Consent and HIPAA Authorization Forms
Informed consent provides research subjects with a description of the study and of its anticipated risks and/or benefits, and a description of how the confidentiality of records will be protected,a mong other things.
An Authorization focuses on privacy risks and states how, why, and to whom protected health information (PHI) will be used and/or disclosed for research. Per the Privacy Rule, covered entities are only allowed to use and disclose PHI for research if authorized to do so by the subject (there are a few exceptions to this Rule).
If the Privacy Rule applies, an Authorization may be a separate document or the elements of an Authorization may be imbedded in the Consent Form.