NHGRI/DIR Bioethics Core

NHGRI生物伦理学核心支持NHGRI内部研究计划，提供与NHGRI机构审查委员会(IRB)相关的基础设施和培训，协调每年负责任的研究教育会议，主持临床遗传学案例会议上的生物伦理学回合，并在临床中心伦理咨询服务和伦理委员会中代表NHGRI。此外，该核心还可用于满足DIR的紧急生物伦理教育和咨询需求。生物伦理学核心负责确保NHGRI遵守管理联邦资助的人类受试者研究的道德行为的法规、政策和指导方针(例如，。45 CFR 46)。这在NIHS目前计划寻求其IRB计划的认证的背景下尤其相关；核心负责确保NHGRI的政策和实践符合认证机构制定的标准。 核心为NHGRI IRB提供管理基础设施。在2009-10年度，这涉及到根据45 CFR 46.115和美国国立卫生研究院联邦范围保障，维护80多个经NHGRI IRB审查的有效内部研究方案的记录系统。这包括处理新的议定书提交、持续和三年一次的审查、终止、修订、不良事件和偏离/违规。核心继续改进电子协议提交和分发应用程序(PTMS)，以精简内部审查机构的基础设施，简化调查人员的审查程序，并减少与该程序相关的文书工作量。 核心定期与DIR调查人员协商，以制定和修订他们的方案和IRB的同意书。这包括所有新议定书提交的正式预审进程，以及提交和审查进程中任何阶段的特别指导。核心向对提交和审查其方案(对于NHGRI IRB以及他们可能需要向其提交其方案的其他IRBs)相关法规和程序有疑问的调查人员提供建议，并综合和传播关于审查/批准过程中的政策和程序变化的新信息。

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 2009-10, this involved maintaining a system of records for more than 80 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.