An Authorization for Research must be written in plain language and must contain ALL of the following elements:

  1. A specific and meaningful description of the information to be used or disclosed.
  2. The name or identification of the persons or class of persons authorized to make disclosures of PHI and to use the PHI for research-related purposes.
  3. The name or identification of the persons or class of persons authorized to receive disclosures of the PHI and to use the PHI for research-related purposes.
  4. A description of each purpose of the use or disclosure.
  5. An expiration date or event, or a statement "end of research study" or "none" when appropriate (ex: for a research database).
  6. The individual's signature (or that of his/her authorized representative as determined by California law) and date.
  7. A statement that the individual may revoke the authorization if done in writing to the principal investigator; however, the researcher may continue to use and disclose, for research integrity and reporting purposes, any PHI collected from the individual pursuant to such Authorization before it was revoked.
  8. A statement that an individual's clinical treatment may not be conditioned upon whether or not the individual signs the research Authorization. However, participation in research may be conditioned on a signed Authorization, including treatment protocols (ex.: Phase III clinical trials).
  9. A statement that information disclosed under the Authorization could potentially be redisclosed by the recipient and would no longer be protected under HIPAA
  10. The individual must be provided with a copy of the signed Authorization.