NHGRI/DIR Bioethics Core

NHGRI/DIR 生物伦理核心

基本信息

批准号：
10022473
负责人：
Sara Hull
金额：
$ 112.04万
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/10022473
关键词：
Accreditation Address Administrator Adoption Advance Directives Alaska Alaska Native Amendment American Indians Area Bioethics Bioethics Consultants Case Study Childhood Chimera organism Clinical Clinical Research Communities Congresses Consent Forms Consult Consultations Data Data Collection Development Education Educational workshop Ethical Issues Ethicists Ethics Ethics Committees Ethics Consultation Evaluation Extramural Activities Forensic Medicine Foundations Genetic Genetic Counseling Genetic Privacy Genetic Research Genetic screening method Genome Genomics Human Human Subject Research Incidental Findings Indonesia Informed Consent Infrastructure Institutes Institution Institutional Review Boards Internships Intramural Research Intramural Research Program Iris Joints Laws Leadership Medical Genetics Medicine Mentors Mentorship Mission Modeling Montana National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Allergy and Infectious Disease Nigeria Pathway interactions Play Policies Process Professional counselor Protocols documentation Publishing Records Regulation Reproductive Technology Research Research Ethics Research Misconduct Research Personnel Review Committee Schedule Secure Services Societies Students System Technology Transfer Testing Time Tissues Training Training Activity Training Programs Training and Education Training and Infrastructure United States Indian Health Service United States National Institutes of Health Update Work Zambia absorption adjudicate case-by-case basis collaborative approach data sharing design education research embryonic stem cell exome exome sequencing explicit bias falls genome sequencing genomic data human subject implicit bias lectures low and middle-income countries meetings member operation organizational structure prenatal programs response responsible research conduct symposium tribal community tribal health waiver web site working group

项目摘要

SUMMARY OF BIOETHICS CORE PROJECTS, 6/1/18 5/31/19 A. Ethics of Human Subjects Research: Administrative Support, Education, and Consultation for the NHGRI Institutional Review Board IRB infrastructure Over the course of the past year, Bioethics Core staff joined with NHLBI IRB analysts to assume responsibility for maintaining a system of records and ethical oversight for a total of 434 protocols, 102 (23%) of which were NHGRI protocols. o A total of 1,947 IRB-related actions were approved in the past year, 359 (18%) of which were for NHGRI protocols. 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, and to implement use of new NIH-wide attestation form and policy that was modeled heavily after the collaborative approach that the NHGRI Bioethics Core and TTO had already been using together for many years. Updated IRB website (http://www.genome.gov/10005807) Produced and distributed agendas, review packets, and minutes for monthly IRB meetings. Developed a more streamlined pathway via protocol navigation for securing DEC Clearance prior to IRB review. Participated in/regularly attended NIH Human Subjects Research Advisory Council (HSRAC), and NIH IRB Professional Administrators Committee (IPAC). These meetings have evolved into a monthly IC liaison meeting, IRB chair meeting, and IRBO staff meetings at which Core staff continue to represent NHGRI. Participated as the NHGRI AAHRPP designated contact responsible for updating and implementing SOPs, data collection, and other activities associated with maintaining accreditation of the NIH Intramural Human Research Protection Program. Education and consultation for NHGRI investigators 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 and revision of protocols and consent forms o Provided significant and systematic pre-review of initial protocol submissions and substantial amendments to identify substantive ethical and administrative issues prior to formal IRB submission. o Consulted on proposals to incorporate whole-exome and genome sequencing into new or existing protocols. Oriented JHU/NIH genetic counseling training program students to the new IRB process. Education and training for IRB professionals Directed the NIH IRB internship program, which trains IRB administrators and professionals from targeted institutions (from low and middle-income countries and tribal communities) in the ethical and regulatory aspects of clinical research ethics and in the operation and management of IRBs. o Hosted interns from Nigeria, Zambia, and Indonesia in Fall 2018, plus did ongoing work with former intern from Blackfeet Nation, Montana. Expanded the reach of research ethics training and capacity building initiatives through partnerships with NIH Tribal Health Research Office, PRIM&R, Indian Health Service, and the National Congress of American Indians o Served on the PRIM&R Core Conference Planning Committee o Attended joint South Central Foundation and NHGRI workshop on genomic research with Alaska Native communities in Anchorage, Alaska. B. Responsible Conduct of Research Education Per PHS Policy, facilitated mandatory DIR-wide discussion modules (2018: Implicit and Explicit Biases in the Research Setting) with a total of 351 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. Clinical Bioethics Education and Consultation Consulted with DIR investigators and IRBs about the ethics of proposed uses of whole exome and genome sequencing in their protocols. 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. Invited to attend ELSI workshop for the All of Us program (June 2019). Served on the NIH embryonic stem cell administrative review committee. Serve as the bioethicist and intramural representative on Exceptions Subcommittee for the NIH Single IRB Policy. 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 Appointed to serve on the NIH chimera policy review committee. Participated as attending ethicists in Clinical Centers Ethics Consultation Service. Represented NHGRI on the Clinical Center/MEC Ethics Committee. Taught sessions on incidental genomic research findings and research with stored tissues for Department of Clinical Bioethics annual NIH-wide training course on the Ethical and Regulatory Aspects of Clinical Research and on ethical issues in genetic testing for the Bioethics Fellows Seminar. Gave lectures on a variety of topics to a number of intramural IRBs, research teams, and community groups. D. Research and Evaluation Continued research to assess IRB practices and IRB members perspectives regarding the management and return of incidental genetic research findings, waivers of informed consent Continue to publish on a wide range of genomics and society related topics, including genetic privacy laws, regulation of genetic testing, incidental findings, the right not to know, genomic data sharing policies, prenatal genome sequencing, pediatric reconsent, tribal perspectives on research ethics and DTC ancestry testing, forensic use of genomic data, and emerging reproductive technologies. Received highly favorable evaluations via the 2019 Clinical Centers Department of Bioethics Board of Scientific Counselors review.

生物伦理核心项目摘要，6/1/18 5/31/19 A.人类受试者的道德研究：行政支持，教育和咨询 NHGRI机构审查委员会 IRB基础设施在过去的一年中，生物伦理核心人员与NHLBI IRB分析师一起加入承担维护记录系统和道德监督系统的责任 434个协议，102（23％）是NHGRI方案。 o过去一年中批准了总共1,947项与IRB相关的行动，其中359（18％）用于NHGRI协议。与NHGRI技术转移办公室紧密合作，就适当性提供建议根据材料和人类衍生的材料和数据的特定MTA和ITA 根据NHGRI IRB批准的协议的主题，并实施新的NIH范围的使用认证表格和政策是在协作方法之后进行了重大建模的 NHGRI Bioethics Core和TTO已经一起使用了很多年。更新IRB网站（http://www.genome.gov/10005807）生产和分发议程，审核数据包以及每月IRB会议的会议记录。通过协议导航开发了更简化的途径，以确保DEC清除在IRB审查之前。参加/定期参加NIH人类受试者研究咨询委员会（HSRAC），和NIH IRB专业管理员委员会（IPAC）。这些会议已经演变成每月一次的IC联络会议，IRB主席会议和IRBO员工会议继续代表NHGRI。参加为NHGRI AAHRPP指定的联系人，负责更新和实施SOP，数据收集和与维护相关的其他活动 NIH壁内研究保护计划的认证。 NHGRI调查人员的教育和咨询与NHGRI调查人员咨询了广泛的新兴（有时是紧急）其协议的设计和实施提出了道德和监管问题。与调查人员有关协议和同意书的制定和修订的咨询 o提供了初始协议提交的重要和系统的预审和实质性修正案，以确定实质性的道德和行政问题正式的IRB提交。 o咨询了将全外观和基因组测序纳入新的建议的建议或现有协议。定向的JHU/NIH遗传咨询培训课程学生参加了新的IRB流程。 IRB专业人员的教育和培训指示NIH IRB实习计划，该计划培训IRB管理员和有针对性机构的专业人士（来自低收入和中等收入国家和部落的专业人士社区）在临床研究伦理的道德和监管方面以及 IRB的操作和管理。 o 2018年秋季从尼日利亚，赞比亚和印度尼西亚接待了实习生，加上正在进行的与蒙大拿州Blackfeet Nation的前实习生合作。扩大了研究道德培训和能力建设计划的覆盖范围与NIH部落健康研究办公室的合作伙伴关系，印度卫生服务部Prim＆R，和美国印第安人国民大会 o在Prim＆R核心会议计划委员会任职 o参加了有关基因组的联合南方基金会和NHGRI的研讨会在阿拉斯加安克雷奇的阿拉斯加土著社区进行研究。 B.负责任的研究教育行为根据PHS政策，促进了强制性的DIR范围讨论模块（2018年：隐性和明确研究环境中的偏见）总共有351名壁内研究人员和员工。代表NHGRI参加了NIH的科学行为与道德委员会，该委员会发展年度培训模块中包括的案件，并裁定报告的案件 NIH壁内研究计划中的研究不当行为。 C.临床生物伦理学教育和咨询向DIR调查人员和IRB咨询了有关整个外显子的拟议用途的道德规范和基因组测序在其方案中。主持了一个NIAID室内研究人员委员会，开发了一套研究所的一组关于返回遗传结果的政策。在NHGRI基因组数据共享政策实施工作组中服役。邀请参加我们所有人计划的ELSI研讨会（2019年6月）。在NIH胚胎干细胞行政审查委员会任职。作为例外小组委员会的生物伦理学家和壁内代表 NIH单一IRB政策。作为OSMB上的生物伦理学代表床旁研究计划。在委员会任职，负责重新审查有关高级指令的CC政策被任命为NIH Chimera政策审查委员会任职。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。就偶然基因组研究发现和研究的研究教授了储存的组织临床生物伦理学系年度NIH范围内的道德和培训课程临床研究的监管方面以及基因检测的道德问题生物伦理研究员研讨会。为许多壁内IRB，研究团队和社区团体。 D.研究与评估继续研究以评估IRB实践和IRB成员的观点偶然遗传研究结果的管理和返回，豁免知情同意继续发表广泛的基因组学和社会相关主题，包括遗传隐私定律，基因检测的调节，偶然发现，不知道的权利基因组数据共享策略，产前基因组测序，小儿重新一致，部落研究伦理学和DTC祖先测试，基因组数据的法医使用以及新兴的生殖技术。通过2019年临床中心生物伦理学系获得了高度有利的评估科学顾问委员会评论。