These consent form templates have been posted for your reference.  When completing and IRB submission in IRBIS, please fill in the application and use the consent form builder specific to your project.  For more information, please find instructions here.

Summary of Changes to Consent Documents:

Summary of Changes to the Regulations for Informed Consent: Revised Common Rule Changes to Informed Consent and Waiver Requirements

• Informed Consent Documents – 08/05/2024 Summary of Changes
• Informed Consent Documents – 04/10/2023 Summary of Changes
• Informed Consent Documents – 10/26/2020 Summary of Changes
• Informed Consent Documents – 01/17/2020 Summary of Changes
• Informed Consent Documents – 12/05/2018 Summary of Changes

There are a few additional forms that are not provided online and may be accessed below.  As needed, these should be completed and uploaded to your IRB application.

Foreign Language Consent Forms

COVID-19 Related Forms:

• Spanish-IRB-COVID Information Sheet
• Spanish COVID Consent Letter v2
• Spanish COVID Informational Sheet Translation Certificate

Informed Consent Short Form

Informed Consent Short Forms are for a single subject who may be illiterate, or otherwise unable to read the consent form. It is used when the full consent form has to be read or translated for subject. Guidance for using the Short Form.

• English
• Spanish
• Arabic
• French
• Italian
• Japanese
• Korean
• Portuguese (Brazil)
• Russian
• Simplified Chinese

HIPAA Templates

• Sample HIPAA Authorization Template (updated 02/2026)
• Sample Spanish Language HIPAA Authorization Template (updated 05/2025)

Additional Documents and Forms

A collection of helpful documents and forms, such as device-related, drug-related, recruitment, and other forms are available online.

Concise Summary examples can be found here.

Guidance on the use of plain language in consent forms:

• Clinical Research Glossary