1. To ensure staff understands the appropriate steps to take when a client chooses to participate or is considering participation in a clinical trial for pharmaceutical clinical trial.
    

1. Human Subjects Research Committee (HSRC): A DMH committee responsible for the review of all research protocols including DMH clients or their data as research subjects within both directly operated and contracted DMH programs. This includes 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.
2. Institutional Review Board (IRB): An administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the authority of the institution with which it is affiliated.
3. Pharmaceutical Clinical Trials: A carefully designed study that tests the benefits and risks of a specific medical treatment or intervention such as a new drug.
4. Treatment Team: DMH Staff involved in a client’s ongoing care, including the prescriber, case manager, and therapist (if applicable).
5. Research Team: Members of the pharmaceutical trial research team overseeing the trial and client participation. 

INTRODUCTION

A. Participation in pharmaceutical trials can provide clients access to cutting-edge treatments and financial incentives, but it also introduces unique challenges. Effective coordination between the treatment and research teams is essential to ensure that trial participation does not interfere with the client’s existing treatment, and that informed decision-making is prioritized 

COMMUNICATION AND CARE COORDINATION

A. DMH staff will immediately notify the client’s assigned prescriber when they are made aware that a client is participating in or considering participation in a pharmaceutical trial 

B. Case manager or prescriber will obtain signed releases of information from the client to collaborate with the Research Team 

INITIAL ASSESSMENT

A. Reassess the client’s stability on their current medication regimen 

B. Collect and review trial information
1.Obtain and scan a copy of pharmaceutical trial information provided to the client in client’s chart. 
2. Conduct online research, if necessary 

C. Consult with the Treatment Team and perform a comprehensive risk-benefit analysis, considering:
1. Trial-related concerns: Risks associated with the study design, eligibility requirements, and procedures, including any potential risks from placebo use, if applicable 
2. High risk factors: Evaluate potential for complications, such as adverse reactions, hospitalization, and suicidality
3. Social and financial factors: Assess the client’s need for financial incentives or any other social determinants that might influence their decision to participate
4. Safety plan: Develop a plan to monitor and address any safety concerns during and after the trial

D. Ethical considerations: Examine potential ethical issues such as coercion, conflicts of interest, or undue compensation. Discuss with client: 
1. Ensure client fully understands the trial details, requirements, risks, and benefits 
2. Verify that informed consent is obtained and that the client’s participation is voluntary 
3. Explain potential adverse events or interactions with investigational treatment
4. Assist the client in a personalized risk-benefit assessment
a. If the risks could jeopardize the client’s health or well-being, advise against participation 
5. Recommend an appropriate recovery period between pharmaceutical trials, if applicable, to manage and regulate any symptoms 
6. Document assessment and discussions 

TREATMENT AND MONITORING  

A. If the client decides to participate or continue participation in pharmaceutical trial, the prescriber will complete the following: 

1. During the trial:
a. Develop a monitoring plan, including:
i. Monitoring frequency and duration 
ii. Assessment of physical or mental health symptoms that may result from investigational treatment
iii. Evaluation of potential adverse effects or interactions 
b. Engage the Treatment Team, ensuring all members are informed of the plan and their roles in monitoring
c. Coordinate with the Research Team, reviewing the client’s progress to ensure all decisions are well-informed and aligned with overall care
d. Modify the client’s treatment strategy as needed based on the client’s trial response 

2. After completion of the trial 
a. Establish a post-trial monitoring plan, including 
i. Monitoring frequency and duration 
ii. Assessment of lingering or new physical or mental health symptoms potentially resulting from the investigational treatment 
iii. Evaluation of potential delayed adverse effects or interactions with new or ongoing medications 
b. Prepare for any post-trial complications and have emergency protocols in place, if necessary 
c. Engage the Treatment Team, ensuring all members are informed of the plan and their roles in post-trial monitoring and contingencies 
d. Modify the client’s treatment strategy as needed based on the client’s post-trial response 

OUTCOMES AND MONITORING

1. Obtain specific time frames for trials
2. Encourage the client to have a specific length of time between any pharmaceutical trials to regulate any symptoms
    

1. Staff should have basic knowledge of DMH Human Subjects Research Committee policy and procedures:
   1. Policy 1400.01 Mental Health Research Review
   2. Policy 300.07 Use of Client Information for Publication 
2. Contact HSRC@dmh.lacounty.gov for any additional information or specific guidance
    

1. Seek assistance at any point from a supervisor or manager.
2. Seek guidance from Chief Medical Officer, County Counsel, and Risk Management as needed.
    

1. American Medical Association Journal of Ethics, AMA Code of Medical Ethics’ Opinions on Clinical Research
2. Code of Federal Regulations Title 45 Sections 46.101 and 46.102
3. National Institutes of Health (NIH) Patient Recruitment Ethics in Clinical Research
4. National Institute of Mental Health (NIMH) Clinical Trials Information for Participants
5. Client Pamphlet:
   1. National Institutes of Health (NIH) What Do I Need to Tell the Doctor?