Worksheet to assist the IRB or designated reviewers when evaluating an application for a Humanitarian Use Device (HUD).

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.

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))  Word Version.

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.

This form should be used when pregnant women/ neonates are research subjects.

This form is used when a waiver of informed consent, alteration of consent, or alteration or waiver of protected health information (PHI) is needed.

This form is used when an exception from informed consent is needed.

This form should be used when it is unclear whether the proposed activities require review by an Institutional Review Board (IRB). 

Request for investigators who are not affiliated with the University of Arizona to access University resources to conduct human research.

Presentation outlining the processes and procedures for submitting a project renewal to the IRB.  December 2015.