Office of the Clinical Director

临床主任办公室

• 批准号: 9357332
• 负责人: Maryland Pao
• 金额: $ 388.52万
• 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/9357332
• 关键词: Accreditation; Adult; Advance Directives; Advertising; Advocacy; Advocate; Amendment; Basic Science; Behavior; Bioethics; Brain; Budgets; Censuses; Charge; Clinical; Clinical Competence; Clinical Data; Clinical Protocols; Clinical Research; Clinical Services; Clinical Trials Data Monitoring Committees; Collaborations; Communication; Communities; Community Outreach; Complex; Consent; Consultations; Credentialing; Development; Diagnosis; E-learning; Education; Education and Outreach; Educational Curriculum; Electronic Mail; Elements; Emergency Situation; Enrollment; Ensure; Evaluation; Event; Extramural Activities; Fellowship; Fragile X Syndrome; Future; Good Clinical Practice; Health Priorities; Health Professional; Health Services Research; Hospitals; Human Resources; Individual; Informed Consent; Inpatients; Institutes; Institutional Review Boards; Internet; Intramural Research; Intramural Research Program; Joints; Lawyers; Leadership; Link; Marketing; Medical; Medical Education; Medical Staff; Medical Students; Mental Health; Minor; Mission; Monitor; National Institute of Mental Health; Neurosciences Research; Nurse Administrator; Participant; Patient Care; Patient Recruitments; Patients; Physician Executives; Physicians; Policies; Preparation; Procedures; Process; Professional Practice; Protocols documentation; Provider; Psychiatrist; Psychiatry; Psychologist; Psychology; Psychosomatic Medicine; Qualifying; Regulation; Reporting; Research; Research Infrastructure; Research Personnel; Research Support; Research Training; Resources; Risk; Risk Management; Schizophrenia; Sentinel; Services; Site; Social Workers; Training; Training Programs; Training and Education; Translational Research; Traumatic Brain Injury; United States National Institutes of Health; Visit; Work; Writing; base; career; clinical care; data sharing; decision-making capacity; design; flu; genomic data; high risk; human subject protection; innovation; interest; meetings; member; mental disorder prevention; multidisciplinary; outreach program; patient population; patient safety; pediatric patients; podcast; programs; quality assurance; response; screening; severe mental illness; social media; suicidal risk; surrogate decision maker; tool; willingness

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 oversight of all clinical aspects of the NIMH IRP including: 1) Risk Management/Patient Safety of the overall clinical program. The OCD administrative team meets regularly with 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; this meeting is a forum for communication of hospital-related policies and regulations. The OCD team has contributed substantially to the implementation of suicide risk screening at the NIH Clinical Center in response to a 2016 Joint Commission (JC) Sentinel Event Alert calling for suicide risk screening of all medical patients in the hospital setting (based on OCD research, see ZIA MH002922-08). 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 IRP investigators. The navigation team provides direct support to individual investigators for all aspects of IRB submissions including writing initial review submissions, submission of annual continuing reviews applications and preparation of protocol amendments. The OCD also coordinates the scientific review of active studies for continuing merit on a triennial basis. 3) The Marketing Communications and Recruitment Unit (MCRU) facilitates comprehensive and diverse NIMH patient recruitment through design and materials development, targeted marketing and advertising planning, and community outreach. In FY16, our Community Outreach Program reached over 8000 individuals through over 200 meetings with providers, consumers, community members, 26 scientific seminars, and electronic mailing subscribers to reach local and national audiences. Social media efforts produced 30 products (Twitter Talks, webinars, podcasts). 4) Quality Assurance (QA) Programs. 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) Hospital credentialing of medical staff. The OCD is responsible for reviewing the qualifications of all clinical personnel and is involved in maintaining the clinical competence of all NIMH health care professionals. 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 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. 7) Data sharing requirements. The OCD works with the Scientific Director to formulate and implement NIH policies that require sharing of genomic and clinical data that are generated by IRP studies. 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. This also includes assent monitoring in the case of minors or adult subjects with surrogate decision makers. 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 selected high-risk studies, a capacity assessment must be completed prior to study participation. Capacity assessments are completed with some patient populations such as Schizophrenia, Fragile X syndrome, Traumatic Brain injury and others. 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 subject's ability to appoint a Durable Power of Attorney (DPA) or Legally Authorized Representative (LAR). 5) Assessing the Appropriateness of the Surrogate: As part of ACAT and in accordance with SOP14E, HSPU assesses the appropriateness of the surrogate (guardian, DPA, LAR) based on requirements for a given protocol and willingness to serve in the capacity of surrogate decision maker. 6) 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 1100 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 10,500 hits since it was originally posted. HSPU provides customized presentations and trainings to meet the specific human subject protection needs of individual research teams at NIH and to extramural researchers as well. 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 and residents about clinical neuroscience research. In addition, the NIMH OCD contributes to initiatives that identify and promote academic research careers among promising early career psychiatrists. The OCD develops, promotes and organizes scientific programs and curriculum materials that educate psychiatrists about recent advances in neuroscience research relating to serious mental illnesses. See OCD Training report ZIEMH002939-04 for additional details. CONSULTATION LIAISON: The NIMH Psychiatry Consultation Liaison Service (PCLS) and Neuro-psychology Consultation Service are teams that provide multidisciplinary clinical services to patients enrolled in clinical protocols at the NIH CC. The teams consists of psychiatrists, psychologists, neuropsychologists, social workers and psychosomatic medicine fellows and other 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. PCLS consultants also provide education, training and outreach in the CC and the NIH campus. PCLS consultants conduct clinical research through active collaborations with investigators from all over the world. See OCD Psychiatry Consultation Liaison Service Research ZIA-MH002922-08 for additional details.

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 NIMH IRP 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。强迫症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、讨论临床问题并规划未来的举措。 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；本次会议是医院相关政策法规沟通的论坛。强迫症团队为 NIH 临床中心实施自杀风险筛查做出了重大贡献，以响应 2016 年联合委员会 (JC) 哨兵事件警报，呼吁对医院环境中的所有医疗患者进行自杀风险筛查（基于强迫症研究，参见 ZIA MH002922-08）。 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 IRP 调查人员提供方案导航服务。导航团队为个别研究者提供 IRB 提交的各个方面的直接支持，包括撰写初步审查提交、提交年度持续审查申请以及准备方案修正案。 OCD 还协调对正在进行的研究进行每三年一次的科学审查，以确保其持续的价值。 3) 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、多样化的 NIMH 患者招募。 2016 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 200 多次会议、26 场科学研讨会以及电子邮件订阅者接触到了当地和全国受众，覆盖了 8000 多人。社交媒体工作产生了 30 个产品（Twitter Talks、网络研讨会、播客）。 4) 质量保证 (QA) 计划。质量保证工作的重点是遵守监管要求和良好临床实践 (GCP)。 OCD 负责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) 医院医务人员资格认证。 OCD 负责审查所有临床人员的资格，并参与维护所有 NIMH 医疗保健专业人员的临床能力。 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 是 CC 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 和 IC 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。 7) 数据共享要求。 OCD 与科学主任合作制定和实施 NIH 政策，要求共享 IRP 研究生成的基因组和临床数据。 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)。这还包括对未成年人或成年受试者与代理决策者的同意监控。 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一名 CRA，该 CRA 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：对于选定的高风险研究，在参与研究之前必须完成能力评估。对一些患者群体（如精神分裂症、脆性 X 综合征、创伤性脑损伤等）完成了能力评估。 4) 指定 NIH 高级指令/持久授权书的能力：对于批准包含没有决策能力的受试者的方案：HSPU 和 CC 生物伦理部门组成同意能力评估小组 (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) 评估代理人的适当性：作为 ACAT 的一部分并根据 SOP14E，HSPU 根据给定协议的要求以及以代理人决策的身份提供服务的意愿来评估代理人（监护人、DPA、LAR）的适当性制造商。 6) 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 1100 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获得超过 10,500 次点击。 HSPU 提供定制的演示和培训，以满足 NIH 各个研究团队以及校外研究人员的特定人类受试者保护需求。 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) 对医学生和住院医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。 OCD 开发、推广和组织科学计划和课程材料，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 ZIEMH002939-04。 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。这些团队由精神科医生、心理学家、神经心理学家、社会工作者、心身医学研究员和其他实习生组成。 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 顾问还在 CC 和 NIH 校区提供教育、培训和外展服务。 PCLS 顾问通过与世界各地的研究人员积极合作进行临床研究。请参阅强迫症精神病学咨询联络服务研究 ZIA-MH002922-08 了解更多详细信息。