Frequently Asked Questions about Human Subjects Protection

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The HSPP offers a variety of training opportunities including workshops and Office Hours. For training details, please visit the IRB Training Opportunities webpage. If you are interested in requesting training on a specific topic or are interested in having an HSPP member present at a class, lab, or faculty meeting, please contact the general inbox at VPR-IRB@arizona.edu

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Prior to IRB submission, all projects that will utilize Banner Health resources (i.e., facilities, patients, employees) must be entered into the University of Arizona Health Sciences (UAHS) Research Administration Portal (RAP). Upon submission to the IRB, please upload RAP approval to eIRB. In addition, the IRB also requires that the UA Medical Consent Form be used when Banner Health resources will be utilized.

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If you are traveling outside of the United States to conduct human subjects research, you will need to register your travel with the UA Travel Registry. For more information on conducting international research, please visit the Office for Human Research Protections' webpage on International Compilation of Human Research Standards.

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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 population includes one or more of these vulnerable populations, the appropriate Appendix for Vulnerable Populations is required with your submission eIRB. Please see our guidance on conducting research in these population:

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

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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. 

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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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Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Human subject means a living individual about whom an investigator (whether professional or student) conducting research (a) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (b) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. For additional information, please see our guidance on What is Human Research

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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