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对于人类多能干细胞、胚胎及相关研究的审查而言，“适当的科学依据”意味着什么？

What does "appropriate scientific justification" mean for the review of human pluripotent stem cell, embryo, and related research?

作者信息

Jonlin Erica C, Fujita Misao, Isasi Rosario, Kato Kazuto, Munsie Megan, Muto Kaori, Niakan Kathy, Saha Krishanu, Sugarman Jeremy, Turner Leigh, Hyun Insoo

机构信息

Institute for Stem Cell and Regenerative Medicine, University of Washington, Seattle, WA, USA.

Uehiro Research Division for iPS Cell Ethics, Center for iPS Cell Research and Application (CiRA), Institute for the Advanced Study of Human Biology (WPI-ASHBi), Kyoto University, Kyoto, Japan.

出版信息

Stem Cell Reports. 2025 May 13;20(5):102479. doi: 10.1016/j.stemcr.2025.102479. Epub 2025 Apr 24.

DOI:10.1016/j.stemcr.2025.102479
PMID:40280137
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12143132/
Abstract

This article complements the 2021 International Society for Stem Cell Research (ISSCR) Guidelines for Stem Cell Research and Clinical Translation by explaining what "adequate and appropriate scientific justification" means for human pluripotent stem cell, embryo, and related research, thus providing practical advice for review and oversight bodies, regulators, and investigators who conduct research in these areas.

摘要

本文通过解释“充分且恰当的科学依据”对于人类多能干细胞、胚胎及相关研究意味着什么，对2021年国际干细胞研究学会（ISSCR）的《干细胞研究与临床转化指南》进行补充，从而为审查监督机构、监管者以及在这些领域开展研究的调查人员提供实用建议。

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'Ceci n'est pas un embryon?' The ethics of human embryo model research.“这不是胚胎吗？”人类胚胎模型研究的伦理问题。
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Comparison of the 2021 International Society for Stem Cell Research (ISSCR) guidelines for "laboratory-based human stem cell research, embryo research, and related research activities" and the corresponding Japanese regulations.2021年国际干细胞研究学会（ISSCR）“基于实验室的人类干细胞研究、胚胎研究及相关研究活动”指南与日本相应法规的比较。
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Democratic Governance of Human Germline Genome Editing.人类生殖系基因组编辑的民主治理。
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A pathway for attesting ethical provenance of cell lines: Lessons from the European human pluripotent stem cell registry (hPSC).一种验证细胞系伦理来源的途径：来自欧洲人类多能干细胞登记处（hPSC）的经验教训。
Stem Cell Res. 2019 Oct;40:101539. doi: 10.1016/j.scr.2019.101539. Epub 2019 Aug 19.
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