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. Please see our guidance on conducting research with these populations.

For specific questions regarding research involving Native American or International Indigenous Populations, contact Claudia Nelson at cen@arizona.edu.

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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). If the University of Arizona IRB is the IRB of Record for another site, the site must follow the same requirements. For additional information, please see our guidance on Reporting New Information. 

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Does my research require IRB approval?

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

Human subjects research is a systematic investigation (research question/hypothesis testing), designed to contribute to generalizable knowledge (add to the scientific knowledgebase in the field) done so while intervening or interacting with living individuals or their identifiable data. For additional information, please see our guidance on What is Human Research and watch our pre-recorded training video: Does Your Project Require IRB Review? 

If you are still unsure whether or not your study is human subjects research, complete and submit the IRB Protocol for Determination of Human Research in eIRB. 

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