•Authorization
–Participant provides authorization to use/disclose PHI as part of the informed consent process. MUST include the following elements:
•Specific description of the information to be used/disclosed
•Who may use or disclose
•To whom the PHI will be disclosed
•Why the use or disclosure is being made (each purpose)
•Statement of how long the use or disclosure will continue
How to use or disclose PHI for research purposes (continued)