Federal regulations require that the IRB review and approve any changes in the approved research prior to implementation except when necessary to eliminate apparent immediate hazards to subjects. Modifications to protocols may be made at any time during the annual approval period. Many modifications are expeditable; but modifications that alter the risk level or significantly change the project’s goals or methodology will be reviewed and approved by the full IRB (typically, at the next scheduled meeting).
A researcher must submit an Unanticipated Problem–Adverse Event report if an unexpected (in nature, severity, or frequency) incident, experience, or outcome occurs that is related or possibly related to the research procedures, and subjects or others are placed at a 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 in order to ensure the safety, welfare, or rights of participants. Please read the policy carefully to see the required timetable for reporting UPs or AEs.
Prior to study expiration, a Closeout Report may be submitted when no further contact with the participants will take place and all data and/or samples are permanently de-identified. A Closeout Report must also be submitted if 1) the study is never initiated, and no enrollment takes place; and 2) a Primary Investigator leaves SU without requesting a change in PI. Following study closure, the researcher may not contact study subjects for further data collection. If the need for more data collection arises, the PI must inform the IRB immediately. The PI may request that the IRB re-open the study by means of continuing review, or a new protocol submission and review may be required.
If a PI will still be enrolling participants, collecting data, or interacting directly with the participants, a CRA must be filed every 365 days, or two years (as indicated on the approval letter). Lapses in IRB approval constitutes non-compliance with the Federal regulations, and all research must stop until approval is reissued. If data collection is complete and the PI will be conducting data analysis only, the PI may request to have the protocol reclassified as exempt, after which annual continuing reviews are no longer required.