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Article: Legal and Ethical Framework for Global Health Information and Biospecimen Exchange - An International Perspective

TitleLegal and Ethical Framework for Global Health Information and Biospecimen Exchange - An International Perspective
Authors
KeywordsData sharing
Biobanking
Big data
Research policies
International exchange
Issue Date2020
PublisherBioMed Central Ltd. The Journal's web site is located at http://www.biomedcentral.com/bmcmedethics/
Citation
BMC Medical Ethics, 2020, v. 21 n. 1, p. article no. 8 How to Cite?
AbstractBackground: 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.
Persistent Identifierhttp://hdl.handle.net/10722/284948
ISSN
2019 Impact Factor: 2.451
2015 SCImago Journal Rankings: 0.859
PubMed Central ID

 

DC FieldValueLanguage
dc.contributor.authorBernasconi, L-
dc.contributor.authorSen, S-
dc.contributor.authorAngerame, L-
dc.contributor.authorBalyegisawa, AP-
dc.contributor.authorHui, DHY-
dc.contributor.authorHotter, M-
dc.contributor.authorHsu, CY-
dc.contributor.authorIto, T-
dc.contributor.authorJorger, F-
dc.contributor.authorKrassnitzer, W-
dc.contributor.authorPhiliips, AT-
dc.contributor.authorLi, R-
dc.contributor.authorStockley, L-
dc.contributor.authorTay, F-
dc.contributor.authorvon Heijne Widlund, C-
dc.contributor.authorWan, M-
dc.contributor.authorWong, C-
dc.contributor.authorYau, H-
dc.contributor.authorHiemstra, TF-
dc.contributor.authorUresin, Y-
dc.contributor.authorSenti, G-
dc.date.accessioned2020-08-07T09:04:44Z-
dc.date.available2020-08-07T09:04:44Z-
dc.date.issued2020-
dc.identifier.citationBMC Medical Ethics, 2020, v. 21 n. 1, p. article no. 8-
dc.identifier.issn1472-6939-
dc.identifier.urihttp://hdl.handle.net/10722/284948-
dc.description.abstractBackground: 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.languageeng-
dc.publisherBioMed Central Ltd. The Journal's web site is located at http://www.biomedcentral.com/bmcmedethics/-
dc.relation.ispartofBMC Medical Ethics-
dc.rightsBMC Medical Ethics. Copyright © BioMed Central Ltd.-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subjectData sharing-
dc.subjectBiobanking-
dc.subjectBig data-
dc.subjectResearch policies-
dc.subjectInternational exchange-
dc.titleLegal and Ethical Framework for Global Health Information and Biospecimen Exchange - An International Perspective-
dc.typeArticle-
dc.identifier.emailWong, C: creanywo@hku.hk-
dc.identifier.emailYau, H: kcyau@hku.hk-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1186/s12910-020-0448-9-
dc.identifier.pmid31964390-
dc.identifier.pmcidPMC6975025-
dc.identifier.scopuseid_2-s2.0-85078116764-
dc.identifier.hkuros312518-
dc.identifier.volume21-
dc.identifier.issue1-
dc.identifier.spagearticle no. 8-
dc.identifier.epagearticle no. 8-
dc.publisher.placeUnited Kingdom-

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