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Principal Investigator: Maryland Pao
Organization: NATIONAL INSTITUTE OF MENTAL HEALTH
Fiscal Year: 2024
Award: $7,910,164
Funding agency: National Institute of Mental Health
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 (SD) office, applies a DEIA lens to all activities, from patient and volunteer recruitment to staff recruitment and education. New clinical trials were launched developing novel therapeutic antidepressants and cognitive psychotherapies and testing non-invasive neuromodulation and sleep devices. Implementation of whole genome sequencing of all NIMH inpatients and a program to study autoimmune brain disorders with new onset psychosis continued.
CLINICAL OVERSIGHT: The OCD team meets regularly with NIH Clinical Center (CC) medical and nursing leadership to discuss clinical concerns and plan for future initiatives. The monthly Patient Safety Quality meeting is a forum for communication of hospital-related policies and regulations with staff. The OCD team helps 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. 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, 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. 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. An OCD representative attends the NIMH monthly safety meetings for basic science labs.
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 polices related to human subject protections; and 4) Educate investigators, trainees, participants and community about human subjects protections. 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) participant monitoring of all NIMH inpatients, 3) capacity assessment for select high-risk studies, 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 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 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 141 OSCE 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 Bioethics 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. Three new protocols were approved in 2024, with 5 in process. A subcommittee conducts annual review of ongoing protocols. In FY24 the CSRP and the Data Management and Sharing (DMS) Committee reviewed and approved DMS plans for all active clinical 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 sponsor (13 effective INDs, 3 approved IDEs, 22NSRs and 1 pending IND) 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 provided protocol navigation services to investigators for 85 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. 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) 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) facilitates comprehensive NIMH patient recruitment through design and and materials development, targeted marketing and advertising planning, and community outreach and engagement. In FY24, MCRU created/revised 207 marketing materials. Our Community Outreach Program reached over 200,000 individuals through 29 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.
MENTAL HEALTH RESPONSE TO THE COVID-19 PANDEMIC:
The NIMH OCD continues to collaborate with NIH Offices and the CC to provide mental health education, guidance and resources to all NIH staff. See ZIA-MH002922 for research related to cognitive and mental health impact of SARS-CoV-2/COVID.
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