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.
- Contact Us
- Deadlines for Full Board Review
- Directions to IRB02 Office
- Required Training for IRB-02
- Other Resources
- Report Non-Compliance to IRB-02
- Web-Based Submission Tracking for Paper Studies within IRB-02
Investigator Information & Guidelines
- myIRB Phase-in Announcement
- Preparing to Submit a Study for Review in myIRB
- Types of Study Review by the IRB
- Converting Paper Studies to myIRB
- FERPA Information for use of Educational Records in Research
- Lotteries and “Random Awards” as Incentives for Research Participation
- Guidelines for Revising an Approved Study
- Definition of Terms Used in IRB02 Documents
- Student Roles & PI Qualifications for IRB-02
- Use of Amazon Mechanical Turk (MTurk) for social/behavioral Research Projects
- Informed Consent Instructions & Procedures
- Adverse Event Reporting Form
- Clinical Trials Assessment Form
- Continuing Review/Study Closure Form
- Cumulative Adverse Event Table for Continuing Review
- Cumulative Deviation Table for Continuing Review
- Debriefing Form: Sample
- Deviation/Non-Compliance Reporting Form
- Legacy Paper Study Submission Form
- Legacy Paper Study Revision Form
- myIRB Protocol Submission Form
- Unaffiliated Investigator IRB02