The HIPAA Privacy Rule is a set of federal regulations providing protections for the confidentiality of health information used in clinical practice, research, and the operations of health care facilities. The intended purpose of the Privacy Rule is to ensure that health information confidentiality risks are minimized.

Studies using or disclosing protected health information (PHI) subject to HIPAA requirements may need to obtain authorization from participants in addition to informed consent. IRB template consent documents include template authorization language.

• HRP-502 – TEMPLATE CONSENT DOCUMENT

The authorization form must include all required elements and statements to be valid, unless the IRB has approved an altered authorization form. Review HRP-330- WORKSHEET: HIPAA Authorization, to ensure all elements and statements are addressed.

• HRP-502a – EXEMPT CONSENT DOCUMENT

For exempt studies, altered authorization should be requested as the language included in the information sheet is condensed and does not include all required elements or a signature line.

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 VA typically requires a separate authorization. See the section on VA Requirements in this manual for more information.