NHGRI/DIR Bioethics Core

NHGRI/DIR 生物伦理核心

• 批准号: 8948415
• 负责人: Sara Hull
• 金额: $ 66.45万
• 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/8948415
• 关键词: Accreditation; Address; Adverse event; Amendment; Area; Bioethics; Clinical; Consent Forms; Consult; Consultations; Development; Education; Electronics; Ensure; Ethics; Ethics Committees; Ethics Consultation; Funding; Genetic; Goals; Guidelines; Human Subject Research; Institutional Review Boards; Intramural Research; Intramural Research Program; National Human Genome Research Institute; Policies; Procedures; Process; Protocols documentation; Records; Regulation; Research Ethics; Research Infrastructure; Research Personnel; Services; Staging; System; Training and Infrastructure; United States National Institutes of Health; human subject; meetings; 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 FY14, this involved maintaining a system of records for 124 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 continues to refine the electronic protocol submission and distribution application (PTMS) to streamline the IRB infrastructure, simplify the review process for investigators, and reduce the volume of paperwork associated with the process. 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.

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）。 在NIHS当前计划寻求其IRB计划认证的情况下，这尤其重要；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2014财年，每45 CFR 46.115和NIH联邦范围内的保证，这涉及维护124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。 核心继续完善电子协议提交和分配应用程序（PTMS）来简化IRB基础架构，简化研究人员的审核过程，并减少与该过程相关的文书工作量。 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。