Human Subjects Protection Program

What is an Investigational Drug?

An investigational drug is defined as:

  • An article that is not approved (for marketing) in the US as a drug.
  • An approved drug that is not used according to the approved label (or a new combination of approved drugs).

What is a test article?

The term includes drugs (including botanicals, biologicals, and gene therapy, and genetically derived products that meet the definition of a “drug”), and medical devices for human use. The FDA has statutory authority to regulate the development and marketing of these products.

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(link sends e-mail)

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 upload RIA approval to eIRB.

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.

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 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:

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(link sends e-mail). 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).

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.

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