The IRB must review and approve any changes in the approved research before implementation, except when necessary to eliminate apparent immediate hazards to subjects. You may modify your protocol at any time during the approval period. Modifications related to full-board protocols that significantly alter the risk level or significantly change a project’s goals or methodology may require review and approval by the full board at the monthly meeting.
Download the current form: IRB Modification Request
Under new federal regulations, you no longer need to submit a continuing review application for ongoing (open enrollment or continuing data collection) minimal risk studies. Instead, the IRB will contact you at the end of the initial approval period with a brief email survey to determine the current status of the project for records compliance.
If you have concluded all data collection and interaction with participants, and you will be analyzing data only, please see "Downgrade to Exempt" below.
If your study was a full-board protocol, the IRB will contact you within a month of your study's approval expiration date regarding appropriate steps for continuing review and approval.
If you have concluded all data collection (no longer interacting with participants) and will conduct data analysis only, you may request to have your study reclassified as exempt, after which IRB oversight is no longer required.
Download the current form: Downgrade to Exempt Application
You should submit a Closeout Report when you will no longer interact with with participants and have concluded your study. You should also submit a Closeout Report if 1) you never initiated the study, and no enrollment took place; and 2) you will leave SU without requesting a change in PI. A Closeout Report is required by Federal regulations for all studies approved by the IRB.
After study closure, you may not contact study subjects for further data collection without consulting with the IRB about re-opening the study by means of continuing review or a new protocol submission.
If a student PI graduates and does not submit a report, a Closeout Report must be completed by the Faculty Adviser.
Download the current form: IRB Closeout Report form
You must submit an Unanticipated Problem–Adverse Event report if an unexpected (in nature, severity, or frequency) incident, experience, or outcome occurs related or possibly related to research procedures, and that places subjects or others at greater risk of harm than previously realized or anticipated.
An unanticipated problem may warrant corrective actions in the research protocol or the informed consent process/document to ensure the safety, welfare, or rights of participants. Please read the policy carefully to see the required timetable for reporting UPs or AEs.
Download the current form: IRB Unanticipated Problem/Adverse Event Report Form