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波兰生物银行活动的伦理、组织和法律方面的分析。

The analysis of the ethical, organizational and legal aspects of Polish biobanks activity.

机构信息

Department of Ethics and Philosophical Anthropology, Medical University of Lublin, Poland.

出版信息

Eur J Public Health. 2010 Dec;20(6):707-10. doi: 10.1093/eurpub/ckp202. Epub 2009 Dec 15.

Abstract

BACKGROUND

Biobanks create new opportunities for the public health (Public Health Genomics) but need some regulations. Polish biobanks are in the phase of dynamic transformations aiming at integrating their activity and adjusting them to the international standards. The aim of this article is to present the current standards held in the most important Polish institutions collecting biological samples.

METHODS

A survey was conducted by the questionnaire filled by managers and directors of 24 Polish biobanks. Questions concerned obtaining patient informed consent (also a consent to some future researches and access to dates by other organizations), protection of privacy, storage of the samples and the relevant information, the opinion related to the need of establishing Polish national DNA data bank and possibilities of the scientific international cooperation.

RESULTS

The written consent to carry out research on the samples is obtained almost everywhere, but 29% of biabanks does not acquire the consent for the future usage of the samples. Almost all inquired banks (93%, n = 22) declare the willingness to start an international cooperation. Most of respondents support the idea of establishing the Polish national DNA bank by the fusion of the already existing banks.

CONCLUSION

The inquiry findings point that the current biobanks procedures do not differ to any relevant degree from procedures applied in the West European countries. Many of Polish biobanking organizations are willing to cooperate with foreign sites. It may enhance the European biobanking network and gene-environmental research.

摘要

背景

生物银行创造了公共卫生(公共卫生基因组学)的新机遇,但需要一些监管。波兰的生物银行正处于动态转型阶段,旨在整合其活动,并使其符合国际标准。本文的目的是介绍目前在波兰最重要的收集生物样本的机构中所遵循的标准。

方法

通过问卷对 24 家波兰生物银行的经理和主任进行了调查。问题涉及获得患者的知情同意(包括对未来研究的同意和允许其他组织访问数据)、保护隐私、储存样本和相关信息、关于建立波兰国家 DNA 数据库的必要性的意见以及开展国际科学合作的可能性。

结果

几乎所有的生物银行都获得了对样本进行研究的书面同意,但有 29%的生物银行没有获得对样本未来使用的同意。几乎所有被调查的银行(93%,n=22)都表示愿意开展国际合作。大多数受访者支持通过整合现有的银行来建立波兰国家 DNA 库的想法。

结论

调查结果表明,目前的生物银行程序与西欧国家应用的程序没有太大区别。许多波兰生物银行组织愿意与外国机构合作。这可能会加强欧洲生物银行网络和基因-环境研究。

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