When conducting human-subject research, regulatory compliance doesn’t end once your study has been approved. Ongoing oversight is a critical part of protecting participants and maintaining study integrity. At Solutions IRB, two key aspects of this oversight are IRB annual check-ins and managing expired studies. Understanding these requirements can help researchers avoid unnecessary delays, added costs, or compliance issues.
Annual Check-Ins: A Required Step for Ongoing Research
Most expedited and full board studies are approved for one year at a time. To continue beyond that year, researchers are required to complete an annual check-in application. This process allows the IRB to re-approve the study for the next year, ensuring that participant protections remain strong and the research continues under ethical oversight.
During the annual check-in, researchers must provide:
Updated consent forms: Consent forms must be clean and current, free of tracked changes or outdated information. These forms are re-approved as part of the process to ensure participants are always receiving accurate, compliant documents.
Progress updates: Researchers report how the study has progressed so far, including the number of participants enrolled, any protocol deviations or adverse events, and whether the research is on track with its goals.
This is not simply a paperwork requirement—it’s an opportunity to evaluate the study, reflect on challenges, and document participant safety measures.
Closing a Study Through the Annual Check-In
Not all studies are meant to run indefinitely. Some reach their goals earlier than expected, while others may conclude naturally after a defined data collection period. If a researcher wishes to close their study instead of renewing, the process is straightforward:
The researcher still completes the annual check-in application.
Within the application, several questions specifically ask if the study will be closed. By selecting this option, the researcher notifies the IRB that no further oversight is needed.
Closing a study properly is essential. It provides formal documentation for your records, ensures all regulatory obligations are met, and avoids any appearance of noncompliance in the future.
The Consequences of Expired Studies
A more complicated situation arises when a study expires instead of being renewed or closed. Expiration happens when a researcher misses the deadline for the annual check-in and allows the approval period to lapse.
If this occurs:
Additional fees apply to cover the administrative burden of handling expired studies.
Research activities must stop immediately. No new participants may be enrolled, and current participants may not continue in the study until re-approval is obtained.
A new application is required to continue. Researchers must resubmit the entire study for review as though it were a new protocol.
In some cases, depending on the nature of the research, participants may need to be re-consented or the study may need to restart entirely. This creates delays, confusion for participants, and added work for the research team.
Best Practices for Researchers
To avoid complications, researchers should:
Mark deadlines early: Put reminders in place well before the annual check-in due date.
Prepare documents in advance: Keep consent forms updated and ready for submission.
Communicate with your IRB: If you anticipate changes, challenges, or closure, reach out early for guidance.
By planning ahead, researchers can ensure smooth renewals, proper closures, and uninterrupted study progress.
Partnering with Solutions IRB
At Solutions IRB, we understand that researchers want to focus on their studies—not administrative hurdles. Our team provides clear instructions, responsive support, and efficient reviews to make annual check-ins and study closures as smooth as possible.
By staying proactive and compliant, you protect your participants, your research, and your reputation. Whether you’re preparing for renewal, closing your project, or navigating an unexpected expiration, Solutions IRB is here to guide you every step of the way.