NHGRI/DIR Bioethics Core

NHGRI生物伦理核心通过提供与NHGRI机构审查委员会（IRB）相关的基础设施和培训，协调年度负责任的研究行为教育会议，在临床遗传学病例会议上主持生物伦理学回合，并代表NHGRI在临床中心伦理咨询服务和伦理委员会中支持NHGRI内部研究计划。此外，该核心还可用于满足生物伦理学委员会紧急的生物伦理学教育和咨询需求。 生物伦理核心负责确保NHGRI符合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NIH目前寻求IRB项目认证的计划中尤其重要;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提供行政基础设施。 2007- 2008年，这涉及到根据45 CFR 46.115和NIH联邦范围保证，为82个NHGRI IRB审查的活跃的校内研究方案维护记录系统。 这包括新方案提交、持续和三年期审查、终止、修订、不良事件和偏离/违背的处理。 核心与NINDS程序员和IRB工作人员合作，调整电子方案提交和分发应用程序（PTMS），以简化IRB基础设施，简化研究者的审查流程，并减少与该流程相关的大量文书工作。 核心委员会定期就IRB研究方案和知情同意书的制定和修订与IRB研究人员进行磋商。 这包括对所有新方案提交的正式预审查过程以及提交和审查过程中任何阶段的特别指导。 核心委员会为研究者提供建议，这些研究者对与方案提交和审查相关的法规和程序有疑问（对于NHGRI IRB以及其他IRB，他们可能需要向其提交方案），并综合和传播有关审查/批准过程中政策和程序变更的新信息。

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 2007-8, this involved maintaining a system of records for 82 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 worked with NINDS programmers and IRB staff to adapt an electronic protocol submission and distribution application (PTMS) to streamline the IRB infrastructure, simplify the review process for investigators, and reduce the extraordinary 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.