The University of Arizona

Amendments and Reportables

Report Misconduct

Ethics Hotline

HSPP Contacts

VPR-IRB@email.arizona.edu

Mariette Marsh, Director
(520) 626-7575

Andi Encinas, IRB Manager
(520) 626-8630

Liz Baldry, IRB Associate
(520) 626-0256

Mason Burchfield, IRB Associate
(520) 626-0433

Gina Fimbres, IRB Associate
(520) 626-0026

Christine Melton-Lopez, IRB Coordinator
(520) 626-5859

Courtney Olson, IRB Associate
(520) 626-1744

Darlene Villicana, IRB Associate
(520) 626-6282

Street Address
1618 E. Helen Street
Tucson, AZ 85721

Mailing Address
POB 210409
Tucson, AZ 85721


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F109: Amendment of Key Personnel (Word)

F213: Amending Approved Human Research (Word)

  • This form is used to request approval to an amendment of previous approved human subject research.
  • For minor amendments (typographical errors, updates to contact information, etc.) use F215: Minor Amendment of Approved Human Research.

See Amending Approved Research for guidance.

F215: Minor Amendment of Approved Human Research (Word)
Use this form if you have minor changes to your documents that have been previous approved by the IRB. Minor changes include, but are not limited to:

  • Typographical, format, and grammatical changes.
  • Updates to contact information
  • New recruitment tools using IRB approved language
  • Translations to documents where the English version is IRB approved
  • Adding site authorization for a research site

See Amending Approved Research for guidance.

F216: Notify IRB (Word)
Use this form to notify the IRB of the following:

  • Updated Investigational Brochure when the updates do not change the risk of the project or the informed consent
  • Updated Site Authorization for a new period of approval
  • Updated sponsor protocol with no local changes and no changes to the consent
  • Data Safety Monitoring Board (DSMB) updates that do not increase risk
  • Site monitor reports that do not increase risk

F224: Reportable Local New Information that is Potentially Problematic (Word)
This form is used to report information (events) that may be problematic to the conduct of the research to the IRB. This information must be reported within ten (10) business days of the discovery of the information.  See the Adverse Events Flowchart for information.

  • Examples of information that must be reported include, but is not limited to:
  • Unanticipated Problems (UP) involving Risks to subjects or others
  • Information that indicates a new or increased risk
  • Withdrawal, restriction, or modification of drug/device/biological approval from the FDA or Sponsor.
  • A breach of confidentiality involving a subject
  • Changes to the protocol made without prior IRB review to eliminate an apparent immediate hazard to subjects
  • Complaint of a subject that indicated unexpected risks or that cannot be resolved by the study team.