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Ethical Aspects of Translating Research with Human Pluripotent Stem Cell Products into Clinical Practice: A Stakeholder Approach
The New Bioethics ( IF 1.4 ) Pub Date : 2020-01-02 , DOI: 10.1080/20502877.2020.1724708
Clemens Heyder 1 , Solveig Lena Hansen 1 , Claudia Wiesemann 1
Affiliation  

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.

中文翻译:

将人类多能干细胞产品的研究转化为临床实践的伦理方面:利益相关者方法

胚胎干细胞(hESCs)和最近的人诱导多能干细胞(hiPSC)的实验疗法在临床实践中稳步发展。这种新颖的高风险/高潜力疗法的实施要求为公众,尤其是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的保障。我们认为,在道德上要求利益相关者积极参与决策。公众和患者的参与是负责任地处理高风险/高潜力临床研究(例如干细胞研究)的必要先决条件。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进行公开辩论。
更新日期:2020-01-02
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