Office of the Clinical Director

临床主任办公室

• 批准号: 10008884
• 负责人: Maryland Pao
• 金额: $ 542.87万
• 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/10008884
• 关键词: Accreditation; Adopted; Adult; Advance Directives; Advertising; Advocacy; Agreement; Basic Science; Behavior; Behavioral; Bioethics; Brain; Budgets; Censuses; Charge; Clinical; Clinical Competence; Clinical Protocols; Clinical Research; Clinical Services; Clinical Trials Data Monitoring Committees; Clinical assessments; Communication; Communities; Community Outreach; Complex; Consent; Consultations; Credentialing; Development; Diagnosis; Discipline of Nursing; E-learning; Electronic Mail; Elements; Enrollment; Ensure; Evaluation; Event; Fellowship; Future; Genetic; Good Clinical Practice; Health Priorities; Health Professional; Health Services Research; Hospitals; Human Resources; Individual; Informed Consent; Inpatients; Institutes; Institution; Institutional Review Boards; Intramural Research Program; Joints; Lawyers; Leadership; Link; Marketing; Medical; Medical Education; Medical Staff; Medical Students; Medical center; Mental Health; Methods; Mission; Modeling; Monitor; National Institute of Mental Health; Neuropsychology; Outpatients; Participant; Patient Recruitments; Patients; Persons; Phenotype; Physicians; Policies; Preparation; Procedures; Process; Protocols documentation; Provider; Psychiatrist; Psychiatry; Regulation; Reporting; Research; Research Infrastructure; Research Personnel; Research Support; Research Training; Review Committee; Risk; Safety; Schedule; Science Policy; Sentinel; Services; Sleep; Training; Training Programs; Training and Education; Translational Research; United States National Institutes of Health; Visit; Work; career; clinical care; clinical implementation; clinical practice; data sharing; design; experience; falls; flu; follow-up; high risk; human subject protection; improved; innovation; investigator training; meetings; member; mental disorder prevention; multidisciplinary; neurodevelopment; outreach program; patient safety; peer; programs; recruit; response; screening; suicidal risk; surrogate decision maker; trend; web site

CLINICAL RESEARCH SUPPORT SERVICES: A central mission of the OCD is to ensure that research participants receive the highest quality clinical care. The OCD is responsible for oversight of all clinical aspects of the NIMH Intramural Research Program (NIMH IRP). HUMAN SUBJECT PROTECTIONS: The mission of the Human Subject Protections Unit (HSPU) is to ensure the protection of vulnerable subjects participating in research and to educate researchers and participants. This team works with investigators, the Institutional Review Board (IRB), and the Clinical Center (CC) Bioethics Department to identify and ameliorate risks for vulnerable subjects. Responsibilities include: 1) Consent and Assent Monitoring which assesses the quality of the informed consent process and ensures that all of the required elements of the protocol are discussed with participants. Assent monitoring ensures the quality of the assent discussion and verifies the agreement of the subject to participate in research. 2) Subject Monitoring of all NIMH inpatients verifies ongoing informed consent over the course of their participation in research. 3) Capacity Assessment is a clinical assessment of an adult participant's ability to provide informed consent for a specific protocol. For select high-risk studies, a capacity assessment must be completed prior to study participation. 4) Ability to Appoint an NIH Advanced Directive/Durable Power of Attorney (DPA) Assessment determines a participant's ability to choose another person to be his/her decision-maker for research participation. 5) Appropriateness of the Surrogate Assessment determines the appointed surrogate decision-maker's ability to represent a participant's wishes and provide consent. 6) Training and Education: The HSPU developed and conducts the Elements of a Successful Consent, a required training for investigators obtaining informed consent. To date, over 1500 NIH staff have completed this training, also available as a computer-based training program. In response to inquiries from other institutions, the HSPU has developed a toolkit to assist research organizations to assess, develop and implement appropriate levels of human subjects protections at their own facilities which will be publically launched this fall. CLINICAL OVERSIGHT: The OCD team meets regularly with NIH Clinical Center (CC) medical and nursing leadership to review CC census (Outpatient census has increased 32% over the same period last year), discuss clinical concerns and plan for future initiatives. The monthly PSQ meeting is also a forum for communication of hospital-related policies and regulations and includes quality improvement projects from each branch/section. The OCD team has coordinated the hospital-wide implementation of suicide risk screening at the CC in response to a Joint Commission Sentinel Event Alert 56 calling for suicide risk screening of all medical patients in the hospital setting (see ZIA MH002922-11). The OCD is responsible for credentialing through reviewing the qualifications of all clinical personnel and is involved in maintaining the clinical competence of all NIMH health care professionals. As the link between the CC hospital and the Institute, the OCD is responsible for the implementation of CC policies and standard operating procedures (SOPs). The OCD participates in annual CC budget planning meetings with the CC and IC Directors and coordinates hospital initiatives such as preparation for Joint Commission accreditation visits, annual flu shot compliance, etc. PATIENT SAFETY AND QUALITY (PSQ): In 2016, the OCD established the Office of Patient Safety and Quality. The Clinical Director, along with other OCD staff, oversees NIMH quality improvement initiatives and meets with each branch/section/lab chief and manager to assist with designing patient safety and quality improvement initiatives, with a dual focus of improving and ensuring quality clinical care, and sharing their experiences with the larger NIMH intramural clinical care group during monthly PSQ meetings. The OCD also tracks and trends Clinical Center occurrences and ensures follow-up. The OCD sends representatives to Clinical Center safety and quality initiatives, including daily patient safety huddles, the hospital-wide Clinical Care and Quality meeting, and the Patient Safety Clinical Practice and Quality Committee. NIMH monthly safety meetings for basic science labs are also attended by an OCD representative. Each branch/lab/section has presented at least one PSQ project and is now being scheduled to present follow up findings for their ongoing continuous quality improvement projects. The OCD PSQ team has also established a method for recredentialing medical staff using the Medical Re-Credentialing Evaluation (MRCE) that allows medical staff to self-evaluate and select peers for evaluations as well. The MRCE project has served as model for the Clinical Center leadership who is adopting a similar program to be implemented hospital-wide. SCIENTIFIC REVIEW: The Committee for Scientific Review of Protocols (CSRP) reviews all new clinical protocols. A subcommittee conducts annual review of ongoing protocols. REGULATORY OVERSIGHT: The Office for Regulatory Oversight (ORO) focuses on compliance with regulatory requirements and Good Clinical Practice (GCP). The NIMH Clinical Director now serves as the IND/IDE sponsor with support from ORSC. This office coordinates the scientific review of new and ongoing protocols and provides protocol navigation services to investigators. The navigation team provides direct support to investigators for all aspects of IRB submissions and tracking of investigator trainings. The OCD has implemented genetic data sharing and data sharing plans for intramural studies in accordance with NIH policy. The OCD coordinates a Data and Safety Monitoring Board (DSMB) to oversee DIRP protocols. Two clinical monitors develop and implement individualized monitoring plans for all active NIMH IRP protocols. This team also provides training and develops corrective action plans as needed. TRAINING AND EDUCATION: The NIMH OCD works in partnership with the NIMH Office of Fellowship Training (OFT) and the Office of Clinical Research and Training in Medical Education (OCRTME) to oversee and participate in several programs that train and educate new physicians and medical students. In addition, the NIMH OCD contributes to initiatives that identify and promote academic research careers among promising early career psychiatrists. See OCD Training report ZIEMH002939-06 for details. CONSULTATION LIAISON: The NIMH Psychiatry Consultation Liaison Service (PCLS) and Neuropsychology Consultation Service are teams that provide multidisciplinary clinical services to patients enrolled in clinical protocols at the NIH CC. Two additional clinical services were added in 2017, the Neurodevelopmental and Behavioral Phenotyping Service (see Dr. Thurm's report ZIC-MH002961-03) and the Sleep and Neurodevelopment Service (see Dr. Buckley's report ZIC-MH002962-03). See OCD Psychiatry Consultation Liaison Service Research ZIA-MH002922-11 for additional details. The MARKETING COMMUNICATIONS AND RECRUITMENT UNIT (MCRU) facilitates comprehensive, creative and diverse NIMH patient recruitment through design and materials development, targeted marketing and advertising planning, and community outreach. In FY18, our Community Outreach Program reached over 38,000 individuals through over 187 meetings with providers, consumers, community members, 34 scientific seminars, and electronic mailings. MCRU provides website support and liaisons with the Office of Science Policy, Planning and Communications.

临床研究支持服务：OCD 的核心使命是确保研究参与者获得最高质量的临床护理。 OCD 负责监督 NIMH 校内研究计划 (NIMH IRP) 的所有临床方面。 人类受试者保护：人类受试者保护部门 (HSPU) 的使命是确保保护参与研究的弱势受试者并教育研究人员和参与者。该团队与研究人员、机构审查委员会 (IRB) 和临床中心 (CC) 生物伦理学部门合作，识别和减轻弱势受试者的风险。职责包括： 1) 同意和同意监控，评估知情同意过程的质量并确保与参与者讨论方案的所有必需要素。 同意监控确保同意讨论的质量并验证受试者参与研究的同意。 2) 对所有 NIMH 住院患者进行受试者监测，以验证他们在参与研究过程中的持续知情同意。 3) 能力评估是对成年参与者对特定方案提供知情同意的能力的临床评估。对于选定的高风险研究，必须在参与研究之前完成能力评估。 4) 任命 NIH 高级指令/持久授权书 (DPA) 的能力评估确定参与者选择另一个人作为他/她参与研究的决策者的能力。 5) 代理评估的适当性决定了指定代理决策者代表参与者意愿并提供同意的能力。 6) 培训和教育：HSPU 制定并实施了成功同意的要素，这是调查人员获得知情同意所需的培训。迄今为止，已有超过 1500 名 NIH 工作人员完成了此项培训，该培训也可作为基于计算机的培训计划进行。为了回应其他机构的询问，HSPU 开发了一个工具包，以协助研究组织在自己的设施中评估、制定和实施适当水平的人类受试者保护措施，该工具包将于今年秋天公开推出。 临床监督：OCD 团队定期与 NIH 临床中心 (CC) 医疗和护理领导层会面，审查 CC 普查（门诊患者普查比去年同期增加了 32%），讨论临床问题并规划未来的举措。每月的PSQ会议也是沟通医院相关政策法规的论坛，包括各分院/科室的质量改进项目。 OCD 团队协调了 CC 在全院范围内实施自杀风险筛查，以响应联合委员会前哨事件警报 56，呼吁对医院环境中的所有患者进行自杀风险筛查（请参阅 ZIA MH002922-11）。 OCD 负责通过审查所有临床人员的资格来进行资格认证，并参与维护所有 NIMH 医疗保健专业人员的临床能力。作为CC医院和研究所之间的纽带，OCD负责CC政策和标准操作程序（SOP）的实施。 OCD 参加与 CC 和 IC 董事举行的年度 CC 预算规划会议，并协调医院的举措，例如联合委员会认证访问的准备、年度流感疫苗合规性等。 患者安全和质量 (PSQ)：2016 年，OCD 设立了患者安全和质量办公室。临床主任与其他 OCD 工作人员一起监督 NIMH 质量改进举措，并与每个分支机构/部门/实验室负责人和经理会面，协助设计患者安全和质量改进举措，双重重点是改善和确保高质量的临床护理，并在每月的 PSQ 会议上与更大的 NIMH 壁内临床护理小组分享他们的经验。 OCD 还跟踪和趋势临床中心的事件并确保跟进。 OCD 派代表参加临床中心安全和质量倡议，包括每日患者安全会议、全院临床护理和质量会议以及患者安全临床实践和质量委员会。 OCD 代表也出席 NIMH 基础科学实验室每月安全会议。每个分支机构/实验室/部门都提交了至少一个 PSQ 项目，现在正计划提交其正在进行的持续质量改进项目的后续调查结果。 OCD PSQ 团队还建立了一种使用医学再认证评估 (MRCE) 来对医务人员进行再认证的方法，该方法允许医务人员进行自我评估并选择同行进行评估。 MRCE 项目已成为临床中心领导层的典范，他们正在采用类似的计划在全院范围内实施。 科学审查：方案科学审查委员会 (CSRP) 审查所有新的临床方案。小组委员会对正在进行的方案进行年度审查。 监管监督：监管监督办公室 (ORO) 专注于遵守监管要求和良好临床实践 (GCP)。 NIMH 临床主任现在在 ORSC 的支持下担任 IND/IDE 申办者。该办公室协调对新的和正在进行的方案的科学审查，并为研究人员提供方案导航服务。导航团队为调查员提供 IRB 提交和跟踪调查员培训的各个方面的直接支持。 OCD 根据 NIH 政策实施了遗传数据共享和校内研究数据共享计划。 OCD 协调数据和安全监控委员会 (DSMB) 来监督 DIRP 协议。两名临床监测员为所有有效的 NIMH IRP 协议制定并实施个性化监测计划。该团队还根据需要提供培训并制定纠正行动计划。 培训和教育：NIMH OCD 与 NIMH 研究员培训办公室 (OFT) 和医学教育临床研究和培训办公室 (OCRTME) 合作，监督和参与多个培训和教育新医生和医学生的项目。此外，NIMH OCD 还致力于识别和促进有前途的早期职业精神病学家的学术研究生涯。有关详细信息，请参阅强迫症培训报告 ZIEMH002939-06。 咨询联络：NIMH 精神病学咨询联络服务 (PCLS) 和神经心理学咨询服务是为 NIH CC 临床方案登记的患者提供多学科临床服务的团队。 2017 年增加了两项额外的临床服务：神经发育和行为表型服务（参见 Thurm 博士的报告 ZIC-MH002961-03）和睡眠和神经发育服务（参见 Buckley 博士的报告 ZIC-MH002962-03）。请参阅强迫症精神病学咨询联络服务研究 ZIA-MH002922-11 了解更多详细信息。 营销传播和招募部门 (MCRU) 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、富有创意和多样化的 NIMH 患者招募。 2018 财年，我们的社区外展计划通过与提供商、消费者、社区成员举行的超过 187 次会议、34 场科学研讨会和电子邮件，覆盖了超过 38,000 人。 MCRU 提供网站支持以及与科学政策、规划和通信办公室的联络。