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 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.