Sample Consent Forms
Consent Form Templates
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 the Regulations for Informed Consent: Revised Common Rule Changes to Informed Consent and Waiver Requirements
Summary of Changes to Consent Documents:
- Informed Consent Documents – Version 2.0 Summary of Changes
- Informed Consent Documents – Version 2.1 Summary of Changes
- Informed Consent Documents – 10/26/2020 Summary of Changes
- Informed Consent Documents – 4/10/2023 Summary of Changes
| Consent Document Type | Last Updated |
|---|---|
| Adult Consent Form | 2024-08-05 |
| Stored Specimens with Identifiers | 2020-01-17 |
| Stored Specimens without Identifiers | 2020-01-17 |
| Parental Permission Form | 2024-08-05 |
| Assent Form Ages 15-17 | 2024-08-05 |
| Assent Form Ages 7-14 | 2024-08-05 |
| Information or Fact Sheet | 2024-08-05 |
| The following documents are samples. IRBIS does NOT generate these documents with application-specific information. | |
| Addendum to provide additional information to subject after original consent | 2024-08-05 |
| Consent Form for Case Report A single case study does not require IRB approval, but this document is provided for convenience. | 2017-08-27 |
| Debriefing Template | 2018-04-19 |
| Expanded Access Devices Consent Template | 2025-04-16 |
| Expanded Access Drugs Consent Template | 2025-04-16 |
| Exempt Research Information Sheet | 2025-04-22 |
| Schedule of Events | 2025-05-08 |
| SSN Collection for Medicare Recipients | 2017-04-17 |
Concise Summary examples can be found here.
Guidance on the use of plain language in consent forms:
- Clinical Research Glossary
- Webinar: The Promise of Plain Language: Launching a Glossary to Support Participant Understanding of Clinical Research – Recording & Slides
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 (for a single subject who may be illiterate, or otherwise unable to read the consent form — used when full consent form has to be read or translated for subject).
- Informed Consent Short Form Guidance
- English
- Spanish
- Arabic
- French
- Italian
- Japanese
- Korean
- Russian
- Simplified Chinese
HIPAA Templates
- Sample HIPAA Authorization Template (updated 5/9/2025)
- Sample HIPAA Authorization Template in Spanish (coming soon)