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:

Should you have questions, please contact the IRB office at (352) 273-9600 or through our web page.