Office of the Clinical Director

临床主任办公室

• 批准号: 7970240
• 负责人: Maryland Pao
• 金额: $ 417.27万
• 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/7970240
• 关键词: Academic Medical Centers; Accreditation; Adherence; Adolescent Psychiatry; Adult; Advertising; Advisory Committees; Advocacy; Ambulatory Care Facilities; American; Anxiety Disorders; Appointment; Area; Arts; Award; Bioethics; Brain; Camping; Care given by nurses; Caring; Censuses; Child; Clinical; Clinical Investigator; Clinical Research; Clinical Research Protocols; Code; Committee Members; Communities; Community Outreach; Community Relations; Consult; Consultations; Credentialing; Decision Making; Development; Education; Educational Curriculum; Emergency Situation; Enrollment; Ensure; Ethics; Event; Exhibits; Family; Fellowship; Fellowship Program; Focus Groups; General Population; Genetic; Guidelines; Health Fairs; Health Personnel; Hospitals; Hour; Human Subject Research; Image; Informed Consent; Inpatients; Institutes; Institution; Intramural Research Program; Joints; Knowledge; Laboratories; Lawyers; Leadership; Marketing; Medical; Medical Staff; Medical Students; Medical center; Mental Health; Mental disorders; Methodology; Molecular Medicine; Monitor; Moods; National Institute of Mental Health; Neuropsychological Tests; Neurosciences; Nurses; Office for Human Research Protections; Participant; Patient Recruitments; Patients; Pediatrics; Performance; Policies; Postdoctoral Fellow; Preparation; Process; Protocols documentation; Provider; Psychiatry; Psychosomatic Medicine; Publications; Regulation; Reporting; Research; Research Ethics Committees; Research Personnel; Research Project Grants; Research Subjects; Residencies; Rotation; Schedule; Schizophrenia; Schools; Series; Services; Social Workers; Students; Surgical Specialties; System; Time; Training; Training Activity; Training Programs; Training and Education; United States Dept. of Health and Human Services; United States Food and Drug Administration; United States National Institutes of Health; Vulnerable Populations; Washington; Work; Writing; behavioral health; clinical care; college; design; graduate medical education; healthy volunteer; high school; hospital organization; human subject; human subject protection; medical specialties; meetings; member; mental health education; multidisciplinary; neuropsychiatry; outreach program; patient safety; research study; working group

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.

I. NIMH DIRP临床支持服务：NIMH DIRP临床主任办公室（OCD）协调一系列临床，行政和研究相关的支持服务，向研究所和科学主管协调一系列临床和科学主任，包括：1）NIMH的行政监督，对NIMH住院单位和门诊临床研究的审查，涉及NIM的审查，涉及NIMH的临床研究，并涉及NIMH的临床研究，工作人员审查协议参与者的临床状况； 2）向所有NIMH研究参与者提供紧急医疗/精神病覆盖范围，每天24小时，7天/周； 3）NIMH医务人员的所有成员的证书； 4）对DHHS，NIH，NIMH DIRP，临床中心和其他监管机构的政策进行教育，培训和监测与人类受试者有关的政策，以保护临床研究。 NIMH临床主任是壁内工作组和NIH心理健康工作组的成员。 ii。人类受试者的保护活动，包括对CNS IRB的支持：NIMH是参与CNS IRB的六家机构之一，该机构审查了近600种临床研究方案（120个NIMH方案）。 强迫症提供行政，监管，教育，道德和科学支持，以帮助研究人员编写和审查协议，并通过继续年度审查以进行研究完成和发布，以确保人类受试者的保护（具有患者受试者和健康的志愿者）。 NIMH临床主任审查了所有NIMH DIRP方案，并担任协议科学审查委员会（CSRP），CNS IRB指导委员会，人类受试者研究咨询委员会（HSRAC）和CC医疗执行委员会（MEC）。 人类受试者保护部（HSPU）是一支屡获殊荣的团队，旨在保护参与心理健康研究的脆弱人类受试者。 由高级实践社会工作者和护士组成的HSPU成员监控知情同意过程（2009财年258个），对涉及潜在受害受试者的研究（27财年）进行决策能力评估，对代理理解进行评估，并评估受试者在受试者的能力上，并评估了任命Adtable Power of Attornors of Attornors of Attornors的能力（5中）（5中）（5 in 9 in fy in 09）。 HSPU成员就57个协议的人类受试者保护问题咨询研究人员，并监视所有NIMH住院受试者（每日平均人口普查为20.5财年）。 HSPU为其他NIH机构的研究人员提供培训和教育，并使用其专业知识为所有NIH研究人员开发知情同意培训视频。 自今年春季以来，HSPU与CC生物伦理学系合作，以监控脆弱的受试者及其家人如何就研究参与做出决定的过程。 营销和社区关系部（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协作的NIMH患者招聘。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计划以及向倡导团体，学校系统和医疗保健提供者提供的演讲，以及其他服务。 MCRU还审查并协助实质性批准符合IRB指南。 在09财年，我们的社区外展计划与社区团体和提供者进行了300多次任命，其中包括9个地区提供者团体，八个地区学校系统和专科学校，12家地区医院等。 此外，调查人员在心理健康博览会上进行了29个社区外展演讲，22个信息摊位展出，每次为100多名与会者举行了3个晚间活动。 iii。培训和教育：NIMH DIRP OCD与NIMH奖学金培训办公室结合，协调了几个培训计划，包括独特的一年一年研究的美国研究生医学教育学院（ACGME）认证的研究生年（PGY）-4精神病学居住；基础和转化实验室的临床研究奖学金；心身医学奖学金，与乔治敦大学医学中心和华盛顿医院中心的合作培训计划；与儿童国家医学中心的联合临床研究奖学金培训计划；以及居民和医学生旋转。 OCD积极支持CC神经精神病学奖学金计划的开发和实施，并帮助开发了关于医疗患者护理护理心理健康方面的每月一次研讨会系列。 OCD负责监督正在进行的临床培训活动中的教育，包括高中生到博士后研究员的学员课程。 NIMH DIRP与董事的NIMH办公室共同赞助了冷泉港的“脑营”，这是一群领先的神经科学家和杰出的精神病学居民，并从美国领先的美国医疗机构提名的杰出精神病学居民，以开发一项相关的临床神经科学课程，以在精神病居民中实施。 目前正在进行进一步开发和实施课程的努力。 此外，强迫症工作人员在协议准备，人类受试者保护以及与调查人员和其他NIMH DIRP研究人员的知情同意下准备和进行培训。 iv。 CC联络活动：NIMH DIRP OCD为CC和其他机构提供各种临床支持服务，包括：1）为参加临床研究的医学和外科手术和外科手术的患者提供精神病学咨询和联络服务（对FY09中的其他新精神病学咨询了600多个新的精神病学咨询）； 2）向所有NIH研究参与者提供紧急医疗/精神病覆盖范围，每天24小时，7天/周； 3）开发用于临床和研究信息的新神经心理测试服务； 4）向关心行为健康相关主题研究参与者的多学科团队的成员提供教育； 5）参加CC行为健康部门合作伙伴工作组以符合监管标准（即医院组织认证联合委员会，人类受试者研究办公室）； 6）为CC提供咨询和专业知识。 V.精神医学研究（精神病学咨询联络服务）致力于将源自基本神经科学和分子医学的知识与最先进的临床护理相结合，以便更好地理解和治疗医学和外科手术和外科手术的精神病。 NIMH DIRP OCD参与了MH002922-01中进一步描述的多个协作临床研究项目。