Form to be completed when the University of Arizona acts as the IRB for other institutions.

Checklist listing the information that must be included in an informed consent for human subjects research.

Outlines the responsibilities of physicians, IRBs, and Humanitarian Device Exemption (HDE) holders.

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.