IRB Review & Approval
Federal regulations and KP policy prohibit the involvement of human subjects in research until the IRB has reviewed and approved the research, including the protocol and informed consent process. The IRB must:
- Approve all research and research documents prior to use, and
- Review and monitor the progress of the research, with special emphasis on the experience of human participants, until the project is complete and a final report has been received and accepted by the IRB.
The IRB has the responsibility and authority to verify whether projects qualify as human subjects research or are exempt from IRB review.
The IRB Inquiry Form is found in the IRBNet Forms and Templates. Use this form when:
- You are not sure if your project requires IRB oversight, or
- You would like a formal determination from the IRB as to whether the project requires IRB oversight, or
- You are conducting research with specimens or data that are not individually identifiable to the research team, but the project involves genetic research.
Upload the Inquiry Form in the IRBNet in place of, or in addition to, a protocol. Note: Inquiries do not require Core Data or Study Team Forms.
If your funding agency requires IRB approval before you have developed the materials needed to submit your study to the IRB, contact the IRB office directly to discuss solutions.
IRB decisions can be appealed in accordance with the IRB Appeal Procedures.