Human Subjects - IRB

What is Human Research?

Let’s start with a few definitions.

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

If your proposed research includes actions which fall into both of the definitions above, then you are undertaking Human Subjects Research and you will need to obtain approval from the Institutional Review Board (IRB) before you can start your research.

If you are unsure if your research falls into the definitions, you may review further information clarifying Human Research.

 

What is the IRB?

The IRB is an independent review committee charged with the protection of human research subjects. An IRB must review all research and related activities involving human subjects conducted at the University of Arizona or in which the University is a responsible participant.

At the University of Arizona we have a dedicated Human Subjects Protection Program (HSPP) who provide the administrative and regulatory support for the IRB and work with in collaboration with the research community to maintain an ethical and compliant research program.

 

My research involves Human Research and needs IRB approval, where do I start?

Serving as a Principal Investigator (PI) on a human research project carries important responsibilities.The PI bears ultimate responsibility for the design, conduct, reporting and management of human research.

The Office of Research, Innovation & Impact (RII) has set guidelines that must be met for the consideration of granting status as a Principal Investigator to any individual.

If a graduate student at the College of Education is serving as the PI, then an eligible PI is required to serve as Co-PI per RII guideline. The advisor must have current human subject training and attest on the IRB submission that they will mentor and oversee the student. They must also be listed as a Co-PI on the protocol

All study team members engaged in human subjects research for your project are required to complete the University of Arizona human subjects component of the Collaborative Institutional Training Initiative (CITI) online training program.

For social/behavioral projects, researchers must complete the CITI Social Behavioral and Native American Research modules. For biomedical projects, researchers must complete the CITI Biomedical and Native American Research modules.

The CITI certificate is valid for four (4) years, after which refresher training must be completed. You should receive an email 90 days before your training will expire. Once received, follow the instructions to complete the refresher courses.   

For projects that involve Banner Health electronic medical records (EMR), researchers must also complete the UA HIPAA Privacy training

All researchers are also required to complete Conflict of Interest (COI) training.

The HSPP has comprehensive guidance on all aspects of IRB submission including

 

COE Dedicated IRB Resource

At the College of Education, we have a dedicated IRB resource, Anna Bounds, who can support you throughout this process.  The support Anna offers is tailored to the individual needs of a PI, but can include:

  • Help clarifying whether research requires an IRB;
  • Identification of all relevant IRB forms and documents required for submission;
  • Preparation of draft documentation, including consent forms, appendices and protocols
  • Set up workflows in the eIRB submission system
  • Assist with amendments and queries from IRB staff during protocol review

If you would like help from Anna, please complete the inquiry form, providing a little information about your proposed research. She will review all the information you have provided and then arrange a meeting to discuss how best to support you through the IRB submission process. 

You can also contact Anna directly by email.