Heyder Clemens, Hansen Solveig Lena, Wiesemann Claudia
Department of Medical Ethics and History of Medicine, University Medical Centre Göttingen, Göttingen, Germany.
New Bioeth. 2020 Mar;26(1):3-16. doi: 10.1080/20502877.2020.1724708. Epub 2020 Feb 19.
Experimental therapies with embryonic stem cells (hESCs) and, more recently, human induced pluripotent stem cells (hiPSCs) are steadily gaining ground in clinical practice. The implementation of such novel high-risk/high-potential treatments calls for proper safeguards for the interests of the public and, most importantly, of research participants directly affected by the design and outcomes of trials. We argue that the active involvement of stakeholders in decision-making is ethically required. Public and patient involvement is a necessary prerequisite for dealing responsibly with high-risk/high-potential clinical research such as stem-cell research. Moreover, there is an urgent need for public debate, regionally and globally, about the present and future value of such types of research. A stakeholder approach that pays attention to all of the people and institutions involved, including patients and their organizations, will guide the translational process and maintain the public's trust in such a rapidly evolving scientific field.
使用胚胎干细胞（hESCs）以及最近使用人类诱导多能干细胞（hiPSCs）的实验性疗法在临床实践中正在稳步取得进展。实施此类新型高风险/高潜力治疗需要为公众利益，最重要的是为直接受试验设计和结果影响的研究参与者的利益提供适当保障。我们认为，利益相关者积极参与决策在伦理上是必要的。公众和患者的参与是负责任地开展诸如干细胞研究等高风险/高潜力临床研究的必要前提。此外，迫切需要在区域和全球范围内就此类研究的当前和未来价值展开公众辩论。一种关注所有相关人员和机构（包括患者及其组织）的利益相关者方法将指导转化过程，并维持公众对这一快速发展的科学领域的信任。
