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Author: Hallinan, Dara × DDC: 610 × Type: Article × WGL Institute: FIZ KA ×

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    Broad consent under the GDPR : an optimistic perspective on a bright future
    (Berlin ; Heidelberg [u.a.] : Springer Open, 2020) Hallinan, Dara
    Broad consent-the act of gaining one consent for multiple potential future research projects-sits at the core of much current genomic research practice. Since the 25th May 2018, the General Data Protection Regulation (GDPR) has applied as valid law concerning genomic research in the EU and now occupies a dominant position in the legal landscape. Yet, the position of the GDPR concerning broad consent has recently been cause for concern in the genomic research community. Whilst the text of the GDPR apparently supports the practice, recent jurisprudence contains language which is decidedly less positive. This article takes an in-depth look at the situation concerning broad consent under the GDPR and-despite the understandable concern flowing from recent jurisprudence-offers a positive outlook. This positive outlook is argued from three perspectives, each of which is significant in defining the current, and ongoing, legitimacy and utility of broad consent under the GDPR: The principled, the legal technical, and the practical. © 2020 The Author(s).
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    International transfers of personal data for health research following Schrems II: a problem in need of a solution
    (Basingstoke : Stockton Press, 2021) Hallinan, Dara; Bernier, Alexander; Cambon-Thomsen, Anne; Crawley, Francis P.; Dimitrova, Diana; Bauzer Medeiros, Claudia; Nilsonne, Gustav; Parker, Simon; Pickering, Brian; Rennes, Stéphanie
    On 16 July 2020, the Court of Justice of the European Union issued their decision in the Schrems II case concerning Facebook's transfers of personal data from the EU to the US. The decision may have significant effects on the legitimate transfer of personal data for health research purposes from the EU. This article aims: (i) to outline the consequences of the Schrems II decision for the sharing of personal data for health research between the EU and third countries, particularly in the context of the COVID-19 pandemic; and, (ii) to consider certain options available to address the consequences of the decision and to facilitate international data exchange for health research moving forward.
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    Data Sharing Under the General Data Protection Regulation: Time to Harmonize Law and Research Ethics?
    (Baltimore, Md. : Williams & Wilkins, 2021) Vlahou, Antonia; Hallinan, Dara; Apweiler, Rolf; Argiles, Angel; Beige, Joachim; Benigni, Ariela; Bischoff, Rainer; Black, Peter C.; Boehm, Franziska; Ceraline, Jocelyn; Chrousos, George P.; Delles, Christian; Evenepoel, Pieter; Fridolin, Ivo; Glorieux, Griet; van Gool, Alain J.; Heidegger, Isabel; Ioannidis, John P. A.; Jankowski, Joachim; Jankowski, Vera; Jeronimo, Carmen; Kamat, Ashish M.; Masereeuw, Rosalinde; Mayer, Gert; Mischak, Harald; Ortiz, Alberto; Remuzzi, Giuseppe; Rossing, Peter; Schanstra, Joost P.; Schmitz-Draeger, Bernd J.; Spasovski, Goce; Staessen, Jan A.; Stamatialis, Dimitrios; Stenvinkel, Peter; Wanner, Christoph; Williams, Stephen B.; Zannad, Faiez; Zoccali, Carmine; Vanholder, Raymond
    The General Data Protection Regulation (GDPR) became binding law in the European Union Member States in 2018, as a step toward harmonizing personal data protection legislation in the European Union. The Regulation governs almost all types of personal data processing, hence, also, those pertaining to biomedical research. The purpose of this article is to highlight the main practical issues related to data and biological sample sharing that biomedical researchers face regularly, and to specify how these are addressed in the context of GDPR, after consulting with ethics/legal experts. We identify areas in which clarifications of the GDPR are needed, particularly those related to consent requirements by study participants. Amendments should target the following: (1) restricting exceptions based on national laws and increasing harmonization, (2) confirming the concept of broad consent, and (3) defining a roadmap for secondary use of data. These changes will be achieved by acknowledged learned societies in the field taking the lead in preparing a document giving guidance for the optimal interpretation of the GDPR, which will be finalized following a period of commenting by a broad multistakeholder audience. In parallel, promoting engagement and education of the public in the relevant issues (such as different consent types or residual risk for re-identification), on both local/national and international levels, is considered critical for advancement. We hope that this article will open this broad discussion involving all major stakeholders, toward optimizing the GDPR and allowing a harmonized transnational research approach.