HIPAA Authorization

UW-Madison is responsible for the review of HIPAA authorization forms. The Reliance Team, rather than WIRB, reviews and accepts all HIPAA forms on behalf of the UW. The HIPAA authorizations are required to be separate from consent documents to facilitate their review by the UW. For more information about UW HIPAA requirements, see the HIPAA website

Requirements for UW HIPAA Authorization Forms

  1. Institutional templates must be used.
  2. All HIPAA language must be removed from the consent documents.

If authorization forms are used to obtain permission for the use of protected health information for multiple components of a study, such as optional sub-studies, they must include corresponding opt in/out check boxes for each component. These check boxes may be located either in section A or the authorization signature section of the document. For guidance and tools to help with drafting HIPAA authorization forms, please see HIPAA Privacy Rule: Forms and HIPAA Wizard.

Special Populations Additional Requirements

  •   Limited or Non-readers

    • When selecting to include limited or non-readers in the study, please add a witness signature line in the HIPAA Authorization signature section.


      ______________________________________________________             _________________

      Signature of Witness Observing the Authorization Process                             Date

  •   Impaired Decision-Making Capacity

    • When selecting to include subjects with impaired decision-making capacity in the study, please add a legally authorized representative signature line in the HIPAA authorization signature section.


      ______________________________________________________             _________________

      Signature of Individual or Personal Representative                                         Date

      If this Authorization Form is signed by a personal representative, please print his or her name and relationship to the individual:

      Name (print): _______________________________

  •   Minors

    • When choosing to include minors in the study, please prepare a HIPAA authorization form addressed to the "Parent or Guardian."

  •   Pregnant Partner

    • A HIPAA authorization form to match a pregnant partner consent is not necessary at the time of initial review submission. In the event that the study team needs to use the pregnant partner consent document, please contact the UW-Madison HIPAA Privacy Officer for direction.

Adding a Sponsor Statement to the HIPAA Authorization Form

If the sponsor would like to add their own language to the UW HIPAA templates, a new section called "Sponsor Additional Information" should be added just prior to the signature section, such as:

    H. Sponsor Additional Information

    The following information is from the sponsor of this study about how the sponsor will use and protect your health information from this research. Federal privacy laws do not generally apply to the sponsor's use of your health information. UW-Madison and its researchers cannot guarantee that the sponsor's statement is correct, complete, or current. The sponsor's use and protection of your health information from this study is the responsibility of the sponsor, not UW-Madison and its researchers.

      [Add the sponsor statement(s) here as indented text.]

      [End of sponsor statement.]

Shared Meriter/UW WIRB Deferral HIPAA Authorization Template

If UW personnel will use Meriter Hospital resources for the research study or enroll Meriter patients and Meriter has also agreed to defer the study to WIRB, use the joint Meriter/UW HIPAA Authorization Template.

Tissue Banking HIPAA Authorization

For guidance about when and how to draft a HIPAA Authorization for tissue banking, please contact submitwirb@medicine.wisc.edu.

Keywords:research authorization form, phi, sub-study, opt in/out, check boxes, templates, optional, optional sub-study, non readers, non-readers, impaired decision making, impaired decision-making, capacity   Doc ID:22425
Owner:Mike B.Group:Western Institutional Review Boards
Created:2012-01-26 12:44 CSTUpdated:2017-10-04 15:16 CST
Sites:Western Institutional Review Boards
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