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干细胞研究与临床转化:关于良好临床实践和患者护理的路线图。

Stem Cell Research and Clinical Translation: A Roadmap about Good Clinical Practice and Patient Care.

作者信息

Frati Paola, Scopetti Matteo, Santurro Alessandro, Gatto Vittorio, Fineschi Vittorio

机构信息

Department of Anatomical, Histological, Forensic and Orthopaedic Sciences, Sapienza University of Rome, Viale Regina Elena 336, 00185 Rome, Italy.

IRCCS Neuromed, Via Atinense 18, 86077 Pozzilli, Italy.

出版信息

Stem Cells Int. 2017;2017:5080259. doi: 10.1155/2017/5080259. Epub 2017 Sep 27.

Abstract

The latest research achievements in the field of stem cells led in 2016 to the publication of "Guidelines for Stem Cell Research and Clinical Translation" by the International Society for Stem Cell Research (ISSCR). Updating the topics covered in previous publications, the new recommendations offer interesting ethical and scientific insights. Under the common principles of research integrity, protection of patient's welfare, respect for the research subjects, transparency and social justice, the centrality of good clinical practice, and informed consent in research and translational medicine is supported. The guidelines implement the abovementioned publications, requiring rigor in all areas of research, promoting the validity of the scientific activity results and emphasizing the need for an accurate and efficient public communication. This paper aims to analyze the aforementioned guidelines in order to provide a valid interpretive tool for experts. In particular, a research activity focused on the bioethical, scientific, and social implications of the new recommendations is carried out in order to provide food for thought. Finally, as an emerging issue of potential impact of current guidelines, an overview on implications of compensation for egg donation is offered.

摘要

干细胞领域的最新研究成果在2016年促使国际干细胞研究学会(ISSCR)发布了《干细胞研究与临床转化指南》。新建议更新了以往出版物中涵盖的主题,提供了有趣的伦理和科学见解。在研究诚信、保护患者福利、尊重研究对象、透明度和社会正义等共同原则下,支持良好临床实践的核心地位以及研究和转化医学中的知情同意。这些指南落实了上述出版物的要求,在研究的各个领域都要求严谨,提高科学活动结果的有效性,并强调准确高效的公众沟通的必要性。本文旨在分析上述指南,以便为专家提供一个有效的解释工具。特别是,开展了一项针对新建议的生物伦理、科学和社会影响的研究活动,以提供思考素材。最后,作为当前指南潜在影响的一个新出现的问题,对卵子捐赠补偿的影响进行了概述。

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