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管理干细胞库和登记处:新出现的问题。

Governing stem cell banks and registries: emerging issues.

作者信息

Isasi Rosario M, Knoppers Bartha M

机构信息

Centre de Recherche en Droit Public, Université de Montréal, C.P. 6128 succ. Centre-ville, Montréal, QC H3C 3J7, Canada.

出版信息

Stem Cell Res. 2009 Sep-Nov;3(2-3):96-105. doi: 10.1016/j.scr.2009.05.003. Epub 2009 May 25.

DOI:10.1016/j.scr.2009.05.003
PMID:19586808
Abstract

The expansion of national and international research efforts in stem cell research is increasingly paired with the trend of establishing stem cell banks and registries. In jurisdictions crossing the spectrum of restrictive to liberal stem cell policies, banks and registries are emerging as an essential resource for transnational access to quality-controlled and ethically sourced stem cell lines. In this study, we report the preliminary findings of a survey of stem cell banks participating in the International Stem Cell Forum's International Stem Cell Banking Initiative (ISCBI). The questionnaire circulated to all ISCBI members addressed both general issues surrounding research policies (e.g., national policies regulating the permissibility of conducting embryonic stem cell research (hESCR)) and, more specifically, issues relating to the governance of stem cell banking projects. The results of the questionnaire were complemented by scholarly research conducted by the authors. This article provides an overview of the current international hESC banking landscape (I). For this purpose, the policy and governance approaches adopted in the surveyed stem cell banks at the national level will be analyzed and areas of convergence and variance will be identified (II). It is beyond the scope of this paper to provide a comprehensive analysis of the wide range of possible governance approaches, policy responses, and their implications. However, we want to provide a starting point for discussion surrounding key questions and challenges as concerns provenance, access, and deposit of hESC lines (III). Finally, while our analysis is focused on research grade hESCs, the lessons to be gleaned from this examination will encourage further thought, analysis, and research into the issues raised in the banking and governance of other sources of stem cell lines (e.g., SCNT, parthenogenesis, iPs) (IV).

摘要

国家和国际层面干细胞研究力度的不断扩大,越来越与建立干细胞库和登记处的趋势相匹配。在干细胞政策从严格到宽松各不相同的司法管辖区,干细胞库和登记处正成为跨国获取质量可控且来源符合伦理的干细胞系的重要资源。在本研究中,我们报告了一项对参与国际干细胞论坛国际干细胞库倡议(ISCBI)的干细胞库的调查的初步结果。分发给所有ISCBI成员的调查问卷既涉及围绕研究政策的一般问题(例如,规范进行胚胎干细胞研究(hESCR)的许可性的国家政策),更具体地说,还涉及与干细胞库项目治理相关的问题。调查问卷的结果得到了作者进行的学术研究的补充。本文概述了当前国际人胚胎干细胞库的情况(一)。为此,将分析所调查的干细胞库在国家层面所采用的政策和治理方法,并确定趋同和差异的领域(二)。对广泛的可能治理方法、政策应对及其影响进行全面分析超出了本文的范围。然而,我们想为围绕人胚胎干细胞系的来源、获取和储存等关键问题及挑战的讨论提供一个起点(三)。最后,虽然我们的分析侧重于研究级别的人胚胎干细胞,但从本次审查中汲取的经验教训将促使人们进一步思考、分析和研究干细胞系其他来源(例如,体细胞核移植、孤雌生殖、诱导多能干细胞)的库建和治理中所提出的问题(四)。

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