Human Subjects Protection & Compliance

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/scholarly project, making changes to an approved project, the annual renewal of your project and concluding your project.

New Project

Approval is required prior to initiating any project. All projects with the application form signed by the appropriate individuals and all required documents attached will be submitted for approval to the Human Subjects Protection Program by the Office of Nursing Research.

  • Complete the relevant form
    • Determination of Human Research
    • Application for Human Research (F200)
    • Application for Retrospective Review of Data or Specimens (F203)
    • Application for Ceded IRB Oversight (F204)
  • Forms can be found at http://rgw.arizona.edu/compliance/human-subjects-protection-program
  • The template for consent documents and Elements of Informed Consent can also be found at this site
  • 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 Nursing Research) 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 Nursing Research will
    • Send the material to the College of Nursing Departmental Review Committee
  • The Departmental Review Committee will
    • Review the material
    • Notify the Principal Investigator if there are any concerns or recommended revisions
    • Review the changes and sign for Scientific/Scholarly Review
  • The Office of Nursing Research will
    • Obtain the signature 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 for the project
  • When approved, the Principal Investigator will receive
    • Approval 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 Nursing Research to approval of the project

Only consenting documents which bear a valid IRB approval stamp can be used for enrollment of research subjects.

Amendment (Changes to an Approved Project)

The Human Subjects Protection Program must approve all modifications to research activities and applications prior to implementation 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.

  • E-mail completed form to Alice Pasvogel (Office of Nursing Research) apasv@email.arizona.edu
  • Include a copy of all revised documents (consent documents, recruitment material, etc.)
  • Principal Investigator will be notified if additional information is needed
  • The Office of Nursing Research will
    • Obtain the signature of the Departmental Head or Designee
    • Send the documents to the University of Arizona Human Subjects Protection Program
  • The Human Subject Protection Program will notify the PI of approval for the modification or the need for additional information

All changes/modifications require approval prior to implementation.

Renewal/Concluding a Project

The Human Subjects Protection Program will email the Principal Investigator approximately 60 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.

  • The Office of Nursing Research will
    • Obtain the signature of the Department Head or Designee
    • 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)

Only consenting documents which bear a valid IRB approval stamp can be used for enrollment of research subjects.

Please note: The Principal Investigator does not need to wait until the next scheduled review to officially conclude a study. The Concluded/Admin Resolution (F212b) can be submitted whenever study activities are completed. Prior to graduation, honors, master's and doctoral 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 the occurrence:
    • New or increased risk, unanticipated harm related to the research
    • Non-compliance, audit or inquiry by a federal agency
    • Failure to follow protocol
    • Breach of confidentiality
    • Change to the protocol to eliminate an immediate hazard
    • Participant unexpectedly becomes a prisoner
    • Unresolved complaint of a subject
    • Unanticipated adverse devise effect
  • Report event to the College of Nursing Associate Dean for Research
  • E-mail completed form to Alice Pasvogel (Office of Nursing Research) at apasv@email.arizona.edu
  • Principal Investigator will be notified if additional information is needed
  • The Office of Nursing Research will
    • Obtain the signature of the Departmental Head or Designee
    • Send documents to the University of Arizona Human Subjects Protection Program