(Update 08/17/2018) Starting August 20, 2018, continuing review requirements will begin to be eliminated on a case-by-case basis for many new and existing, minimal risk studies. Investigators on existing studies will be notified if their study is transitioned via an email in AURA, or via their approval letter if the project is approved on or after 08/20/2018. If not notified, the expiration date listed in AURA applies, and a continuing review is still required. Please note that federally funded studies, if eligible, will be transitioned at their next continuing review due to regulatory considerations (so at least one more continuing review is required if your minimal risk project has ever had federal funding).
NOTE: In all cases, investigators will still be responsible for submitting amendments (including the addition of new funding), event reports, and for letting the office know when the research is no longer being conducted, even if no continuing review applications are required.
------------------------------------------------------------------------------------------------------------(Original Posting) Federal regulations require an IRB to conduct substantive, meaningful continuing review of human subjects research that is within the IRB's jurisdiction. For federally funded research, continuing review of human subjects research projects is required at least annually even if no changes have occurred to the recruitment materials, research procedures, or subject population during the IRB approval period. For many studies that are minimal risk and not federally funded, the SBS IRB grants 3-year IRB approvals. The SBS IRB's 3-year approval policy is available on the IRB website. If a project has completed data collection and is only doing data analysis and manuscript preparation, the project must still undergo continuing review if any personally identifiable information is being analyzed.
Changes to the protocol or study documents may be submitted at the same time as the continuing review, but any proposed changes to the protocol or study documents must be submitted as an amendment rather than as part of the continuing review application.
The Principal Investigator is responsible for submitting a continuing review application through AURA with sufficient time prior to the expiration of the current IRB approval so that no lapse in study approval occurs. AURA will send reminder notices beginning 3 months before a study's IRB approval is scheduled to expire. The average time for the SBS IRB to process a continiung review submission is 2 to 3 weeks (this allows time for any clarifications needed during the review process), so please submit the continuing review application through AURA at least 3 weeks before your study's expiration date. It is ultimately the investigator's responsibility to submit a continuing review application and to allow sufficient time for the review and re-approval process to be completed before the current IRB approval expires.
If IRB approval expires, all research activities involving human subjects MUST STOP, including subject contact, data collection, and data analysis. The only exception to this requirement is for activities that should be continued for reasons of participant safety. No new subjects may be enrolled after IRB approval lapses. If human subjects research activities continue after the expiration date, the investigator is out of compliance with the federal regulations. The IRB cannot grant retroactive approval for research done after the expiration date. Even if the continuing review application has been submitted to the IRB, all research activities must stop until the IRB renews approval for the project.
If you engage in human subjects research activities while IRB approval for your project has lapsed, you will be required to complete an Unanticipated Problem report in AURA.