What is a “waiver of authorization” and how do I obtain such a waiver?
• Provide a brief description of the PHI [private health information] for which use or access has been determined to be necessary. • Inform CGIRB that the research involves no more than a minimal risk to the privacy of the subject, based on, at least, the presence of the following elements: • An adequate plan to protect the PHI from improper use or disclosure. • An adequate plan to destroy the identifiers linked to the PHI at the earliest opportunity consistent with the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law. • Declare that the PHI will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of PHI would be permitted by the regulation. • Declare that the waiver will not adversely affect the rights and welfare of the subject.
