NHGRI/DIR Bioethics Core

NHGRI/DIR 生物伦理核心

• 批准号: 10691164
• 负责人: Sara Hull
• 金额: $ 122.33万
• 依托单位: NATIONAL HUMAN GENOME RESEARCH INSTITUTE
• 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/10691164
• 关键词: Accreditation; Address; Amendment; Bioethics; Book Chapters; Brain; COVID-19; Case Study; Clinical Research; Clinical Trials Data Monitoring Committees; Communities; Conflict of Interest; Consent Forms; Consult; Consultations; Data; Development; Education; Enrollment; Ensure; Ethical Issues; Ethicists; Ethics; Ethics Committees; Ethics Consultation; Evaluation; Extramural Activities; Fostering; Funding; Genomics; Human; Human Subject Research; Institutional Review Boards; Internships; Intramural Research; Intramural Research Program; Justice; Lead; Leadership; Logistics; Maintenance; Medical; Medical Genetics; Medical center; Medicine; Mentors; Minor; Mission; National Heart, Lung, and Blood Institute; National Human Genome Research Institute; Nature; Paper; Persons; Policies; Postdoctoral Fellow; Procedures; Process; Protocols documentation; Publishing; Reporting; Research; Research Activity; Research Ethics; Research Misconduct; Research Personnel; Research Project Grants; Research Training; Retirement; Review Committee; Science; Services; Shapes; Technology; Technology Transfer; Time; Training; Training Activity; Travel; Trust; United States National Institutes of Health; Work; adjudicate; case-by-case basis; clinical center; data management; data sharing; design; development policy; education research; embryonic stem cell; ethical, legal, and social implication; genomic data; health disparity; human subject; meetings; member; operation; pandemic disease; pressure; programs; protocol development; racial and ethnic; responsible research conduct; symposium; telework; tribal health; virtual; working group

I. I. SUMMARY OF BIOETHICS CORE PROJECTS, 6/1/21 5/31/22 A. Ethics of Human Subjects Research/NIH Intramural Institutional Review Board IRB Navigation and Support Supported a total of 76 NHGRI intramural IRB-reviewed protocols in various stages of implementation, excluding 27 that were determined to be exempt from IRB review and ten that were determined not to involve human subjects. Three new protocols were approved with a remaining five still under review/draft. A total of ten protocols have closed in the last year. Provided leadership (e.g., chairing weekly meetings, participate in bi-weekly IRB leadership meetings) and membership (participating in at least one meeting per month) to the NIH Intramural IRB. Worked closely with the NHGRI Technology Transfer Office to advise on the appropriateness of specific MTAs and ITAs on a case-by-case basis for materials and data derived from human subjects under NHGRI IRB-approved protocols. Handled IRB-related submissions to the NHGRI Ethics Office to avoid/address investigator conflicts of interest. Tracked required human subjects research training across NHGRI investigators engaged in NIH IRB-reviewed human subjects research. Participated as the designated NHGRI contact for Association for the Accreditation of Human Research Protection Programs (AAHRPP) planning to support maintenance of accreditation of the NIH Intramural Human Research Protection Program. Consulted with NHGRI investigators on a wide range of emergent (and sometimes urgent) ethical and regulatory concerns raised by the design and implementation of their protocols. Consulted with investigators in the development of protocols and consent forms. Provided significant and systematic pre-review of initial protocol submissions, amendments, and continuing reviews to address substantive issues prior to formal IRB submission. Coordinated Scientific Review Committee (SRC) review for eight new protocols and six quadrennial reviews. Capacity Building for Research Ethics Oversight Renewed MOU with NIH Tribal Health Research Office (THRO) for a two-year part time detail to focus on the development of policies, procedures, and training mechanisms to enhance the ethical conduct of Tribal research. Expanded existing partnership with Public Responsibility in Medicine & Research (PRIM&R) to strengthen collaborative research ethics training and capacity building initiatives. B. Responsible Conduct of Research Education for NHGRI Researchers Per PHS Policy, facilitated mandatory DIR-wide discussion modules (2021: Science Under Pressure) with a total of 354 intramural researchers and staff. Particular efforts were successfully made this year to ensure maximal participation of trainees; NHGRI was commended by the Agency Intramural Research Integrity Officer (AIRIO) for achieving 93% trainee compliance. Represented NHGRI on the NIH Committee on Scientific Conduct and Ethics, which develops the cases that are included in the annual training modules and adjudicates reported cases of research misconduct in the NIH intramural research program. C. IC- and NIH-Wide Education, Consultation, and Service Served and continue to serve as team-lead for NHGRI Racial and Ethnic Equity Plan (REEP) Working Group. Finalized report from an NIH intramural working group to develop a comprehensive IRB guidance regarding the return of genomic research results after receiving IRB and Medical Executive Committee (MEC) approval. Currently working with the IRB Office on implementation of the new guidance, in consultation with stakeholders across the NIH IRP. Served on the NHGRI Genomic Data Sharing Governance Committee; will continue to serve on Data Management and Sharing Committee that has been tapped to address NIH policies regarding a broader range of data types. Participated and continue to participate on All of Us ELSI Brain Trust advisory group as a member of the planning team. o Led facilitation of multiple consultations on topics relating to expanding enrollment minors and people who lack capacity. Served and continue to serve on the NIH embryonic stem cell administrative review committee. Served and continue to serve as the bioethics representative on the Observational Safety Monitoring Board (OSMB) for the extramural NHLBI Bassinet to Bedside research program. Participated as attending ethicists in Clinical Centers Ethics Consultation Service. Represented NHGRI on the Clinical Center/MEC Ethics Committee. Taught several sessions for the Department of Bioethics annual NIH-wide course on the Ethical and Regulatory Aspects of Clinical Research the First Year Fellows Bioethics Seminar. Led regular ethics sessions with the medical genetics fellows. D. Research and Evaluation Led program of research that focuses on a broad range of emerging ethical issues related to the conduct of genomic research. o One book chapter & 16 papers published/accepted (since June 2020); 13 empirical and conceptual projects in active status. o Research activities supported by both NHGRI and CC funded postbacs/postdocs. Invited to collaborate on a variety of research projects on the intersections between research ethics, health disparities, priority setting, and pandemic-related issues. II. CURRENT ISSUES AND RECENT CHANGES Although COVID-19 has disrupted operations across NIH, the NHGRI Bioethics Core has been able to be functional and productive via telework and use of virtual meeting technologies. The Core expects to be able to continue to provide the same levels of service to NHGRI DIR investigators in the upcoming year, both remote and on campus. We also expect that COVID-19 will continue to shape the nature of the Bioethics Cores work to some extent, both in terms of responsive consultation and support of DIR investigators as well as the topics of our own research. Core staff have been participating in a wide range of research projects, NIH initiatives, and community conversations on antiracism, inclusion, and diversity, which are consistent with our overall mission to create a culture that promotes the ethical principles of equity and justice. With the retirement of Victoria Willits at the end of 2021, we were successful at reassigning tasks to ensure continuous staff coverage of all key roles that are critical to the Cores functioning. Nancy Mickey is providing administrative support for purchasing, travel, and training logistics; while Brenton Yanos has assumed responsibility for the management of the SRC.

I. I.生物伦理核心项目摘要，6/1/21 5/31/22 A.人类受试者的道德研究/NIH壁内机构审查委员会 IRB导航和支持 在各个实施阶段，总共支持76个NHGRI壁内IRB评审方案，不包括27个被确定不受IRB审查的审查，而十项被确定不涉及人类受试者。批准了三个新协议，其余五个仍在审查/草案中。去年，总共十个协议已经关闭。 提供领导力（例如，主持每周会议，参加每两周一次的IRB领导会议）和成员资格（每月至少参加一次会议）。 与NHGRI技术转移办公室紧密合作，以根据NHGRI IRB批准的协议逐案的材料和数据为材料和数据提供有关特定MTA和ITA的适当性的建议。 处理与IRB相关的提交给NHGRI伦理办公室，以避免/解决调查人员的利益冲突。 经过跟踪的人类受试者研究培训，跨NHGRI研究人员从事NIH IRB评审的人类受试者研究。 作为指定的NHGRI联系人的人类研究保护计划协会（AAHRPP）的参与，计划支持维持NIH壁内人类研究保护计划的认证。 与NHGRI调查人员咨询了有关其协议的设计和实施引起的广泛的新兴（有时是紧急）的道德和监管问题。 与调查人员协商方案和同意书的制定。 在正式IRB提交之前，提供了最初的协议提交，修正案和持续审查的初步协议提交，修正案和持续审查的重大审查。 协调的科学审查委员会（SRC）审查了八种新协议和六项四年审查。 研究道德监督的能力建设 与NIH部落健康研究办公室（THRO）更新谅解备忘录进行了两年的兼职细节，以关注政策，程序和培训机制的制定，以增强部落研究的道德行为。 扩大了与医学与研究（PRIM＆R）公共责任的现有合作伙伴关系，以加强协作研究伦理培训和能力建设计划。 B.为NHGRI研究人员负责研究教育 根据PHS政策，促进了强制性的跨越范围的讨论模块（2021：在压力下的科学），共有354名壁内研究人员和员工。今年成功做出了特别的努力，以确保受训者的最大参与。 NHGRI受到机构室内研究完整性官员（Airio）的赞扬，该官员获得了93％的学员合规性。 代表NHGRI参加了NIH科学行为与伦理委员会，该委员会在NIH室内研究计划中开发了年度培训模块中包含的案件，并裁定报告了研究不当行为的案件。 C. IC和NIH范围内的教育，咨询和服务 服务并继续担任NHGRI种族和种族公平计划（REEP）工作组的团队领导。 NIH室内工作组的最终报告，以在获得IRB和医疗执行委员会（MEC）批准后制定有关基因组研究结果的全面指南。目前与IRB办公室实施新指南，并与NIH IRP的利益相关者协商。 在NHGRI基因组数据共享治理委员会任职；将继续在数据管理和共享委员会上任职，该委员会已被利用，以解决有关更广泛的数据类型的NIH政策。 参加并继续参加我们所有的ELSI Brain Trust咨询小组，作为计划团队的成员。 o领导促进有关与扩大入学人数和缺乏能力的人有关的主题的多次磋商。 在NIH胚胎干细胞行政审查委员会任职并继续任职。 在观察性安全监测委员会（OSMB）上担任生物伦理学的代表，并担任卫生部NHLBI Bassinet到床边研究计划的代表。 参加临床中心伦理咨询服务的伦理学家。 代表NHGRI参加了临床中心/MEC伦理委员会。 第一年的《临床研究的道德和法规方面》第一年的伦理和法规方面，为生物伦理学系年度NIH范围的年度课程教授了几次会议。 领导的与医学遗传研究员的常规道德会议。 D.研究与评估 LED研究计划的重点是与基因组研究的进行有关的广泛的伦理问题。 o一本书的一章和16篇论文发表/接受（自2020年6月以来）； 13活跃状态的经验和概念项目。 o NHGRI和CC资助的后邮记/博士后支持的研究活动。 邀请合作研究研究伦理，健康差异，优先设置和与大流行有关的问题之间的相互作用的各种研究项目。 ii。 当前问题和最近的变化 尽管COVID-19在NIH中破坏了运营，但NHGRI BioEthics Core能够通过远程办公和使用虚拟会议技术具有功能性和富有成效的作用。核心预计，在接下来的一年中，无论是遥远还是在校园内，都可以继续为NHGRI DIR调查人员提供相同水平的服务。我们还期望Covid-19将继续塑造生物伦敦的性质在某种程度上起作用，无论是在响应式咨询和DIR研究人员的支持方面以及我们自己研究的主题。核心人员一直在参与有关反种族主义，包容和多样性的广泛研究项目，NIH计划以及社区对话，这与我们创建一种促进公平和正义原则的文化的整体使命是一致的。 随着2021年底的维多利亚·威尔特（Victoria Willits）的退休，我们成功地重新分配任务，以确保员工对所有关键角色的持续覆盖，这对核心运作至关重要。南希·米奇（Nancy Mickey）为购买，旅行和培训后勤提供行政支持；而布伦顿·亚诺斯（Brenton Yanos）负责SRC的管理。