BACKGROUND The progress of electronic health technologies and biobanks holds enormous promise for efficient research. Evidence shows that studies based on sharing and secondary use of data/samples have the potential to significantly advance medical knowledge. However, sharing of such resources for international collaboration is hampered by the lack of clarity about ethical and legal requirements for transfer of data and samples across international borders. MAIN TEXT Here, the International Clinical Trial Center Network (ICN) reports the legal and ethical requirements governing data and sample exchange (DSE) across four continents. The most recurring requirement is ethical approval, whereas only in specific conditions approval of national health authorities is required. Informed consent is not required in all sharing situations. However, waiver of informed consent is only allowed in certain countries/regions and under certain circumstances. The current legal and ethical landscape appears to be very complex and under constant evolution. Regulations differ between countries/regions and are often incomplete, leading to uncertainty. CONCLUSION With this work, ICN illuminates the unmet need for a single international collaborative framework to facilitate DSE. Harmonising requirements for global DSE will reduce inefficiency and waste in research. There are many challenges to realising this ambitious vision, including inconsistent terminology and definitions, and heterogeneous and dynamic legal constraints. Here, we identify areas of agreement and significant difference as a necessary first step towards facilitating international collaboration. We propose the establishment of a working group to continue the comparison across jurisdictions, create a standardised glossary and define a set of basic principles and fundamental requirements for DSE.

中文翻译：

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全球卫生信息和生物样本交换的法律和道德框架-国际视野。

背景技术电子卫生技术和生物库的进步为高效研究带来了巨大的希望。证据表明，基于数据/样本的共享和二次使用的研究有可能显着提高医学知识。但是，由于缺乏关于跨境转移数据和样本的道德和法律要求的明确性，阻碍了此类资源用于国际合作的共享。主要内容在这里，国际临床试验中心网络（ICN）报告了在四大洲管理数据和样品交换（DSE）的法律和道德要求。最经常出现的要求是道德批准，而仅在特定情况下需要国家卫生主管部门的批准。并非在所有共享情况下都需要知情同意。然而，仅在某些国家/地区和某些情况下允许放弃知情同意。当前的法律和道德形势似乎非常复杂，并且正在不断发展。法规因国家/地区而异，并且往往不完整，导致不确定性。结论通过这项工作，ICN阐明了为促进DSE的单一国际协作框架的未满足需求。统一全球DSE的要求将减少研究的低效率和浪费。实现这一雄心勃勃的愿景面临许多挑战，包括不一致的术语和定义，以及各种多样且动态的法律约束。在这里，我们确定达成共识和存在重大差异的领域，这是促进国际合作的必要的第一步。