LOS ANGELES COUNTY
DEPARTMENT OF MENTAL HEALTH
  Policy 500.05 Use and Disclosure of Protected Health Information for Research
 
Policy Category:  Administrative
Distribution Level:  Directly Operated
Responsible Party:  Human Subject Research Committee
 
Approved by TaNeisha Franklin, ASM III, on March 9, 2022
 
 
I.  PURPOSE
 
To secure the privacy of Protected Health Information (PHI) of individuals who are participants or subjects in research within the Los Angeles County Department of Mental Health (DMH).

To ensure all applicable standards and regulations of the Health Insurance Portability and Accountability Act (HIPAA) are enforced for research within DMH.
 
II.  DEFINITIONS
 
Authorization: An individual’s permission to use or disclose that individual’s PHI for purposes that do not fall within the definitions of treatment, payment, health care operation activities, or other purposes that do not require the individual’s signature.

Human Subjects Research Committee (HSRC): The DMH committee responsible for the review of all research protocols, including DMH clients as research subjects and research protocols already approved by an outside Institutional Review Board (IRB), to ensure that all research is conducted in accordance with the standards and policies of DMH. The HSRC is not a federally registered IRB. The HSRC provides an extra level of human subjects protection with respect to DMH clients and their data.

Institutional Review Board (IRB): A board established in accordance with applicable federal regulations to review research protocols, protect the rights of research participants, and minimize risks related to the research. 
 
III.  POLICY
 
DMH shall permit the use and disclosure of PHI for research purposes, regardless of the research funding source, under the following circumstances:
  • The individual who is the subject of the PHI provides prior authorization.
  • Without the individual’s prior authorization when:
    • An IRB has approved a waiver of the consent/authorization requirement.
    • Representations are obtained from the researcher that the use or disclosure of the PHI is solely for the preparation of the research.
    • PHI is de-identified in compliance with HIPAA’s de-identification requirements or a limited data set is used. (DMH Policy 500.04)
    • Representations are obtained from the researcher that the use or disclosure of PHI is solely for research on the PHI of decedents.
IV.  PROCEDURES
 
Procedures - Use and Disclosure of Protected Health Information for Research
 
V.  AUTHORITY
 
VI.  ATTACHMENTS
 
Representation of Researcher to Review Protected Health Information Held by Los Angeles County Department of Mental Health to Prepare for Research
Representation of Researcher to Review Protected Health Information of Decedents Held by Los Angeles County Department of Mental Health