Human subjects research requires review and approval by an Institutional Review Board (IRB) before subject recruitment, data collection, or any use of Private Health Information (PHI).

The Scholarly Projects and Medical Student Research at the College of Medicine – Phoenix serves as a resource for investigators and students to ensure compliance with research protocols and IRB requirements. All student research involving human subjects must go through Keilana Valdez, MSc, Senior Research Specialist, to receive guidance on the necessary training and IRB application process.
If you need further IRB assistance, please complete Keilana’s IRB Support Google Form. to receive the most relevant forms and instructions.
 
Below are the steps to guide you through the process:
 
Step 1.  Reach out to Keilana for Protocol Process & Development.

Before starting the IRB process, please fill out Keilana's Google Form, which will help her provide the most relevant IRB forms and guidance tailored to your project. Keilana will create your eIRB draft on your behalf.

Step 2.  Determine if your project involves human subjects’ research.

Determining whether your project involves human subjects can be complex if you're unfamiliar with federal regulations. Generally, if your project includes data that identifies patients or involves interaction/intervention with participants, it is likely considered human subjects’ research.

To assist in making this determination, please complete the Determination of Human Research form.  Submit the completed form to Keilana and fill out her IRB Support Google Form for further assistance.

Step 3: If your project is human subjects research, complete required training.

If your project qualifies as human subjects research, you will need to complete both:

  • Collaborative Institutional Training Initiative (CITI): Complete the Biomedical Research Investigator CITI training course. Use the Single Sign-On (SSO) option to log in. Select "University of Arizona" from the institution list, and sign in with your NetID and password.
  • Conflict of Interest (COI): Contact Keilana to receive your eDisclosure form and any other relevant forms for research personnel.
Step 4: Fill out the human subject research application.

Once your project is confirmed as involving human subjects, you’ll need to complete the eIRB application items Keilana provides you with any necessary supplementary information for UA IRB review. Keilana will upload the eIRB items where they need to go in your eIRB draft set for submission.

The latest forms can be found on the HSPP website.

For additional resources and clinical research training, please visit the Clinical Research Training section on the website.