Hoogstraaten Marjolein J, Vriend Jelle, de Leeuw Victoria C, Negro Simona O, Moors Ellen H M, Kienhuis Anne S, Hoekman Jarno
Copernicus Institute of Sustainable Development, Utrecht University, Utrecht, The Netherlands.
Breakthrough Tech Innovation Group, Vrije Universiteit Amsterdam (VU), De Boelelaan 1108, 1081 HZ, Amsterdam, The Netherlands.
Arch Toxicol. 2025 Jan;99(1):43-56. doi: 10.1007/s00204-024-03878-0. Epub 2024 Oct 4.
This perspective paper, which is the result of a collaborative effort between toxicologists and scholars in innovation and transition studies, presents a heuristic framework based on innovation system literature for understanding and appraising mission achievement to animal-free chemical safety assessment using New Approach Methodologies (NAMs). While scientific and technical challenges in this area are relatively well known, the recent establishment of missions and roadmaps to accelerate the acceptance and effective use of NAMs for chemical safety assessment raises new questions about how we can grasp the systemic nature of all changes needed in this transition. This includes recognising broader societal, institutional, and regulatory shifts necessary for NAM acceptance and uptake. Our paper discusses how the innovation system approach offers insights into key processes and associated activities that include as well as transcend the technical and scientific realm, and can help to accelerate acceptance and uptake of NAMs. Based on these insights, we present a comprehensive framework that, next to scientific and technological developments, recognises the need for coordinated efforts in areas like education, training, funding, policy-making, and public engagement to promote the acceptance and uptake of NAMs. Our framework can be used to perform structural and functional analyses of the innovation system of NAMs and animal-free safety assessment and as such provides handholds to track progress and organise collective efforts of actors to make sure we are moving in the right direction.
这篇观点论文是毒理学家与创新和转型研究领域学者合作的成果，它基于创新系统文献提出了一个启发式框架，用于理解和评估使用新方法（NAMs）实现无动物化学安全评估的任务完成情况。虽然该领域的科学技术挑战相对广为人知，但最近为加速NAMs在化学安全评估中的接受和有效使用而设立的任务和路线图，引发了关于我们如何把握这一转型所需的所有变革的系统性本质的新问题。这包括认识到NAMs被接受和采用所需的更广泛的社会、制度和监管转变。我们的论文讨论了创新系统方法如何为关键过程和相关活动提供见解，这些过程和活动包括并超越了技术和科学领域，并有助于加速NAMs的接受和采用。基于这些见解，我们提出了一个综合框架，该框架除了考虑科学技术发展外，还认识到在教育、培训、资金、政策制定和公众参与等领域需要协调努力，以促进NAMs的接受和采用。我们的框架可用于对NAMs和无动物安全评估的创新系统进行结构和功能分析，从而为跟踪进展情况和组织各方的集体努力提供抓手，以确保我们朝着正确的方向前进。
