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 oversite program for clinical research including the DIRP Data and Safety Monitoring Board and an Intramural Research Auditing Committe. 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 currently serving as Acting Deputy Scientific Director as well as Vice Chair of the CC Medical Executive Committee and serves on numerous NIH committees. 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 FY13 our community outreach program made over 200 appointments with 2000 community groups and providers. MCRU has garnered over 3000 electronic mail subscribers and organized 57 targeted recruitment and outreach presentations and 20 exhibits at conferences. Over 100 referrals were generated as a direct result of outreach. MCRU created 206 new materials and revised 71 items. The MCRU completed Usability Testing of the NIMH DIRP Programs Website and helped to launch a new NIMH website. 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 Managment 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. The OCD team provides training and quality assurance presentations for NIMH research staff. The Intramural Research Auditing Committee performed 24 audits in FY13. HSPU members, composed of social workers and nurses, monitor the informed consent process (268 new consents in FY13), performed protocol specific decision making capacity assessments for studies involving potentially impaired subjects (86 in FY13), performed 17 assessments of surrogate understanding, and conducted 11 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 FY13 YTD). HSPU members provided more than 120 hours of expert training and education of researchers in other NIH Institutes (1-2 per month) using an informed consent training video for all NIH investigators available on the NIH CC Intranet as well as the NIMH IRP website. The HSPU, with the MCRU and NIMH Outreach Partners (Idaho), also gave a nationally broadcast educational webinar on """"""""Research, Ethics and Informed Consent at NIMH."""""""" Given the unique setting of the NIH CC where all patients are enrolled in research protocols, the OCD and HSPU developed an Observed Structured Clinical Evaluation (OSCE) on the informed consent process for the NIH Graduate Medical Education Committee. The OSCE was developed to assist Accreditation Council for Graduate Medical Education (ACGME) programs at NIH in educating trainees in the core competency areas of professionalism and interpersonal and communication skills, in addition to the informed consent process itself. HSPU also developed and presented an informed consent presentation for the """"""""Fundamentals of Clinical Research"""""""" for the Research Nurse Training Program for the CC Nursing Department. 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 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 a Pain and Palliative Care 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 002939-01 for additional details. CC LIAISON: In addition to interpretation and implementation of CC policies, the NIMH OCD provides a variety of psychiatric clinical support services to the CC and its users including: 1) providing psychiatric consultation/liaison services to medically- and surgically-ill patients enrolled in research at the CC (447 new consultations FY13);2) provision of emergency medical/psychiatric coverage to NIH CC research participants 24 hours/day, seven days/week;3) provision of neuropsychological testing services (372 patients FY13);4) providing mental health education to other institutes and NIH groups e.g., nursing, 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.