Office of the Clinical Director

NIMH DIRP临床支持服务：NIMH临床主任办公室(OCD)协调向研究所提供的一系列临床和研究相关支持服务，包括：1)通过图表审计对NIMH住院病房和门诊诊所进行行政监督，审查涉及NIMH对象的事件报告，每月召开业绩改进会议，每周与临床研究人员及其工作人员开会，审查方案参与者的临床状况；2)向所有NIMH研究参与者提供24小时、每周7天的紧急医疗/精神保险；3)对NIMH所有医务人员进行资格认证；以及4)在进行临床研究期间，教育、培训和监测卫生部、NIH、NIMH DIRP、临床中心和其他监管机构与人体受试者安全相关的政策。人类受试者保护活动，包括对CNS IRB的支持：NIMH是参加CNS IRB的五个研究所之一。强迫症提供行政、监管、教育、伦理和科学支持，以帮助调查人员编写和审查方案，并确保人类受试者(包括患者受试者和健康志愿者)通过持续的年度审查，防止首次提交方案，直至研究完成和发表。副临床主任从CNS IRB成立(2006年)到2008年7月1日一直担任副主席，并从2008年7月1日起任命一名新的副主席进入白色小组。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、人体研究咨询委员会(HSRAC)和CC医学执行委员会(MEC)的成员。 人类受试者保护股(HSPU)，前身是中央招募和评估办公室(CORE)，是一个获奖团队，旨在保护参与心理健康研究的脆弱人类受试者。HSPU成员由高级执业社会工作者和护士组成，监督知情同意程序(2008财年为286人)，为涉及潜在受损对象的研究进行决策能力评估(08财年为23人)，就人类对象保护问题咨询调查人员，并监控所有NIMH住院对象(08财年平均每天人口普查21人)。鉴于该单位的成功，我们参与了对其他NIH研究所研究人员的培训和教育。HSPU正在为NIMH调查人员和CC工作人员制作知情同意培训视频。营销和社区关系股(MCRU)负责以各种方式促进NIMH科目的招募，包括直接有针对性的广告，以及安排调查人员为当地和全国社区组织、精神健康倡导协会和学校进行陈述。培训和教育：NIMH DIRP OCD与NIMH研究员培训办公室合作，协调了几个培训计划，包括独特的一年制美国研究生医学教育学院(ACGME)认可的研究生四年住院医师；基础实验室和翻译实验室的临床研究奖学金；心身医学奖学金，这是与乔治敦大学医学中心和华盛顿医院中心合作的培训计划；与儿童国家医学中心联合的临床研究奖学金培训计划；以及住院医生和医学生轮换。强迫症负责监督持续进行的临床培训活动中的教育，包括学员的课程。此外，强迫症工作人员准备并进行礼仪编制、人类受试者保护以及与调查人员和其他NIMH DIRP研究人员进行知情同意方面的培训。四.协调中心联络活动：NIMH DIRP OCD向协调委员会和其他机构提供各种临床支助服务，包括：1)为登记参加临床研究的内科和外科病人提供精神科咨询和联络服务(2008财年向其他机构提供500个新的精神科咨询)；2)向多学科小组的成员提供教育，照顾行为健康相关主题的研究参与者；3)参加协调委员会行为卫生单位伙伴工作组，以达到监管标准(即，医院组织认证联合委员会、人类主题研究办公室)；和4)为CC提供咨询和专业知识(例如，放射科搜索委员会主任、灵能部搜索委员会主任、研究参与者满意度焦点小组主持人)。研究：心身医学研究致力于将基础神经科学和分子医学中迅速发展的知识与最先进的临床护理相结合，以便更好地了解和治疗内科和外科病人的精神疾病。NIMH DIRP OCD参与了多个合作的临床研究项目(08-M-N070)以及学术努力(23个地方、国家和国际演讲；6张海报；4篇论文和4个章节)，以实现这一目标。

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.