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在进行BSL3级研究和开发方面发挥着核心的区域作用 以及维持生物治疗的防备。RBL于2009年开业，自那以来一直由 联邦机构、基金会和产业界开展精选代理商研究。RBL维护健壮的系统 对于BSL3业务活动，以确保快速反应、科学完整性和公共安全，并有效 监测、核查和维护RBL生物遏制设施。该核心描述了生物安全 和生物安全实践、风险评估、法规遵从性和其他与维护AS有关的实践 安全、可靠、有效的研究计划。多个组件将集成在冗余和 互补的系统。此外，该核心协调各部门的培训方案，以协调专业知识 和能力，以提供可持续和现代的劳动力。涉及的部门包括RBL 实验室、RBL实验室、设施、机构规划与运营、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) 发展RBL、BSL3和ABSL3做法和生物安全培训和教育中心，该中心将 整合基本和高级实践和培训。核心2将开发一套集成单元：生物安全 BSL3科学实践组、ABSL3动物实践组、职业卫生组、 生物安全股、应急管理和演练股。这些结构提供了协调一致的 各部门的标准化培训系统，以统一和整合日常和应急/危机应对 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 需要由下列委员会执行的监督职能网络：A/BSL3标准作业 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)、关注两用研究(DURC)和机构审查实体(IRE)，以及 院校评审委员会(IRB)。必要的和/或必需的研究计划和方案的批准 受这些监督的制约，系统往往会因连续的审批要求和时间滞后而被拖延。 我们将建立一个监督机制体系，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、高效、能够进一步增长的研究计划的机制 和快速反应。