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.

2021, Anzt, Hartwig, Bach, Felix, Druskat, Stephan, Löffler, Frank, Loewe, Axel, Renard, Bernhard Y., Seemann, Gunnar, Struck, Alexander, Achhammer, Elke, Aggarwal, Piush, Appel, Franziska, Bader, Michael, Brusch, Lutz, Busse, Christian, Chourdakis, Gerasimos, Dabrowski, Piotr Wojciech, Ebert, Peter, Flemisch, Bernd, Friedl, Sven, Fritzsch, Bernadette, Funk, Maximilian D., Gast, Volker, Goth, Florian, Grad, Jean-Noël, Hegewald, Jan, Hermann, Sibylle, Hohmann, Florian, Janosch, Stephan, Kutra, Dominik, Linxweiler, Jan, Muth, Thilo, Peters-Kottig, Wolfgang, Rack, Fabian, Raters, Fabian H. C., Rave, Stephan, Reina, Guido, Reißig, Malte, Ropinski, Timo, Schaarschmidt, Joerg, Seibold, Heidi, Thiele, Jan P., Uekermann, Benjamin, Unger, Stefan, Weeber, Rudolf

Research software has become a central asset in academic research. It optimizes existing and enables new research methods, implements and embeds research knowledge, and constitutes an essential research product in itself. Research software must be sustainable in order to understand, replicate, reproduce, and build upon existing research or conduct new research effectively. In other words, software must be available, discoverable, usable, and adaptable to new needs, both now and in the future. Research software therefore requires an environment that supports sustainability. Hence, a change is needed in the way research software development and maintenance are currently motivated, incentivized, funded, structurally and infrastructurally supported, and legally treated. Failing to do so will threaten the quality and validity of research. In this paper, we identify challenges for research software sustainability in Germany and beyond, in terms of motivation, selection, research software engineering personnel, funding, infrastructure, and legal aspects. Besides researchers, we specifically address political and academic decision-makers to increase awareness of the importance and needs of sustainable research software practices. In particular, we recommend strategies and measures to create an environment for sustainable research software, with the ultimate goal to ensure that software-driven research is valid, reproducible and sustainable, and that software is recognized as a first class citizen in research. This paper is the outcome of two workshops run in Germany in 2019, at deRSE19 - the first International Conference of Research Software Engineers in Germany - and a dedicated DFG-supported follow-up workshop in Berlin.

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.