Office of the Clinical Director-Core Activities

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CLINICAL RESEARCH SUPPORT SERVICES: A central mission of the OCD is to ensure that research participants receive the highest quality clinical care. The OCD is responsible for oversight of all clinical aspects of the NIMH Intramural Research Program (NIMH IRP). The OCD, along with Scientific Director's office, applies a DEIA lens to all activities, from patient and volunteer recruitment to staff recruitment and education. New clinical trials and sleep studies were launched as well as ongoing implementation of initiatives such as whole genome sequencing of all NIMH inpatients and a program to study autoimmune brain disorders with new onset psychosis. CLINICAL OVERSIGHT: The OCD team meets regularly with NIH Clinical Center (CC) medical and nursing leadership to review CC census, discuss clinical concerns and plan for future initiatives. The monthly Patient Safety Quality meeting is also a forum for communication of hospital-related policies and regulations and continued to meet monthly, virtually, during pandemic teleworking status. The OCD team coordinated the CC hospital-wide implementation of suicide risk screening and participated in validation of suicide risk screening tools in patients across the lifespan. The OCD is responsible for credentialing through reviewing the qualifications of all clinical personnel and is involved in maintaining the clinical competence of all NIMH health care professionals. As the link between the CC hospital and the Institute, the OCD is responsible for the implementation of CC policies and standard operating procedures (SOPs). The OCD participates in annual CC budget planning meetings and coordinates hospital initiatives such as preparation for Joint Commission accreditation visits, annual flu shot compliance, Physician Wellbeing programs etc. PATIENT SAFETY AND QUALITY (PSQ): The OCD Office of Patient Safety and Quality oversees NIMH quality improvement initiatives by each branch/section/lab chief and manager with a dual focus of improving and ensuring quality clinical care, and sharing their experiences with the larger NIMH intramural clinical care group during monthly PSQ meetings. The OCD also tracks and trends Clinical Center occurrences and ensures follow-up. The OCD has representatives on the Clinical Center (CC) safety and quality initiatives, including daily patient safety huddles, the hospital-wide Clinical Care and Quality meeting, and the Patient Safety Clinical Practice and Quality Committee. Each branch/lab/section has presented at least one PSQ project and is scheduled to present follow up findings for their ongoing continuous quality improvement projects. An OCD representative attends the NIMH monthly safety meetings for basic science labs. HUMAN SUBJECT PROTECTIONS: The mission of the Human Subject Protections Unit (HSPU) is to ensure the protection of potentially vulnerable subjects participating in research and to educate researchers and participants. This team works with investigators, the Institutional Review Board (IRB), and the CC Bioethics Department to identify and ameliorate risks for vulnerable subjects. Responsibilities include: 1) Consent and Assent Monitoring, 2) Subject Monitoring of all NIMH inpatients, 3) Capacity Assessment-for select high-risk studies, 4) Ability to Appoint an NIH Advanced Directive/Durable Power of Attorney (DPA) Assessment, 5) Appropriateness of the Surrogate Assessment, and 6) Training and Education. The HSPU developed and conducts the "Elements of a Successful Consent", a required training for investigators obtaining informed consent. To date, 1826 NIH staff have completed this training. The HSPU launched the NIMH Toolkit for Human Subjects Protections: https://www.nimh.nih.gov/hspu to assist other research organizations to assess, develop and implement appropriate levels of human subjects protections at their own facilities. HSPU developed an observed Objective Structural Clinical Exam (OSCE) to evaluate professionalism, communication and informed consent delivery. HSPU assessments and trainings have been provided via telehealth or virtually as needed in response to COVID-19. SCIENTIFIC REVIEW: The Committee for Scientific Review of Protocols (CSRP) reviews all new clinical protocols. Three new protocols were approved in 2022, with 7 in process. A subcommittee conducts annual review of ongoing protocols. REGULATORY OVERSIGHT: The Office for Regulatory Oversight (ORO) focuses on compliance with regulatory requirements and Good Clinical Practice (GCP). The NIMH Clinical Director now serves as the IND (17 active, 1 pending)/IDE (3 approved) sponsor with support from the Office of Research Support and Compliance (ORSC) via quarterly meetings. The ORO coordinates the scientific review of new and ongoing protocols and provides protocol navigation services to investigators. The navigation team provides direct support to investigators in all aspects of IRB submissions and tracking of investigator trainings. The OCD and SD have implemented genetic data sharing and data sharing plans for intramural studies in accordance with NIH policy. The OCD coordinates a Data and Safety Monitoring Board (DSMB) to oversee NIMH IRP protocols. Two clinical monitors develop and implement individualized monitoring plans for all active NIMH IRP protocols to assure Good Clinical Practice (GCP) compliance, providing training and corrective action plans as needed. TRAINING AND EDUCATION: The NIMH OCD works in partnership with the NIMH Office of Fellowship Training (OFT) and the Office of Clinical Research and Training in Medical Education (OCRTME) to oversee and participate in several programs that train and educate new physicians, medical students, and psychology practicum students from diverse backgrounds. In addition, the NIMH OCD contributes to initiatives that identify and promote academic research careers among promising early career psychiatrists. See OCD Training report ZIE-MH002939-10. CONSULTATION SERVICES: The NIMH Psychiatry Consultation Liaison Service (PCLS) the Neuropsychology Consultation Service, the Neurodevelopmental and Behavioral Phenotyping Services (see ZIA-MH002961-06) and the Sleep and Neurodevelopment Service (ZIC-MH002962-06) are teams that provide multidisciplinary clinical services to patients enrolled in NIH clinical protocols. See OCD Psychiatry Consultation Liaison Service Research ZIA-MH002922-13 for additional details. MENTAL HEALTH RESPONSE TO THE COVID-19 PANDEMIC: The NIMH Clinical Director co-Chaired with NIH OD, the Trans-NIH Mental Health Response Team responsible for providing mental health education, guidance and resources for all NIH staff adapting to work-life changes due to the pandemic. This has been transformed into the NIH-Wide Mental Health and Well-being Action Team. HERE 2 LISTEN - Staff Support Line: In the wake of the COVID pandemic, the NIMH OCD team, supported the NIH Employee Assistance Program, establishing an NIH-wide Staff Support Line to give staff a place to relieve stress during the pandemic. Staffed by NIMH mental health clinicians and staff in FY21 and again from January thru June 2022, the revived telephone support line was available to any NIH employee, trainee or contractor and again received over 100 calls. The MARKETING COMMUNICATIONS AND RECRUITMENT UNIT (MCRU) facilitates comprehensive, creative and diverse NIMH patient recruitment through design and materials development, targeted marketing and advertising planning, and community outreach and engagement. In FY 2022,MCRU created or revised 529 marketing materials. Our Community Outreach Program reached over 200,000 individuals through 55 meetings and webinars with providers, consumers, and community members. MCRU provides website and social media support and liaisons with the Office of Science Policy, Planning and Communications.