HRP-502-TEMPLATE CONSENT DOCUMENT includes language to add to your consent form if your study is subject to HIPAA. You are encouraged to use a combined consent and authorization form. In the event you need a separate authorization form, refer to the Templates page.

The consent/authorization document should be uploaded to the application in Word format, as this allows for reviewer edits and comments to be easily placed in the document.

Note that all required elements and statements found in HRP-330-WORKSHEET: HIPAA Authorization must be included in your authorization form, absent an IRB approved altered authorization or waiver of authorization.

Studies that meet the requirements for an exemption and that collect and analyze identifiable health information may still be subject to HIPAA and may require an authorization, an IRB waiver of authorization or a data use agreement.