Investigators must request review of proposed changes to IRB studies, and obtain IRB approval, prior to implementing any changes. The Modification Submission form in Cayuse Human Ethics is used to propose changes to an existing study.
The only exception to this requirement is when a change is necessary to eliminate apparent immediate hazards to subjects. In this case, a Modification Submission should be submitted to the IRB for review promptly following implementation. The IRB will review the change to ensure the subjects’ continued welfare.
Changes that need review
Anything outside of typographical errors or reordering of questions must be reviewed and approved as a modification. This includes:
- The addition or removal of study team members.
- Changes to study procedures or instruments (questionnaires, consent documents, recruitment materials, etc.).
- Changes to subject populations or study locations.
- Changes in recruitment or consenting procedures.
- Changes in funding support.
Create a Modification Submission
- Log in to Cayuse Human Ethics.
- Find your study on the dashboard in “Approved Studies” and select it.
- In the top right corner select the “+ New Submission” button.
- Choose “Modification.”
- Select the “Complete Submission” link and follow the instructions to fill out the submission.
- When the submission is complete, follow the instructions for submitting.
- The PI and the co-PI (if applicable) will be sent emails with instructions for certifying the submission in Cayuse.
- Once all certifications are entered, the submission will be routed to ORCA and you will receive an acknowledgment email.