Health Information is among the most sensitive types of personal information. The Health Insurance Portability and Accountability Act of 1996 (also known as HIPAA) protects the privacy and security of patient health information. Protected Health Information (PHI) under HIPAA includes oral, written or electronic information that relates to an individual’s physical or mental health, or the provision of health care to an individual or payment for health care. In most instances, investigators must obtain an authoriation (Form B) from the research participant or a waiver of the requirement for an authorization before accessing PHI. More information on the HIPAA Privacy Rules can be found HERE. The full biomedical consent template with the HIPAA language included in English can be found HERE (see consent templates).HIPAA Research Authorization Consent Templates
Authorization for the Release of Individually Health Information for Research
JMH Research Authorization
JMH Research Authorization (Creole)
JMH Research Authorization (Spanish)
UM Research Authorization
UM Research Authorization (Creole)
UM Research Authorization (Spanish)
Other HIPAA Forms
*HIPAA waiver form (to waive the requirement for signature and date) *Only required when the protocol is NOT being revised For guidance on COVID, please review our Covid Page
HRP - 216 – FORM – Application for External IRB Reliance HRP - 217 - FORM - Application For IRB Review of External Site
The HSRO recommends the use of the NIH IRB Authorization Agreement template for reliance on external IRBs.