T502a: Informed Consent Form Template (version 2016-07) (Word)
This consent template is for non-medical research. It should be used to obtain permission from subjects to participate in research being conducted by the University of Arizona. This consent template is recommended, but not required. If this consent template is not going to be used, please develop a consent form that addresses the required elements of consent.
T503a: University of Arizona- Banner Health Consent Form Template (version 2016-10) (Word)
This consent template is required for any research occurring at Banner– University Medical Centers Tucson, South or Phoenix campuses. This consent template is required to be used as of September 1 2016. The template combines informed consent and Protected Health Information (PHI) required language.
T502b: Addendum Template (version 2016-07) (Word)
This consent addendum template should be used when there is a new portion of a research project that requires a participants’ signature. This template is recommended, but not required.
T504a: PHI Authorization Form Template (revised January 2016) (Word)
A written authorization if required for the use or disclosure of Protected Health Information. The authorization must be completed and signed by the individual with authority to authorize use or disclosure, i.e., the individual or their personal representative. All authorizations must be documented and retained.
See Requirements for Obtaining Information Consent for guidance.
C101: Protected Health Information (PHI) Guidelines (Word)
Provides language for combining a Protected Health Information (PHI) authorization with the Subject Consent Form.
Additional Consent Templates
Using the Short Consent Form
Short Consent Form (from the University of Minnesota)
Consent form in English, Spanish, and other languages.
Instructions for using the Short Form
What is a short form?
A short form is a written document stating that the elements of informed consent required by 45 CFR 46.116 have been presented to the subject or the subject's legally authorized representative.
When can a short form be used?
A short form can be used when the majority of subjects are English-speaking, but a small portion of the sample population is expected to prefer the consent process to be conducted in another language. Use of the short form to obtain consent ensures equal access for potential participants.
If the majority of the anticipated subjects to be enrolled do not speak English or will be unable to understand the consent form written in English, the consent form must be translated into a language understandable to the subjects.
How to use short forms
A short form must be used in conjunction with an oral presentation of the consent information required by 45 CFR 46.116. A summary of what will be said to the subject or representative must be approved by the IRB and then presented orally to the subject or representative in front of a witness. A copy of the short form and a copy of the summary must be given to the subject or representative.
Required signatures with short forms
- Short Form - Subject/Representative and the Witness
- Copy of Summary - Witness and Person obtaining consent
What must be approved by the IRB?
Use of a short form must be reviewed by the IRB prior to use. F213: Amendment of Approved Human Research should be submitted to the IRB with the following information:
- Justification for the use of the short form.
- Summary of what will be presented to the subject or representative (this can be the English version of the informed consent document).
- Text of short form or assurance that University of Minnesota IRB Short Forms will be used.
After a short form has been used with a subject submit the F216: Notify IRB. This information is also reportable on the Renewal Progress Report.
How is Protected Health Information (PHI) Authorization obtained when a short form process is used?
There is no short form process for obtaining PHI Authorization. A full PHI Authorization must be translated and used in addition to the IRB approved short form consent process.