Is there a difference between informed consent and authorization?
Yes. Under the Privacy Rule, a patient’s authorization allows for the use and disclosure (or release) of “PHI for research purposes. In contrast, an individual’s informed consent is a consent to participate in the research study as a whole, not simply a consent for the research use or disclosure of PHI. For this reason, there are important differences between the Privacy Rule’s requirements for individual authorization, and the Common Rule’s and FDA’s requirements for informed consent. We will comply with all three sets of regulations, as applicable to our research activities.
