Office of the Clinical Director

I. NIMH DIRP临床支持服务：NIMH DIRP临床主任办公室（OCD）为研究所和科学主任协调一系列临床、行政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。NIMH临床主任是校内工作组和美国国立卫生研究院心理健康工作组的成员。二世。人类受试者保护活动包括支持CNS IRB: NIMH是参与CNS IRB的六个研究所之一，该机构审查了近600项临床研究协议（120项是NIMH协议）。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。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。人类受试者保护小组（HSPU）是一个屡获殊荣的团队，旨在保护参与心理健康研究的弱势人类受试者。HSPU成员由高级社会工作者和护士组成，负责监督知情同意过程（2009财年为258人），对涉及潜在受损受试者的研究进行决策能力评估（2009财年为27人），对代理理解进行评估（2009财年为8人），并评估受试者指定持久授权书的能力（2009财年为5人）。HSPU成员就57项协议中的人类受试者保护问题向调查人员进行咨询，并监测所有NIMH住院受试者（2009财年平均每日人口普查20.5人）。HSPU为NIH其他研究所的研究人员提供培训和教育，并利用他们的专业知识为NIH所有研究人员开发了知情同意培训视频。自今年春天以来，HSPU一直与CC生物伦理部合作，监督脆弱的受试者及其家属如何决定是否参与研究。市场营销和社区关系部门（MCRU）负责通过设计和材料开发、有针对性的市场营销和广告规划以及社区外展，促进NIMH患者的全面和协作招募。服务包括创建品牌和统一的招聘材料、网站、广告时间表、调查人员演示的活动规划、向倡导团体、学校系统和医疗保健提供者进行演示等服务。MCRU还审查并协助材料批准，以满足IRB的指导方针。在2009财年，我们的社区外展项目与社区团体和提供者进行了300多次预约，包括9个地区提供者团体、8个地区学校系统和专科学校、12个地区医院等。此外，调查人员进行了29次社区外展演讲，在心理健康博览会上展出了22个信息亭，并为公众举办了3次晚间活动，每次参加人数超过100人。三世。培训和教育：NIMH DIRP强迫症，与NIMH奖学金培训办公室合作，协调几个培训计划，包括一个独特的一年研究导向的美国研究生医学教育学院（ACGME）认可的研究生年(PGY)-4精神病学住院医师；基础实验室和转化实验室的临床研究奖学金；心身医学奖学金，与乔治城大学医学中心和华盛顿医院中心合作培训项目；与国家儿童医疗中心联合开展临床研究奖学金培训项目；住院医师和医学生轮岗OCD积极支持CC神经精神病学护士奖学金计划的发展和实施，并帮助制定了关于医疗患者护理的心理健康方面的月度系列研讨会。OCD负责监督临床培训活动的持续教育，包括从高中生到博士后研究员的培训课程。NIMH DIRP与NIMH主任办公室在冷泉港联合发起了“脑营”，这是一个由美国主要医疗机构提名的主要神经科学家和杰出精神病学住院医师组成的焦点小组，旨在开发相关的临床神经科学课程，以便在精神病学住院医师中实施。目前正在努力进一步发展和实施课程。此外，强迫症的工作人员准备并开展有关方案准备、人类受试者保护、调查员和NIMH DIRP其他研究人员知情同意行为的培训。四、CC联络活动：NIMH DIRP OCD为CC和其他研究所提供各种临床支持服务，包括：1)为参加临床研究的内科和外科疾病患者提供精神病学咨询和联络服务（2009财年为其他研究所提供了600多例新的精神病学咨询）；2)为所有NIH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)开发新的神经心理测试服务，为临床和研究提供信息；4)对多学科团队成员提供行为健康相关主题的教育；5)参加CC行为健康单位合作伙伴工作组，以达到监管标准（即医院组织认证联合委员会，人体受试者研究办公室）；6)向CC提供咨询和专业知识。V.身心医学研究（精神病学咨询联络服务）努力将基础神经科学和分子医学中快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疾病中的精神疾病。NIMH DIRP强迫症参与了MH002922-01中进一步描述的多个合作临床研究项目。

I. NIMH DIRP CLINICAL SUPPORT SERVICES: The NIMH DIRP Office of the Clinical Director (OCD) coordinates a range of clinical, administrative, and research-related support services to the Institute and Scientific Director 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. The NIMH Clinical Director serves as a member of the Intramural Working Group and the NIH Work Group on Mental Health. II. HUMAN SUBJECTS PROTECTIONS ACTIVITIES INCLUDING SUPPORT OF THE CNS IRB: NIMH is one of six Institutes participating in the CNS IRB which reviews nearly 600 clinical research protocols (120 are NIMH protocols). 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 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) 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 (258 in FY09), perform decisionmaking capacity assessments for studies involving potentially impaired subjects (27 in FY09), perform assessments of surrogate understanding (8 in FY09) and assessments of a subject's ability to appoint a Durable Power of Attorney (5 in FY 09). HSPU members consult to investigators on human subjects protections issues on 57 protocols, and monitor all NIMH inpatient subjects (average daily census 20.5 in FY09). HSPU provides training and education of researchers in other NIH Institutes and has used their expertise to develop an informed consent training video for all NIH investigators. Since spring of this year, HSPU has worked collaboratively with the CC Bioethics Department to monitor the process of how vulnerable subjects and their families make decisions regarding research participation. The Marketing and Community Relations Unit (MCRU) is responsible for facilitating comprehensive and collaborative NIMH patient recruitment through design and materials development, targeted marketing and advertising planning, and community outreach. Services include creating branded and unified recruitment materials, websites, advertising schedules, event planning for investigators' presentations, and presentations to advocacy groups, school systems, and health care providers, among other services. MCRU also reviews and assists with material approvals to meet IRB guidelines. In FY09, our community outreach program made over 300 appointments with community groups and providers, including nine area providers groups, eight area school systems and specialty schools, 12 area hospitals, and others. In addition, investigators made 29 community outreach presentations, 22 information booths were exhibited at mental health fairs, and 3 evening events for the general public were held with over 100 attendees each time. 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 has actively supported the development and implementation of the CC Neuropsychiatry Nurse Fellowship Program and helped to develop a monthly seminar series on mental health aspects of nursing care of medical patients. The OCD is responsible for overseeing ongoing education in clinical training activities including the curriculum of trainees from high school students to postdoctoral fellows. The NIMH DIRP jointly sponsored with the NIMH Office of the Director, "Brain Camp" at Cold Spring Harbor, a focus group of leading neuroscientists and outstanding psychiatric residents nominated from leading US medical institutions, in an effort to develop a relevant clinical neuroscience curriculum to be implemented in psychiatric residencies. Current efforts at further development and implementation of the curriculum are underway. 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 (more than 600 new psychiatric consultations to other Institutes in FY09); 2) the provision of emergency medical/psychiatric coverage to all NIH research participants 24 hours/day, 7 days/week; 3) the development of a new neuropsychological testing service for clinical and research information; 4) providing education to members of the multidisciplinary teams caring for research participants in behavioral health related topics; 5) 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 6) providing consultation and expertise to the CC. V. RESEARCH IN PSYCHOSOMATIC MEDICINE (Psychiatric Consultation Liaison Service) strives to integrate 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 further described in MH002922-01.