Human Subjects Protection Program

I'm conducting human subjects research in a vulnerable population. What do I need to know?

The HSPP considers Children, Cognitively Impaired Individuals, Pregnant Women and Neonates, Prisoners, and Native American or International Indigenous Populations to be vulnerable populations that require additional protections and safeguards. When your targeted study population includes one or more of these vulnerable populations, the appropriate Appendix for Vulnerable Populations is required with your eIRB submission.

Who can I contact if I have immediate questions?

For questions that require immediate attention, please email the general inbox at VPR-IRB@arizona.edu. This inbox is continuously monitored, and your questions will be directed to the appropriate individual.

How do I report an unanticipated complication and/or adverse event?

Investigators are required to report local problems, concerns, serious risks, and failure to follow the protocol to the IRB for all human subjects research. These reports must be submitted to the IRB within ten (10) business days of discovery. Changes made to eliminate risk to subjects must be reported to the IRB within five (5) business days of discovery. Reportable items must be submitted in eIRB as a Reportable New Information (RNI).

I need IRB approval. Where do I start?

Please visit our Getting Started webpage.

Does my research require IRB approval?

IRB review and approval is required for research projects involving human subjects.

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