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Office of Research > Resources for Researchers > Compliance & Security > Human Research Protection Program > After Approval (HRPP)

After Approval

Information on this page may be outdated as we are no longer using Cayuse Human Ethics. Please refer to the PERA IRB Go-Live website for information on how to apply to the IRB.

Go to the PERA website

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 its type. Finally, when a project ends, you will need to close your protocol with IRB.

If you have any questions about these processes, please contact irb@purdue.edu.

If anything in your protocol changes after approval, you will need to amend your IRB protocol.

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.

Select a button below to access available PERA IRB training:

Study modifications
Update study details

If an adverse event or something unexpected occurs, notify the IRB.

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.

Use the button below to report anonymously via Purdue’s Hotline.

Submit a report

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.

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.

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.

steps to close a study

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