Office of the Clinical Director

Pao, Maryland

Abstract

CLINICAL RESEARCH SUPPORT: The NIMH OCD is responsible for many critical clinical, administrative, and research-related support services including: 1) administrative oversight and quality performance improvement of NIMH inpatient units and outpatient clinic through monitoring of high risk protocols, chart auditing, monthly PI and patient care meetings, weekly meetings with clinical investigators/staff and audits of FDA regulated studies;2) provision of emergency medical/psychiatric coverage to all NIMH research participants 24 hours/day, seven days/week;3) credentialing of NIMH professional staff;4) education, training and monitoring of DHHS, NIH, NIMH IRP, CC and other regulatory agencies'policies related to human subjects safeguards during the conduct of clinical research and 5) providing a comprehensive monitoring and oversight program for clinical research including the DIRP Data and Safety Monitoring Board and an Intramural Research Auditing Committee. The OCD provides a competency training program for NIMH Intramural Research Training Awardees (IRTAs) to assure staff with patient contact are competent for interacting with research subjects. The NIMH Clinical Director (CD) is also the Deputy Scientific Director and serves on numerous NIH committees including a newly formed trans-NIH working group to study fMRI imaging data sharing across the NIH intramural program as well as with the extramural community. The Deputy Scientific Director has also worked with the Scientific Director on several initiatives including NIH and NIMH IRP strategic planning, and establishing the Human Brain Core Collection (HBCC) as a new shared resource at NIMH (reported separately by HBCC Core Director). The MCRU is responsible for facilitating comprehensive and diverse NIMH patient recruitment through design and materials development, targeted marketing and advertising planning, and community outreach. MCRU reviews recruitment materials approvals for compliance with IRB guidelines. In FY14 our community outreach program reached over 5000 individuals through over 200 meetings with providers, consumers, community members and electronic mailing subscribers to reach local and national audiences. Over 50 free education seminars, webinars and podcasts for the public are hosted throughout the year. Efforts with Outreach Partners and through social media have garnered over 100 direct referrals. MCRU has created and revised 144 ads, 29 flyers, 17 brochures, 7 posters, 62 research study descriptions, and 3 re-branding initiatives. They are actively involved in a website development project and strategized and assisted with placing 35 advertising campaigns, 4 articles and one booklet. HUMAN SUBJECTS PROTECTIONS: The NIMH continues to participate in the CNS IRB, which reviews 128 active NIMH clinical research protocols. The OCD provides administrative, regulatory, educational, ethical and scientific support to investigators to ensure human subjects protections from initial protocol submission through continuing annual reviews to study completion and publication. The NIMH CD reviews all NIMH IRP protocol actions, and serves as a member of the Committee for Scientific Review of Protocols, the CNS IRB and Protocol Tracking Management System Steering Committees. OCD staff actively monitor the CC occurrence report system and the submission of serious adverse events and protocol violations to the IRB. In December 2012, the OCD established the NIMH Data and Safety Monitoring Board over oversight of randomized clinical trials. In January 2014, the multi-institute IRP auditing committee (IRPAC) was established with NIAAA and NIDA for oversight of intramural protocols. The OCD team provides training and quality assurance presentations for NIMH research staff. The IRPAC performed 20 audits in FY13. HSPU members, composed of social workers and nurses, monitor the informed consent process (over 200 new consents in FY14), performed protocol specific decision making capacity assessments for studies involving potentially impaired subjects (86 in FY14), performed 20 assessments of surrogate understanding, and conducted 13 assessments of subjects'ability to appoint a Durable Power of Attorney. HSPU members consulted to investigators on human subjects'protections issues on 64 protocols, and monitored all NIMH inpatient subjects (average daily census 20 in FY14 YTD). HSPU members provided more than 120 hours of expert training and education of researchers in other NIH Institutes (1-2 per month). An informed consent training video produced by the Clinical Research Advocates of the HSPU is being used for training in all the Graduate Medical Education Programs at the NIH as well as throughout the CC. HSPU continues to collaborate with the CC Bioethics Department in monitoring the process of how vulnerable subjects and their families make decisions regarding research participation. TRAINING AND EDUCATION: The NIMH OCD, in collaboration with the NIMH IRP Office of Fellowship Training, oversees a Clinical Fellowship Program that recruits promising young physicians scientists to come to the Bethesda campus for a 3-year research training program, generally after completion of residency in psychiatry or a related medical field, e.g. neurology. Psychiatry residents who are eager to jump start their research careers can apply to transfer to the fellowship program and enter our ACGME-accredited PGY4 residency program. The Clinical Fellowship Program is mentor-driven and trainees can choose to train in basic, translational or clinical laboratories. The ACGME-approved psychiatry residency serves as the sponsoring program for the Hospice and Palliative Care Medicine fellowship program at the NIH CC that underwent a successful site review this year. Two other ACGME programs that the OCD helps support are a Psychosomatic Medicine Fellowship with Georgetown University Medical Center and Washington Hospital Center and a three year Combined NIMH Child Psychiatry Clinical Fellowship program with Children's National Medical Center. The OCD also coordinates medical student and resident rotations with other local and national medical institutions. To enhance neuroscience training and research among psychiatry residents nationally, the NIMH IRP, including OCD staff, helps to fund and organize the Outstanding Resident Award Program (ORAP) and the annual """"""""Brain Camp"""""""" program. See OCD Training report MH 002939-02 for additional details. CC LIAISON: In addition to interpretation and implementation of CC policies, the NIMH OCD provides a variety of psychiatric clinical and educational support services to the CC and its users including: 1) providing psychiatric consultation/liaison services to medically- and surgically-ill adult (80%) and pediatric (20%) patients enrolled in research at the CC (400 new consultations in FY14);2) providing emergency medical/psychiatric coverage to NIH CC research participants 24 hours/day, seven days/week;3) provision of neuropsychological testing services (300 patients FY14);4) providing mental health education to other institutes and NIH groups e.g., nursing, social work, genetic counselors across NIH Institutes, Children's Inn staff, CIVIL, 5) training and education in a 1 year Psychosomatic Medicine fellowship, and 6) providing consultation and expertise to the CC to support NIH/community efforts such as the DC-NIH Partnership for AIDS Progress. This interdisciplinary, cross-institutional research collaborative effort with local investigators will enhance knowledge on the mental health aspects of HIV/AIDS and is more fully described in the OCD Research Annual Report MH 002922-06.