Annual IRB Review

If you are on the medical campus please visit the BUMC IRB website.

Continuing Review

Federal regulations (45 CFR 46.109(e)) mandate that ongoing Expedited or Full Board human research studies be reviewed at intervals appropriate to the degree of risk, but not less than once per year from the previous date of approval.

Studies which are not re-approved by the expiration date are no longer in compliance with IRB regulations and will be terminated. Once the study has expired, no research activities can be conducted.

Which Studies Require Annual Re-approval

All studies that are reviewed by Expedited or by the Full IRB Committee require an annual re-review. If the study is no longer active, you may be able to submit a request to close the project. For details, please refer to “When a Study Can be Closed” section further below.

1. At least six (6) weeks prior to study expiration, complete and sign a Continuing Review application
2. If your study requires full board review, you must submit your application prior to the submissions deadline
3. Provide the current progress of your project
4. Include an accurate update on enrollment numbers
5. Submit a separate Word document that lists the names of ALL of the previously-approved instruments that are currently being used in the study. If, changes are being proposed to any instrument or if any instrument is being removed or added, please submit an amendment to reflect the changes. Additionally, submit a list to document all of the non-changed instruments.
6. Submit documents to be re-reviewed and approved as separate documents, including consent forms (submit as a Word document), advertisements etc. Please see point #5 for instructions for re-submitting study instruments.
7. Submit all applicable documents as listed in the Checklist on the Continuing Review Form
8. Submit your application packet and all supporting documents through the IRB inbox

What Happens if IRB Approval has Lapsed

If your approval has expired in the last 30 days, please complete a Continuing Review application as well as an Event Form (to document the lapsed status and corrective action).

If your approval has been expired for > 30 days, you will need to submit a new IRB application. If you wish to utilize data from your lapsed protocol, please reference this request in your new application form.

In accordance with Federal Regulations, all human subjects related activities (including, but not limited to, enrollment, randomization, recruitment, data collection, study interventions, data analysis and long-term follow-up) must cease until IRB approval is re-obtained. Conducting human subject research, without IRB approval is a violation of institutional policy.

Annual Review Reminders

As a courtesy, the IRB sends out email reminders to studies requiring annual re-review. Reminders are sent six (6) and two (2) weeks prior to study expiration.

Additionally, on your end, there are steps that can be taken to ensure expiration does not occur. To help keep track of study expiration, we suggest that you add a reminder to your Outlook calendar.

Alternatively, you could create a shared Google Calendar where important study-related deadlines/tasks could be managed and accessed by concerned members of your team.

When a Study can be closed

If ALL of the below are true, your research study can be closed:

• The study is permanently closed to enrollment
• All subjects have completed all study procedures
• Data collection is complete
• Analysis of identifiable* (directly or indirectly) data is complete
• All identifiers* (including codes, links, or key to identifiers) have been destroyed

If your study has closed, please complete the Final Report Form and submit to the IRB.

* See the definitions list for additional clarity.