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.

Criteria for Waiver or Alteration

• an adequate plan to protect the identifiers from improper use and disclosure;
• an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and
• adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted by this subpart;

2. The research could not practicably be conducted without the waiver or alteration; and

3. The research could not practicably be conducted without access to and use of the protected health information.

When is this appropriate?

Waiver

• identifying eligible potential participants for a clinical trial through medical record review (Part of the project)
• secondary use research on a large set of medical records (Entire project)

Waiver for part of a project, or an entire project, can also be appropriate in other situations.

Research activities that involve PHI should be conducted whenever practicable with patient authorization.

• It may be feasible to obtain signed authorization from each individual in a small data set.
• Data custodians may be able to provide a study team with a de-identified or Limited Data Set that fulfills the research needs. Contact the UMMS Data Office for Clinical and Translational Research.

Alteration

Any of the HIPAA authorization requirements in 45 CFR 164.508 can be altered (modified or removed) by the IRB. The most frequent HIPAA alterations accompany a waiver of documentation of informed consent under 45 CFR 46.117(c)(1):

• Removal of the requirement that the participant signs and dates the HIPAA authorization form
• Removal of the requirement that the participant receives a copy of the signed, dated form