Office of the Clinical Director

临床研究支持：NIMH OCD负责许多关键的临床、行政和与研究相关的支持服务，包括：1)通过监测高风险协议、图表审计、每月PI和患者护理会议、每周与临床研究者/员工的会议和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和质量绩效改进；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)教育、培训和监测DHHS、NIH、NIMH IRP、CC和其他监管机构在临床研究过程中与人类受试者安全相关的政策；5)领导CC行为健康单位合作伙伴工作组，与NIH CC护理人员一起制定和审查精神和行为健康政策。强迫症为NIMH校内研究培训奖获得者（irta）提供能力培训计划，以确保与患者接触的工作人员有能力与研究对象互动。OCD举办了“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医学执行委员会主席，并在许多NIH委员会任职。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。MCRU审查招聘材料的批准是否符合IRB的指导方针。在2012财年，我们的社区外展计划通过与供应商、消费者和社区成员的400次会议，与2000多个社区联系人合作，覆盖了75000多人，并利用电子邮件与当地和全国的受众进行了接触。全年为市民举办免费的教育讲座。MCRU制作了63个广告、39个传单、4个小册子、7个海报、5个广播脚本、46个研究报告描述、重新设计了一个网站、策划并协助放置了52个广告活动，并制定了一个标志和医疗问卷。MCRU获得了由项目评估和绩效办公室（NIH/OD/DPCPSI）提供的评估预留奖的全部资金，以支持“NIMH DIRP项目网站的可用性测试”项目。人类受试者保护：NIMH继续参与CNS IRB，审查139个活跃的NIMH临床研究方案。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。OCD工作人员积极监督CC事件报告系统，向IRB提交严重不良事件和违反协议的情况，并为NIMH工作人员编写QA演示文稿。由社会工作者和护士组成的HSPU成员监督知情同意过程（2012财年至今新增300份同意书），对涉及潜在受损受试者的研究（2012财年为87份）进行具体方案决策能力评估，进行24项替代理解评估，并对受试者指定持久授权书的能力进行17项评估。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，并对所有NIMH住院受试者进行了监测（2012财年至今平均每日人口普查20人）。HSPU成员为其他NIH研究所的研究人员提供专家培训和教育（每月1-2次），为所有NIH研究人员制作了知情同意培训视频，可在NIH CC内部网和NIMH IRP网站上获得。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还为CC护理部门的研究护士培训计划制定并提交了“临床研究基础”的知情同意报告。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 OCD与NIMH IRP奖学金培训办公室合作，监督临床奖学金计划，招募有前途的年轻医生到Bethesda校区进行为期3年的研究培训计划，通常在完成精神病学或相关医学领域（如神经病学）的住院医师后。渴望开始自己研究生涯的精神病学住院医师可以申请转到奖学金项目，并进入我们的acgme认证的PGY4住院医师项目。临床奖学金项目由导师主导，受训者可以选择在基础实验室、转化实验室或临床实验室进行培训。今年，从美国顶尖住院医师中招募了7名新的临床研究员。acgme批准的精神病学住院医师是NIH CC疼痛和姑息治疗奖学金项目的赞助项目，该项目今年成功地进行了现场审查。OCD帮助支持的另外两个ACGME项目是乔治城大学医学中心和华盛顿医院中心的心身医学奖学金项目，以及国家儿童医学中心的为期三年的NIMH儿童精神病学临床奖学金项目。OCD还协调医科学生和住院医师与其他地方和国家医疗机构的轮转。为了加强全国精神病学住院医师的神经科学培训和研究，NIMH IRP，包括强迫症的工作人员，帮助资助和组织杰出住院医师奖励计划和年度“大脑训练营”计划。第二个在线神经科学模块强调了医学和精神病学教育中使用的基于病例的临床神经科学概念，已于今年完成，并可在NIMH网站上获得。中心联络：NIMH OCD提供各种精神病学临床支持服务，包括：1)为在中心参加研究的内科和外科疾病患者提供精神病学咨询/联络服务（2012财年年初至年底新增咨询395例）；2)每周7天，每天24小时为NIH CC研究参与者提供紧急医疗/精神病学服务；3)提供神经心理测试服务（2012财年至今共197例）；4)为其他机构和NIH团体提供心理健康教育，例如护士、儿童旅馆员工、CIVIL； 5)提供为期一年的心身医学奖学金的培训和教育；6)为CC提供咨询和专业知识，以支持NIH/社区的努力，例如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，强迫症研究年度报告对此作了更全面的描述。

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) leading the CC Behavioral Health Units Partners working group which develops and reviews mental and behavioral health policies with NIH CC Nursing staff. 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 OCD hosts "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 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 FY12 our community outreach program reached over 75,000 individuals through 400 meetings with providers, consumers and community members and worked with over 2,000 community contacts, and utilized electronic mailings to reach local and national audiences. Free education seminars for the public are hosted throughout the year. MCRU has created 63 ads, 39 flyers, 4 brochures, 7 posters, 5 radio scripts, 46 research study descriptions, a website re-design, strategized and assisted with placing 52 advertising campaigns, and developed a logo and medical questionnaire. The MCRU received full funding for an Evaluation Set-Aside Award by the Office of Program Evaluation and Performance (NIH/OD/DPCPSI) to support a project,"Usability Testing of the NIMH DIRP Programs Website". HUMAN SUBJECTS PROTECTIONS: The NIMH continues to participate in the CNS IRB, which reviews 139 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 PTMS Steering Committees. OCD staff actively monitor the CC occurrence report system and the submission of serious adverse events and protocol violations to the IRB and develop QA presentations for NIMH staff. HSPU members, composed of social workers and nurses, monitor the informed consent process (300 new consents in FY12 YTD), performed protocol specific decision making capacity assessments for studies involving potentially impaired subjects (87 in FY12), performed 24 assessments of surrogate understanding, and conducted 17 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 FY12 YTD). HSPU members provide expert training and education of researchers in other NIH Institutes (1-2 per month) developed an informed consent training video for all NIH investigators available on the NIH CC Intranet as well as the NIMH IRP website. 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. This year, seven new clinical fellows were recruited from top residencies in the U.S. 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 and the annual "Brain Camp" program. A second online neuroscience module that highlights case-based clinical neuroscience concepts for use in medical and psychiatric education was completed this year and is available on the NIMH website. CC LIAISON: The NIMH OCD provides a variety of psychiatric clinical support services including: 1) providing psychiatric consultation/liaison services to medically- and surgically-ill patients enrolled in research at the CC (395 new consultations YTD FY12); 2) provision of emergency medical/psychiatric coverage to NIH CC research participants 24 hours/day, seven days/week; 3) provision of neuropsychological testing services (197 patients YTD FY12); 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.