Guidelines for Revising an Approved Study
All changes, revisions, and modifications to approved studies, must be reviewed and approved prior to implementation. Types of revisions that require IRB approval are:
- Change in Protocol Title
- Change in Investigator(s)/Supervisor
- Addition of Advertisements
- Changes to Flyers
- Modifications to Methodology
- Change in Number of Participants
- Change to Questionnaire
- Change to Informed Consent
- Change in Sponsorship (Adding or Deleting a Funding Source)
Revisions for studies approved in the Legacy Paper system:
- To begin, download the Protocol Revision Form.
- Forward to the IRB a copy of the document that shows what changes have been made. You may use the strikethrough method or bold or highlight the changes. In addition to the “changes copy” submit a “clean” copy of the revised document.
- Please allow seven to ten days for revisions to be approved.
- If a revision requires Full Board review and approval, you will be notified via email of the date, time, and location of the meeting.
Revisions for studies approved in myIRB:
- Please refer to the myIRB Researcher Manual for instructions.
Should you have questions, please contact the IRB office at 392-0433 or firstname.lastname@example.org.