Here you'll find answers to frequently asked questions about human subjects research at the University of Arizona.
1. What qualifies as human subjects research?
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 Determination of Human Research Form.
2. I need IRB approval. Where do I start?
Please visit our Getting Started webpage.
3. 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 on the Amendment and Reportable to Approved Human Research form. 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 Local Information.
4. Who can I contact if I have immediate questions?
For questions that require immediate attention, please email the general inbox at VPR-IRB@email.arizona.edu. This inbox is continuously monitored, and your questions will be directed to the appropriate individual.
5. I'm conducting human subjects research in a vulnerable population. What do I need to know?
The HSPP considers Children, 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 Appendix for Vulnerable Populations is required with your submission to the IRB. Please see our guidance on conducting research in these population:
- Research Involving Children
- Research Involving Pregnant Women
- Research Involving Neonates
- Research Involving Prisoners
- Research Involving Native American or International Indigenous Populations
For specific questions regarding research involving Native American or International Indigenous Populations, please contact Claudia Nelson at firstname.lastname@example.org.
6. I'm conducting human subjects research in an international location. What do I need to know?
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. The HSPP requires your travel be registered and approved before any research begins. For more information on conducting international research, please visit the Office for Human Research Protections' webpage on International Compilation of Human Research Standards.
7. I'm using Banner Health resources. What do I need to know?
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 Intake Application (RIA). Upon submission to the IRB, please include the RIA approval email generated from UAHS. In addition, the IRB also requires that the UA Medical Consent Form be used when Banner Health resources will be utilized.
8. What training opportunities are available?
The HSPP offers a variety of training opportunities including Brown Bag Sessions 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@email.arizona.edu.