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/BSL3 实践核心（实践核心）- 摘要 罗格斯大学 RBL 在执行 BSL3 级研究和开发方面发挥着中心、区域性作用 并保持生物威胁准备。 RBL 于 2009 年开业，此后一直由 联邦机构、基金会和行业开展精选代理研究。 RBL 维持稳健的系统 对于 BSL3 业务活动，确保快速响应、科学完整性和公共安全，并采取有效措施 RBL 生物防护设施的监测、验证和维护。该核心描述了生物安全 和生物安全实践、风险评估、监管合规性以及与维护相关的其他实践 安全、可靠和有效的研究计划。多个组件将以冗余方式集成 互补系统。此外，该核心协调跨部门的培训计划，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。 Core 2 有两个目标。目标1) 开发 RBL BSL3 和 ABSL3 实践和生物安全培训和教育中心，该中心将 整合基础和高级实践和培训。 Core 2 将开发一套集成单元：生物安全 实践单位、BSL3 科学实践单位、ABSL3 动物实践单位、职业健康单位、 生物安全股、应急管理和演习股。这些结构提供了协调和 跨部门的标准化培训系统，以统一和整合日常和紧急/危机应对 研究职能。目标 2. 加强和整合必要的监督计划。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/BSL3 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)、双重用途研究关注 (DURC) 和机构审查实体 (IRE) 以及 机构审查委员会 (IRB)。研究计划和协议的必要和/或必需的批准 受这些监督系统的约束往往会因连续的批准要求和时间滞后而被拖延。 我们将开发一个监督机制系统，允许更灵活的响应时间和同步 审查程序。我们将描述这些相互关联的监督如何为所有三个核心提供服务 支持资金充足、合规、高产、能够进一步发展的研究计划的机制 和快速反应。