Congratulations on the initial IRB approval of your study!
The IRB-HSR staff look forward to continuing to work with you and your study team over the life of the study to help support you as the PI in ensuring ongoing compliance for your study.
Please see the drop-down menus below for common touch points where the study team and IRB connect. If you have any questions, please reach out to us and we are happy to help you.
Changing Personnel and/or Study Procedures
The IRB system is used for all study modifications. Modifications must be approved by the IRB prior to changing the study. Common reasons to modify a study include:
When key personnel are added to or removed from a project.
When researchers update the techniques, recruitment, survey questions, assessments, compensation, or other methodologies in an approved IRB protocol.
Follow these steps to submit a study modification.
Reporting Adverse Events or Deviations
Promptly report any adverse events or deviations to the protocol if they occur.
When should I report problems to the IRB?
Follow these steps to submit an incident report.
Click here to report on unanticipated and/or serious adverse events.
Click here to report a protocol deviation or noncompliance.
Research that has been determined to be exempt does not require renewal by the IRB.
Other approved protocols, depending on the level of risk in the study, may need to be renewed.
To ensure uninterrupted IRB approval, be sure to submit your continuing review prior to the study’s expiration date!
Follow these continuing review steps to renew the IRB approval for your study.
Routine review is a necessary component of an IRB protocol and contributes toward the shared goal of human subjects research protections. Monitoring is conducted in accordance with University of Virginia HRPP Standard Operating Procedure. In-person reviews are conducted between designated post-approval monitoring staff and research personnel to confirm that all measures are documented appropriately in an IRB approved protocol.
Click here to learn more about Post-Approval Monitoring. Review Process
After you have completed your research, you will need to close the study. In most cases, study data should be kept in a secure location (hard copy or electronic) for a minimum of three years. Some retention times may be longer; contact IRB should you have questions.
Follow these steps to close a study.
As with all university records, research records need to be maintained after the closure of the study for a set period of time. The retention times are subject to federal and state laws as well as university policies and contracts with the study sponsor. The most conservative duration for retention time should be honored. See our page on record retention for more details and always check with UVA's Records and Information Management office to confirm approval before destroying old records.
If you have any questions about these processes, please contact irbhsr@virginia.edu.