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HIPAA Authorization

Guidance on HIPAA Requirements for WIRB Submissions

UW-Madison is responsible for the review of HIPAA authorization forms.  The UW WIRB Gateway 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 in order to facilitate their review.

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.


Adding 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 approved Meriter/UW HIPAA Authorization Template.

Banking HIPAA Authorization

For guidance about when and how to draft a HIPAA Authorization for banking, please contact a WIRB Gateway Team member.

HIPAA Related Presentations

Contact Information
For additional assistance regarding HIPAA requirements, contact:

Rebecca Hutton, J.D., M.S.
UW-Madison HIPAA Privacy Officer

Office of the Provost
Room 150 Bascom Hall
500 Lincoln Drive
Madison, WI 53706

Phone: 608-890-3941
E-mail: rchutton@wisc.edu

For more information about UW HIPAA requirements, see http://hipaa.wisc.edu/ .




Keywords: research authorization form, phi, sub-study, opt in/out, check boxes, templates, optional, optional sub-study   Doc ID: 22425
Owner: Chelsea D.Group: Western Institutional Review Boards
Created: 2012-01-26 13:44 CDTUpdated: 2013-11-11 13:05 CDT
Sites: Western Institutional Review Boards