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Biobanking Within the European Regulatory Framework:Opportunities and Obstacles

机译：欧洲监管框架内的生物银行：机遇与障碍

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摘要

A common feature of the European ethical and legal regulatory framework is that biobank-based research has a significant potential of providing new benefits to European citizens in terms of new medical treatment, and this research is therefore something that should be promoted. At the same time the legislatures are concerned, and rightly so, about the integrity of patients and healthy volunteers who provide samples and data. There is now ample evidence of how biobank-based research has provided great opportunities for new care. At the same time there are a growing number of reports about rash judgments about integrity by ethical review boards and data inspection authorities that are not in the best interest of patients. It is here argued that legislatures, ethical review boards, and data inspection authorities need to adopt a wider view of integrity and take into consideration the patients’ interest in a sound scientific basis for medical diagnosis and treatment.
机译：欧洲道德和法律法规框架的一个共同特征是，基于生物库的研究具有很大的潜力，可以在新的医疗方法方面为欧洲公民提供新的利益，因此，应促进这一研究。同时，立法机关也应正确地关心提供样本和数据的患者和健康志愿者的完整性。现在有足够的证据表明基于生物库的研究如何为新的护理提供了巨大的机会。同时，越来越多的关于伦理审查委员会和数据检查机构对完整性进行轻率判断的报告越来越多，这些报告都不符合患者的最大利益。有人认为，立法机关，道德审查委员会和数据检查机构需要采取更广阔的诚信观，并在合理的医学诊断和治疗基础上考虑患者的兴趣。

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