Office of the Clinical Director

NIMH OCD协调广泛的基本临床、行政和研究相关的支持服务，包括：1)通过对FDA监管研究的审计对NIMH住院病房和门诊诊所进行行政监督，监测高风险协议，图表审计，每月患者护理会议和每周与临床研究人员和工作人员的会议；2)为所有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专业人员的资格认证；4)对DHHS、NIH、NIMH、IRP、CC等监管机构在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。强迫症为NIMH校内研究培训奖获得者（irta）建立并实施了一项能力培训计划，以确保与患者接触的员工有能力与研究对象互动。OCD创建了“生命实验室”，这是NIMH基础研究人员和临床研究人员之间的一个互动项目，旨在加强精神病学的转化研究。NIMH临床主任（CD）是CC MEC的主席，也是CC ABCR的临时成员。她是美国国立卫生研究院院长多样性工作组和美国国立卫生研究院心理健康工作组的成员。MCRU负责通过设计和材料开发、有针对性的营销和广告规划以及社区外展，促进全面和多样化的NIMH患者招募。服务包括：创建品牌，统一的招聘材料，网站和广告时间表，以及调查人员向倡导团体，学校系统和卫生保健提供者进行演讲的活动策划。MCRU也审查招聘材料的批准是否符合IRB的指导方针。我们的社区外展项目安排了近200个预约，并与1700多个社区联系人合作。MCRU为公众举办了免费研讨会，每次有100多名与会者，并协调NIMH参加在华盛顿举行的美国科学节。创建了一项新的通讯倡议：专题：快速链接，以便在全国范围内分发，以便更好地向公众通报精神卫生障碍、最新研究成果和现有的研究机会。MCRU制作了78个广告，47个传单，8个宣传册，10个直邮计划，并放置了105个平面广告。MCRU维护和推广患者招募网站，并协助调查人员进行有效的网络安置；它被项目评估和绩效办公室（NIH/OD/DPCPSI）授予评估预留奖，以支持一个名为“NIMH内部研究项目网站部门的可用性测试”的项目，希望在2012财年获得资助。MCRU员工因在NIMH校内研究项目中支持患者招募工作的杰出服务而获得2011年NIMH董事奖。人体主体保护活动；支持CNS IRB: NIMH继续参与CNS IRB，该委员会审查了近600项临床研究方案（其中135项是NIMH方案）。最初的CNS工作人员，包括NIMH强迫症的几名工作人员，因其成功的创建和实施而获得了2011年NIH主任奖。OCD为研究人员提供行政、监管、教育、伦理和科学方面的支持，通过持续的年度审查来确保人类受试者从最初的方案提交到研究完成和发表的保护。NIMH CD审查所有NIMH IRP协议行动，并担任协议科学审查委员会、CNS IRB和PTMS指导委员会的成员。HSPU成员由社会工作者和护士组成，负责监督知情同意过程（2011财年为312人），并对涉及潜在受损受试者的研究（2011财年为133人）进行方案特定决策能力评估，对替代理解进行24次评估，并对受试者指定持久授权书的能力进行15次评估。HSPU成员就64项协议中人类受试者的保护问题向调查人员进行了咨询，并监测了所有NIMH住院受试者（2011财年全年平均每日普查22.7人）。HSPU成员为其他NIH研究所的研究人员提供培训和教育（每月1-2次），并利用他们的专业知识为所有NIH研究人员开发了知情同意培训视频，该视频可在NIH CC内部网和NIMH IRP网站上访问，并供广泛的NIH工作人员使用，以准备获得知情同意。鉴于NIH CC的独特设置，所有患者都参加了研究方案，强迫症和HSPU为NIH研究生医学教育委员会制定了关于知情同意过程的观察结构化临床评估（OSCE）。建立欧安组织是为了协助国立卫生研究院研究生医学教育认证委员会（认可委员会）的方案，在知情同意程序本身之外，对受训者进行专业精神、人际关系和沟通技巧等核心能力领域的培训。HSPU继续与CC生物伦理部合作，监测脆弱的受试者及其家属如何决定参与研究的过程。培训和教育：NIMH强迫症与NIMH IRP奖学金培训办公室一起获得了2011年NIMH主任奖，以表彰其在IRP方面的杰出培训。OCD协调几个培训项目，包括一个独特的为期一年的研究型，acgme认证的研究生学年(PGY)-4精神病学住院医师；为完成住院医师培训的精神科医生提供基础实验室和转化实验室的临床研究奖学金；住院医师和医科学生轮转；与乔治城大学医学中心和华盛顿医院中心合作的心身医学奖学金培训项目；以及与国家儿童医疗中心合作的为期三年的联合临床研究儿童精神病学奖学金培训项目。NIMH PGY4精神病学住院医师项目中期审查是今年由NIH研究生医学教育委员会进行的。ACGME批准的精神病学项目也赞助了CC新的和扩大的疼痛和姑息治疗（PPC）培训项目。OCD负责监督临床培训活动中的持续教育，包括从高中生到博士后研究员的培训课程。NIMH IRP与NIMH主任办公室在纽约州冷泉港联合主办了第三届年度“大脑训练营”。这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科住院医师组成的焦点小组，旨在制定相关的临床神经科学课程，以便在精神科住院医师中实施。针对精神科医生的教育网络工具的开发已经开始，并且第一个模块可以在NIMH的主页上找到。CC联络：NIMH强迫症中心提供多种临床支持服务，包括：1)为内科和外科病人提供精神病学咨询/联络服务（新增咨询550人次）；2)每周7天，每天24小时为NIH研究参与者提供紧急医疗/精神病学服务；3)新的神经心理测试服务（144例）；4)向多学科团队提供有关行为健康主题的教育；5)参加CC行为健康单位合作伙伴工作组；6)向CC提供咨询和专业知识，以支持NIH/社区的努力，如DC-NIH艾滋病进展伙伴关系。这项与当地调查人员进行的跨学科、跨机构的研究合作将增进对艾滋病毒/艾滋病心理健康方面的认识。

The NIMH OCD coordinates a wide range of essential clinical, administrative, and research-related support services including: 1)administrative oversight of NIMH inpatient units and outpatient clinics through audits of FDA regulated studies, monitoring of high risk protocols, chart auditing, monthly patient care meetings and weekly meetings with clinical investigators and staff; 2) provision of emergency medical/psychiatric coverage to all NIMH research participants 24 hours/day, seven days/week; 3) credentialing of members of the NIMH professional staff;and 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. The OCD established and implemented 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 OCD created "Labs to Life," an interactive program between NIMH basic and clinical researchers, to enhance translational research in psychiatry. The NIMH Clinical Director (CD) is Chair of the CC MEC and is an ad hoc member of the CC ABCR. She serves on the NIH Directors Task Force on Diversity and the NIH Work Group on Mental Health. 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. Services include: creating branded, unified recruitment materials, websites and advertising schedules, and event planning for investigators' presentations to advocacy groups, school systems, and health care providers. The MCRU also reviews recruitment materials approvals for compliance with IRB guidelines. Our community outreach program made nearly 200 appointments and worked with over 1,700 community contacts. The MCRU hosted free seminars for the public with over 100 attendees each and coordinated NIMH participation in the USA Science Festival in DC. A new newsletter initiative Featured Topic: Quick Links was created for nationwide distribution to better inform the public on mental health disorders, latest research findings and available research opportunities. The MCRU has created 78 ads, 47 flyers, eight brochures, 10 direct mail plans, and placed 105 print advertisements. The MCRU maintains and promotes a patient recruitment website and assists investigators with effective web placement; it was awarded an Evaluation Set-Aside Award by the Office of Program Evaluation and Performance (NIH/OD/DPCPSI) to support a project titled "Usability Testing of the NIMH Division of Intramural Research Programs Website," hopefully to be funded in FY12. The MCRU staff received a 2011 NIMH Directors Award for outstanding service in support of patient recruitment efforts in the NIMH Intramural Research Program. HUMAN SUBJECTS PROTECTIONS ACTIVITIES; SUPPORT OF THE CNS IRB: The NIMH continues to participate in the CNS IRB, which reviews almost 600 clinical research protocols (135 are NIMH protocols). The original CNS staff members, including several NIMH OCD staff, received a 2011 NIH Directors award for its successful creation and implementation. 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, serves as a member of the Committee for Scientific Review of Protocols, the CNS IRB and PTMS Steering Committees. The HSPU members, composed of social workers and nurses, monitors the informed consent process (312 in FY11), and performed protocol specific decision making capacity assessments for studies involving potentially impaired subjects (133 in FY11), performed 24 assessments of surrogate understanding, and conducted 15 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 22.7 in FY11 YTD). HSPU members provide training and education of researchers in other NIH Institutes (1-2 per month) and used their expertise to develop an informed consent training video for all NIH investigators that is accessible on the NIH CC Intranet as well as the NIMH IRP website, and is used by a broad range of NIH staff in preparation for obtaining informed consent. 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 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 conjunction with the NIMH IRP Office of Fellowship Training, received a 2011 NIMH Directors Award for outstanding training in the IRP. The OCD coordinates several training programs, including a unique one-year research-oriented, ACGME-accredited post-graduate year (PGY)-4 psychiatry residency; clinical research fellowships in basic and translational laboratories for psychiatrists who have completed their residencies; resident and medical student rotations; a collaborative Psychosomatic Medicine Fellowship training program with Georgetown University Medical Center and the Washington Hospital Center; and a three year joint clinical-research child psychiatry fellowship training program with Children's National Medical Center. The NIMH PGY4 psychiatry residency program mid-cycle review was conducted this year by the NIH Graduate Medical Education Committee. The ACGME approved psychiatry program also sponsors the CC's new and expanding Pain and Palliative Care (PPC) Training Program. 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 IRP jointly sponsored with the NIMH Office of the Director the third annual "Brain Camp" at Cold Spring Harbor, NY. This focus group of leading neuroscientists and outstanding psychiatric residents nominated from leading U.S. medical institutions met to develop a relevant clinical neuroscience curriculum to be implemented in psychiatric residencies. Development of education web tools highlighting relevant neuroscience for psychiatrists commenced and the first module is available on the NIMH home page. CC LIAISON: The NIMH OCD provides a variety of clinical support services including: 1) providing psychiatric consultation/liaison services to medically- and surgically-ill patient (>550 new consultations);2) provision of emergency medical/psychiatric coverage to NIH research participants 24 hours/day, seven days/week; 3) a new neuropsychological testing service(144 patients YTD); 4) providing education to multidisciplinary teams on behavioral health topics; 5) participating in the CC Behavioral Health Units Partners working group; 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.