Department of Biotechnology, Section of Biotechnology and Society, Delft University of Technology, Van der Maasweg 9, 2629 HZ, Delft, The Netherlands.
Sci Eng Ethics. 2021 Mar 29;27(2):22. doi: 10.1007/s11948-021-00300-1.
Genetic engineering techniques (e.g., CRISPR-Cas) have led to an increase in biotechnological developments, possibly leading to uncertain risks. The European Union aims to anticipate these by embedding the Precautionary Principle in its regulation for risk management. This principle revolves around taking preventive action in the face of uncertainty and provides guidelines to take precautionary measures when dealing with important values such as health or environmental safety. However, when dealing with 'new' technologies, it can be hard for risk managers to estimate the societal or environmental consequences of a biotechnology that might arise once introduced or embedded in society due to that these sometimes do not comply with the established norms within risk assessment. When there is insufficient knowledge, stakeholders active in early developmental stages (e.g., researchers) could provide necessary knowledge by conducting research specifically devoted to what these unknown risks could entail. In theory, the Safe-by-Design (SbD) approach could enable such a controlled learning environment to gradually identify what these uncertain risks are, to which we refer as responsible learning. In this paper, we argue that three conditions need to be present to enable such an environment: (1) regulatory flexibility, (2) co-responsibility between researchers and regulators, and (3) openness towards all stakeholders. If one of these conditions would not be present, the SbD approach cannot be implemented to its fullest potential, thereby limiting an environment for responsible learning and possibly leaving current policy behind to anticipate uncertain risks.
基因工程技术（例如 CRISPR-Cas）推动了生物技术的发展，可能带来不确定的风险。欧盟旨在通过将预防原则嵌入其风险管理法规中，来预测这些风险。该原则围绕着在面对不确定性时采取预防措施，并为在处理健康或环境安全等重要价值观时采取预防措施提供指导。然而，当涉及到“新技术”时，风险管理者可能难以估计生物技术可能带来的社会或环境后果，因为这些技术有时不符合风险评估中的既定规范。当知识不足时，在早期发展阶段活跃的利益相关者（例如研究人员）可以通过专门针对这些未知风险进行研究来提供必要的知识。从理论上讲，安全设计（SbD）方法可以使这种受控的学习环境能够逐步确定这些不确定的风险是什么，我们称之为负责任的学习。在本文中，我们认为需要具备三个条件才能实现这种环境：（1）监管灵活性；（2）研究人员和监管机构之间的共同责任；（3）对所有利益相关者的开放。如果这些条件之一不存在，SbD 方法就无法充分发挥作用，从而限制了负责任学习的环境，并可能使当前的政策落后于预测不确定的风险。
