Greene Daniel, Alexanian Tessa, Palmer Megan J
Center for International Security and Cooperation, Stanford University, Stanford, CA, United States.
iGEM Foundation, Paris, France.
Front Bioeng Biotechnol. 2025 Aug 14;13:1620678. doi: 10.3389/fbioe.2025.1620678. eCollection 2025.
When a life science project is identified as potential dual use research of concern (DURC), United States government policy and biorisk management professionals recommend conducting a risk assessment of the project and using its results to choose strategies to manage any associated risks. However, there is little empirical research on how real-world projects score on DURC assessments, the extent to which reviewers agree or disagree about risks for a given project, or how risk judgments map to recommended risk management strategies. By studying the process of DURC risk assessment, it may be possible to develop methods that are more consistent, accurate, and cost-effective.
Using a modified version of the framework in the Companion Guide to the United States Government Policies for Oversight of Life Sciences Dual Use Research of Concern, we elicited detailed reviews from 18 experienced DURC reviewers and 49 synthetic biology students of the risks, benefits, and recommended risk management strategies for four real-world synthetic biology projects.
We found significant variation among experts, as well as between experts and students, in both perceived DURC risk and recommended risk management strategies. For some projects, expert risk assessments spanned 4 out of 5 possible ratings. We found substantial disagreement between participants about the appropriate actions to take to manage the DURC risks of each project.
The observed variation in participants' judgments suggests that decisions for similar projects may vary significantly across institutions, exposing the public to inconsistent standards of risk management. We provide several research-based suggestions to reduce reviewer disagreement and manage risk more efficiently when reviewers disagree.
当一个生命科学项目被认定为潜在的两用关注研究（DURC）时，美国政府政策和生物风险管理专业人员建议对该项目进行风险评估，并利用评估结果选择管理任何相关风险的策略。然而，关于实际项目在DURC评估中的得分情况、评审人员对给定项目风险的认同或分歧程度，以及风险判断如何映射到推荐的风险管理策略等方面，实证研究很少。通过研究DURC风险评估过程，有可能开发出更一致、准确且具成本效益的方法。
我们采用了《美国政府生命科学两用关注研究监督政策配套指南》中框架的修改版本，从18名经验丰富的DURC评审人员和49名合成生物学专业学生那里获取了对四个实际合成生物学项目的风险、益处及推荐风险管理策略的详细评审意见。
我们发现，在感知到的DURC风险和推荐的风险管理策略方面，专家之间以及专家与学生之间都存在显著差异。对于一些项目，专家风险评估涵盖了5个可能评级中的4个。我们发现参与者在应对每个项目的DURC风险应采取的适当行动上存在很大分歧。
观察到的参与者判断差异表明，类似项目的决策可能在不同机构间存在显著差异，使公众面临风险管理标准不一致的情况。我们提供了一些基于研究的建议，以减少评审人员之间的分歧，并在评审人员存在分歧时更有效地管理风险。
