Elements of Informed Consent
All consent forms must include the required Elements of Informed Consent. Templates provided below already include these elements. This document can be used as a reference tool to ensure consent forms include all required elements of informed consent. This is particularly useful if you decide to create your own consent form.
This consent template is for externally-funded or supported, non-medical research. This consent should be used to obtain permission from subjects or the parent(s) of subjects (if minors will be enrolled) to participate in research being conducted by the University of Arizona. This consent template is required for externally-funded or supported, non-medical research.
This consent template is for internally-funded or non-funded, non-medical research. This consent should be used to obtain permission from subjects or the parent(s) of subjects (if minors will be enrolled) 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 of informed consent provided above.
This consent template is required for any medical research. If research is occurring at Banner– University Medical Centers Tucson, South or Phoenix campuses please include the grey language within the document and the Banner-UA logo. The template combines informed consent and Protected Health Information (PHI) required language. This consent template is required.
Additional Consent Templates
This assent form should be used to obtain assent from minors to participate in research being conducted by the University of Arizona. This assent template is recommended, but not required, when children between the ages of 8-12 years will be enrolled.
This assent form should be used to obtain assent from minors to participate in research being conducted by the University of Arizona. This assent template is recommended, but not required, when children between the ages of 13-17 years will be enrolled.
This consent addendum template should be used when there is a new portion of a research project that requires a participant’s signature. This template is recommended, but not required.
Using the Short Consent Form
Short Consent Form
These templates are from the National Institutes of Health (NIH) Office of Human Research Protections and are 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 a short form is used more than five times for one language, the IRB will require that the project be amended to provide fully translated consent forms to be used with that population. Note, it is at the discretion of the IRB Chair to request fully translated documents at any time.
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. A Modification should be submitted in eIRB 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 a Reportable New Information (RNI) in eIRB. This information is also reportable on the Continuing Review Smart Form in eIRB, if applicable.
For FDA-regulated studies, the investigator must promptly obtain a translated copy of the IRB-approved English version of the consent form and submit it to the IRB for review and approval via a Modification in eIRB. Once the translated consent form is approved by the IRB, the investigator must provide it to the subject as soon as possible. Please review the FDA Guidance on Informed Consent for more information.
HIPAA Authorization and the Short Form Process
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.
If a fully translated HIPAA authorization will not be provided during the short form process, the project must have an approved Waiver of PHI Authorization on file. Banner Health has available a Stand-alone HIPAA Spanish Authorization form that should be used during a Spanish short form discussion. This document does not require review by the IRB before use.