IRB Process

The process for protecting human research subjects reflects federal regulations and University of Arizona policies. Below are College of Nursing and Human Subjects Protection Program procedures and processes for obtaining approval of your research/DNP Project/scholarly project, making changes to an approved project, renewal of your project, and concluding your project.

New Project

Approval/determination is required prior to initiating any project. The application form and all required documents will be submitted for approval/determination to the Human Subjects Protection Program by the Office of Research & Scholarship. The following are steps in completing the process to obtain approval/determination

  • Complete the relevant form
    • Determination of Human Research
    • Application for Human Research 
  • Forms can be found at http://rgw.arizona.edu/compliance/human-subjects-protection-program
  • The template for consent documents can also be found at this site. A template for a Disclosure form can be found at: https://www.nursing.arizona.edu/resources/faqs-helpful-hints-tips-comple...
  • Students are expected to work closely with their Committee Chair when completing the form.
  • E-mail completed form and supporting documents to
    • Alice Pasvogel (Office of Research & Scholarship) apasv@email.arizona.edu
    • All material must be included to facilitate the review process
    • Principal Investigator will be notified of any concerns or recommended revisions
  • The Office of Research & Scholarship will
    • Send the material to the College of Nursing Departmental Review Committee
  • The Departmental Review Committee will
    • Review the material
    • The Principal Investigator will be notified if there are any concerns or recommended revisions
    • Review the revised documents
  • The Office of Research & Scholarship will
    • Obtain confirmation email from Advisor (Committee Chair) for student projects
    • Obtain the confirmation email for Scientific/Scholarly Review, if needed
    • Obtain the confirmation email for Department/Center/Section Review
    • Send the documents to the University of Arizona Human Subjects Protection Program
  • Human Subject Protection Program will notify the PI of the need for changes or approval/determination for the project
  • When approved, the Principal Investigator will receive
    • Approval/Determination Letter
    • Consenting document(s) with an IRB approval stamp and expiration date (if applicable)
  • Allow at least 2 months for the process from submission of the material to the Office of Research & Scholarship to approval/determination

Amendment (Changes to an Approved Project)

The Human Subjects Protection Program must approve all changes to previously approved research prior to implementing the change unless it is to eliminate apparent hazards to the participant. Modifications/additions include: protocol changes, personnel changes, recruitment material, form changes/additions (consents, questionnaires), enrollment changes, etc. Review the guidance received with your approval regarding when an amendment is needed.

Renewal/Concluding a Project

The Human Subjects Protection Program will email the Principal Investigator 60 and 30 days prior to the expiration date of the project. Materials must be submitted to the Human Subjects Protection Program 30 to 45 days prior to the expiration date. If re-approval is not obtained prior to the expiration date, the project will be administratively closed by the Human Subjects Protection Program.

  • Complete the Renewal/Closure for Human Subjects
  • The form can be found at http://rgw.arizona.edu/compliance/human-subjects-protection-program
  • E-mail to Alice Pasvogel (Office of Research & Scholarship) apasv@email.arizona.edu
    • Completed form
    • Copy of the consent documents to be used in the next approval period (if applicable)
    • Other documents (if applicable)
  • The Office of Research & Scholarship will
    • Obtain the confirmation email of the Department Head/Designee Approval if needed
    • Send documents to the University of Arizona Human Subjects Protection Program
  • The PI will be notified of new approval dates for the project
    • Stamped Consent document(s) with a new expiration date will be emailed to the Principal Investigator (if applicable)

Please note: The Principal Investigator does not need to wait until the next scheduled review to officially conclude a study. The Renewal/Closure for Human Subjects can be submitted whenever study activities are completed. Prior to graduation, students must submit the required paperwork to conclude their project.

Potentially Problematic Events

Events may occur that were not planned or anticipated. These events may place participants at risk and must be reported to the Human Subjects Protection Program.

  • Any of the following events must be reported to the Human Subjects Protection Program within 10 business days of discovery:
    • Unanticipated problem involving risk to subjects
    • Information that indicates new or increased risk
    • Breach of confidentiality
    • Change to protocol without prior IRB review to eliminate immediate hazard to subjects
    • Unresolved complaint of a subject
    • Audit, inspection, or inquiry by a federal agency
    • Failure to follow protocol
    • Participant unexpectedly becomes a prisoner
    • Any other problem the PI believes needs to be reported to the IRB
  • Report event to the College of Nursing Associate Dean for Research
  • Complete the Amendment to Approved Human Research
  • E-mail completed form to Alice Pasvogel (Office of Research & Scholarship) at apasv@email.arizona.edu
  • Principal Investigator will be notified if additional information is needed
  • The Office of Research & Scholarship will
    • Obtain the confirmation email of the Departmental Head/Designee Approval
    • Send documents to the University of Arizona Human Subjects Protection Program