Tips for Creating a Consent Document

The consent form or study information sheet is a document used to guide your consenting process. The consent form should include several sections, which are called “elements.”

In order to help investigators create a consent document that includes all of the necessary elements, and is more readable, the IRB has created consent/assent form templates. We recommend that investigators use the templates OR use them as a guide in creating a consent document.

To get a sense of how the IRB reviews consent forms, please review the Consent Form Review Checklist. This document is used by the IRB reviewers when reviewing submissions and can be used as a guide when preparing your consent document.

Consent Language for Exempt Studies

Consent Language for Expedited or Full Board Studies

Consent Form Preparation Tips

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