1. The staff reviewer assigned to the exemption application conducts a pre-review of the submission to evaluate the research, applicable consent documents and any other accompanying materials to:
   1. ensure the study does not fall under FDA regulations
   2. determine whether the study meets the criteria for exemption (If DOJ funded, must meet the criteria for exemption under the old Common Rule, not the revised Common Rule.)
   3. ensure the study complies with applicable federal regulations (e.g. VA), state law, UW-Madison policies, and ethical principles relating to the protection of human subjects
   4. ensure compliance with the HIPAA Privacy Rule as applicable
   5. For exemption applications that require a consent process, the IRBS should confirm that all required information is provided (See: HRP-312, Worksheet: Exemption and Limited Review, section 2).
2. If the exemption reviewer determines that the study is not eligible for exemption, the reviewer will request a change in application type.
   
   Note:     At UW, we do not apply multiple exemption categories to single submissions unless the categories apply to different participant groups. For example, a submission can include both category 2 for interviews of nurses and category 4 for a review of patient medical records. If multiple categories would be applied to the same participants, we would not exempt the submission. Instead, we would apply the expedited criteria.

3. If the reviewer determines that the study is eligible for exemption (See: HRP-312), after all issues have been addressed, the reviewer will complete the following checklists:

   • HRP-401:

     • Leave the Common Rule boxes unchecked; the Common Rule is not applied to exemptions.

     • Consent waivers or checklists associated with the 111 criteria (children, prisoner, pregnant participants, etc.) do not need to be completed because the Common Rule is not applied to exemptions.

     • Do not use the “Notes” section of this form.

   • HRP-441: If a new full, altered and/or partial HIPAA waiver of authorization needs to be approved as part of the change, the assigned IRBS will document this approval using HRP-441 before completing 402. 

     If the assigned IRBS is not an IRBM, they will notify the Team Manager that a waiver or alteration of authorization needs to be documented for the exemption. The Manager will then access the study in ARROW and complete the HIPAA Waiver activity form, returning the application to the IRBS when the HIPAA Waiver form is complete.

4. If the exemption reviewer determines that the study requires limited review (applies to Category 2 and 3), the reviewer may contact a privacy and/or security expert to serve as a consultant on the privacy and confidentiality measures. If the assigned IRBS is not an IRBM, they need to contact the team manager to complete a review of the privacy and confidentiality measures and document that they are adequate. Once the manager records their review, the study will transition back to the IRBS to finalize the review.

5. Completing 402:

   • Use the “Notes” section to leave any notes of import for posterity.

   • Report on an agenda if:

     • If the exemption is under VA purview.

     • If the exemption requires limited review.

   • Otherwise, select ‘**NOT DISPLAYED ON AGENDA OR MINUTES**.

6. Draft correspondence for the study team using the Edit Letter to Study Team activity, select the appropriate letter template using the drop-down menu. Then, complete the Send Correspondence activity. ARROW will ask whether the minutes have been completed; while there are no minutes for exemptions, select “Yes” anyway.

Changes should be submitted based on the Exemption Change Guidance Table.

If the change will alter the study such that it no longer qualifies for exemption, the IRBS should email the study team to explain the situation and determine whether the study team wants to alter the change such that the exemption status of the research is not affected or submit a new application for full review.

• We do not cede or serve as IRB of Record for exempt studies. See Reliance Manual.
• We cannot exempt parts of a study, including when another part of the study is being done at a different institution.
• Use of virtual reality goggles does not qualify for exemption.
• Data cannot be collected via physical procedures such as blood pressure monitoring, EEG, activity trackers (e.g., Fitbit), eye trackers, or blood draws. Eye tracking is permitted if eye movements are recorded using a digital camera (e.g. no devices are attached to the person).
• Currently, we do not apply exemption categories 7 & 8.
• 3-year expiration date assigned in ARROW; STs can extend to keep open.