A5032131977- Ethics in Clinical Research
- Biomedical Ethics and Regulation
- Legal Studies and Reforms
- Law, AI, and Intellectual Property
- Intellectual Property and Patents
- Privacy, Security, and Data Protection
- Ethics in medical practice
- Patient Dignity and Privacy
- Ethics and Legal Issues in Pediatric Healthcare
- Child and Adolescent Health
- Economic Issues in Ukraine
- Digitalization, Law, and Regulation
- European and International Law Studies
- CRISPR and Genetic Engineering
- BRCA gene mutations in cancer
- Health Systems, Economic Evaluations, Quality of Life
- COVID-19 Digital Contact Tracing
- Neuroethics, Human Enhancement, Biomedical Innovations
- International Human Rights and Reproductive Law
- Reproductive Health and Technologies
- Ukrainian Legal and Forensic Studies
- Privacy-Preserving Technologies in Data
- Science, Research, and Medicine
- Sexual Differentiation and Disorders
- Freedom of Expression and Defamation
Uppsala University
2015-2024
Biomedical Research Foundation of the Academy of Athens
2023
Biobanking and Biomolecular Resources Research Infrastructure Consortium
2023
University of Copenhagen
2022
Lund University
2018-2019
Riga Stradiņš University
2018
The General Data Protection Regulation (GDPR) came into force in May 2018. aspiration of providing for a high level protection to individuals' personal data risked placing considerable constraints on scientific research, which was contrary various research traditions across the EU. Therefore, along with set carefully outlined subjects' rights, GDPR provides two-level framework enable derogations from these rights when is concerned. First, by directly invoking provisions condition that...
Abstract The COVID-19 pandemic demonstrated the benefits of international data sharing. Data sharing enabled health care policy makers to make decisions based on real-time data, it tracking virus, and importantly development vaccines that were crucial mitigating impact virus. This is not norm as needs navigate complex ethical legal rules, in particular, fragmented application General Protection Regulation (GDPR). introduction draft regulation for a European Health Space (EHDS) May 2022 seeks...
Despite the increasing availability of direct-to-consumer (DTC) genetic testing, it is currently unclear how such services are regulated in Europe, due to lack EU or national legislation specifically addressing this issue. In article, we provide an overview laws that could potentially impact regulation DTC testing 26 European countries, namely Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg,...
Abstract Biobanks’ activity is based not only on securing the technology of collecting and storing human biospecimen, but also preparing formal documentation that will enable its safe use for scientific research. In context, issue informed consent, reporting incidental findings Transfer Agreements remain a vast challenge. This paper aims to offer first–hand tangible solutions those issues in context collaborative transnational biobanking It presents four‐step checklist aiming facilitate...
The collection and use of biological samples data for genetic research, or storage in a biobank databank future impacts upon many fundamental rights, including the right to dignity, private family life, protection personal data, freedom arts sciences, non-discrimination. other health-related this context must be used manner that is rooted human rights. Owing part General Data Protection Regulation (GDPR) coming into force, scientific research has been afforded increasing attention. GDPR...
... Biobanks and biobank research are essential for understanding the human genome, disease aetiology translation, as well furthering medicine.1 However, several preconditions to carry out this type of research. Among these existence necessary infrastructures availability both a sufficient amount appropriate quality samples data. Over past decades, investments in scientifically advanced countries have been commonplace.2 In Europe alone, number biobanks is considerable growing. For example,...
Nonconsensual gender-conforming interventions on children with intersex conditions have recently come under sharp criticism from human rights authorities within the United Nations, Council of Europe, and European Union, which identified these as violating children's to bodily integrity, privacy, protection violence, torture, degrading treatment. Responding largely requests for intervention nongovernmental organizations, called upon nations reform their legal frameworks, both prevent...
Santa Slokenberga* Biobanking, data sharing, and states of interestBiobanking is a privacy-intrusive activity.With advances in biobanking its associated science, the intensity depth privacy intrusions are increasing.These can occur number ways, which be largely divided into following three groups: first, through sample collection, particular, approach that being used for participant recruitment, types specimen, how they obtained; secondly, processing during research; thirdly, sharing.The...
Abstract In biobanking, collaboration and data sharing contribute to building genomic research capacity, have the potential further scientific advances that ultimately can result in clinical care. However, absence of common applicable legal frameworks enable collaboration, capacity is hindered. With applicability General Data Protection Regulation, obstacles which involve export from European Union Member States third countries are expected grow, rendering between EU even more challenging....
This article examines the content of data portability right (II), operationalisation in health research context and related challenges (III) by considering both GDPR provisions special Guidelines from European Data Protection Board (ex-Article 29 Working Party). We provide depth analysis tables for easing identification potential implementation contexts. Keywords: Portability, Scientific Research, GDPR, Health Data, Subject's Rights, Union
Abstract As genomic research becomes commonplace across the world, there is an increased need to coordinate practices among researchers, especially with regard data sharing. One such way international code of conduct. In September 2020, expert panel consisting representatives from various fields convened discuss a draft proposal formed via synthesis existing professional codes and other recommendations. This article presents overview analysis main issues related that were discussed by panel,...
In this study, we examined the ethical implications of Egypt's new clinical trial law, employing framework proposed by Emanuel et al. and comparing it to various national supranational laws. This analysis is crucial as Egypt, considered a high-growth pharmaceutical market, has become an attractive location for trials, offering insights into implementation bioethical regulations in large population country with robust healthcare infrastructure predominantly treatment-naïve patients.
Rapid advances in genomics and technology have rendered genetic testing services easily accessible to consumers over the Internet form of direct-to-consumer testing. In eu , ivd Directive has been animadverted for its inability tackle challenges posed. Currently, legislation is a transition state. It thus, timely assess, what extent proposed Regulation intended address performance requirements utility tests, which are made available within Internet, discuss developments vis-à-vis Directive....
This article sheds a light on how the data protection requirements enshrined in General Data Protection Regulation (GDPR) relate to shaping genetic privacy context of complex and integrated testing enterprise. It suggests that informational dimension era could be described as sphere controlled access. Given GDPR does not prescribe quantitative or contextual limitations relating access once applicable are met, one argue there good preconditions for field head direction transparency. puts...