After Approval

Changing Personnel and/or Study Procedures

Modifications on non-exempt studies 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 study.
• When researchers update the techniques, recruitment, survey questions, assessments, compensation, or other methodologies in an approved IRB protocol.

PERA IRB training is available: Study Modifications and Update Study Details

Reporting Adverse Events or Deviations

Review “What are my obligations after IRB approval?” and “What if something goes wrong with my study?” in HRP-103 - INVESTIGATOR MANUAL to determine if you have a reportable event, noting that non-compliance and serious adverse events must be reported to the HRPP/IRB office within 48 hours of the investigator learning of the incident.

Reportable New Information (RNI) must be submitted in PERA IRB. Anyone can submit an RNI on any study at any time.

To report anonymously via Purdue’s Hotline, see www.purdue.edu/hotline

Exempt research does not require renewal by the IRB.

Other approved protocols, depending on conditions set by IRB, may need to be renewed. Studies reviewed by expedited review will need to submit a Continuing Review every three years to ensure the study is still ongoing and in good-standing.

Studies that require Continuing Review will need to be renewed at least annually by submitting a Continuing Review in PERA.

To ensure uninterrupted approval, be sure to submit your continuing review at least 30 days prior to the study’s expiration date!

Follow these steps for study renewals.

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 HRP-096-SOP- Post Approval Monitoring. In-person reviews are conducted between the Post-Approval Monitoring Administrator 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.

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. Note that these are the same steps followed as submitting a Continuing Review.