NHGRI/DIR Bioethics Core

NHGRI/DIR 生物伦理核心

基本信息

批准号：
10901697
负责人：
Sara Hull
金额：
$ 140.62万
依托单位：
NATIONAL HUMAN GENOME RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
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/10901697
关键词：
Accreditation Address Amendment Bioethics Brain COVID-19 Case Study Clinical Research Clinical Trials Data Monitoring Committees Collaborations Conflict of Interest Consent Forms Consult Consultations Core Facility Data Development Education Educational process of instructing Enrollment Ensure Ethical Issues Ethicists Ethics Ethics Committees Ethics Consultation Ethnic equity Evaluation Exclusion Extramural Activities Fostering Funding Genomics Human Human Subject Research Hybrids Informed Consent Institutional Review Boards Internships Intramural Research Intramural Research Program Leadership Maintenance Medical Genetics Mentors Minor Mission Modeling National Heart, Lung, and Blood Institute National Human Genome Research Institute Nature Paper Persons Policies Postbaccalaureate Postdoctoral Fellow Process Productivity Protocols documentation Publishing Racial Equity Research Research Activity Research Ethics Research Misconduct Research Personnel Research Project Grants Research Training Review Committee Services Shapes Technology Transfer Training Training Activity Travel Tribes Trust United States National Institutes of Health Work adjudication case-by-case basis clinical center data management data sharing design diversity and equity education research embryonic stem cell ethical, legal, and social implication genomic data health disparity health equity human subject meetings member operation pandemic disease professional atmosphere programs protocol development responsible research conduct symposium training opportunity tribal institution working group

项目摘要

I. SUMMARY OF BIOETHICS CORE PROJECTS, 6/1/22 - 7/31/23 A. Ethics of Human Subjects Research/NIH Intramural Institutional Review Board i. IRB Navigation and Support Supported a total of 91 NHGRI intramural IRB-reviewed protocols in various stages of implementation, excluding five protocols exempt from IRB review and two that were determined not to involve human subjects. Four new protocols were approved with a remaining three still under review/draft. A total of two 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 four new protocols and five quadrennial reviews. ii. Capacity Building for Research Ethics Oversight Expanded Tribal Research Ethics Capacity-building Consortium (TRECC) efforts to develop collaborative research ethics training and capacity building initiatives related to respecting Tribal Sovereignty within the NIH Data Management and Sharing Policy and models of Tribal IRB review. B. Responsible Conduct of Research Education for NHGRI Researchers Per PHS Policy, facilitated mandatory DIR-wide discussion modules (2022: Use of Human Biospecimens and Informed Consent) with a total of 357 intramural researchers and staff. Particular efforts were made this year to continue ensuring maximal participation of trainees. 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 co-lead for NHGRI Racial and Ethnic Equity Plan (REEP) Working Group. Implemented comprehensive IRB guidance regarding the return of genomic research results, in consultation with IRB staff, members, and research teams 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. Collaborated with and continue to collaborate with NHGRI Training, Diversity, and Health Equity (TiDHE) Office on a variety of initiatives to expand training opportunities for TCUs and Tribal IRBs. Participated and continue to participate on All of Us ELSI Brain Trust advisory group as a member of the planning team. 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. 9 papers published/accepted (since June 2022); 14 empirical and conceptual projects in active status. 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 disrupted operations across NIH, the NHGRI Bioethics Core has been able to be functional and productive in a hybrid work environment. We 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. With the reorganization of the Bioethics Core into the newly formed Office for Scientific Core Facilities, corresponding adjustments were made to ensure adequate program support for purchasing, travel, trainees, and other administrative functions.

I.生物伦理核心项目摘要，6/1/22-7/31/23 A.人类受试者的道德研究/NIH壁内机构审查委员会我。 IRB导航和支持在实施的各个阶段，总共支持91个NHGRI壁内IRB评审方案，不包括五个不受IRB审查的协议，而两项决心不涉及人类受试者。批准了四个新协议，其余三个仍在审查/草案中。去年总共关闭了两个协议。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）审查了四个新协议和五项四年审查。 ii。研究道德监督的能力建设扩大部落研究道德的能力建设联盟（TRECC）为开发与尊重NIH数据管理中的部落主权以及部落IRB IRB审查的政策以及分享政策和模型的合作研究道德培训和能力建设计划的努力。 B.为NHGRI研究人员负责研究教育根据PHS政策，总共有357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（2022：使用人类生物测量和知情同意）。今年采取了特殊的努力，以继续确保受训者的最大参与。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，咨询和服务并继续担任NHGRI种族和种族公平计划（REEP）工作组的团队共同领导。在NIH IRP的IRB员工，成员和研究小组协商中，实施了有关基因组研究结果回报的全面指南。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。与NHGRI培训，多样性和健康公平（Tidhe）办公室合作并继续合作，开展了各种计划，以扩大TCU和部落IRB的培训机会。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。领导促进有关扩大入学率和缺乏能力的人的主题的多次咨询。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。发表/接受的9篇论文（自2022年6月以来）； 14个活跃状态的经验和概念项目。 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在混合工作环境中仍然能够发挥功能和生产力。我们预计，在响应式咨询和DIR研究人员的支持以及我们自己的研究主题方面，Covid-19将继续塑造生物伦敦核心的性质。随着对新成立的科学核心设施办公室的重组，进行了相应的调整，以确保为购买，旅行，受训者和其他行政职能提供足够的计划支持。

项目成果

期刊论文数量（18）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Identifiability and privacy in pluripotent stem cell research.

DOI：
10.1016/j.stem.2014.03.014
发表时间：
2014-04-03
期刊：
Cell stem cell
影响因子：
23.9
作者：
Isasi R;Andrews PW;Baltz JM;Bredenoord AL;Burton P;Chiu IM;Hull SC;Jung JW;Kurtz A;Lomax G;Ludwig T;McDonald M;Morris C;Ng HH;Rooke H;Sharma A;Stacey GN;Williams C;Zeng F;Knoppers BM
通讯作者：
Knoppers BM

Grappling with genomic incidental findings in the clinical realm.

应对临床领域的基因组偶然发现。