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View article: Learnings From Unboxing the Black Box
Learnings From Unboxing the Black Box Open
View article: Peaking in the Black Box of AI and Its Many Layers
Peaking in the Black Box of AI and Its Many Layers Open
View article: Artificial Intelligence in Biobanking
Artificial Intelligence in Biobanking Open
View article: A comparative ethical analysis of the Egyptian clinical research law
A comparative ethical analysis of the Egyptian clinical research law Open
View article: Ethical, legal, and social implications in research biobanking: A checklist for navigating complexity
Ethical, legal, and social implications in research biobanking: A checklist for navigating complexity Open
Biobanks’ activity is based not only on securing the technology of collecting and storing human biospecimen, but also on preparing formal documentation that will enable its safe use for scientific research. In that context, the issue of in…
View article: Governing, Protecting, and Regulating the Future of Genome Editing
Governing, Protecting, and Regulating the Future of Genome Editing Open
This edited collection examines the ethical, legal, social and policy implications of genome editing technologies. Moreover, it offers a broad spectrum of timely legal analysis related to bringing genome editing to the market and making it…
View article: What Would It Take to Enable Germline Editing in Europe for Medical Purposes?
What Would It Take to Enable Germline Editing in Europe for Medical Purposes? Open
Commonly, the regulation on germline editing in Europe is described through the two prohibitions: the prohibition set out in Article 13 of the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the …
View article: Preliminary Material
Preliminary Material Open
View article: Introduction: The Significance of ELSPI Perspectives in Governing, Protecting, and Regulating the Future of Genome Editing
Introduction: The Significance of ELSPI Perspectives in Governing, Protecting, and Regulating the Future of Genome Editing Open
With the recent breakthroughs in genomics and advances in genome-editing techniques, most notably the discovery of the clustered regularly interspaced short palindromic repeats (CRISPR)-associated protein 9 (Cas9),1 the matter of genome ed…
View article: Scientific research regime 2.0? Transformations of the research regime and the protection of the data subject that the proposed EHDS regulation promises to bring along
Scientific research regime 2.0? Transformations of the research regime and the protection of the data subject that the proposed EHDS regulation promises to bring along Open
The proposed European Health Data Space regulation (the proposed EHDS regulation) intends to facilitate the secondary use of electronic health data for scientific research purposes. The mechanism that the proposal contains will co-exist wi…
View article: Etik som rättsligt verktyg? Etikprövning av forskning som rättslig skyddsåtgärd för enskilda
Etik som rättsligt verktyg? Etikprövning av forskning som rättslig skyddsåtgärd för enskilda Open
Ethical review has in recent decades played an increasingly prominent role in the research community. In addition to the main function of the ethics review – to assess the benefits and risks of a planned research project – a further functi…
View article: What Would It Take to Enable Germline Editing in Europe for Medical Purposes?
What Would It Take to Enable Germline Editing in Europe for Medical Purposes? Open
Commonly, the regulation on germline editing in Europe is described through the two prohibitions: the prohibition set out in Article 13 of the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the …
View article: Appropriate Safeguards and Article 89 of the GDPR: Considerations for Biobank, Databank and Genetic Research
Appropriate Safeguards and Article 89 of the GDPR: Considerations for Biobank, Databank and Genetic Research Open
The collection and use of biological samples and data for genetic research, or for storage in a biobank or databank for future research, impacts upon many fundamental rights, including the right to dignity, the right to private and family …
View article: The Legal Implications of COVID-19 Vaccination Certificates: Implementation Experiences from Nordic and Baltic Region
The Legal Implications of COVID-19 Vaccination Certificates: Implementation Experiences from Nordic and Baltic Region Open
EU Digital green certificates were initially envisaged as a joint EU initiative to facilitate free movement during the pandemic. However, many countries rapidly extended their use in different contexts at the national level, raising seriou…
View article: Harmonization after the GDPR? Divergences in the rules for genetic and health data sharing in four member states and ways to overcome them by EU measures: Insights from Germany, Greece, Latvia and Sweden
Harmonization after the GDPR? Divergences in the rules for genetic and health data sharing in four member states and ways to overcome them by EU measures: Insights from Germany, Greece, Latvia and Sweden Open
View article: Case C-243/19, A v Veselības ministrija, Judgement of the Court (Second Chamber) of 29 October 2020, EU:C:2020:872
Case C-243/19, A v Veselības ministrija, Judgement of the Court (Second Chamber) of 29 October 2020, EU:C:2020:872 Open
View article: You can't put the genie back in the bottle: on the legal and conceptual understanding of genetic privacy in the era of personal data protection in Europe
You can't put the genie back in the bottle: on the legal and conceptual understanding of genetic privacy in the era of personal data protection in Europe Open
This article sheds a light on how the data protection requirements enshrined in the General Data Protection Regulation (GDPR) relate to shaping genetic privacy in the context of a complex and integrated genetic testing enterprise. It sugge…
View article: SIENNA D6.2: Report on adapting methods for legal analysis of emerging technologies
SIENNA D6.2: Report on adapting methods for legal analysis of emerging technologies Open
<p>The report outlines a revised general approach for legal analysis of emerging technologies. It elaborates and adapts the original approach developed in the SIENNA methodological Handbook which was applied to SIENNA legal studies i…
View article: Enhancing EU legal frameworks for genetics & genomics research SIENNA project Policy Brief #2
Enhancing EU legal frameworks for genetics & genomics research SIENNA project Policy Brief #2 Open
<p>The existing EU legal frameworks (e.g., clinical trials and advanced therapy medicinal products, data protection, in vitro diagnostic medical devices, medical devices, and fundamental rights) are relevant for regulating human…
View article: Biobanking Across Europe Post-GDPR: A Deliberately Fragmented Landscape
Biobanking Across Europe Post-GDPR: A Deliberately Fragmented Landscape Open
View article: GDPR and Biobanking
GDPR and Biobanking Open
View article: Introduction
Introduction Open
The General Data Protection Regulation (GDPR) is already four years old legal instrument, with over two years of practical experience, yet, several central questions on its application, its importance in scientific research, rights of the …
View article: Setting the Foundations: Individual Rights, Public Interest, Scientific Research and Biobanking
Setting the Foundations: Individual Rights, Public Interest, Scientific Research and Biobanking Open
View article: SIENNA D5.6: Recommendations for the enhancement of the existing legal frameworks for genomics, human enhancement, and AI and robotics
SIENNA D5.6: Recommendations for the enhancement of the existing legal frameworks for genomics, human enhancement, and AI and robotics Open
<p>This report identifies potential changes needed in the existing legal and human rights frameworks (international, EU and national) that might be necessary or desirable to create an environment in which the SIENNA proposals for eth…
View article: Biobanking and data transfer between the EU and Cape Verde, Mauritius, Morocco, Senegal, and Tunisia: adequacy considerations and Convention 108
Biobanking and data transfer between the EU and Cape Verde, Mauritius, Morocco, Senegal, and Tunisia: adequacy considerations and Convention 108 Open
Santa Slokenberga* Biobanking, data sharing, and states of interestBiobanking is a privacy-intrusive activity.With advances in biobanking and its associated science, the intensity and depth of privacy intrusions are increasing.These intrus…
View article: The GDPR and the research exemption: considerations on the necessary safeguards for research biobanks
The GDPR and the research exemption: considerations on the necessary safeguards for research biobanks Open
View article: SIENNA D2.2 Analysis of the legal and human rights requirements for genomics in and outside the EU
SIENNA D2.2 Analysis of the legal and human rights requirements for genomics in and outside the EU Open
<p>This report examines how the law currently responds to challenges in the area of genetics and genomics, and identifies the challenges, limitations and gaps that emerge.It also identifies key human rights norms and regula…
View article: The right to science and human germline editing: Sweden, its external commitments and the ambiguous national responses under the Genetic Integrity Act
The right to science and human germline editing: Sweden, its external commitments and the ambiguous national responses under the Genetic Integrity Act Open
THE RIGHT TO SCIENCE AND HUMAN GERMLINE EDITING. Sweden, its external commitments and the ambiguous national responses under the Genetic Integrity Act
View article: Analysis of the legal and human rights requirements for genomics in and outside the EU : SIENNA D2.2
Analysis of the legal and human rights requirements for genomics in and outside the EU : SIENNA D2.2 Open
SIENNA
View article: EU data transfer rules and African legal realities: is data exchange for biobank research realistic?
EU data transfer rules and African legal realities: is data exchange for biobank research realistic? Open
Key Points To effectively collaborate in biobanking and build capacity in low and middle-income countries, data transfer from European Union (EU) Member States to states in Africa is crucial. Although under the General Data Protection Regu…