What is the difference between HIPAA “Authorization” and informed consent?
Informed consent is required under federal research regulations for the protection of human subjects. The HIPAA Privacy rule, a different regulation, separately requires that patients give written Authorization before a covered entity may use or disclose patients’ protected health information for research. There are different requirements for the content of informed consent and HIPAA Authorization; however both may be combined in one form (see templates on the HIPAA forms page). An IRB may waive both consent and Authorization if the research meets all of the waiver criteria established by each of the applicable regulations.
