Waiver or Alteration of HIPAA Authorization
To use and/or disclose Protected Health Information (PHI) for research purposes, the HIPAA Privacy Rule in general requires that researchers obtain signed authorization from the individual. An IRB can grant a Waiver of HIPAA Authorization to permit use and/or disclosure of PHI for research purposes, without obtaining authorization. An IRB may also approve an alteration of the requirements of written HIPAA Authorization provided the research meets the criteria for waiver or alteration (see info below).
Michigan Medicine study teams request waivers and alterations of HIPAA authorization through eResearch Regulatory Management application sections 25-1 (select the box for waiver) and 25-2 (complete the waiver request).
NOTE: If the HIPAA authorization will be obtained electronically, the electronic medium should be HIPAA compliant. For example: SignNow or Qualtrics with signature question.
Questions?
Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)
2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800
A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.
Edited By: larkspur@umich.edu
Last Updated: September 21, 2020 3:00 pm