An empirical survey on biobanking of human genetic material and data in six EU countries
An empirical survey on biobanking of human genetic material and data in six EU countries
复制标题
DOI：
10.1038/sj.ejhg.5201007
复制
发表时间：
2003-06-01
影响因子：
5.2
通讯作者：
Cambon-Thomsen, A
中科院分区：
文献类型：
--
作者：
Hirtzlin, I;Dubreuil, C;Cambon-Thomsen, A
生物库对应不同的情况：研究和技术开发、医疗诊断或治疗活动。他们的地位没有明确界定。我们的目标是调查欧洲的人类生物库，特别是在不同国家背景下的组织，经济和道德问题。作为欧洲研究项目的一部分，收集了在六个欧盟国家（法国、德国、荷兰、葡萄牙、西班牙和英国）进行的一项调查的数据，该项目检查了人类和非人类生物库（EUROGENBANK，由JC Galloux教授协调）。通过问卷和访谈对总共147个涉及人体样本和数据生物库的机构进行了调查。大多数接受调查的机构属于公共或私营非营利部门，这些部门在生物库中发挥着关键作用。这一活动在所有国家都在增加，因为丢弃的样本很少，遗传研究也在激增。收藏品的大小各不相同，许多都很小，只有少数非常大。他们的目的通常是研究，或研究和医疗保健，主要是在疾病研究的背景下。很少为生物库分配具体预算，也不经常评估成本。样品通常是免费提供的，礼物和交换是常见的规则。一般都遵循良好做法准则，并进行质量控制，但质量程序并不总是得到明确解释。相关数据通常是计算机化的（已识别或可识别的样本）。生物银行通常倾向于集中数据而不是样本。欧洲内部的法律的和伦理的协调被认为可能促进国际合作。我们提出了一系列的建议和意见所产生的欧洲银行项目。
Biobanks correspond to different situations: research and technological development, medical diagnosis or therapeutic activities. Their status is not clearly defined. We aimed to investigate human biobanking in Europe, particularly in relation to organisational, economic and ethical issues in various national contexts. Data from a survey in six EU countries ( France, Germany, the Netherlands, Portugal, Spain and the UK) were collected as part of a European Research Project examining human and non-human biobanking (EUROGENBANK, coordinated by Professor JC Galloux). A total of 147 institutions concerned with biobanking of human samples and data were investigated by questionnaires and interviews. Most institutions surveyed belong to the public or private non-profit-making sectors, which have a key role in biobanking. This activity is increasing in all countries because few samples are discarded and genetic research is proliferating. Collections vary in size, many being small and only a few very large. Their purpose is often research, or research and healthcare, mostly in the context of disease studies. A specific budget is very rarely allocated to biobanking and costs are not often evaluated. Samples are usually provided free of charge and gifts and exchanges are the common rule. Good practice guidelines are generally followed and quality controls are performed but quality procedures are not always clearly explained. Associated data are usually computerised ( identified or identifiable samples). Biobankers generally favour centralisation of data rather than of samples. Legal and ethical harmonisation within Europe is considered likely to facilitate international collaboration. We propose a series of recommendations and suggestions arising from the EUROGENBANK project.