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dc.contributor.authorVears, Danya F.
dc.contributor.authorHallowell, Nina
dc.contributor.authorBentzen, Heidi Beate
dc.contributor.authorEllul, Bridget
dc.contributor.authorNøst, Therese Haugdahl
dc.contributor.authorKerasidou, Angeliki
dc.contributor.authorKerr, Shona M.
dc.contributor.authorMayrhofer, Michaela Th.
dc.contributor.authorMežinska, Signe
dc.contributor.authorOrmondroyd, Elizabeth
dc.contributor.authorSolberg, Berge
dc.contributor.authorSand, Birgitte Wirum
dc.contributor.authorLjøsne, Isabelle Sylvie Budin
dc.date.accessioned2023-04-12T11:29:23Z
dc.date.available2023-04-12T11:29:23Z
dc.date.issued2023-03-22
dc.description.abstractAn increasing number of European research projects return, or plan to return, individual genomic research results (IRR) to participants. While data access is a data subject’s right under the General Data Protection Regulation (GDPR), and many legal and ethical guidelines allow or require participants to receive personal data generated in research, the practice of returning results is not straightforward and raises several practical and ethical issues. Existing guidelines focusing on return of IRR are mostly projectspecific, only discuss which results to return, or were developed outside Europe. To address this gap, we analysed existing normative documents identified online using inductive content analysis. We used this analysis to develop a checklist of steps to assist European researchers considering whether to return IRR to participants. We then sought feedback on the checklist from an interdisciplinary panel of European experts (clinicians, clinical researchers, population-based researchers, biobank managers, ethicists, lawyers and policy makers) to refine the checklist. The checklist outlines seven major components researchers should consider when determining whether, and how, to return results to adult research participants: 1) Decide which results to return; 2) Develop a plan for return of results; 3) Obtain participant informed consent; 4) Collect and analyse data; 5) Confirm results; 6) Disclose research results; 7) Follow-up and monitor. Our checklist provides a clear outline of the steps European researchers can follow to develop ethical and sustainable result return pathways within their own research projects. Further legal analysis is required to ensure this checklist complies with relevant domestic laws.en_US
dc.identifier.citationVears, Hallowell, Bentzen, Ellul, Nøst, Kerasidou, Kerr, Mayrhofer, Mežinska, Ormondroyd, Solberg, Sand, Ljøsne. A practical checklist for return of results from genomic research in the European contex. European Journal of Human Genetics. 2023:1-9en_US
dc.identifier.cristinIDFRIDAID 2139930
dc.identifier.doi10.1038/s41431-023-01328-6
dc.identifier.issn1018-4813
dc.identifier.issn1476-5438
dc.identifier.urihttps://hdl.handle.net/10037/28959
dc.language.isoengen_US
dc.publisherSpringer Natureen_US
dc.relation.journalEuropean Journal of Human Genetics
dc.rights.accessRightsopenAccessen_US
dc.rights.holderCopyright 2023 The Author(s)en_US
dc.rights.urihttps://creativecommons.org/licenses/by/4.0en_US
dc.rightsAttribution 4.0 International (CC BY 4.0)en_US
dc.titleA practical checklist for return of results from genomic research in the European contexen_US
dc.type.versionpublishedVersionen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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