| I. PURPOSE
| | To establish a mechanism for review and approval of human subjects research activities involving staff, clients, or data related to Los Angeles County Department of Mental Health (DMH/Department) directly operated programs and legal entity contracted providers.
To assure that all research is conducted in accordance with the standards and policies of DMH.
Contracted agencies shall develop an internal policy and associated procedures that are consistent with their organizational practices and meet the requirements set forth in this policy.
| | II. DEFINITIONS
| Research: A systematic investigation, including research development, testing, and evaluation designed to develop or contribute to generalizable knowledge.
Human Subject: A living individual about whom an investigator or investigation team, conducting research obtains information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens; or obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Human Subjects Research Committee (HSRC): A DMH committee responsible for the review of all research protocols including DMH clients and DMH workforce members or their data as research subjects within DMH programs, both directly operated and contracted programs. This includes those research protocols already approved by a federally registered Institutional Review Board (IRB). The HSRC is not an IRB; it serves to provide an extra level of human subject protection with respect to DMH clients and DMH workforce members.
Principal Investigator (PI): An individual with primary responsibility for a research grant or project, who is a professional or student in the field of behavioral health or a closely related field.
| | III. POLICY
| | All approved research shall: -
Have the intent of increasing knowledge pertaining to the mental health field; -
Be consistent with the Department’s mission; -
Be consistent with applicable Department conflict of interest policies; -
Use Department resources appropriately; -
Be consistent with applicable ethical values; and, -
Be consistent with applicable laws, regulations, and policies. All proposed human subjects research activities that involve directly operated and/or contracted programs shall first be reviewed by the DMH HSRC before commencing research activities.
The HSRC shall be responsible to: -
Review all research protocols involving clients; -
Review research already approved by an IRB to assess whether the investigator has the capacity to conduct research in accordance with DMH policies, procedures, and parameters; -
Review protocols that involve the use of DMH data or other resources, such as staff time or clinic space; -
Ensure that human subjects’ protection is present in all research activities involving DMH programs; -
Recommend the suspension or termination of an approved research project if: -
Research does not meet HSRC requirements; or, -
Research has been associated with unexpected serious harm to participants. All DMH services provided as part of research activities shall fully meet the Department's clinical, programmatic, and fiscal requirements, including those related to practice parameters, policies and procedures, and medical necessity.
Research activities shall not result in any denial or delay in a client receiving appropriate services.
Clients shall always be made aware of activities that are research-related or research-sponsored as opposed to usual services.
Workforce members shall always be made aware of activities that are research-related or research-sponsored.
Only those studies approved by DMH HSRC shall post recruitment flyers for research volunteers in DMH contracted or directly operated facilities.
The HSRC may set priorities (e.g., relevance to program needs, etc.) that affect time frames for proposal review and possible approval in order to ensure compliance with the DMH mission and adequate protection of DMH clients and DMH Workforce members.
The HSRC shall provide an extra level of human subjects protection with respect to DMH clients and DMH Workforce members.
| | IV. PROCEDURES
| Procedures - Mental Health Research Review
| | V. AUTHORITY
| | | | VI. ATTACHMENTS
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