Office of the Clinical Director

临床主任办公室

• 批准号: 9152161
• 负责人: Maryland Pao
• 金额: $ 384.45万
• 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/9152161
• 关键词: Accreditation; Adult; Advance Directives; Advertising; Advocacy; Advocate; Alzheimer' s Disease; Amendment; Authorization documentation; Basic Science; Behavior; Bioethics; Brain; Budgets; Censuses; Charge; Clinical; Clinical Protocols; Clinical Research; Clinical Services; Clinical Trials Data Monitoring Committees; Cognition; Collaborations; Communication; Communities; Community Outreach; Competence; Complex; Consent; Consultations; Credentialing; Development; Diagnosis; Disease; E-learning; Education; Education and Outreach; Educational Curriculum; Electronic Mail; Elements; Emergency Situation; Enrollment; Ensure; Evaluation; Extramural Activities; Fellowship; Fragile X Syndrome; Future; Good Clinical Practice; HIV; Health Priorities; Health Professional; Health Services Research; Hospitals; Human Resources; Individual; Informed Consent; Inpatients; Institutes; Institutional Review Boards; International; Internet; Intramural Research; Intramural Research Program; Joints; Lawyers; Leadership; Link; Malignant Neoplasms; Marketing; Medical Education; Medical Staff; Medical Students; Mental Health; Mission; Monitor; National Institute of Mental Health; Neurocognitive; Neurologic; Neuropsychology; Neurosciences Research; Nurse Administrator; Participant; Patient Care; Patient Recruitments; Patients; Phenotype; Physician Executives; Physicians; Policies; Population; Preparation; Procedures; Process; Professional Practice; Protocols documentation; Provider; Psychiatrist; Psychiatry; Psychologist; Psychosomatic Medicine; Qualifying; Recommendation; Regulation; Reporting; Research; Research Infrastructure; Research Personnel; Research Support; Research Training; Resources; Risk; Risk Management; Services; Site; Social Workers; Time; Training; Training Programs; Training and Education; Translational Research; United States National Institutes of Health; Visit; Work; Writing; base; career; clinical care; decision-making capacity; design; flu; high risk; human subject protection; innovation; interest; meetings; member; mental disorder prevention; multidisciplinary; neuropsychological; outreach program; patient population; patient safety; pediatric patients; programs; quality assurance; severe mental illness; social; tool

HUMAN SUBJECTS PROTECTIONS: The Human Subject Protections Unit (HSPU) is dedicated to ensuring adequate protections are in place for all NIMH intramural research participants. Established in 2005, this team of Clinical Research Advocates (CRAs) works with PIs, the IRB, the CC Bioethics Department, and individual participants to identify and ameliorate risks for vulnerable subjects. Activities include: 1) Consent Monitoring: CRAs monitor the informed consent process for potentially vulnerable patients as stipulated by the IRB. Thus, a CRA is present during the consent process and observes the quality of the process, ensuring that all required elements (45CFR46) are discussed; 2) Protocol Monitoring: All inpatient research participants are further protected by our protocol monitoring program in which each patient is assigned a CRA who meets with the participant at least weekly to reaffirm their interest in continuing in the study; 3) Capacity Assessment: For some particularly high-risk studies, a capacity assessment must be completed prior to study participation. Capacity assessments are completed with various patient populations such as Fragile X syndrome, Alzheimer's Disease and some cancer, HIV, and neurological populations; 4) Ability to Appoint an NIH Advanced Directive/Durable Power of Attorney: For protocols approved to include subjects without decision-making capacity, HSPU and the CC Bioethics Department, form the Ability to Consent Assessment Team (ACAT). These clinicians assess a subjects ability to appoint a Durable Power of Attorney (DPA) or Legally Authorized Representative (LAR); 5) Training and Education: In 2008, the HSPU developed an informed consent training, Elements of a Successful Informed Consent, which is required for investigators approved to obtain informed consent. To date, over 800 staff have completed the "Elements of a Successful Informed Consent" training. In 2010, an educational video and a computer-based training program were created highlighting the best practices in obtaining informed consent. The video is accessible on the web at http://nimhconsentvideo.nimh.nih.gov. This site has had over 4000 hits since it was originally posted. CLINICAL RESEARCH SUPPORT SERVICES: An important mission of the OCD is to ensure that subjects participating in NIMH protocols receive the highest quality clinical care. The OCD is responsible for the oversight of all clinical aspects of the DIRP including: 1) Risk Management/Patient Safety of the overall clinical program: The OCD administrative team meets regularly with the medical directors and nursing leadership to review census, discuss clinical concerns and plan for future initiatives. The OCD coordinates a monthly patient care meeting focused on patient safety, quality improvement and quality assurance in patient care. It also serves as a forum for communication of hospital-related policies and regulations; 2) Management of the NIMH protocol review process: The OCD coordinates the scientific review of protocols prior to IRB submission and provides protocol navigation services to DIRP investigators. The navigation team provides direct support to individual investigators for all aspects of IRB submissions. This includes drafting and writing initial review submissions, submission of annual continuing reviews (CR) applications and preparation of protocol amendments; 3) In addition the OCD provides a centralized Marketing Communications and Recruitment Unit (MCRU): 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. From 2010-2015, our Community Outreach Program reached over 5000 individuals through over 450 meetings with providers, consumers, community members, 203 scientific seminars, and electronic mailing subscribers to reach local and national audiences. Social media efforts produced 23 products (Twitter Talks, webinars, podcasts); 4) Quality Assurance (QA) Program: QA efforts focus on compliance with regulatory requirements and Good Clinical Practice (GCP). The OCD coordinates a Data and Safety Monitoring Board (DSMB) that oversees several DIRP protocols; 5) Authorization of medical staff credentials: The OCD is responsible for vetting of all clinical personnel and is involved in maintaining competence of all health care professionals within the Institute. This includes oversight of the hospital credentialing process for all NIMH professional staff. In 2014, the OCD implemented an evaluation tool to supplement the hospital-required Ongoing Professional Practice Evaluation (OPPE) prior to renewal of credentials; 6) Allocation of CC resources: The OCD serves as the link between the 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 Director and coordinates hospital initiatives such as preparation for Joint Commission accreditation visits, annual flu shot compliance, etc. 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: 1) provide research training for qualified physicians who intend to pursue scientific research careers; 2) allow advanced psychiatry residents to jump start their research training; and 3) educate medical students about clinical neuroscience research. In addition, the NIMH OCD contributes to initiatives that identify and promote academic research careers among promising early career psychiatrists. Lastly, we develop, promote and organize scientific programs or curriculum materials that educate psychiatrists about recent advances in neuroscience research relating to serious mental illnesses. See OCD Training report MH ZIE-MH002939-03 for additional details. CONSULTATION LIAISON: The NIMH Psychiatry Consultation Liaison Service (PCLS) is a multidisciplinary team that provides clinical services to patients enrolled in clinical protocols at the NIH CC. The core PCLS team consists of psychiatrists, psychologists, neuropsychologists, social workers and psychosomatic medicine fellow trainees. PCLS consultants evaluate and manage patients in need of routine or emergency mental health assessments in adult and pediatric patients participating in clinical research. The PCLS Neuropsychology Consultation Service is responsible for providing (1) clinical neuropsychological evaluations to assist with diagnosis and treatment recommendations for patients enrolled in clinical research throughout the CC on a referral basis, and (2) formal neuropsychological evaluations for selected NIH protocols in order to assist with neurocognitive phenotyping of various disorders and conditions, or for the purposes of matching subject groups and assessing for change in cognition over time. PCLS consultants also provide education, training and outreach in the CC on the larger NIH-campus. PCLS consultants conduct clinical research through active collaborations with investigators from other NIH Institutes as well as with national and international research groups. See OCD Psychiatry Consultation Liaison Service Research ZIA-MH002922-07 for additional details.

人类受试者保护：人类受试者保护部门 (HSPU) 致力于确保为所有 NIMH 校内研究参与者提供充分的保护。该临床研究倡导者 (CRA) 团队成立于 2005 年，与 PI、IRB、CC 生物伦理学部门和个人参与者合作，识别和减轻弱势受试者的风险。 活动包括： 1) 同意监控：CRA 按照 IRB 的规定监控潜在弱势患者的知情同意流程。因此，CRA 在同意过程中存在并观察该过程的质量，确保讨论所有必需的要素 (45CFR46)； 2) 方案监控：所有住院研究参与者都受到我们的方案监控计划的进一步保护，其中为每位患者分配了一名 CRA，他至少每周与参与者会面，以重申他们有兴趣继续研究； 3）能力评估：对于一些特别高风险的研究，在参与研究之前必须完成能力评估。 对各种患者群体完成了能力评估，例如脆性 X 综合征、阿尔茨海默病以及一些癌症、艾滋病毒和神经系统疾病群体； 4) 指定 NIH 高级指令/持久授权书的能力：对于批准的方案，其中包括没有决策能力的受试者，HSPU 和 CC 生物伦理学部门，组建同意能力评估小组 (ACAT)。这些临床医生评估受试者指定持久授权书 (DPA) 或合法授权代表 (LAR) 的能力； 5) 培训和教育：2008 年，HSPU 制定了知情同意培训《成功知情同意的要素》，这是批准获得知情同意的调查人员所必需的。迄今为止，已有 800 多名员工完成了“成功知情同意的要素”培训。 2010 年，制作了一个教育视频和一个基于计算机的培训计划，重点介绍了获得知情同意的最佳实践。该视频可通过以下网址访问：http://nimhconsentvideo.nimh.nih.gov。该网站自最初发布以来已有超过 4000 次点击。 临床研究支持服务：OCD 的一项重要使命是确保参与 NIMH 方案的受试者获得最高质量的临床护理。 OCD 负责监督 DIRP 的所有临床方面，包括： 1) 整个临床计划的风险管理/患者安全：OCD 管理团队定期与医疗主管和护理领导层会面，审查人口普查、讨论临床问题和计划未来的举措。 OCD 每月协调一次患者护理会议，重点关注患者安全、患者护理质量改进和质量保证。也是医院相关政策法规沟通的论坛； 2) NIMH 方案审查流程的管理：OCD 在 IRB 提交之前协调方案的科学审查，并向 DIRP 调查人员提供方案导航服务。导航团队为个别调查员提供 IRB 提交的各个方面的直接支持。这包括起草和撰写初步审查意见书、提交年度持续审查（CR）申请以及准备方案修正案； 3) 此外，OCD 还设有一个集中的营销传播和招募部门 (MCRU)：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。 从 2010 年到 2015 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 450 多次会议、203 场科学研讨会和电子邮件订阅者覆盖了 5000 多人，以接触当地和全国受众。社交媒体工作产生了 23 个产品（Twitter Talks、网络研讨会、播客）； 4) 质量保证 (QA) 计划：QA 工作的重点是遵守法规要求和良好临床实践 (GCP)。 OCD 协调数据和安全监控委员会 (DSMB)，该委员会负责监督多个 DIRP 协议； 5) 医务人员资格证书的授权：OCD 负责对所有临床人员进行审查，并参与维护研究所内所有医疗保健专业人员的能力。这包括监督所有 NIMH 专业人员的医院认证流程。 2014 年，OCD 实施了一种评估工具，以补充医院在更新证书之前所需的持续专业实践评估 (OPPE)； 6）CC资源的分配：OCD充当医院和研究所之间的纽带。 OCD 负责实施 CC 政策和标准操作程序 (SOP)。 OCD 与 CC 主任一起参加年度 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。 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，监督和参与多个项目：1) 为合格的人员提供研究培训打算从事科学研究职业的医生； 2）允许高级精神病学住院医师快速开始他们的研究培训； 3）对医学生进行临床神经科学研究方面的教育。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。最后，我们开发、推广和组织科学计划或课程材料，向精神病学家介绍与严重精神疾病相关的神经科学研究的最新进展。有关更多详细信息，请参阅强迫症培训报告 MH ZIE-MH002939-03。 咨询联络：NIMH 精神病学咨询联络服务 (PCLS) 是一个多学科团队，为 NIH CC 临床方案登记的患者提供临床服务。 PCLS的核心团队由精神病学家、心理学家、神经心理学家、社会工作者和心身医学实习生组成。 PCLS 顾问评估和管理参与临床研究的成人和儿童患者中需要常规或紧急心理健康评估的患者。 PCLS 神经心理学咨询服务负责提供 (1) 临床神经心理学评估，以协助在转介的基础上为整个 CC 中参加临床研究的患者提供诊断和治疗建议，以及 (2) 为选定的 NIH 方案提供正式的神经心理学评估，以便协助各种疾病和病症的神经认知表型分析，或用于匹配受试者组并评估认知随时间的变化。 PCLS 顾问还在更大的 NIH 校区的 CC 中提供教育、培训和外展服务。 PCLS 顾问通过与其他 NIH 研究所以及国内和国际研究小组的研究人员积极合作来开展临床研究。请参阅强迫症精神病学咨询联络服务研究 ZIA-MH002922-07 了解更多详细信息。