Obtaining IRB Waiver or Alteration

In cases where it is impossible or impracticable to obtain individual authorization, a researcher may apply to the IRB for a waiver or alteration of the individual authorization requirement. The IRB will review all requests based on evaluation of the criteria for waiver or alteration, and will approve, modify or deny each request.

Internal researchers may apply for a waiver or alteration of the HIPAA authorization requirement.

External researchers may apply for an alteration of the HIPAA authorization requirement, but will be required to obtain from the individual authorization that meets Minnesota state law requirements at a minimum.

PROCESS FOR REQUESTING WAIVER OR ALTERATION

The person requesting disclosure of PHI must apply for IRB waiver or alteration of individual authorization using the appropriate appendix to the relevant IRB application form. All of the following criteria must be met and demonstrated:

1. The research could not be practicably conducted without the access to or use of the PHI.
2. The use or disclosure of PHI involves no more than the minimal risk to the privacy of the individuals based on the presence of all of the following:
   1. Adequate plan to protect identifiers from improper use and disclosure;
   2. An adequate plan to destroy the identifiers at the earliest opportunity consistent with the conduct of the research, unless there is a health or research justification for retaining identifiers or retention of identifiers is required by law; and
   3. Adequate written assurances that the PHI will not be reused or disclosed to any other person or entity except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of PHI would be permitted by the HIPAA Privacy Rule.
3. The research could not be practicably conducted without the waiver or alteration.

IRB ACTION

The IRB will document the disposition of any waiver or alteration request.

If the waiver or alteration of individual authorization is approved, the IRB will provide documentation to the person requesting the waiver.

If the waiver or alteration is denied, the IRB will document the denial and will provide explanation of the grounds for denial to the researcher requesting the waiver or alteration.

USE AND DISCLOSURE OF PHI WITH IRB WAIVER OR ALTERATION

The researcher may use or disclose the PHI described in the waiver or alteration for research purposes only in accordance with the waiver or alteration.

Documentation of IRB approval must be presented to the person or entity from which PHI is requested before the PHI may be disclosed pursuant to a waiver or alteration.