Policies for On-going Actions Post-Approval

Modification Request Policy

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 approval period. Most modifications are expeditable; but 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 (typically, at the next monthly meeting).

Download the current form: IRB Modification Request

 

Continuing Review / Downgrade to Exempt Policy

If a PI will still be enrolling participants, collecting data, or interacting directly with the participants, a CRA must be filed at least one week prior to the approval expiry date indicated in the original IRB approval letter. Lapses in IRB approval constitutes non-compliance with 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 continuing review/approval is no longer required.

Download the current form: Continuing Review and Downgrade to Exempt Request Form

 

Closeout Report Policy

A Closeout Report should 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.

Download the current form: IRB Closeout Report form

 

Unanticipated Problem/Adverse Event Policy

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 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