Office of the Clinical Director

临床主任办公室

• 批准号: 8342313
• 负责人: Maryland Pao
• 金额: $ 489.26万
• 依托单位: NATIONAL INSTITUTE OF MENTAL HEALTH
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8342313
• 关键词: AIDS/HIV problem; Academic Medical Centers; Accreditation; Acquired Immunodeficiency Syndrome; Adherence; Adolescent Psychiatry; Adult; Advertisements; Advertising; Advisory Committees; Advocacy; Ambulatory Care Facilities; Anxiety; Appointment; Area; Award; Awareness; Bioethics; Brain; Camping; Censuses; Child; Child Psychiatry; Clinical; Clinical Investigator; Clinical Research; Clinical Research Protocols; Clinical Trials; Code; Collaborations; Committee Members; Communities; Community Outreach; Community Relations; Consult; Consultations; Country; Credentialing; Decision Making; Development; District of Columbia; Education; Educational Curriculum; Emergency Situation; Enrollment; Ensure; Ethics; Evaluation; Event; Family; Fellowship; Festival; Focus Groups; Funding; Genetic; Goals; Guidelines; Health Personnel; Health Professional; Home Page; Hospitals; Hour; Human; Image; Informed Consent; Inpatients; Institutes; Institution; Institutional Review Boards; International; Internet; Intramural Research; Intramural Research Program; Intranet; Joints; Knowledge; Laboratories; Lawyers; Leadership; Life; Link; Mails; Marketing; Medical; Medical Psychology; Medical Students; Medical center; Mental Health; Mental disorders; Methodology; Monitor; Moods; National Institute of Allergy and Infectious Disease; National Institute of Mental Health; Neuropsychological Tests; Neurosciences; Newsletter; Nurses; Office for Human Research Protections; Pain; Palliative Care; Pamphlets; Participant; Patient Care; Patient Recruitments; Patients; Performance; Personal Communication; Policies; Postdoctoral Fellow; Preparation; Printing; Process; Program Evaluation; Protocols documentation; Psyche structure; Psychiatrist; Psychiatry; Psychosomatic Medicine; Publications; Regulation; Research; Research Personnel; Research Subjects; Research Training; Residencies; Rotation; Schedule; Schizophrenia; Schools; Science; Services; Social Workers; Structure; Students; System; Testing; Training; Training Activity; Training Programs; Training and Education; Translational Research; United States Dept. of Health and Human Services; United States Food and Drug Administration; United States National Institutes of Health; Vulnerable Populations; Washington; Work; autism spectrum disorder; base; behavioral health; clinical care; decision-making capacity; design; graduate medical education; healthy volunteer; high risk; high school; human subject; human subject protection; innovation; meetings; member; mental health education; multidisciplinary; new technology; outreach program; patient safety; programs; research clinical testing; severe mental illness; skills; tool; usability; web site; working group

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.

NIMH OCD通过通过FDA受监管的研究监测高风险协议，图表审核，每月的患者培训会议以及与临床研究员和员工的临床调查人员和员工和员工的每周会议，通过审核NIMH住院单位和门诊诊所来协调各种基本的临床，行政和研究有关的支持服务，包括：1）对NIMH住院单位和门诊诊所的行政监督； 2）为所有NIMH研究参与者提供紧急医疗/精神病覆盖范围，每天24小时，每周7天； 3）NIMH专业人员的认证； 4）DHHS，NIH，NIMH IRP，CC和其他监管机构在进行临床研究期间与人类受试者有关的保障的教育，培训和监测。 OCD为NIMH壁内研究培训奖（IRTA）建立并实施了一项能力培训计划，以确保患者接触的员工有能力与研究对象进行互动。强迫症创建了NIMH基础研究人员和临床研究人员之间的互动程序“生命实验室”，以增强精神病学的转化研究。 NIMH临床总监（CD）是CC MEC的主席，是CC ABCR的临时成员。她在NIH多样性工作组和NIH心理健康工作组任职。 MCRU负责通过设计和材料开发，有针对性的营销和广告计划以及社区宣传来促进全面和多样化的NIMH患者招聘。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，学校系统和医疗保健提供者的活动计划。 MCRU还审查了招聘材料批准，以符合IRB指南。我们的社区外展计划进行了近200次任命，并与1,700多个社区联系人合作。 MCRU为公众举办了免费研讨会，每个与100多名与会者共同参加了NIMH参加DC的美国科学节。一项新的新闻通讯倡议主题：快速链接是为全国性分销而创建的，以更好地告知公众心理健康障碍，最新研究结果和可用的研究机会。 MCRU创建了78个广告，47个传单，8个手册，10个直接邮件计划，并发布了105个印刷广告。 MCRU维护和促进了患者招聘网站，并协助调查人员有效的网络放置；它被计划评估与绩效办公室（NIH/OD/DPCPSI）授予评估固定奖，以支持一个标题为“ NIMH室内研究计划网站NIMH部门可用性测试”的项目。 MCRU工作人员获得了2011年NIMH董事奖，以支持NIMH壁内研究计划中的患者招聘工作。人类受试者保护活动； 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).最初的CNS工作人员，包括几名NIMH OCD员工，因其成功的创建和实施而获得了2011年NIH董事奖。 OCD向研究人员提供行政，监管，教育，道德和科学支持，以确保人类受试者通过继续年度审查以研究完成和发表来保护人类受试者免受初始协议提交的保护。 NIMH CD审查了所有NIMH IRP协议行动，是CNS IRB和PTMS指导委员会的科学审查委员会的成员。由社会工作者和护士组成的HSPU成员监视知情同意过程（FY11中的312），并对涉及潜在受损受试者的研究进行了特定于协议的决策能力评估（FY11中的133个），对杂物的评估进行了24次评估，并对受试者的任命能力进行了15次评估。 HSPU成员就64个协议的人类受试者的保护问题咨询了调查人员，并监视了所有NIMH住院受试者（平均每日人口普查22.7 in 11 YTD）。 HSPU成员为其他NIH机构（每月1-2）的研究人员提供培训和教育，并使用其专业知识为所有NIH CC Intranet以及NIMH IRP网站上都可以访问的所有NIH调查人员制定知情的同意培训视频，并被一系列NIH员工使用，以准备获得知情同意。鉴于NIH CC的独特设置，所有患者都纳入了研究方案，因此OCD和HSPU在NIH研究生医学教育委员会的知情同意过程中开发了观察到的结构化临床评估（OSCE）。 OSCE的开发是为了协助NIH的研究生医学教育（ACGME）计划的认证委员会，以教育在专业精神和人际关系和沟通技巧的核心能力领域，除了知情同意程序本身外。 HSPU继续与CC生物伦理学系合作监测脆弱的受试者及其家人如何就研究参与做出决定的过程。培训和教育：NIMH OCD与NIMH IRP奖学金培训办公室一起获得了2011年NIMH董事奖在IRP中获得的杰出培训奖。 OCD协调了几个培训计划，包括一年以一年的研究，以ACGME认可的研究生年（PGY）-4精神病学居留；完成居住的精神科医生基础和转化实验室的临床研究奖学金；居民和医学生的轮换；与乔治敦大学医学中心和华盛顿医院中心合作的心身奖学金培训计划；以及与儿童国家医疗中心的三年联合临床研究儿童精神病学奖学金培训计划。 NIMH PGY4精神病学居住计划中期审查是由NIH研究生教育委员会今年进行的。 ACGME批准的精神病学计划还赞助了CC的新疼痛和姑息治疗（PPC）培训计划。 OCD负责监督临床培训活动中正在进行的教育，包括高中生到博士后研究员的学员课程。 NIMH IRP联合赞助了纽约州冷春港的第三届年度“脑营”的NIMH办公室。 来自美国领先医疗机构提名的主要神经科学家和杰出的精神病学家的焦点小组开会，开发了一项相关的临床神经科学课程，将在精神病学居住中实施。教育网络工具的开发突出了对精神科医生的相关神经科学的开始，并在NIMH主页上提供了第一个模块。 CC联络：NIMH OCD提供了各种临床支持服务，包括：1）为医学和外科手术和外科手术的患者提供精神病学咨询/联络服务（> 550个新咨询）; 2）提供紧急医疗/精神病学参与者为NIH研究参与者提供24小时/天，每天，每周7天； 3) a new neuropsychological testing service(144 patients YTD); 4）为行为健康主题的多学科团队提供教育； 5）参加CC行为健康部门合作伙伴工作组； 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艾滋病进步伙伴关系。这项跨学科的跨机构研究合作与当地研究人员的合作将增强有关艾滋病毒/艾滋病心理健康方面的知识。