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Research

Protocol Modification Requests

Federal regulations and ISU policy require that changes to an existing approved protocol may not be initiated prior to IRB review and approval except in very limited circumstances. If approval is required, a modification must be submitted in Cayuse IRB (now called Human Ethics) for review. Until the modification has been approved, the last approved version of the protocol can continue to be followed.

Changes to Full Board Review and Expedited Review Protocols

All changes must be submitted to the IRB except minor changes to adjust for typos or simplify text that does not change the meaning of the approved text. Most modifications to Full Board Review protocols will have to be reviewed by the convened IRB. Consult the meeting schedule for submission deadlines. Expedited Review modifications are handled by expedited review unless the modification no longer qualifies the study for expedited review.

Changes to Exempt Protocols

Modifications to Exempt protocols have fewer requirements. Any modification that may impact the exempt determination must be submitted. Documentation of site permission for studies involving minors must be submitted via email to the Human Subjects Research Specialist. The following changes do not need to be submitted for Exempt protocols:

  1. Revisions made to address the reviewer's comments on a protocol when the determination letter indicated that those revisions made to address those comments do not need to be resubmitted for review.
  2. Personnel changes when the PI is not being changed. PIs must still maintain accurate records of active study personnel and documentation of their training.
  3. Revisions made to recruitment materials when they do not change the recruitment plan and the materials were not included in the last approved version of the protocol.
  4. Unless minors are involved, addition of a new research site or documentation of site permission does not require modification but records must be kept by the PI.

How to Submit a Modification in Cayuse IRB (now called Human Ethics)

  1. Log into Cayuse IRB (now called Human Ethics).
  2. Locate the study you would like to create a new submission for in Cayuse IRB (now called Human Ethics.
  3. Click on the study.
  4. Click on "+ New Submission" in the upper right corner.
  5. Select "Modification" Please note that only one modification can be created at a time but each submission can include multiple modifications.
  6. Once the submission details page loads, click on the "Edit" button to enter into the submission.
  7. Instructions and requirements on modifications are provided at the beginning of the form.
  8. Follow instructions, complete revisions, and answer required questions.
  9. Complete the submission and have the PI certify that the submission is ready for review.
  10. The submission should appear in "Pre-Review" if the submission has been successfully been sent out for review.