LOS ANGELES COUNTY
DEPARTMENT OF MENTAL HEALTH
  Policy 1400.01 Mental Health Research Review
 
  PROCEDURES
  1. Membership of the Human Subject Research Committee (HSRC)
     
    1. The membership shall consist of representatives of the different Los Angeles County Department of Mental Health (DMH/Department) divisions, including, but not limited to: Patients' Rights Office; Chief Information Office; Compliance; Representatives from peer services, psychiatry, psychology, nursing; and, Other representatives as determined by the DMH Director.
       
    2. HSRC members shall possess various qualifications and experiences.
       
    3. HSRC shall consist of an HSRC Chairperson and at least four (4) members.
       
  2. HSRC Meetings
     
    1. HSRC meetings shall be scheduled as necessary, depending on the number of pending applications for review.
       
    2. HSRC meeting minutes shall include a record of attendance, proposals discussed, and any recommendations by the HSRC.
       
    3. HSRC may elect to invite investigators to appear before the HSRC in person or by teleconference.
       
    4. HSRC may also elect to invite subject matter expert(s) to participate in meetings. Invited guests may not participate during the voting process to approve the proposal(s).
       
  3. HSRC Notifications
     
    1. HSRC Chairperson shall notify investigators in writing of decisions made or modifications required.
       
    2. If HSRC review results in failure to approve a research activity, the HSRC Chair shall provide a written notification including a statement of the reason for its decision. Investigators may reapply in the event of HSRC non-approval.
       
    3. HSRC shall notify the Principal Investigator (PI) in the event that an HSRC approved research project is being suspended or terminated for any reason including failure to conduct research in accordance with the HSRC’s requirements or unexpected serious harm to participants.
       
    4. The manager overseeing the facilities, resources, or programs involved in the proposed research is responsible for administrative approval to commit resources and to identify relevant issues (i.e., regarding the use of DMH resources at the clinic level, the suitability of the particular program for participation, applicable site-specific conditions, etc.) for consideration by the HSRC.
       
  4. HSRC Records
     
    1. HSRC shall maintain adequate documentation of its activities including copies of all research applications, annual reports, HSRC meeting minutes, and a list of HSRC members.
       
    2. Records listed above shall be retained for at least 10 years.
       
    3. Per DMH Policy 500.06, any documentation related to waivers approved by the HSRC shall be retained for 10 years after the research is complete.
       
  5. Criteria for Approval of Research
     
    1. The research is of sufficient importance to the mission of the Department to justify Department participation.
       
    2. The risk to participants is minimized to the greatest extent possible and is reasonable in relation to anticipated benefits, if any, including the importance of the knowledge that can reasonably be expected to result from the research.
       
    3. The selection of participants is equitable.
       
    4. Informed consent of human subjects, unless waived, is sought and appropriately documented. Requests for waiver or alteration of consent process shall require documentation regarding the level of risk, the effect on the rights or welfare of participants, and the practicality of conducting research without a waiver. The requirement for a waiver of consent documentation shall include documentation regarding risk, whether the consent would be the only link with participants, and the risk of a breach in confidentiality.
       
    5. There are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.
       
    6. Adequate safeguards are included to protect the rights and welfare of vulnerable populations.
       
    7. The research design appears sufficiently scientifically sound to reasonably expect results that are valuable to the mission of DMH.
       
    8. Investigators are qualified and have appropriate experience to carry out the proposed research.
       
    9. Investigators and responsible DMH workforce must adhere to applicable conflict of interest policies.
       
    10. Research projects have Institutional Review Board (IRB) approval from their home institution’s federally registered IRB. These IRBs must include an association with a specific research institution located in Los Angeles County. Other IRBs may be considered on a case-by-case basis.
       
    11. Case studies must be reviewed by the HSRC for purposes of determining the sufficiency of the de-identification of Protected Health Information (PHI) in instances where they meet the definition of research.
       
    12. An HSRC Application for research approval must be fully and accurately completed and must include any required supplemental documents and appendices.
       
      1. The completed application must be signed by the PI and submitted to the HSRC.
         
      2. The completed application and all supporting documents must be submitted within a six (6) month timeframe from the date of initial submission.
         
        1. After 6 months, the HSRC Chairperson shall notify the PI in writing that the application has been terminated.
        2. Notification shall include the option for the PI to resubmit the proposal as a new application.
           
  6. Types of HSRC Outcomes
     
    1. Approval: The Department approves the research project.
       
    2. Conditional Approval: Minor changes are requested. Full approval commences when documentation of requested changes is received.
       
    3. Time-Limited Approval: Approval is for less than one (1) year, after which all approvals must be renewed.
       
    4. Non-Approval: Application and/or supplemental documents and appendices did not meet criteria for approval for research. Resubmissions will be considered.
       
  7. Expedited Review Procedures
     
    1. Research projects are exempt from full HSRC review if the research falls into one (1) or more of the eight (8) federally defined categories specified in 45 CFR § 46.104(d).
       
    2. The HSRC Chairperson or an HSRC member designated by the Chairperson must determine that a project is eligible for expedited review.
       
    3. The research protocol must have received exempted approval from its home institution’s designated IRB.
       
    4. Research projects granted expedited review must still be reviewed by the Department's Privacy and Information Security Officers.
       
  8. Continuing Review
     
    1. Investigators are required to submit an annual Continuing Review Form (CRF) to keep the HSRC updated as to the progress of the research, recruitment of participants, and occurrence of significant adverse events (e.g., death or injury requiring medical treatment). Typically, CRFs are to be provided on an annual basis; however, in some instances, the HSRC may require more frequent reporting.
       
    2. Investigators who fail to submit their CRF within 60 days from the date of their HSRC approval expiring will be considered delinquent and have their HSRC approval revoked. All research activities must cease at that time.
       
  9. Final Report
     
    1. Investigators are required to submit a final report to HSRC within 90 calendar days after the completion of the research project.
       
    2. Failure to provide a final report may result in sanctions up to and including prohibition against any future research being conducted within the Department and formal complaints to relevant agencies.
       
  10. Publications and Presentation

         1. All investigators must submit copies of any publications resulting from the research to the HSRC as they                             become available.

         2. Investigators may also be asked to present their research findings to the HSRC or the larger DMH community.

         3. Failure to provide publication(s) or present research findings as requested by the HSRC may result in sanctions                 up to and including prohibition against any future research being conducted within the Department.