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  3. IRB Process

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 for obtaining approval of your research/DNP Project/scholarly project, making changes to an approved research project, and concluding your project.

New Project

IRB approval/determination is required prior to initiating any project.
The following are steps in completing the process to obtain IRB approval/determination.

Complete the relevant form:

  • IRB Protocol for Determination of Human Research
  • IRB Protocol for Human Subjects Research
  • IRB Protocol for Human Subjects Research – Retrospective Data Review
  • IRB Protocol for Projects Using External IRB

Forms can be found at https://research.arizona.edu/compliance/human-subjects-protection-progra...

 
 

Submit documents to Alice Pasvogel (apasv@arizona.edu) for review.

Include IRB Protocol form, recruitment material, consent document(s), participant material (educational video, written material as applicable), data collection tools, and site authorization as applicable.

 
 
Revise documents if requested
 
 
When documents are ready to submit in eIRB, Alice Pasvogel will obtain the Advisor Attestation (student projects) and send to student.
Alice Pasvogel will send the Attestation for Scientific Review and Department Review, if applicable.
 
 

In eIRB (https://uaccess.arizona.edu):

  • Complete the Smart Form
  • Assign Alice Pasvogel as Primary Contact
  • Assign DNP Project/Dissertation Chair as PI Proxy (students)
 
 
Notify Alice Pasvogel when Smart Form is complete (apasv@arizona.edu);
include Study Number (STUDY00001151) in the email.
 
 
Alice Pasvogel will review the Smart Form and let Principal Investigator know when it is ready to submit.
 
 
Submit documents in eIRB

Allow 1-2 months for the process from submission of documents to the Office of Research & Scholarship (to Alice Pasvogel) to IRB approval/determination.

Additional information about the process of obtaining IRB approval/determination:

Modification (Changes to Approved Human Subject Research)

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 include protocol changes; personnel changes; changes to recruitment material, consents, questionnaires; enrollment changes; etc. Review the guidance on the University of Arizona IRB website for exempt and minimal risk research regarding when a modification is needed (https://research.arizona.edu/compliance/human-subjects-protection-program/guidance-researchers).

In eIRB (https://uaccess.arizona.edu), open the approved study then click on Create Modification/CR and complete the form

E-mail Alice Pasvogel (apasv@arizona.edu) if Attestation for Department/Center/Section Review is needed

The Human Subject Protection Program will notify the PI of approval for the modification or if additional information is needed

Project Conclusion

In eIRB (https://uaccess.arizona.edu), open the approved study then click on Create Modification/CR

Complete and submit the form

Closures for deferred studies, those using an external IRB, should be submitted via the main study workspace Comment section by attaching the Closure Notice from the external site to the Comment; no other modification/submission is needed. Select notify “IRB Coordinator” to ensure that your submission is processed.

Please note:  Prior to graduation, students must conclude their project.

 

Reportable New Information

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
    • Incarceration of a subject enrolled in a protocol not approved to enroll prisoners
    • Unanticipated adverse device effect
    • Any conflict of interest previously undisclosed or managed
    • Any other problem the PI believes needs to be reported to the IRB

Report event to the College of Nursing Associate Dean for Research

E-mail Alice Pasvogel (apasv@arizona.edu) for the Attestation for Department/Center/Section Review

In eIRB (https://uaccess.arizona.edu), open the approved study then click on Report New Information and complete the form

Submit the RNI in eIRB. If changes to study materials are needed as a result of an RNI, submit a separate Modification in eIRB

 

Contact Information

Alice Pasvogel, PhD, RN
Assistant Research Scientist
apasv@arizona.edu