NHGRI/DIR Bioethics Core

NHGRI/DIR 生物伦理核心

• 批准号: 9552586
• 负责人: Sara Hull
• 金额: $ 105.31万
• 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/9552586
• 关键词: Accreditation; Address; Adverse event; Amendment; Area; Bioethics; Clinical; Consent Forms; Consult; Consultations; Development; Devices; Disease; Education; Ensure; Ethical Review; Ethics; Ethics Committees; Ethics Consultation; Evaluation Research; Funding; Genetic; Genomics; Goals; Guidelines; Human Subject Research; Institution; Institutional Review Boards; Intervention; Intramural Research; Intramural Research Program; Investigation; Leadership; Medical Genetics; National Human Genome Research Institute; Policies; Procedures; Process; Program Evaluation; Protocols documentation; Recommendation; Records; Regulation; Research; Research Ethics; Research Infrastructure; Research Personnel; Role; Services; System; Training and Infrastructure; United States National Institutes of Health; data sharing; genomic data; human data; human subject; member; next generation sequencing; programs; responsible research conduct; symposium

The NHGRI Bioethics Core supports the NHGRI intramural research program by providing infrastructure and training related to the NHGRI Institutional Review Board (IRB), coordinating annual Responsible Conduct of Research educational sessions, moderating bioethics rounds at the clinical genetics case conference, and representing NHGRI within the Clinical Centers ethics consultation service and Ethics Committee. In addition, the Core is available to address emergent bioethics education and consultation needs for the DIR. The Bioethics Core is responsible for ensuring that NHGRI is compliant with the regulations, policies, and guidelines governing the ethical conduct of federally-funded human subjects research (e.g,. 45 CFR 46). This is especially relevant in the context of NIHs current plans to seek accreditation of its IRB program; the Core is responsible for ensuring that NHGRI policies and practices meet the standards set forth by the accrediting body. The Core provides the administrative infrastructure for the NHGRI IRB. In FY17, this involved maintaining a system of records for 107 active NHGRI IRB-reviewed intramural research protocols, per 45 CFR 46.115 and the NIH Federal-Wide Assurance. This included processing of new protocol submissions, continuing and triennial reviews, terminations, amendments, adverse events, and deviations/violations. The Core regularly consults with DIR investigators on the development and revisions of their protocols and consent forms for the IRB. This includes a formal pre-review process of all new protocol submissions as well as ad hoc guidance at any stage in the submission and review process. The Core advises investigators who have questions concerning regulations and procedures related to the submission and review of their protocols (for the NHGRI IRB as well as other IRBs to which they may need to submit their protocols), and synthesizes and disseminates new information regarding policy and procedural changes in the review/approval process. Bioethics Core responsibilities over the past year have included ongoing implementation of the NIH Genomic Data Sharing policy as well as the new DIR Human Data Sharing policy, establishing the IRBs role in relation to the FDAs regulation of genomic sequencing as an investigational device, and functioning as the central IRB of record for the Undiagnosed Diseases Network. In addition, staff has continued to expand IRB membership and educational opportunities for IRB members, consult with investigators, streamline IRB processes, and be involved in research ethics oversight capacity-building activities with other institutions. The Core continues to receive many consultation requests around next generation sequencing, data sharing, and management of incidental genetic findings, and well as an increasing numbers of consults related to the conduct of clinical intervention protocols. While the Bioethics Cores role did not substantially change in the past year, it is anticipated that tasks relating to IRB management will change significantly in the coming year because of a planned reorganization of the NIH intramural IRB program. Although we assume that some of the Cores role in providing administrative support for the IRB will eventually be subsumed into the proposed centralized IRB office, the majority of the Cores tasks and contributions to NHGRI will remain unchanged. All of our team members are actively working in leadership roles to help create the new IRB system, and it is possible that some administrative staff will move to the new centralized office once it is operational in mid-2018. Even in the new system, the NHGRI Bioethics Core will continue to be integrally involved in the ethical review of NHGRI protocols and will remain committed to the goal of ensuring that NHGRI research receives efficient and high quality ethical review.

The NHGRI Bioethics Core supports the NHGRI intramural research program by providing infrastructure and training related to the NHGRI Institutional Review Board (IRB), coordinating annual Responsible Conduct of Research educational sessions, moderating bioethics rounds at the clinical genetics case conference, and representing NHGRI within the Clinical Centers ethics consultation service and Ethics Committee.此外，该核心可用于满足DIR的新兴生物伦理学教育和咨询需求。 生物伦理学核心负责确保NHGRI符合管理联邦资助的人类受试者研究道德行为的法规，政策和准则（例如45 CFR 46）。 这在NIHS当前计划寻求其IRB计划的认证的背景下尤其重要；核心负责确保NHGRI政策和实践符合认证机构规定的标准。 核心为NHGRI IRB提供了管理基础架构。 在2017财年，每45 CFR 46.115和NIH联邦范围内的保证，这涉及维护107个主动NHGRI IRB评论的壁内研究方案的记录系统。 这包括处理新协议提交，持续和三年期审查，终止，修正案，不利事件和偏差/违规行为。 核心定期向DIR调查人员咨询有关IRB协议的开发和修订形式的修订。 这包括所有新协议提交的正式审查过程以及在提交和审查过程中的任何阶段的临时指导。 核心建议调查人员有关与提交和审查其协议有关的法规和程序有疑问的调查人员（对于NHGRI IRB以及他们可能需要提交协议的其他IRB），并综合并传播有关审查/批准过程中有关政策和程序更改的新信息。 过去一年中的生物伦理学核心职责包括持续实施NIH基因组数据共享政策以及新的DIR人类数据共享政策，确立了IRB在FDAS调节中的作用，以作为研究设备的FDAS调节，并充当未诊断疾病网络的记录中心IRB。 此外，工作人员继续扩大IRB成员资格和IRB成员的教育机会，咨询调查人员，简化IRB流程，并参与与其他机构的研究伦理监督能力建设活动。 核心继续收到围绕下一代测序，数据共享和偶然遗传发现的管理以及与临床干预方案的进行有关的越来越多的咨询的许多咨询请求。 尽管在过去的一年中，生物伦理核心的角色并没有实质性变化，但预计与IRB管理有关的任务将在来年发生重大变化，因为NIH壁内IRB计划的计划重组。尽管我们假设最终将核心在为IRB提供行政支持方面的角色最终将被包含在拟议的集中IRB办公室中，但大多数核心任务和对NHGRI的贡献将保持不变。 我们所有的团队成员都在积极担任领导职务，以帮助创建新的IRB系统，一旦2018年中期运营，一些行政人员可能会搬到新的集中式办公室。 即使在新系统中，NHGRI Bioethics Core仍将继续参与NHGRI协议的道德综述，并将继续致力于确保NHGRI Research获得有效和高质量的道德审查。