After Approval
Research evolves over time. Therefore, your approved protocol may require revision to update procedures or add personnel. You also may need to renew your protocol depending on it's type. Finally, when a project ends, you will need to close your protocol with IRB.
If anything in your protocol changes after approval, you will need to amend your IRB protocol.
Changing Personnel and/or Study Procedures
The Cayuse IRB system is now 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.
If an adverse event or something unexpected occurs, notify the IRB.
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 in Cayuse IRB.
Click here to report on unanticipated and/or adverse events.
Click here to report a protocol deviation or noncompliance.
Please complete the appropriate form and e-mail to irb@purdue.edu
Some approved protocols require periodic IRB renewal
Research that has been determined to be exempt does not require renewal by the IRB.
Other approved protocols, depending on conditions set by IRB, may need to be renewed.
To ensure uninterrupted approval, be sure to submit your continuing review prior to the study’s expiration date!
Post Approval Monitoring
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 Purdue University HRPP Standard Operating Procedure 306, “Post Approval Monitoring”. 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.
When you’ve completed your research, you will need to close your protocol with IRB
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.
If you have any questions about these processes, please contact irb@purdue.edu.
