NHGRI/DIR Bioethics Core

NHGRI/DIR 生物伦理核心

• 批准号: 10267138
• 负责人: Sara Hull
• 金额: $ 114.96万
• 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/10267138
• 关键词: Accreditation; Address; Advance Directives; Amendment; American Indians; Bioethics; Book Chapters; Brain; COVID-19; Case Study; Clinical Research; Communities; Congresses; Consent Forms; Consult; Consultations; Data; Development; Distance Learning; Education; Ethical Issues; Ethicists; Ethics; Ethics Committees; Ethics Consultation; Evaluation; Extramural Activities; Fostering; Funding; Genetic; Genomics; Human; Human Subject Research; Informed Consent; Institutes; Institutional Review Boards; Internships; Intramural Research; Intramural Research Program; Justice; Language; Leadership; Maintenance; Medical Genetics; Mentors; Mission; National Heart, Lung, and Blood Institute; National Human Genome Research Institute; National Institute of Allergy and Infectious Disease; Nature; Paper; Participant; Policies; Postdoctoral Fellow; Process; Protocols documentation; Publishing; Research; Research Activity; Research Ethics; Research Misconduct; Research Personnel; Research Project Grants; Review Committee; Services; Site; Surveys; Technology; Technology Transfer; Training; Training Activity; Trust; United States Indian Health Service; United States National Institutes of Health; Work; adjudicate; case-by-case basis; clinical center; coronavirus disease; data sharing; design; education research; embryonic stem cell; experience; explicit bias; genomic data; health disparity; human subject; implicit bias; meetings; member; operation; pandemic disease; programs; protocol development; responsible research conduct; symposium; telework; tribal health; virtual; working group

I. SUMMARY OF BIOETHICS CORE PROJECTS, 6/1/19 5/31/20 A. Ethics of Human Subjects Research/NIH Intramural Institutional Review Board IRB Navigation and Support Supported a total of 104 NHGRI intramural protocols in various stages of implementation, including 6 that were determined to be exempt from IRB review and 4 that were determined not to involve human subjects. Provided leadership (e.g., chairing weekly meetings, participate in bi-weekly IRB leadership meetings) and membership (participating in at least 1 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. Participated as the NHGRI AAHRPP designated contact 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 and amendments to address substantive issues prior to formal IRB submission. Capacity Building for IRB professionals Surveyed previous participants in the NIH IRB internship program (which is on hold due to COVID-related limitations) to evaluate 10 years of experience with the program. o Considering a re-design that utilizes distance learning in combination with a shorter but more intensive on-site program that more people will be able to take advantage of in conjunction with their current professional commitments Nurtured partnerships with NIH Tribal Health Research Office, PRIM&R, Indian Health Service, and the National Congress of American Indians 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 (2019: Implicit and Explicit Biases in the Research Setting) with a total of 317 intramural researchers and staff. 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. NIH-Wide Education, Consultation, and Service Initiated NIH intramural working group to develop a consistent IRB policy regarding the return of genomic research results. (Note: Meetings will resume this month after COVID-19 related delays.) Participated in and provide administrative support for EAWG-OSP Sub-Committee on Harmonizing NIH Informed Consent Language Options for Broad Data Sharing. Chaired a committee of NIAID intramural researchers to develop an institute-wide set of policies about returning genetic results. Served on the NHGRI Genomic Data Sharing Policy Implementation Working Group. Participate on All of Us ELSI Brain Trust advisory group. Served on the NIH embryonic stem cell administrative review committee. Serve as the bioethics representative on the OSMB for the extramural NHLBI Bassinet to Bedside research program. Served on the committee tasked with reexamining CC policies about advanced directives. 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. 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 5 book chapters & 14 papers published/accepted (2019); 8 currently under review 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 significantly disrupted research and operations throughout the NIH, the NHGRI Bioethics Core has been able to be fully 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, whether remote or on campus. We also expect that COVID-19 will continue influence the nature of the Bioethics Cores work substantially, both in terms of the nature of consultation and support of DIR investigators as well as the topics of our own research. Members of the Core 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.

I.生物伦理核心项目摘要，6/1/19 5/31/20 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104个NHGRI壁内协议，其中6项被确定不受IRB审查的豁免和4项，而该审查被确定为不涉及人类受试者。 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1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。 参加了NHGRI AAHRPP指定的联系，以支持维持NIH壁内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。 在正式提交IRB提交之前，提供了初始协议提交和修正案的重大和系统的审查，以解决实质性问题。 IRB专业人士的能力建设 对NIH IRB实习计划的先前参与者进行了调查（由于与共同相关的限制而被搁置），以评估该计划的10年经验。 o考虑使用远程学习的重新设计与较短但更密集的现场计划相结合 与NIH部落健康研究办公室，PRIM＆R，印度卫生服务局和美国印第安人国民大会培育合作伙伴关系，以加强合作研究道德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，总共有317位壁内研究人员和员工，促进了强制性的跨越范围的讨论模块（2019年：研究环境中的隐性和明确偏见）。 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. NIH范围内的教育，咨询和服务 启动了NIH壁内工作组，以制定有关基因组研究结果返回的IRB政策。 （注意：COVID-19相关延迟之后的本月会议将恢复。） 参与并为EAWG-oss小组委员会提供了管理支持，以协调NIH知情同意语言选项，以进行广泛的数据共享。 主持了一个NIAID壁内研究人员委员会，制定了有关返回遗传结果的一套范围内的政策。 在NHGRI基因组数据共享政策实施工作组中服役。 参加我们所有的Elsi Brain Trust咨询小组。 在NIH胚胎干细胞行政审查委员会任职。 作为OSMB的生物伦理学代表，用于壁外NHLBI Bassinet到床边研究计划。 在委员会任职，负责重新审查有关高级指令的CC政策。 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。 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第5章章节和14篇论文（2019年）； 8目前正在审核 o NHGRI和CC资助的后邮记/博士后支持的研究活动 邀请合作研究有关研究伦理，健康差异，优先设置和与大流行有关的问题之间交集的各种研究项目 ii。 当前问题和最近的变化 尽管Covid-19在整个NIH中都严重破坏了研究和运营，但NHGRI BioEthics Core能够通过远程办公和使用虚拟会议技术来完全发挥功能和生产力。核心预计，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将继续影响生物伦敦的性质，无论是在DIR调查人员的咨询和支持的性质以及我们自己研究的主题方面都具有很大的作用。核心的成员一直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道德原则的文化的整体使命是一致的。