"Here's your swarm medicine prescription": Investigating the ethical and regulatory complexity of in-human testing of robotic nanoswarms

本项目福尔斯属于EPSRC临床技术研究领域，其中医疗保健技术是本网站https://www.epsrc.ac.uk/research/ourportfolio/themes/上列出的主题或研究领域之一。癌症药物，如化疗是全身性的，这意味着它们也可以杀死癌细胞的健康细胞，导致潜在的副作用。纳米医学是纳米技术的医学应用，它致力于在纳米尺度上操纵物质，例如可以帮助将化疗药物输送到癌细胞的纳米颗粒。科学家和工程师可以使用基于纳米颗粒设计的计算机模型来选择纳米颗粒，因此药物可以更有效地到达肿瘤，同时避免健康细胞。现在，科学家和工程师们正在研究控制，并将人工群体智能（存在于鸟类，蚂蚁，鱼类和白蚁等社会动物中）添加到纳米粒子和纳米机器人中。Nanoswarm是多个代理，可以相互作用或与环境相互作用以实现任务（例如，将化疗药物输送到肿瘤而不杀死健康细胞），表现出受群体行为启发的集体行为。当这项技术准备好进行首次人体测试时，必须决定如何安全地进行测试。在整个研究过程中，评估利益攸关方和主要利益攸关方群体的参与至关重要，这是比较有效性研究的核心特征。我们的目标是为第一个人体内纳米群临床试验创建一个监管框架，该试验结合了群机器人技术、定性研究方法、生物伦理学和纳米医学（参见Swana，M.，Blee，J.，Stillman，N.，伊韦斯，J.，Hauert，S.（2022年）。蜂群：癌症纳米医学的下一个前沿。In：Balaz，I.，Adamatzky，A. (eds)癌症，复杂性，计算。涌现，复杂性和计算，第46卷。斯普林格https://doi.org/10.1007/978-3-031-04379-6_12).其中一部分涉及SWARM研究（SWARM -具有集体行为的小型机器人作为人工智能驱动的癌症疗法;为未来的纳米药物建立法规）-该项目已由布里斯托大学工程学院研究伦理委员会审查和批准（参考：11141）。

This project falls within the EPSRC clinical technologies research area where healthcare technologies is one of the themes or research areas listed on this website https://www.epsrc.ac.uk/research/ourportfolio/themes/. Cancer drugs, such as chemotherapy are systemic, this means they can also kill healthy cells alongside cancerous cells leading to potential side effects. Nanomedicine is the medical application of nanotechnology which works on manipulating matter at the nanoscale, such as nanoparticles that can assist the delivery of chemotherapy drugs to cancer cells. Scientists and Engineers can use in silico models for selecting nanoparticles based on nanoparticle design, so drugs can more effectively reach the tumour while avoiding healthy cells. Now, scientists and engineers are working on control and adding artificial swarm intelligence (present in social animals such as birds, ants, fish and termites) to nanoparticles and nanorobots. Nanoswarms are multiple agents that can interact with each other or their environment to achieve a task (e.g. deliver chemotherapy to a tumour without killing healthy cells), exhibiting collective behaviour inspired by swarm behaviour. As and when this technology becomes ready for first-in-human tests, decisions will have to made about how it can and should be safely tested. It is essential to evaluate stakeholders and engagement of key stakeholder groups throughout the research process, which is a core feature of comparative effectiveness research. We aim to create a regulatory framework for the first in-human nanoswarm clinical trial combining swarm robotics, qualitative research methods, bioethics and nanomedicine (see Swana, M., Blee, J., Stillman, N., Ives, J., Hauert, S. (2022). Swarms: The Next Frontier for Cancer Nanomedicine. In: Balaz, I., Adamatzky, A. (eds) Cancer, Complexity, Computation. Emergence, Complexity and Computation, vol 46. Springer. https://doi.org/10.1007/978-3-031-04379-6_12). A part of this involves the SWARM study (SWARM - Small robots With collective behaviour as AI-driven cancer therapies; building Regulations for future nanoMedicines) - This project has been reviewed and approved by the University of Bristol Faculty of Engineering Research Ethics Committee (Ref: 11141).