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Ecologists are increasingly tackling difficult issues like global change, loss of biodiversity and sustainability of ecosystem services. These and related topics are enormously challenging, requiring unprecedented multidisciplinary collaboration and rapid synthesis of large amounts of diverse data into information and ultimately knowledge. New sensors, computers, data collection and storage devices and analytical and statistical methods provide a powerful tool kit to support analyses, graphics and visualizations that were unthinkable even a few years ago. New and increased emphasis on accessib

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.

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.

[Preprint] Abstract zum Panel der DHd-AG Datenzentren bei der DHd-Tagung 2019 Kurzfassung: Der Prozess der Bildung einer nationalen Forschungsdateninfrastruktur (NFDI), der durch die Veröffentlichung des Positionspapiers "Leistung aus Vielfalt" (RfII 2016) durch den RfII und das BMBF eingeleitet wurde, trifft auf einen bereits in Bewegung befindlichen Prozess der Selbstorganisation der Akteure im Bereich des geisteswissenschaftlichen Forschungsdatenmanagements. 24 Institutionen aus Deutschland, Österreich und der Schweiz kommen mittlerweile in der AG Datenzentren des DHd-Verbands zusammen und nutzen das Forum zur Abstimmung und gemeinsamen Interessenvertretung. Die Zusammensetzung der AG ist ein Abbild der Vielfalt innerhalb der Forschungsdatenlandschaft. Die einzelnen Zentren verfügen über verschiedene Förderungs- und Finanzierungsmodelle, strategische Ausrichtungen und institutionelle Verortung. Fachspezifische, methodenbasierte, Datentyp-orientierte, institutionelle oder politisch-geographische Zuständigkeiten und Zugänglichkeiten stehen nebeneinander. In diesem Panel möchte die AG Datenzentren unterschiedliche Perspektiven zur Gestaltung von Organisationsformen im geisteswissenschaftlichen Datenmanagement zu Wort kommen lassen, Herausforderungen und Lösungswege mit Vertreter*innen der Fachcommunities diskutieren und damit auch einen Beitrag zum übergreifenden Diskurs zur Bildung einer NFDI leisten. Webseite der AG Datenzentren im DHd Verband: https://dhd-ag-datenzentren.github.io/