Revisions to the Protocol Application Form – Exempt

May 20, 2024

The DHR has revised Protocol application form – exempt, 05.20.2024. Revisions were made to:

  1. Clarify PI eligibility requirements and expectations.
  2. Improve the wording of questions about dual appointments for clarity.
  3. Provide clear instructions when investigators need to be added to the Research Team Form, as submissions often incorrectly included non-NU investigators for studies ineligible for a reliance agreement and/or IIA.
  4. Add a section for non-NU investigators now instructing more information regarding non-NU collaborators.

None of these changes affect the scope of review by the NU IRB/DHR for exempt research. While point 4 includes new data, it formalizes the expectation that research teams have a clear plan for training, oversight, and communication with non-NU collaborators. This allows for better documentation of these plans in the protocol and ensures that research teams are clear that external collaborators will not be covered by the NU FWA.

Because the edits to the form do not impact review expectations, the IRB will continue to accept applications using the old form. However, submitting with the new form is highly encouraged to minimize the amount of back-and-forth during the review process. The new form is available on the Forms page and has replaced the previous version.