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 (patients and healthy volunteers) 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 applies a standard that ensures that patients receive first class clinical care while taking part in state-of-the-art studies of brain function throughout the lifespan, ranging from molecular, cellular, systems, and behavioral studies, to clinical treatment and translational investigations of mental illness. New clinical trials were launched developing novel therapeutic antidepressants and trials continue for cognitive psychotherapies and testing non-invasive neuromodulation and sleep devices. The OCD helped an NIMH investigator to launch a natural history study of immune-mediated neuropsychiatric illness in adults this year, while continuing work on pediatric patients with autoimmune brain disorders with new onset psychosis. Implementation of whole genome sequencing of all NIMH inpatients continued. This year we sequenced 88 participants from NIMH, bringing the five-year total to 817. This year includes more than 50 clinically significant results returned with appropriate genetic counseling along with several publications listed elsewhere in NIMH PI annual reports. CLINICAL OVERSIGHT: The OCD team meets regularly with NIH Clinical Center (CC) medical, nursing and executive leadership to discuss clinical concerns and plan for future initiatives. The monthly Patient Safety Quality meeting and the bimonthly Principal investigator Meetings serve as a forum for communication of hospital-related policies and regulations with staff. The OCD team helped to coordinate the CC outpatient implementation of suicide risk screening and provides ongoing expertise in implementation. 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. The OCD is responsible for the implementation of CC policies and standard operating procedures (SOPs) and 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, Nursing Magnet Recognition, annual flu shot compliance, Physician Wellbeing programs and the Pediatric Strategic Planning Working Groups. 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. Each group meets with PSQ staff to ensure that they have ongoing Quality Improvement and Patient Safety initiatives and that they present their work to the larger NIMH Intramural community for educational purposes. The OCD continues to track and trend Clinical Center occurrences and ensures follow-up through the CC STARS reporting system. 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. An OCD representative attends the NIMH monthly safety meetings as the clinical representative for basic science labs. STAFF SAFETY INITIATIVES: The OCD staff collaborated with other NIH CC departments such as Nursing, Patient Safety and Wellness to conduct Suicide Prevention Town Halls with staff as a suicide prevention initiative. Two suicide survivors, who were healthcare workers, gave invited presentations of lived experiences. Staff were encouraged to ask questions; resources for the NIH Employee Assistance Program (EAP) and National Suicide Prevention initiatives such as 988 were provided. The last Town Hall was conducted in December of 2024, with a large turnout, over 400 views of the webcast, and received positive feedback from NIH CC Leadership for the initiative. HUMAN SUBJECT PROTECTIONS: The mission of the HSPU is to 1) Provide protection and advocacy for potentially vulnerable participants; 2) Assess, develop and implement human subjects’ protections for research participants; 3) Assist in the application of federal regulations, NIH, NIMH and CC policies related to human subject protections; and 4) Educate investigators, trainees, participants and community about human subjects’ protections. This team works with investigators, Office of Human Subjects Research Protections (OHSRP) and the CC Bioethics Department to identify and mitigate risks for research participants. Responsibilities include providing: 1) consent and assent monitoring, 2) participant monitoring of all NIMH inpatients, 3) capacity assessment for select more than minimal risk studies identified by the OCD or the NIH Institutional Review Board, 4) ability to assign 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 a two-part informed consent training, required for all NIMH investigators who obtain consent. OHSRP also requires this training for post-doc IRTAs/fellows in all institutes. 2374 NIH staff and trainees have attended part 1 of this training. Part 2 is the NIMH HSPU-developed observed "Objective Structured Clinical Exam for the Evaluation of the Informed Consent Process (OSCE IC)" which evaluates an investigator’s abilities in three domains: professionalism, interpersonal communication and the general requirements for informed consent. HSPU has administered 228 OSCE across all ICs. The HSPU provided educational presentations to participant groups at the Bioethics department annual Ethical and Regulatory Aspects of Clinical Research training, and for the NIH Clinical Center Ethics Committee. 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. Seven new protocols were approved in 2025, with one in process. A subcommittee conducts annual review of ongoing protocols. In FY25 the CSRP and the Data Management and Sharing (DMS) Committee reviewed and approved DMS plans for all active clinical protocols. REGULATORY OVERSIGHT: The NIMH 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 (Investigational New Drug) sponsor (13 effective INDs, 3 approved Investigational New Device (IDEs), 35 Non-Significant Risk (NSR) device determinations and 1 pending IND) with support from the Office of Research Support and Compliance (ORSC) in the NIH Clinical Center via quarterly meetings. The NIMH ORO coordinates the scientific review of new and ongoing protocols and provided protocol navigation services to investigators for 92 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 and other IRP protocols. Clinical monitors develop and implement individualized monitoring plans for all active NIMH IRP protocols to assure US Code of Federal Regulations and GCP compliance throughout the life of the protocol, providing training and corrective action plans as needed. Clinical monitors conduct Site Initiation Visits before enrollment begins, Interim Monitoring Visits while the study is open and Close Out Visits when the protocol is closing to ensure proper storage and audit readiness. 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. 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. CONSULTATION SERVICES: The NIMH Psychiatry Consultation Liaison Service (PCLS) the Neuropsychology Consultation Service, the Neurodevelopmental and Behavioral Phenotyping Services (see ZIA-MH002961) and the Sleep and Neurodevelopment Service (ZIC-MH002962) are teams that provide multidisciplinary clinical services to patients enrolled in NIH clinical protocols. See OCD Psychiatry Consultation Liaison Service Research ZIA-MH002922 for additional details. The MARKETING COMMUNICATIONS AND RECRUITMENT UNIT (MCRU) facilitated comprehensive NIMH patient recruitment through design and materials development, targeted marketing and advertising planning, and community outreach and engagement. In FY25, MCRU created/revised marketing materials, facilitated community outreach programing through meetings and webinars with providers, consumers, and community members. MCRU provided website and social media support and liaisons with the Office of Science Policy, Planning and Communications. In FY25 the MCRU was eliminated as part of workforce reductions.