NIMH Office of the Clinical Director-Core Activities

National Institute Of Mental Health

Investigators

Linked publications & trials

Abstract

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. The OCD team is helping to coordinate the CC outpatient implementation of suicide risk screening. 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 review of non-sterile pharmacy product development, preparation for Joint Commission accreditation visits, annual flu shot compliance, Physician Wellbeing programs and the Pediatric Strategic Planning Working Groups 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 presents 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 HSPU is to ensure the protection of potentially vulnerable subjects participating in research and to educate investigators and participants. This team works with investigators, OHSRP and the CC Bioethics Department to identify and ameliorate risks for research participants. Responsibilities include providing: 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) confirmation of validity of the Legally Authorized Representative (LAR) and 6) training and education. The HSPU provides an informed consent training, required for all NIMH investigators who obtain consent. OHSRP also requires this training per Policy 301 for post-doc IRTAs/fellows in all institutes. 2140 NIH staff and trainees have attended part 1 of this training. Part 2 of the training is the observed "Objective Structured Clinical Exam for the Evaluation of the Informed Consent Process (OSCE)" which evaluates three domains: professionalism, interpersonal communication and the general requirements for informed consent. HSPU has administered 86 OSCE informed consents in the last two years. The HSPU NIMH Toolkit for Human Subjects Protections: https://www.nimh.nih.gov/hspu assists other research organizations to assess, develop and implement appropriate levels of human subjects protections at their own facilities. SCIENTIFIC REVIEW: The Committee for Scientific Review of Protocols (CSRP) reviews all new clinical protocols. Four new protocols were approved in 2023, with 4 in process. A subcommittee conducts annual review of ongoing protocols. In FY23 the CSRP and the Data Management and Sharing (DMS) Committee reviewed and approved DMS plans for all active clinical protocols and all basic lab and branch chiefs. 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 (13 active INDs for 25 protocols, 3 IDEs and 1 IND on full clinical hold) 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 for 83 active clinical protocols during a massive transition of the NIH protocol management systems to Protect and Protrak. The navigation team provides direct support to investigators in all aspects of IRB submissions and tracking of investigator trainings. The OCD and SD have reviewed and approved 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 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-MH002939-11. 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-MH002922-15 for additional details. 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 FY23,MCRU created or revised 529 marketing materials. Our Community Outreach Program reached over 200,000 individuals through 37 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. They also serve as the lead for DEIA efforts within the OCD. MENTAL HEALTH RESPONSE TO THE COVID-19 PANDEMIC: The NIMH Clinical Director co-Chaired with NIH OD, the NIH-Wide Mental Health and Well-being Action Team responsible for providing mental health education, guidance and resources for all NIH staff adapting to work-life changes due to the pandemic. This team conducted a landscape analysis, helped to develop an NIH resource website, and NIMH OCD staff participate in an NIH-wide mental health speakers bureau for mental health events at NIH and for other federal agencies.