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体受试者安全相关的政策；5)为临床研究提供全面的监测和现场计划，包括DIRP数据和安全监测委员会和内部研究审计委员会。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。NIMH临床主任（CD）目前还担任代理副科学主任以及CC医学执行委员会副主席，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2013财年，我们的社区外展计划与2000个社区团体和提供者进行了200多次预约。MCRU已获得超过3000个电子邮件订户，并组织了57个有针对性的招聘和推广演讲和20个会议展览。由于外联活动，直接产生了100多个转诊病例。MCRU新增206个材料，修改71个项目。MCRU完成了NIMH DIRP项目网站的可用性测试，并帮助启动了一个新的NIMH网站。人类受试者保护：NIMH继续参与CNS IRB，该委员会审查了128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和协议跟踪管理系统指导委员会的成员。OCD工作人员积极监督CC事件报告系统，并向IRB提交严重不良事件和违反协议的情况。2012年12月，强迫症成立了NIMH数据和安全监测委员会来监督随机临床试验。强迫症小组为NIMH研究人员提供培训和质量保证演示。内部研究审计委员会在2013财年进行了24次审计。由社会工作者和护士组成的HSPU成员监督知情同意过程（2013财年新增268份同意），对涉及潜在受损受试者的研究（2013财年为86份）进行具体方案决策能力评估，对替代理解进行17次评估，并对受试者指定持久授权书的能力进行11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，并对所有NIMH住院受试者进行了监测（2013财年全年平均每日人口普查20人）。HSPU成员为其他NIH研究所的研究人员提供了超过120小时的专家培训和教育（每月1-2小时），使用NIH CC内部网和NIMH IRP网站上提供的所有NIH研究人员的知情同意培训视频。HSPU与MCRU和NIMH外展伙伴（爱达荷州）还举办了一次全国广播的教育网络研讨会，主题是“NIMH的研究、伦理和知情同意”。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。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（ORAP）和年度“大脑训练营”计划。详见强迫症培训报告MH 002939-01。中心联络：除了解释和执行中心政策外，NIMH OCD还为中心及其用户提供各种精神病学临床支持服务，包括：1)为在中心注册研究的内科和外科疾病患者提供精神病学咨询/联络服务（2013财年新增咨询447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（2013财年372例）；4)为其他机构和NIH团体提供心理健康教育，如护理、儿童旅店员工、CIVIL； 5)提供为期一年的身心医学奖学金培训和教育；6)为CC提供咨询和专业知识，以支持NIH/社区努力，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，强迫症研究年度报告MH 002922对此有更全面的描述。

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) providing a comprehensive monitoring and oversite program for clinical research including the DIRP Data and Safety Monitoring Board and an Intramural Research Auditing Committe. 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 NIMH Clinical Director (CD) is also currently serving as Acting Deputy Scientific Director as well as Vice 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 FY13 our community outreach program made over 200 appointments with 2000 community groups and providers. MCRU has garnered over 3000 electronic mail subscribers and organized 57 targeted recruitment and outreach presentations and 20 exhibits at conferences. Over 100 referrals were generated as a direct result of outreach. MCRU created 206 new materials and revised 71 items. The MCRU completed Usability Testing of the NIMH DIRP Programs Website and helped to launch a new NIMH website. HUMAN SUBJECTS PROTECTIONS: The NIMH continues to participate in the CNS IRB, which reviews 128 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 Protocol Tracking Managment System Steering Committees. OCD staff actively monitor the CC occurrence report system and the submission of serious adverse events and protocol violations to the IRB. In December 2012, the OCD established the NIMH Data and Safety Monitoring Board over oversight of randomized clinical trials. The OCD team provides training and quality assurance presentations for NIMH research staff. The Intramural Research Auditing Committee performed 24 audits in FY13. HSPU members, composed of social workers and nurses, monitor the informed consent process (268 new consents in FY13), performed protocol specific decision making capacity assessments for studies involving potentially impaired subjects (86 in FY13), performed 17 assessments of surrogate understanding, and conducted 11 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 FY13 YTD). HSPU members provided more than 120 hours of expert training and education of researchers in other NIH Institutes (1-2 per month) using an informed consent training video for all NIH investigators available on the NIH CC Intranet as well as the NIMH IRP website. The HSPU, with the MCRU and NIMH Outreach Partners (Idaho), also gave a nationally broadcast educational webinar on "Research, Ethics and Informed Consent at NIMH." 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. 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 (ORAP) and the annual "Brain Camp" program. See OCD Training report MH 002939-01 for additional details. CC LIAISON: In addition to interpretation and implementation of CC policies, the NIMH OCD provides a variety of psychiatric clinical support services to the CC and its users including: 1) providing psychiatric consultation/liaison services to medically- and surgically-ill patients enrolled in research at the CC (447 new consultations FY13); 2) provision of emergency medical/psychiatric coverage to NIH CC research participants 24 hours/day, seven days/week; 3) provision of neuropsychological testing services (372 patients FY13); 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 MH 002922.