Office of the Clinical Director
临床主任办公室
基本信息
- 批准号:8557129
- 负责人:
- 金额:$ 459.53万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:
- 资助国家:美国
- 起止时间:至
- 项目状态:未结题
- 来源:
- 关键词:AIDS/HIV problemAcademic Medical CentersAccident and Emergency departmentAccreditationAcquired Immunodeficiency SyndromeAdherenceAdvertisingAmbulatory Care FacilitiesAnnual ReportsAnxietyAreaAwardAwarenessBioethicsBrainCampingCensusesChildChild PsychiatryClinicalClinical InvestigatorClinical ResearchClinical Research ProtocolsClinical TrialsCodeCollaborationsCommittee MembersCommunitiesCommunity OutreachCommunity RelationsConsentConsultConsultationsCredentialingDecision MakingDevelopmentDiscipline of NursingDistrict of ColumbiaEducationEducational MaterialsElectronic MailEmergency SituationEnrollmentEnsureEpidemiologyEthicsEvaluationExtramural ActivitiesFacultyFamilyFellowshipFellowship ProgramFundingGeneral HospitalsGeneticGoalsGuidelinesHealth PolicyHealth ProfessionalHospitalsHourHumanHuman Subject ResearchImageIndividualInformed ConsentInpatientsInstitutesInstitutionInstitutional Review BoardsIntramural ResearchIntramural Research ProgramIntranetInvestigationKnowledgeLaboratoriesLawyersLeadershipLifeMarketingMedicalMedical PsychologyMedical StudentsMedical centerMedicineMental HealthMentorsMolecular and Cellular BiologyMonitorMoodsMultimediaNational Institute of Mental HealthNeurobiologyNeurologyNeuropsychological TestsNeurosciencesNursesNursing ResearchNursing StaffPainPalliative CarePamphletsParticipantPatient CarePatient RecruitmentsPatientsPerformancePersonal CommunicationPhysiciansPoliciesProceduresProcessProgram EvaluationProtocols documentationProviderPsyche structurePsychiatryPsychosomatic MedicinePubertyPublicationsQuestionnairesRadioRecruitment ActivityRegulationReportingResearchResearch MethodologyResearch PersonnelResearch SubjectsResearch SupportResearch TrainingResidenciesRotationSafetySchizophreniaScreening procedureSerious Adverse EventServicesSiteSocial WorkersStatistical MethodsStructureStudentsSuicideSystemTelephoneTestingTrainingTraining ProgramsTraining and EducationTranslational ResearchUnited States Dept. of Health and Human ServicesUnited States Food and Drug AdministrationUnited States National Institutes of HealthVulnerable PopulationsWashingtonWorkautism spectrum disorderbehavioral healthcareercase-basedcollegedecision-making capacitydesignexperiencegraduate medical educationhealthy volunteerhigh riskhuman subjecthuman subject protectioninnovationmeetingsmembermental health educationnew technologyoutreach programpostersprogramsprotocol violationresearch clinical testingresearch studysevere mental illnessskillsusabilityweb siteworking group
项目摘要
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.
临床研究支持:NIMH OCD 负责许多关键的临床、行政和研究相关的支持服务,包括:1) 通过监测高风险方案、图表审核、每月对 NIMH 住院部和门诊部进行行政监督和质量绩效改进。 PI 和患者护理会议、与临床研究人员/工作人员的每周会议以及 FDA 监管研究的审核; 2) 每周 7 天、每天 24 小时向所有 NIMH 研究参与者提供紧急医疗/精神科保险; 3) NIMH专业人员的资格认证; 4) 对 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保障相关的政策进行教育、培训和监督,以及 5) 领导 CC 行为健康单位合作伙伴工作组,该工作组制定和审查心理研究NIH CC 护理人员的行为健康政策。 OCD 为 NIMH 校内研究培训获奖者 (IRTA) 提供能力培训计划,以确保接触患者的工作人员有能力与研究对象互动。 OCD 主办“Labs to Life”,这是 NIMH 基础研究人员和临床研究人员之间的互动项目,旨在加强精神病学的转化研究。 NIMH 临床主任 (CD) 是 CC 医疗执行委员会的主席,并在多个 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,促进全面且多样化的 NIMH 患者招募。 MCRU 审查招聘材料的批准是否符合 IRB 指南。 2012 财年,我们的社区外展计划通过与提供商、消费者和社区成员举行的 400 次会议,覆盖了超过 75,000 人,并与 2,000 多个社区联系人合作,并利用电子邮件来接触当地和全国受众。全年为公众举办免费教育研讨会。 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 个研究描述、重新设计了一个网站、制定了策略并协助投放了 52 个广告活动,并开发了徽标和医疗调查问卷。 MCRU 获得了项目评估和绩效办公室 (NIH/OD/DPCPSI) 颁发的评估预留奖的全额资助,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,该机构审查 139 项活跃的 NIMH 临床研究方案。 OCD 为研究人员提供行政、监管、教育、伦理和科学支持,以确保人类受试者从最初的方案提交到持续的年度审查再到研究完成和出版都受到保护。 NIMH CD 审查所有 NIMH IRP 方案行动,并担任方案科学审查委员会、CNS IRB 和 PTMS 指导委员会的成员。 OCD 工作人员积极监控 CC 发生报告系统以及向 IRB 提交严重不良事件和违反协议的情况,并为 NIMH 工作人员制定 QA 演示文稿。 HSPU 成员由社会工作者和护士组成,负责监督知情同意流程(2012 财年迄今有 300 份新同意书),对涉及潜在受损受试者的研究进行特定方案的决策能力评估(2012 财年有 87 份),对代理人理解进行了 24 项评估,并对受试者任命持久授权书的能力进行了 17 项评估。 HSPU 成员就 64 项方案的人类受试者保护问题向调查人员进行了咨询,并监测所有 NIMH 住院受试者(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 内联网和 NIMH IRP 网站上观看。鉴于 NIH CC 的独特环境(所有患者都参加研究方案),OCD 和 HSPU 为 NIH 研究生医学教育委员会制定了关于知情同意流程的观察结构化临床评估 (OSCE)。 OSCE 的成立是为了协助 NIH 的研究生医学教育认证委员会 (ACGME) 项目,除了知情同意过程本身之外,对学员进行专业精神、人际交往和沟通技巧等核心能力领域的教育。 HSPU 还为 CC 护理部的研究护士培训计划制定并提交了“临床研究基础”的知情同意书演示。 HSPU 继续与 CC 生物伦理学部门合作,监测弱势受试者及其家人如何做出有关研究参与的决定的过程。培训和教育:NIMH OCD 与 NIMH IRP 研究员培训办公室合作,监督一项临床研究员计划,该计划招募有前途的年轻医生来贝塞斯达校区参加为期 3 年的研究培训计划,通常是在完成住院医师培训后精神病学或相关医学领域,例如神经病学。渴望开始研究生涯的精神病学住院医师可以申请转入研究金计划,并进入我们经 ACGME 认证的 PGY4 住院医师计划。临床奖学金计划由导师驱动,学员可以选择在基础实验室、转化实验室或临床实验室接受培训。今年,从美国顶级住院医师培训中招募了 7 名新的临床研究员。ACGME 批准的精神病学住院医师培训项目是 NIH CC 疼痛和姑息治疗奖学金项目的赞助项目,该项目今年成功进行了现场审查。 OCD 帮助支持的另外两个 ACGME 项目是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项目,以及与国家儿童医学中心合作的为期三年的 NIMH 儿童精神病学临床联合奖学金项目。 OCD 还与其他地方和国家医疗机构协调医学生和住院医生的轮换。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(包括强迫症工作人员)帮助资助和组织杰出住院医师奖励计划和年度“脑营”计划。第二个在线神经科学模块于今年完成,该模块强调用于医学和精神病学教育的基于案例的临床神经科学概念,可在 NIMH 网站上获取。 CC 联络:NIMH OCD 提供各种精神科临床支持服务,包括:1) 为参加 CC 研究的内科和外科疾病患者提供精神科咨询/联络服务(2012 财年至今共 395 次新咨询); 2) 每周 7 天、每天 24 小时向 NIH CC 研究参与者提供紧急医疗/精神科保险; 3) 提供神经心理学测试服务(2012 财年至今已有 197 名患者); 4) 向其他机构和 NIH 团体提供心理健康教育,例如护理、儿童旅馆工作人员、公民,5) 为期 1 年心身医学奖学金的培训和教育,以及 6) 向 CC 提供咨询和专业知识,以支持 NIH/社区工作,例如 DC-NIH 艾滋病进展合作伙伴关系。与当地研究人员进行的这种跨学科、跨机构的研究合作将增强对艾滋病毒/艾滋病心理健康方面的了解,并在强迫症研究年度报告中进行了更全面的描述。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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{{ truncateString('Maryland Pao', 18)}}的其他基金
Office of the Clinical Director-Psychiatry Clinical Research Training
临床主任办公室-精神病学临床研究培训
- 批准号:
8745800 - 财政年份:
- 资助金额:
$ 459.53万 - 项目类别:
Office of the Clinical Director-Psychiatry Clinical Research Training
临床主任办公室-精神病学临床研究培训
- 批准号:
10266660 - 财政年份:
- 资助金额:
$ 459.53万 - 项目类别:
Psychiatry Clinical Research Training-NIMH Office of the Clinical Director
精神病学临床研究培训-NIMH 临床主任办公室
- 批准号:
10929869 - 财政年份:
- 资助金额:
$ 459.53万 - 项目类别:
Office of the Clinical Director-Psychiatry Clinical Research Training
临床主任办公室-精神病学临床研究培训
- 批准号:
8940188 - 财政年份:
- 资助金额:
$ 459.53万 - 项目类别:
Clinical Research in the NIMH Office of the Clinical Director
NIMH 临床主任办公室的临床研究
- 批准号:
10929831 - 财政年份:
- 资助金额:
$ 459.53万 - 项目类别:
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