BSL-3 Practices core (Practice core)

BSL-3 实践核心（实践核心）

• 批准号: 10793865
• 负责人: Preeti Bharaj
• 金额: $ 51.33万
• 依托单位: RUTGERS BIOMEDICAL AND HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-18 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10793865
• 关键词: Address; Animal Care and Use Committees; Animal Model; Animals; Certification; Development; Disasters; Elements; Emergency Situation; Emergency response; Ensure; Environment; Environmental Health; Exercise; Foundations; Funding; Growth; Health; Human Resources; IACUC; Industry; Information Technology; Institution; Institutional Review Boards; Internet; Joints; Laboratories; Maintenance; Monitor; Occupational Health; Play; Procedures; Productivity; Protocols documentation; Public Health; Reaction Time; Readiness; Records; Regulatory Affairs; Research; Resources; Risk Assessment; Role; Safety; Science; Secure; Standardization; Structure; System; Time; Training; Training Programs; Training Support; Training and Education; United States Department of Agriculture; Universities; Work; Workforce Development; animal care; biocontainment facility; biosecurity; biothreat; first responder; innovation; institutional biosafety committee; laboratory experience; novel; operation; pandemic disease; programs; research and development; response

Core 2: A/BSL3 Practices Core (Practice Core) - ABSTRACT The Rutgers University RBL plays a central, regional role in performing BSL3-level research and development and maintaining biothreat preparedness. The RBL opened in 2009 and has since been continuously funded by federal agencies, foundations and industry to carry out select agent research. The RBL maintains robust systems for BSL3 operational activities to ensure rapid response, scientific integrity and public safety, with effective monitoring, verification and maintenance of the RBL biocontainment facility. This Core describes the biosecurity and biosafety practices, risk assessment, regulatory compliance and other practices relevant to maintaining as safe, secure and effective research program. Multiple components will be integrated in redundant and complementary systems. In addition, this Core coordinates training programs across sectors to align expertise and capabilities to provide a sustainable and contemporary workforce. The sectors involved include the RBL laboratories, the RBL vivarium, Facilities, Institutional Planning & Operations, Information Technology, Environmental Health and Safety, Occupational Health, Emergency Management. Core 2 has two aims. Aim 1) To develop the RBL BSL3 and ABSL3 Practices and Biosecurity Training and Education Center which will integrate basic and advanced practices and training. Core 2 will develop a suite of integrated Units: Biosafety Practices Unit, BSL3 Scientific Practices Unit, ABSL3 Animal Practices Unit, Occupational Health Unit, Biosecurity Unit, Emergency Management and Exercise Unit. These structures provide coordinated and standardized training systems across sectors, to unify and integrate routine and emergency/crisis response research functions. Aim 2. Enhance and integrate necessary oversight programs. Safe and secure science requires a web of oversight functions carried out by the following committees: A/BSL3 Standard Operating Procedures (SOPs) Committee, the Institutional Biosafety Committee (IBC), The Institutional Animal Care and Use Committee (IACUC), Dual Use Research of Concern (DURC) and Institutional Review Entity (IRE), and the Institutional Review Board (IRB). Necessary and/or required approvals of research programs and protocols subject to these oversight systems can often be delayed by successive approval requirements and time lags. We will develop a system of oversight mechanisms that allow more agile response times and simultaneous review procedures. We will describe how all the three Cores are served by these interrelated oversight mechanisms to support a well-funded, compliant, highly productive research program capable of further growth and rapid response.

核心2：A/BSL 3实践核心（实践核心）-摘要 罗格斯大学RBL在执行BSL 3级研究和开发方面发挥着核心的区域作用 并保持生物威胁准备。RBL于2009年开业，此后一直由 联邦机构、基金会和工业界进行选择代理研究。RBL保持了强大的系统 BSL 3业务活动，以确保快速反应、科学完整性和公共安全， RBL生物防护设施的监测、核查和维护。本核心描述了生物安全 和生物安全实践、风险评估、法规遵守和其他与维持 安全、可靠和有效的研究计划。多个组件将集成在冗余和 互补系统。此外，该核心协调各部门的培训计划，以调整专业知识 以及提供可持续和现代劳动力的能力。涉及的部门包括RBL 实验室，RBL动物园，设施，机构规划和运营，信息技术， 环境健康与安全、职业健康、应急管理。核心2有两个目标。目标1） 建立RBL BSL 3和ABSL 3实践和生物安全培训和教育中心， 将基本和先进的做法和培训结合起来。核心2将开发一套综合单元：生物安全 实践部门、BSL 3科学实践部门、ABSL 3动物实践部门、职业卫生部门， 生物安保股、应急管理和演习股。这些机构提供协调和 标准化的跨部门培训系统，以统一和整合日常和紧急/危机反应 研究功能。目标2.加强和整合必要的监督方案。安全可靠的科学 需要由以下委员会执行的监督职能网络：A/BSL 3标准操作 程序（SOP）委员会、机构生物安全委员会（IBC）、机构动物护理和 使用委员会（IACUC）、双重用途关注研究（DURC）和机构审查实体（IRE），以及 机构审查委员会（IRB）。研究项目和方案的必要和/或必需批准 在这些监督制度下，经常会因连续的批准要求和时间滞后而被拖延。 我们将建立一个监督机制系统，使反应时间更灵活， 审查程序。我们将描述所有三个核心是如何通过这些相互关联的监督服务的 机制，以支持一个资金充足，合规，高生产力的研究计划能够进一步增长 和快速反应。