Office of the Clinical Director

I. NIMH DIRP临床支持服务：NIMH DIRP临床主任办公室（OCD）为研究所协调一系列临床和研究相关的支持服务，包括：1)通过图表审核、审查涉及NIMH受试者的发生报告、每月绩效改进会议和每周与临床研究者及其工作人员开会审查方案参与者的临床状况，对NIMH住院单位和门诊诊所进行行政监督；2)向所有NIMH研究参与者提供紧急医疗/精神病学服务，每天24小时，每周7天；3) NIMH所有医务人员的资格认证；4)对DHHS、NIH、NIMH DIRP、临床中心等监管机构在开展临床研究过程中与人体受试者保障相关的政策进行教育、培训和监测。二世。人类受试者保护活动包括对CNS IRB的支持：NIMH是参与CNS IRB的五个研究所之一。OCD提供行政、监管、教育、伦理和科学方面的支持，以帮助研究人员编写和审查协议，并确保人类受试者（包括患者受试者和健康志愿者）从最初的协议提交到持续的年度审查，直至研究完成和发表。从CNS IRB成立（2006年）到2008年7月1日，副临床主任担任其副主席，并于2008年7月1日任命了一名新的副主席。NIMH临床主任审查所有NIMH DIRP方案，并担任方案科学审查委员会（CSRP）、CNS IRB指导委员会、人类受试者研究咨询委员会（HSRAC）和CC医学执行委员会（MEC）的成员。

I. NIMH DIRP CLINICAL SUPPORT SERVICES: The NIMH DIRP Office of the Clinical Director (OCD) coordinates a range of clinical and research-related support services to the Institute including: 1) administrative oversight of NIMH inpatient units and outpatient clinics through chart auditing, review of occurrence reports involving NIMH subjects, monthly performance improvement meetings and weekly meetings with clinical investigators and their staff to review the clinical status of protocol participants; 2) the provision of emergency medical/psychiatric coverage to all NIMH research participants 24 hours/day, 7 days/week; 3) credentialing of all members of the NIMH medical staff; and 4) education, training and monitoring of DHHS, NIH, NIMH DIRP, Clinical Center and other regulatory agencies' policies related to human subjects safeguards during the conduct of clinical research. II. HUMAN SUBJECTS PROTECTIONS ACTIVITIES INCLUDING SUPPORT OF THE CNS IRB: NIMH is one of five Institutes participating in the CNS IRB. The OCD provides administrative, regulatory, educational, ethical and scientific support to help investigators write and review protocols and to ensure human subjects protections (with patient subjects and healthy volunteers) from initial protocol submission through continuing annual reviews to study completion and publication. The Deputy Clinical Director served as the Vice-Chair of the CNS IRB from its inception (2006) through July 1, 2008 and appointed a new Vice-Chair to the white panel beginning July 1, 2008. The NIMH Clinical Director reviews all NIMH DIRP protocols and serves as a member of the Committee for Scientific Review of Protocols (CSRP), the CNS IRB Steering Committee, the Human Subjects Research Advisory Committee (HSRAC), and the CC Medical Executive Committee (MEC). The Human Subjects Protections Unit (HSPU), formally the Central Office for Recruitment and Evaluation (CORE), is an award-winning team that was created to protect vulnerable human subjects participating in mental health research. The HSPU members, composed of advanced practice social workers and nurses, monitor the informed consent process (286 in FY08), perform decisionmaking capacity assessments for studies involving potentially impaired subjects (23 in FY08), consult to investigators on human subjects protections issues, and monitor all NIMH inpatient subjects (average daily census of 21 in FY08). Given the Unit's success, we have been involved in training and education of researchers in other NIH Institutes. The HSPU is developing an informed consent training video for NIMH investigators and CC staff. The Marketing and Community Relations Unit (MCRU) is responsible for facilitating NIMH subject recruitment in a variety of ways including direct targeted advertisements and arrangement of presentations by investigators for local and national community organizations, mental health advocacy associations, and schools. III. TRAINING AND EDUCATION: The NIMH DIRP OCD, in conjunction with the NIMH Office of Fellowship Training, coordinates several training programs including a unique one-year research oriented American College of Graduate Medical Education (ACGME) accredited Post-Graduate Year (PGY)-4 psychiatry residency; clinical research fellowships in basic and translational laboratories; Psychosomatic Medicine Fellowship, a collaborative training program with Georgetown University Medical Center and the Washington Hospital Center; a joint clinical-research fellowship training program with Children's National Medical Center; and resident and medical student rotations. The OCD is responsible for overseeing ongoing education in clinical training activities including the curriculum of trainees. In addition, OCD staff members prepare and conduct training in protocol preparation, human subjects protection, and the conduct of informed consent with investigators and other NIMH DIRP research staff. IV. CC LIAISON ACTIVITIES: The NIMH DIRP OCD provides a variety of clinical support services to the CC and other Institutes including: 1) providing psychiatric consultation and liaison services to medically- and surgically-ill patient subjects enrolled in clinical research (500 new psychiatric consultations to other Institutes in FY08); 2) providing education to members of the multidisciplinary teams caring for research participants in behavioral health related topics; 3) participating in the CC Behavioral Health Units Partners working group in order to meet regulatory standards (i.e., Joint Commission for Accreditation of Hospital Organizations, Office of Human Subjects Research); and 4) providing consultation and expertise to the CC (e.g., Chief of Radiology Department Search Committee, Chief of Spiritual Ministry Department Search Committee, Research Participant Satisfaction focus group moderator). V. RESEARCH: Research in Psychosomatic Medicine strives to integrate the rapidly evolving knowledge derived from basic neuroscience and molecular medicine with state-of-the-art clinical care in order to better understand and treat psychiatric conditions in the medically- and surgically-ill. The NIMH DIRP OCD participates in multiple collaborative clinical research projects ( 08-M-N070) as well as academic endeavors (23 local, national and international presentations; 6 posters; 4 papers and 4 chapters) to achieve this goal.