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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:

Consent Document Type Last Updated
Adult Consent Form 2023-07-14
Stored Specimens with Identifiers 2020-01-17
Stored Specimens without Identifiers 2020-01-17
Parental Permission Form 2020-01-17
Assent Form Ages 15-17 2023-04-10
Assent Form Ages 7-14 2023-06-27
Consent Addendum for Unencrypted Communication 2020-10-26
Information or Fact Sheet 2023-04-10
The following documents are samples.
IRBIS does NOT generate these documents with application-specific information.
Exempt Research Information Sheet 2017-10-30
Addendum to provide additional information to subject after original consent 2013-03-14
SSN Collection for Medicare Recipients 2017-04-17
Debriefing Template 2018-04-19

Concise Summary examples can be found here.

Guidance on the use of plain language in consent forms:

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:

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).

HIPAA Templates