Expired Study Continuation
When a study's approval period expires, all study procedures must stop. Study procedures may not begin again until a new approval is in place. There is no grace period extending the conduct of the research beyond the expiration date of IRB approval.
However, the IRB can grant a limited expired study continuation in cases where there is evidence that stopping certain procedures during the period of expiration could harm the safety and/or well-being of the currently enrolled participants.
For example:
- Stopping study treatment during the expiration period would harm the participants’ health.
- Stopping the assessment of adverse events could harm the participants' health.
The IRB does not grant continuations in cases where there is not an immediate need for protecting participant safety during the expiration period.
The following stipulations must be considered:
- The IRB will not grant continuations if the study has been administratively closed due to a failure to submit a continuing review application in ERICA.
- Submitting a continuation request does not provide you with extra time to complete and submit your continuing review application.
- Continuing any study procedures during expiration is a protocol deviation and can be considered for serious and continuing non-compliance.
- An expired study continuation is limited only to the procedures that prevent harm to the safety and wellbeing of enrolled participants. It does not allow for conduct of all other study procedures during the period of expiration.
How to Request an Expired Study Continuation
- Open the study.
- Click on the Continuing Reviews tab.
- Click on the link for the Continuing Review in progress, opening the workspace for that Continuing Review.
- Click Request Expired Study Continuation in the Activities list on the left side of the page.
- Complete the form in the activity window and click OK.
- You will receive confirmation of your submission via an email notification from the ERICA system. This is not approval of your request. Do not begin any study procedures until you receive a separate notice of continuation approval via an email notification from the ERICA system.