Study Update Forms
Under the Revised Common Rule, not all Expedited studies require an annual continuing review. The IRB has decided that annual continuing review will be required for Expedited studies in the following circumstances:
- The participant population is vulnerable
- The research collects sensitive information or is risky to participants
- The study is FDA-regulated
- There is a Reliance Agreement or Individual Investigator Agreement in place
- Other reasons at the discretion of the IRB
Although some Expedited studies and all Exempt studies do not require an annual continuing review, these studies will only be approved for a 3-year period. If the researcher wishes to extend the study beyond that expiration date, a Study Update Form must be submitted and approved via iMedRIS.
A step-by-step guide on how to submit a Study Update can be found below:
What is a Continuing Review?
Continuing review is required yearly for all Full Board studies and for some Expedited studies until the Principal Investigator has completed all research-related interactions/interventions and the study is closed to enrollment. The continuing review allows the IRB to monitor the progress of the study and ensure that it continues to meet institutional and federal requirements.
The PI is notified 60, 30, and 25 days prior to expiration of the study that a continuing review form needs to be submitted. If the continuing review has not been submitted and approved prior to the expiration date, the study will be administratively closed the day after expiration. If this occurs, you must halt all research activities until approval has been reinstated.
For studies in which written informed consent has been collected, a signed consent form from the past year must be submitted along with the continuing review request. IRB members review the consent audit to ensure that consent was obtained appropriately from study participants and to ensure that researchers have not deviated from their approved protocols and procedures.
When Should I Submit the Continuing Review?
Your first notification that a continuing review is due will be sent 60 days before your study expires. However, the regulations do not allow the IRB to complete the continuing review more than 30 days before the study’s expiration date. You may submit your continuing review early, and the IRB will hold onto it until it is eligible to be reviewed.
Do not wait until one or two days before your study’s expiration date to submit the continuing review. Our reviewers are very busy and will not have time to complete your review before the study expires. You should aim to submit the continuing review 3-4 weeks before the study expires.
A step-by-step guide on how to submit a continuing review can be found below:
Continuing Review Request (Form 3)
If upon submitting your continuing review you recognize a deviation from your protocol please review the Submitting a reportable/ unanticipated problem or event page.
If you have questions about the timeline of review please visit the Review Process page.