My Quorum consent form does not have a section on HIPAA. Do I need to have participants sign a separate HIPAA document?
If the model consent does not contain a HIPAA section, your site needs to present a HIPAA authorization according to your site’s requirements. The Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) requires investigators who are “covered entities” to obtain a HIPAA Authorization from each participant in a research trial. Obtaining a HIPAA Authorization from a research participant allows the investigator to use and disclose the participant’s protected health information (PHI) for research purposes.