not received documentation from an Institutional Review Board (IRB) or HIPAA Privacy Board approving a waiver or alteration of Authorizations and reasons exist that make it impractical or impossible for the researcher to obtain Authorizations from each research participant, the PI may submit an Application for a Waiver of Authorization or an Altered Authorization. A TMA Privacy Board member will conduct an expedited review of the completed application and determine whether to approve or deny an altered Authorization or a full or partial waiver of Authorizations.

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