LOS ANGELES COUNTY
DEPARTMENT OF MENTAL HEALTH
  Policy 500.05 Use and Disclosure of Protected Health Information For Research
 
  PROCEDURES
  1. Use and Disclosure of Protected Health Information (PHI) for Research with Authorization
     
    1. The researcher shall ensure that authorization for use or disclosure of PHI form is included when needed.
       
    2. All research participants shall have the capacity to give informed consent.
       
      1. Proxy/surrogate consent shall not be used for research conducted within the Los Angeles County Department of Mental Health (DMH/Department) or its contract agencies that require authorization by the individual research.
         
      2. Capacity to consent shall be determined by a psychiatrist, clinical psychologist, or other qualified professional not otherwise involved in the research.
         
      3. Research protocols shall not include cognitively impaired individuals lacking the capacity to give informed consent.
         
    3. For studies including minors, the researcher shall ensure that the person signing the authorization for use or disclosure of PHI on behalf of the minor has appropriate authority as the minor’s representative.
       
      1. Minors who are in the custody of the court (i.e., dependent child or ward status) shall have the authorization for use or disclosure of PHI signed by the court.
         
    4. Certain research protocols may require that the research participant not know the exact nature of the therapeutic intervention.
       
      1. It is not required that an individual be provided with access to their PHI while they are participating in a clinical trial. In such cases, the research participant shall be informed of this on the authorization for use or disclosure of PHI and/or on the informed consent form to participate in the research.
         
    5. If the research participant refuses to sign the authorization for use or disclosure of PHI, they shall not participate in the clinical trial. The authorization for use or disclosure of PHI shall contain a statement to that effect.
       
    6. PHI shall be used or disclosed in a manner consistent with the terms of the authorization language.
       
      1. Any additional uses or disclosures of PHI not covered by the signed authorization require another authorization for use or disclosure of PHI.
         
      2. The researcher shall present it to Human Subjects Research Committee (HSRC) for approval.
         
        1. The HSRC may require a Request for Amendment Form and other supporting documents to be submitted. 
           
  2. Use and Disclosure without Authorization
     
    1. There may be instances where it is not possible to obtain authorization for use or disclosure of PHI (e.g., research involving records only). The Department shall permit the use or disclosure of PHI without authorization when the HSRC approves the Waiver of HIPAA Research Authorization (Waiver) found within the HSRC Application (Part III, Section C).
       
    2. The HSRC shall evaluate the request for a waiver by reviewing research protocols to determine the following criteria are met:
       
      1. The research cannot be conducted without the Waiver.
         
      2. The research cannot be conducted without access to and use of PHI.
         
      3. Use or disclosure of PHI involves no more than minimal risk to the privacy of the individual based on at least one (1) of the following requirements:
         
        1. There is an adequate plan to protect the identifiers from improper uses and disclosures
        2. There is an adequate plan to destroy the identifiers at the earliest opportunity, unless:
           
          • There is a health or research justification for retention; or
          • Required by law.
             
        3. There are adequate written assurances from researchers that the PHI shall not be further used or disclosed except:
           
          • As required by law;
          • For authorized research oversight; or
          • For other research which would be permitted by the Health Insurance Portability and Accountability Act (HIPAA).
             
  3. Review of PHI in Preparation for Research
     
    1. DMH may permit researchers to access PHI without individuals’ prior authorization and without HSRC approval of a Waiver of HIPAA Research Authorization if the following requirements are met:
       
      1. The researchers review and sign the Representation of Researcher to Review Protected Health Information held by the Los Angeles County Department of Mental Health to Prepare for Research Form, indicating that the researcher shall attest to one or more of the following to the HSRC:
         
        1. Review of PHI shall be limited as necessary to prepare for research.
        2. The researcher shall not remove the PHI and shall record it only in de-identified form.
        3. Review of the PHI is necessary for the research.
           
      2. The HSRC approves the request to review PHI in preparation for research.
         
    2. Only the researchers who have signed the Representation of Researcher to Review Protected Health Information held by Los Angeles County Department of Mental Health to Prepare for Research Form shall have access to PHI for research preparation.
       
  4. Research on PHI of Decedents
     
    1. In the event that access to PHI is needed solely to conduct research of decedents' PHI, DMH may permit researchers to access PHI without authorization for use or disclosure of PHI form and without HSRC approval of a Waiver of HIPAA Research Authorization if the following requirements are met:
       
      2. The researcher makes the following representations to the HSRC and DMH:
         
        1. Only the PHI of decedents will be reviewed for the research.
        2. Review of PHI is necessary for the research.
        3. At the Department’s request, the researcher shall provide documentation of the individual's death.