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弥合生物安全与生物安保差距:来自美国机构的两用研究关注(DURC)和公私合作计划(ePPP)政策见解

Bridging biosafety and biosecurity gaps: DURC and ePPP policy insights from U.S. institutions.

作者信息

Gillum David R, Tran An, Fletcher Jennifer, Vogel Kathleen M

机构信息

School for the Future of Innovation and Society, Arizona State University, Tempe, AZ, United States.

Research and Innovation, University of Nevada, Reno, NV, United States.

出版信息

Front Bioeng Biotechnol. 2024 Sep 25;12:1476527. doi: 10.3389/fbioe.2024.1476527. eCollection 2024.

Abstract

OVERVIEW

This study provides empirical data on the knowledge and practices of biosafety and biosecurity professionals and researchers involved in research on enhanced Potential Pandemic Pathogens (ePPPs) and Dual Use Research of Concern (DURC) within various U.S. sectors. The goal is to improve public health interventions and oversight for DURC and ePPP, contributing valuable insights for policy development. A notable finding was the association between larger biosafety/biosecurity teams and a higher likelihood of conducting high-risk biological research.

METHODS

A survey of 541 biosafety and biosecurity professionals was conducted between March 8 and 10 April 2024, with results analyzed using SAS at a significance level of 0.05. The study received approval from the Institutional Review Boards (IRBs) at Arizona State University and the University of Nevada, Reno.

RESULTS

Government organizations were more likely to conduct DURC compared to other sectors (e.g., Academic, Commercial, Consulting). Public institutions reviewed more experiments outside the scope of the U.S. DURC Policy than private for-profit institutions. Institutions with larger biosafety/biosecurity teams reported greater research activity and more effective non-compliance reporting mechanisms (e.g., anonymous hotlines, reporting forms). Additionally, financial support and the challenges of policy implementation varied significantly across sectors.

DISCUSSION

The findings emphasize the need for appropriate staffing and resource allocation for high-risk biosafety and biosecurity research. A differentiated regulatory approach and equitable distribution of resources are essential for effective oversight. Moreover, robust non-compliance reporting systems are critical to mitigating the risks associated with DURC and ePPP research.

摘要

概述

本研究提供了关于美国各部门参与增强型潜在大流行病原体(ePPP)和两用关注研究(DURC)研究的生物安全和生物安保专业人员及研究人员的知识与实践的实证数据。目标是改善对DURC和ePPP的公共卫生干预及监督,为政策制定提供有价值的见解。一个显著发现是,规模较大的生物安全/生物安保团队与进行高风险生物学研究的较高可能性之间存在关联。

方法

于2024年3月8日至4月10日对541名生物安全和生物安保专业人员进行了调查,使用SAS对结果进行分析,显著性水平为0.05。该研究获得了亚利桑那州立大学和内华达大学雷诺分校的机构审查委员会(IRB)的批准。

结果

与其他部门(如学术、商业、咨询)相比,政府组织更有可能开展DURC。公立机构审查的超出美国DURC政策范围的实验比私立营利性机构更多。拥有较大生物安全/生物安保团队的机构报告称研究活动更多,且有更有效的违规报告机制(如匿名热线、报告表格)。此外,各部门在资金支持和政策实施挑战方面存在显著差异。

讨论

研究结果强调了为高风险生物安全和生物安保研究配备适当人员和分配资源的必要性。差异化的监管方法和资源的公平分配对于有效监督至关重要。此外,强大的违规报告系统对于降低与DURC和ePPP研究相关的风险至关重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ca08/11467424/57a63f31e5fa/fbioe-12-1476527-g001.jpg

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