The University of Arizona

Appendices

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

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Tucson, AZ 85721

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Appendix A: Children (Word)
This form should be used when children/wards are engaged in the research. Children are defined as individuals who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. See Research Involving Children for guidance.

Appendix B: Drugs and Devices (Word, PDF)
This form should be used when the Human Research is a clinical investigation of a drug or device, which is "any experiment that involves a test article on one or more human subjects that either (1) requires FDA approval, or (2) is intended to be submitted to or inspected by the FDA for research or a marketing permit." (21 CFR 50.3(c))

Appendix C: Multi-Site Research (Word)
A multi-site study is a study that involves multiple institutions engaged in the research project. This form should be used when the University of Arizona IRB will review research activities for an investigator or research staff who are not affiliated with the University. See Ceded IRB Review for more information. This form is not needed if each research site will obtain their own IRB approval.

Appendix D: Pregnant Women and Neonates (Word)
This form should be used when pregnant women/ neonates are research subjects.  See the guidance on Pregnant Women and Neonates for more information.

Appendix E: Prisoners (Word)
This form should be used when prisoners are research subjects.  See the guidance on Prisoners for more information.

Appendix F: Waivers of Consent and Signatures or Alterations (Word)
This form is used when a waiver of informed consent, alteration of consent, or alteration or waiver of protected health information (PHI) is needed.

Appendix G: Exceptions from Informed Consent (EFIC) (Word)
This form is used when an exception from informed consent is needed.

Appendix H: Native American or Indigenous Research (Word)
This form is used when an the research includes Native American or Indigenous individuals as participants. See the guidance on Native Americans or International Indigenous Population for more information.