University of Tasmania, Hobart, Australia.
ARC Centre of Excellence for Electromaterials Science (ACES), Wollongong, Australia.
Sci Eng Ethics. 2018 Feb;24(1):73-91. doi: 10.1007/s11948-017-9874-6. Epub 2017 Feb 9.
Recent developments of three-dimensional printing of biomaterials (3D bioprinting) in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article (1) considers whether there is a limit as to what should be bioprinted in medicine; (2) examines key risks of significant harm associated with testing 3D bioprinting for humans; (3) investigates the clinical trial paradigm used to test 3D bioprinting; (4) analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; (5) explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments.
近年来，医学领域的生物材料三维打印（3D 生物打印）技术取得了长足的发展，被认为具有改变某些医疗方法的潜力，包括为器官损伤或衰竭提供新的应对措施。然而，在炒作之外，在 3D 生物打印器官准备好移植到人体之前，需要解决几个重要的伦理问题和监管问题。本文首先提出了与生物打印在医学中的应用相关的一般伦理问题，然后重点讨论了与在人体上进行实验测试相关的更具体的伦理问题，以及缺乏当前指导这些实验的国际监管指令。因此，本文（1）考虑了在医学中应该进行生物打印的限制；（2）探讨了与人体 3D 生物打印测试相关的重大伤害风险；（3）调查了用于测试 3D 生物打印的临床试验范式；（4）分析了不可逆性、治疗机会丧失和可重复性的伦理问题；（5）探讨了目前缺乏 3D 生物打印治疗监管和测试的具体框架。
