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dc.contributor.authorBernasconi, Lara
dc.contributor.authorŞen, Selçuk
dc.contributor.authorAngerame, Luca
dc.contributor.authorBalyegisawa, Apolo P.
dc.contributor.authorHong Yew Hui, Damien
dc.contributor.authorHotter, Maximilian
dc.contributor.authorHsu, Chung Y.
dc.contributor.authorIto, Tatsuya
dc.contributor.authorJörger, Francisca
dc.contributor.authorKrassnitzer, Wolfgang
dc.contributor.authorPhillips, Adam T.
dc.contributor.authorLi, Rui
dc.contributor.authorStockley, Louise
dc.contributor.authorTay, Fabian
dc.contributor.authorvon Heijne Widlund, Charlotte
dc.contributor.authorWan, Ming
dc.contributor.authorWong, Creany
dc.contributor.authorYau, Henry
dc.contributor.authorHiemstra, Thomas F.
dc.contributor.authorUresin, Yagiz
dc.contributor.authorSenti, Gabriela
dc.description.abstractAbstract: 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.
dc.publisherBioMed Central
dc.rightsAttribution 4.0 International (CC BY 4.0)en
dc.subjectEthics in Public Health, medical law, and health policy
dc.subjectData sharing
dc.subjectBig data
dc.subjectResearch policies
dc.subjectInternational exchange
dc.titleLegal and ethical framework for global health information and biospecimen exchange - an international perspective
prism.publicationNameBMC Medical Ethics
dc.contributor.orcidSenti, Gabriela [0000-0002-0103-1162]

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Attribution 4.0 International (CC BY 4.0)
Except where otherwise noted, this item's licence is described as Attribution 4.0 International (CC BY 4.0)