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  • 1.
    Barkane, Irena
    et al.
    Univ Latvia, Riga, Latvia..
    O'Cathaoir, Katharina
    Univ Copenhagen, Copenhagen, Denmark..
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Eenmaa, Helen
    Univ Tartu, Tartu, Estonia..
    The legal implications of covid-19 vaccination certificates: Implementation experiences from Nordic and Baltic region2022In: New legal reality: Challenges and perspectives, Riga: University of Latvia Press, 2022, Vol. 2, p. 209-223Conference paper (Refereed)
    Abstract [en]

    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 serious ethical and legal concerns and questions, in particular, on how to strike a right balance between the interests of the individual and the interests of society. The paper aims to explore the legal implications of using vaccination certificates at the national level, in particular by exploring and comparing practices in selected Nordic and Baltic countries. The article emphasises that, despite COVID-19 crises, the governments should protect fundamental rights and values and when deciding on new restrictions carefully assess their necessity and proportionality. National responses call for a new regulatory framework to ensure responsible use of digital technologies in public interests.

  • 2.
    Chassang, Gauthier
    et al.
    Inserm, Toulouse, France; Université Paul Sabatier Toulouse, France; US13, Infrastructure Biobanques, CS ELSI, Inserm, Paris, France; BBMRI-ERIC, Graz, Austria..
    Southerington, Tom
    University of Turku, Finland; Hospital District of Southwest Finland; Finnish Biobank Cooperative FINBB; BBMRI-ERIC, Graz, Austria.
    Tzortzatou, Olga
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Biomedical Research Foundation of the Academy of Athens, Greece; Hellenic Health Foundation, Athens, Greece; BBMRI-ERIC, Graz, Austria.
    Boeckhout, Martin
    Julius Center for Health Sciences and Primary Care, Department of Medical Humanities, University Medical Center Utrecht, The Netherlands.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Faculty of Law, Lund University, Sweden; Faculty of Law, Riga Stradins University, Latvia..
    Data Portability in Health Research and Biobanking2018In: European Data Protection Law Review, ISSN 2364-2831, Vol. 4, no 3, p. 296-307Article in journal (Refereed)
    Abstract [en]

    This article examines the content of data portability right (II), operationalisation of data portability in health research context and related challenges (III) by considering both GDPR provisions and special Guidelines from the European Data Protection Board (ex-Article 29 Data Protection Working Party). We provide in depth analysis of the provisions and tables for easing the identification of potential implementation of data portability in health research contexts.

  • 3.
    Fåhraeus, David
    et al.
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Reichel, Jane
    Department of Law, Stockholm University; Stockholm , Sweden.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    The European Health Data Space: Challenges and Opportunities2024Report (Other academic)
    Abstract [en]

    In her 2020 State of the Union address, the European Commission President Ursula von der Leyen announced a new legislative proposal to create a European Health Data Space. Its aim is to make electronic health data accessible in order to support healthcare delivery, health research, innovation, effective policymaking and regulation, and personalised medicine. This European Policy Analysis examines the Commission’s proposal and its implications for patients, healthcare providers, market actors and national administrations.

    The analysis shows that the Commission’s Proposal has significant potential benefits for a wide range of stakeholders. However, concerns still remain regarding aspects such as the empowerment of individuals in relation to their data, adjustments that will need to be made by the healthcare sector, incentives for innovation, and trust in EU governance. At the time of writing, the European Parliament and the Council have adopted their negotiating positions. However, a number of changes are likely to be introduced before the Commission’s Proposal is agreed and can be implemented in the Member States. 

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  • 4.
    Garland, Jameson
    et al.
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Slokenberga, Santa
    Faculty of Law, Lund University, Lund, Sweden.
    Protecting the Rights of Children with Intersex Conditions from Nonconsensual Gender-Conforming Medical Interventions: The View from Europe2019In: Medical Law Review, ISSN 0967-0742, E-ISSN 1464-3790, Vol. 27, no 3, p. 482-508Article in journal (Refereed)
    Abstract [en]

    Nonconsensual gender-conforming interventions on children with intersex conditions have recently come under sharp criticism from human rights authorities within the United Nations, the Council of Europe, and the European Union, which have identified these interventions as violating children’s rights to bodily integrity, privacy, and protection from violence, torture, and degrading treatment. Responding largely to requests for intervention from nongovernmental organizations, these authorities have called upon nations to reform their legal frameworks, both to prevent these rights violations and to redress them. To date, however, few nations have endeavored to prohibit nonconsensual gender-conforming procedures on children with intersex conditions, and none have enacted significant reforms of their frameworks to redress rights violations. This particular ‘compliance gap’ between human rights recommendations and law reform stems from a failure of national legal orders to formally recognize the scope of rights that are threatened by nonconsensual gender-conforming interventions—rights that are well-established as part of states’ positive obligations to prevent physical and psychological harm to children. This article, therefore, analyzes the nature of the rights at stake and the importance of reporting human rights violations to generate direct calls for reform wherever violations occur. The article further analyzes how developments in Europe may have special significance for legal framework reforms—particularly if they facilitate judicial actions against national authorities through the European Convention of Human Rights, which may serve as a model for litigation elsewhere.

  • 5. Kadile, Laura
    et al.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Ārstniecības iestāžu darbības tiesiskie aspekti2022In: Medicīnas tiesības: Otrais papildinātais izdevums / [ed] Agnese Gusarova; Aldis Lieljuksis; Aleksandrs Potaičuks; Laura Šāberte; Santa Slokenberga; Solvita Olsena; Ronalds Rožkalns; Liene Elizabete Tauriņa; Ilze Vilka; Niāra Zālīte; Anita Slokenberga; Karina Palkova; Laura Kadile; Olga Šķerberga; Signe Mežinska, Tiesu namu aģentūra , 2022, 2, p. 99-123Chapter in book (Other academic)
  • 6. Kalokairinou, L
    et al.
    Howard, Heidi Carmen
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Fisher, E
    Flatscher-Thöni, M
    Hartlev, M
    van Hellemondt, R
    Juškevičius, J
    Kapelenska-Pregowska, J
    Kováč, P
    Lovrečić, L
    Nys, H
    de Paor, A
    Phillips, A
    Prudil, L
    Rial-Sebbag, E
    Romeo Casabona, CM
    Sándor, J
    Schuster, A
    Soini, S
    Søvig, KH
    Stoffel, D
    Titma, T
    Trokanas, R
    Borry, P
    Legislation of direct-to-consumer genetic testing in Europe:: a fragmented regulatory landscape2018In: Journal of Community Genetics, ISSN 1868-310X, E-ISSN 1868-6001, Vol. 9, no 2, p. 117-132Article, review/survey (Refereed)
    Abstract [en]

    Despite the increasing availability of direct-to-consumer (DTC) genetic testing, it is currently unclear how such services are regulated in Europe, due to the lack of EU or national legislation specifically addressing this issue. In this article, we provide an overview of laws that could potentially impact the regulation of DTC genetic testing in 26 European countries, namely Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, the Netherlands and the United Kingdom. Emphasis is placed on provisions relating to medical supervision, genetic counselling and informed consent. Our results indicate that currently there is a wide spectrum of laws regarding genetic testing in Europe. There are countries (e.g. France and Germany) which essentially ban DTC genetic testing, while in others (e.g. Luxembourg and Poland) DTC genetic testing may only be restricted by general laws, usually regarding health care services and patients’ rights.

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  • 7.
    Lind, Anna-Sara
    et al.
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Kindström Dahlin, MoaUppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.Garland, JamesonUppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.Slokenberga, SantaUppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.Singer, AnnaUppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Festskrift till Elisabeth Rynning: Integritet och rättssäkerhet inom och bortom den medicinska rätten2023Collection (editor) (Other academic)
  • 8.
    Martin, Sylvia
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Ancillotti, Mirko
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Matar, Amal
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Clinical Immunology and Transfusion Medicine Department, Uppsala University Hospital, Uppsala, Sweden.
    A comparative ethical analysis of the Egyptian clinical research law2024In: BMC Medical Ethics, E-ISSN 1472-6939, Vol. 25, no 1, article id 48Article in journal (Refereed)
    Abstract [en]

    Background

    In this study, we examined the ethical implications of Egypt’s new clinical trial law, employing the ethical framework proposed by Emanuel et al. and comparing it to various national and supranational laws. This analysis is crucial as Egypt, considered a high-growth pharmaceutical market, has become an attractive location for clinical trials, offering insights into the ethical implementation of bioethical regulations in a large population country with a robust healthcare infrastructure and predominantly treatment-naïve patients.

    Methods

    We conducted a comparative analysis of Egyptian law with regulations from Sweden and France, including the EU Clinical Trials Regulation, considering ethical human subject research criteria, and used a directed approach to qualitative content analysis to examine the laws and regulations. This study involved extensive peer scrutiny, frequent debriefing sessions, and collaboration with legal experts with relevant international legal expertise to ensure rigorous analysis and interpretation of the laws.

    Results

    On the rating of the seven different principles (social and scientific values, scientific validity, fair selection of participants, risk-benefit ratio, independent review, informed consent and respect for participants) Egypt, France, and EU regulations had comparable scores. Specific principles (Social Value, Scientific Value, and Fair selection of participants) were challenging to directly identify due to certain regulations embodying 'implicit' principles more than explicitly stated ones.

    Conclusion

    The analysis underscores Egypt's alignment with internationally recognized ethical principles, as outlined by Emanuel et al., through its comparison with French, Swedish, and EU regulations, emphasizing the critical need for Egypt to continuously refine its ethical regulations to safeguard participant protection and research integrity. Key issues identified include the necessity to clarify and standardize the concept of social value in research, alongside concerns regarding the expertise and impartiality of ethical review boards, pointing towards a broader agenda for enhancing research ethics in Egypt and beyond.

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  • 9. Molnar-Gabor, Fruzsina
    et al.
    Sellner, Julian
    Pagil, Sophia
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Tzortzatou, Olga
    Nyström, Katarina
    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 Sweden2022In: Seminars in Cancer Biology, ISSN 1044-579X, E-ISSN 1096-3650, Vol. 84, p. 271-283Article in journal (Refereed)
    Abstract [en]

    The EU member states’ healthcare and health-related research sectors are both characterized by an emerging infrastructural coalescence on a national and European level. The culmination of this coalescence is the planned creation of a European Health Data Space, an EU-wide infrastructure for the processing of personal data for healthcare and for secondary uses such as scientific research. In contrast to growing technical interoperability, the legal framework for such integration is not yet defined in detail, particularly with regard to data protection law. Its development is accompanied by discussions about divergent member state implementations of the EU General Data Protection Regulation (GDPR) that affect data sharing between healthcare and scientific research actors and across various sectors driven by divergent processing purposes.

    The article presents four member states’ main rules on data sharing based on the respective provision of the GDPR in six health-related contexts regarding data sharing across the healthcare and research sector and between the main actors of those sectors. The striking differences are then evaluated from the perspective of their factual effect on European data sharing depending on the legal characteristics of the GDPR provisions they rely on. Against this backdrop, the planned regulatory measures for the setup of the European Health Data Space are introduced and evaluated with regard to further harmonization between member states’ laws and possibilities to overcome divergences in data protection rules relevant for European data sharing.

    The results of the analysis point to the conclusion that the destructive effect of divergent member state rules depends on the legal qualification of the EU provisions they rely on and that this qualification also determines which further EU regulatory measure would be the most effective to set the framework for the European Health Data Space.

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  • 10.
    Reichel, Jane
    et al.
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Roxana, Merino Martinez
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Olga, Tzortzatou
    Final Ethics and Legal Framework2018Report (Other academic)
  • 11.
    Siemaszko, Konrad
    et al.
    Helsinki Foundation for Human Rights.
    Rodrigues, Rowena
    Trilateral Research.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Rességuier, Anaïs (Contributor)
    Trilateral Research.
    D5.6: Recommendations for the enhancement of the existing legal frameworks for genomics, human enhancement, and AI and robotics2020Report (Other academic)
    Abstract [en]

    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 ethical human genetics and genomics, human enhancement technologies and AI and robotics could be implemented most effectively. It also includes recommendations to improve enforcement and promote the uptake and effectiveness of the existing legislation in thesefields. The desired or necessary changes advanced are specified in the report along with related actions, actors responsible for implementing them, their priority levels, implementation challenges and how these could be addressed. The report also discusses the interrelations between ethics and law from the perspective of policymakers. 

  • 12.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Howard, Heidi Carmen (Contributor)
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Romano, Virgina (Contributor)
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Soulier, Alexandra (Contributor)
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Niemiec, Emilia (Contributor)
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Siemaszko, Konrad (Contributor)
    Helsinki Foundation for Human Rights.
    Warso, Zuzanna (Contributor)
    Helsinki Foundation for Human Rights.
    Analysis of the legal and human rights requirements for genomics in and outside the EU: SIENNA D2.22019Report (Other academic)
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  • 13.
    Slokenberga, Santa
    Lund University, Lund, Sweden.
    Biobanking and data transfer between the EU and Cape Verde, Mauritius, Morocco, Senegal, and Tunisia: adequacy considerations and Convention 1082020In: International Data Privacy Law, ISSN 2044-3994, E-ISSN 2044-4001, Vol. 10, no 2, p. 132-145Article in journal (Refereed)
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  • 14.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Lund Univ, Fac Law, Lund, Sweden; Riga Stradins Univ, Fac Law, Riga, Latvia.
    Biobanking between the EU and Third Countries - Can Data Sharing Be Facilitated via Soft Regulatory Tools?2018In: European Journal of Health Law, ISSN 0929-0273, E-ISSN 1571-8093, Vol. 25, no 5, p. 517-536Article in journal (Refereed)
    Abstract [en]

    In biobanking, collaboration and data sharing contribute to building genomic research capacity, and have the potential to further scientific advances that ultimately can result in advances in clinical care. However, in the absence of common applicable legal frameworks that enable collaboration, capacity building is hindered. With the applicability of the General Data Protection Regulation, the obstacles to data sharing which involve export of data from European Union Member States to third countries are expected to grow, rendering the collaboration between the EU and third countries even more challenging. This article examines how, if at all, data sharing in biobank research between the EU and third countries could be facilitated via the use of soft regulatory tools. It argues that although the existing soft tools might not in itself be suitable for meeting all the GDPR requirements, they could be the basis on which to raise the area-specific data protection bar globally.

  • 15.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Book review - T.K. Hervey, C.A. Young and L.E. Bishop (eds.) Research Handbook on EU Health Law and Policy (Cheltenham: Edward Elgar Publishing, 2017), ISBN 978-1785364716, 592 pp.2018In: European Journal of Health Law, ISSN 0929-0273, E-ISSN 1571-8093, Vol. 25, no 3, p. 355-360Article, book review (Other academic)
  • 16.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Case C-243/19, A v Veselibas ministrija, Judgement of the Court (Second Chamber) of 29 October 2020, EU:C:2020:8722021In: European Journal of Health Law, ISSN 0929-0273, E-ISSN 1571-8093, Vol. 28, no 3, p. 285-306Article in journal (Other academic)
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  • 17.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Riga Stradins University, Latvia.
    Country report: an overview of animal protection in Latvia2017In: Scritti su etica e legislazione medica e veterinaria / [ed] Il comitato scientifico del Progetto, Bari: Cacucci Editore , 2017, p. 149-158Chapter in book (Other academic)
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  • 18.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Direct-to-consumer Genetic Testing: Changes in the EU Regulatory Landscape2015In: European Journal of Health Law, ISSN 0929-0273, E-ISSN 1571-8093, Vol. 22, p. 463-480Article in journal (Refereed)
    Abstract [en]

    Rapid advances in genomics and technology have rendered genetic testing services easily accessible to consumers over the Internet in the form of direct-to-consumer genetic testing. In the EU, the IVD Directive has been animadverted for its inability to tackle the challenges direct-to-consumer genetic testing has posed. Currently, the EU legislation is in a transition state. It is thus, timely to assess, to what extent the proposed IVD Regulation is intended to address the performance requirements and utility of direct-to-consumer genetic tests, which are made available to consumers within the EU over the Internet, and discuss the developments vis-à-vis the IVD Directive. To compare with the IVD Directive, the IVD Regulation presents a major shift in how direct-to-consumer genetic testing is treated in the EU. It remains unclear, whether and how the EU requirements can be applied beyond the EU market.

  • 19.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Eiropas Savienība un veselība2022In: Medicīnas tiesības: Otrais papildinātais izdevums / [ed] Agnese Gusarova; Aldis Lieljuksis; Aleksandrs Potaičuks; Laura Šāberte; Santa Slokenberga; Solvita Olsena; Ronalds Rožkalns; Liene Elizabete Tauriņa; Ilze Vilka; Niāra Zālīte; Anita Slokenberga; Karina Palkova; Laura Kadile; Olga Šķerberga; Signe Mežinska, Tiesu namu aģentūra , 2022, 2, p. 69-98Chapter in book (Other academic)
  • 20.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    EU regulatory responses to medical machine learning in paediatric care: A missed opportunity to overcome a therapeutic gap?2022In: De lege Yearbook 2021:Law, AI and Digitalisation / [ed] De Vries, Dahlberg, Iustus förlag, 2022, p. 379-400Chapter in book (Other academic)
  • 21.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    European Legal Perspectives on Health-Related Direct-to-Consumer Genetic Testing2016Doctoral thesis, monograph (Other academic)
    Abstract [en]

    This doctoral thesis examines how the coexistence of the Council of Europe and the EU

    influences rules on direct-to-consumer genetic testing, as well as how these influences

    reflect on individual states that are simultaneously bound to both of the legal orders of

    interest.

    Through the lens of legal pluralism and state sovereignty this research examines the

    competence and authority of the Council of Europe and the EU to handle the market aspects

    (technical performance and utility) as well as privacy (consent to a medical service

    and data protection requirements), and examines the obligations these two legal orders

    place on the Member States of the EU. This research traces the avenues for coexistence

    between the legal orders in relation to direct-to-consumer genetic testing, and examines

    how the coexistence of the Council of Europe and the EU is reflected in the legal framework

    that is relevant to the regulation of direct-to-consumer genetic testing.

    It can be observed that the EU is soaking in the Council of Europe norms in some areas,

    as with valid consent to a medical intervention, but also exporting its own norms to

    the Council of Europe in other areas, as with the area of data protection. Consequently,

    one can question whether it is increasingly becoming more difficult to draw clear limits

    between the ‘Council of Europe law’ and the ‘EU law’ in these areas. The Council of Europe

    by aligning its laws with the EU creates far-reaching implications to the states that

    are members of the Council of Europe but are not the Member States of the EU.

    This thesis claims that the resulting fragmented regulatory space and the interaction

    between the Council of Europe and the EU make the legal sources challenging to interpret

    and foresee as a result the principle of legal certainty could be undermined. In the

    absence of formalized interaction between the two legal orders, interpretation difficulties

    could create further challenges.

  • 22.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    EVDT regulas priekšlikumsun Datu otrreizējās izmantošanaslikumprojekts2023In: Jurista vārds: una lex - una iustitia omnibus, ISSN 1691-2462, Vol. 32, no 7, p. 37p. 32-37Article in journal (Other academic)
  • 23.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Lunds universitet..
    Genetik2022In: Medicinsk rätt / [ed] Zillén, Mattsson, Slokenberga, Norstedts Juridik AB, 2022, 2, p. 237-253Chapter in book (Other academic)
  • 24.
    Slokenberga, Santa
    Lunds universitet.
    Genetik2022In: Medicinsk rätt, Stockholm: Norstedts Juridik AB, 2022, 2, p. 237-254Chapter in book (Other academic)
  • 25.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Genetiska interventioner inom och utanför hälso- och sjukvården2020In: Medicinsk rätt, Norstedts Juridik AB, 2020, p. 185-200Chapter in book (Other academic)
  • 26.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Latvia2020In: International Encyclopaedia of Laws: Medical Law / [ed] Herman Nys, Kluwer Law International, 2020, p. 1-170Chapter in book (Refereed)
  • 27.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Pacienta datu aizsardzība2022In: Medicīnas tiesības: Otrais papildinātais izdevums / [ed] Agnese Gusarova; Aldis Lieljuksis; Aleksandrs Potaičuks; Laura Šāberte; Santa Slokenberga; Solvita Olsena; Ronalds Rožkalns; Liene Elizabete Tauriņa; Ilze Vilka; Niāra Zālīte; Anita Slokenberga; Karina Palkova; Laura Kadile; Olga Šķerberga; Signe Mežinska, Tiesu namu aģentūra , 2022, 2, p. 258-300Chapter in book (Other academic)
  • 28.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Problemātika ar ES pievienošanos Eiropas Cilvēktiesību konvencijai [The EU accession to the ECHR: Opinion 2/2013 and related issues]2015In: Jurista Vārds, Vol. 872, no 20, p. 8-25Article in journal (Other academic)
  • 29.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Pārskats par seksuālajām un reproduktīvajām tiesībām2015In: Medicīnas Tiesības / [ed] A-Slokenberga, Santa, Riga: Tiesu Namu Aģentūra , 2015, p. 515-586Chapter in book (Other academic)
  • 30.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Scientific research regime 2.0?: How the proposed EHDS Regulation may change the GDPR Research Regime2022In: Technology and regulation, E-ISSN 2666-139X, p. 135-147Article in journal (Refereed)
    Abstract [en]

    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 with the scientific research regime that has been established under the General Data Protection Regulation. This article examines how the proposed EHDS regulation promises to transform the EU scientific research regime and protection of a data subject in scientific research. This paper shows that a scientific research regime 2.0 is put forward, where sharing is enhanced at the cost of self-determination of the individual and without resolving many of the challenges that emerged under the GDPR.

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  • 31.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Setting the Foundations: Individual Rights, Public Interest, Scientific Research and Biobanking2021In: GDPR and Biobanking: Individual Rights, Public Interest and Research Regulation across Europe / [ed] Slokenberga S., Tzortzatou O., Reichel J., Springer, 2021, p. 11-30Chapter in book (Other academic)
    Abstract [en]

    The principle of conferral tames the EU competence to regulate research in a comprehensive manner, yet furthering research is one of its aspirations. Data protection, however, is an area within which the EU has legislated extensively. During the development of the General Data Protection Regulation (GDPR), an important issue to tackle was how to balance the ambitious EU aspirations and differing stakeholder interests, on the one hand, with limited competences in research regulation, on the other, and how to determine the extent to which data protection could be used as a means to further scientific research in the EU legal order. The outcome is the GDPR multifaceted research regime that sets forth EU policy and opens up for further regulations from the Member States as well as the EU.

    The research regime that the GDPR has created poses numerous questions. Key among these is, what are the implications of the operationalisation of Article 89 GDPR in biobanking? This chapter sets out some of the underlying tensions in the area and pins down key conceptual foundations for the book. It provides insights into the EU’s interests in the area of biobanking and maps out central elements of the research regime that has been built within the GDPR. Thereafter, it analyses the key concepts used in the book, including biobank and biobanking, scientific research as undertaken under the GDPR, individual rights and public interest. Lastly, it shares some preliminary reflections as starting points for the analysis to come.

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  • 32.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    The standard of care and implications for paediatric decision-making: the Swedish viewpoint2021In: Routledge Handbook of Global Health Rights / [ed] Clayton Ó Néill, Charles Foster, Jonathan Herring, John Tingle, Routledge, 2021Chapter in book (Other academic)
  • 33.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Valsts prezidenta veselība: divas slimnīcas un divas atšķirīgas reakcijas [President’s health: two hospitals and two differnt approaches (concerning health data sharing with media)]2016In: Jurista Vārds, Vol. 907, no 4Article in journal (Other academic)
  • 34.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    What Would It Take to Enable Germline Editing in Europe for Medical Purposes?2022In: European Journal of Health Law, ISSN 0929-0273, E-ISSN 1571-8093, Vol. 29, no 3-5, p. 521-542Article in journal (Refereed)
    Abstract [en]

    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 Application of Biology and Medicine: Convention on Human Rights and Biomedicine and the prohibition that is set out in the EU Clinical Trials Regulation. These prohibitions reflect the European regional position regarding the ethical and legal questions raised by the technology, and an unwillingness to enable such interventions in Europe. Simultaneously, these prohibitions have been shaped prior to the recent breakthroughs in the field, such as the discovery of the CRISPR-Cas technology, which has initiated a new era in the field. This contribution examines what it would take to enable human germline gene editing in Europe for medical purposes. It scrutinises in detail the content and context of the existing bans, as well as mechanisms to lift them. It argues that the bans that are prescribed by each of the European regional legal orders are embedded in strong structures, composed of values and principles. For the human germline gene editing to be enabled in Europe for health-related purposes, the approach to these values and principles needs to change. Only then can the machinery to lift the bans lead to a change.

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  • 35.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    What Would It Take to Enable Germline Editing in Europe for Medical Purposes?2023In: Governing, Protecting, and Regulating the Future of Genome Editing: The Significance of ELSPI Perspectives / [ed] Santa Slokenberga; Timo Minssen; Ana Nordberg, Leiden; Boston: Brill Nijhoff, 2023, p. 200-221Chapter in book (Refereed)
    Abstract [en]

    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 Application of Biology and Medicine: Convention on Human Rights and Biomedicine and the prohibition that is set out in the EU Clinical Trials Regulation. These prohibitions reflect the European regional position regarding the ethical and legal questions raised by the technology, and an unwillingness to enable such interventions in Europe. Simultaneously, these prohibitions have been shaped prior to the recent breakthroughs in the field, such as the discovery of the CRISPR-Cas technology, which has initiated a new era in the field. This contribution examines what it would take to enable human germline gene editing in Europe for medical purposes. It scrutinises in detail the content and context of the existing bans, as well as mechanisms to lift them. It argues that the bans that are prescribed by each of the European regional legal orders are embedded in strong structures, composed of values and principles. For the human germline gene editing to be enabled in Europe for health-related purposes, the approach to these values and principles needs to change. Only then can the machinery to lift the bans lead to a change.

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  • 36.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    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 Europe2021In: BIOLAW JOURNAL-RIVISTA DI BIODIRITTO, ISSN 2284-4503, no 1, p. 223-250Article in journal (Refereed)
    Abstract [en]

    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 suggests that the informational dimension of genetic privacy in the era of data protection could be described as a sphere of controlled access. Given that the GDPR does not prescribe quantitative or contextual limitations relating to access once the applicable requirements are met, one could argue that there are good preconditions for the field to head in the direction of genetic transparency. This puts on the agenda the questions of what challenges this could bring and whether adequate mechanisms exist to deal with them.

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  • 37.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Ārstniecības personu administratīvā atbildība: slazds, kas ietverts LAPK [Healthcare professionals’ administrative liability: trap in the law’]2013In: Jurista Vārds, Vol. 792, no 41Article in journal (Other academic)
  • 38.
    Slokenberga, Santa
    et al.
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Gusarova, Agnese
    Riga Stradins University.
    Veselības aprūpe un Eiropas Savienība (EU law and health care)2015In: Medicīnas tiesīnas, Riga: Tiesu Namu Aģentūra , 2015, p. 69-148Chapter in book (Other academic)
  • 39.
    Slokenberga, Santa
    et al.
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Gusarova, Agnese
    Veselības datu tiesiskā regulējuma transformācija2023In: Jurista vārds una lex - una iustitia omnibus, ISSN 1691-2462, Vol. 7, no 1273, p. 6-7Article in journal (Other academic)
  • 40.
    Slokenberga, Santa
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Howard, Heidi Carmen
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    The Regulation of Human Germline Genome Modification in Sweden2019In: Human Germline Genome Modification and the Right to Science: A Comparative Study of National Laws and Policies, Cambridge: Cambridge University Press, 2019, p. 281-308Chapter in book (Other academic)
  • 41.
    Slokenberga, Santa
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Howard, Heidi Carmen
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    THE RIGHT TO SCIENCE AND HUMAN GERMLINE EDITING. Sweden, its external commitments and the ambiguous national responses under the Genetic Integrity Act2019In: Förvaltningsrättslig Tidskrift, ISSN 0015-8585, Vol. 2, p. 199-222Article in journal (Refereed)
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  • 42.
    Slokenberga, Santa
    et al.
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Merino Martinez, Roxana
    Karolinska institutet.
    Reichel, Jane
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Legal and ethical governance of intercontinental biobanking: Some experiences from a H2020 project2017In: Förvaltningsrättslig Tidskrift, ISSN 0015-8585, no 1, p. 169-192Article in journal (Refereed)
    Abstract [en]

    Biobanks exist today on every continental though they have evolved differently in different parts of the world. The African States have been involved in biobank research for a considerable time but for decades large volumes of data and samples have been transferred outside the continent to developed countries for their storage and eventual further use, thus affecting the capacity-building and development for researchers in Africa. Currently, there are ongoing projects to build biobank research capacity within the regions where they are at an early developmental stage and collaborate transnationally in that regard. One of them is B3Africa, an EU-funded project that aims to facilitate collaboration between selected EU Member States and the African States and enhance mutual data and sample exchange between the EU and African States. Within the project, an informatics platform, the eB3Kit, is being developed. The platform integrates available open-source software, services and tools for biobanking and bioinformatics. Further, an ethical and legal framework for collaboration is being drafted that may bridge biobank research activities in the EU Member States and the African States. This article focuses on the latter, the ethical and legal framework.

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  • 43.
    Slokenberga, Santa
    et al.
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Minssen, Timo
    Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen, Copenhagen, Denmark .
    Nordberg, Ana
    Faculty of Law, Lund University, Lund, Sweden .
    Governing, Protecting, and Regulating the Future of Genome Editing: The Significance of ELSPI Perspectives2022In: European Journal of Health Law, ISSN 0929-0273, E-ISSN 1571-8093, Vol. 29, no 3-5, p. 327-340Article in journal (Refereed)
    Download full text (pdf)
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  • 44.
    Slokenberga, Santa
    et al.
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Minssen, TimoNordberg, Ana
    Governing, Protecting, and Regulating the Future of Genome Editing: The Significance of ELSPI Perspectives2022Collection (editor) (Other academic)
    Abstract [en]

    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 available to patients, including addressing genome editing technology regulation through procedures for regulatory approval, patent law and competition law. 

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  • 45.
    Slokenberga, Santa
    et al.
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Minssen, Timo
    Nordberg, Ana
    Introduction: The Significance of ELSPI Perspectives in Governing, Protecting, and Regulating the Future of Genome Editing2023In: Governing, Protecting, and Regulating the Future of Genome Editing: The Significance of ELSPI Perspectives / [ed] Santa Slokenberga; Timo Minssen; Ana Nordberg, Leiden; Boston: Brill Nijhoff, 2023, p. 1-14Chapter in book (Other academic)
    Download full text (pdf)
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  • 46.
    Slokenberga, Santa
    et al.
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Olsena, Solvita
    Ievads2022In: Medicīnas tiesības: Otrais papildinātais izdevums / [ed] Agnese Gusarova; Aldis Lieljuksis; Aleksandrs Potaičuks; Laura Šāberte; Santa Slokenberga; Solvita Olsena; Ronalds Rožkalns; Liene Elizabete Tauriņa; Ilze Vilka; Niāra Zālīte; Anita Slokenberga; Karina Palkova; Laura Kadile; Olga Šķerberga; Signe Mežinska, Tiesu namu aģentūra , 2022, 2, p. 21-27Chapter in book (Other academic)
  • 47.
    Slokenberga, Santa
    et al.
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Olsena, Solvita
    Medicīnas tiesības2022Collection (editor) (Other academic)
  • 48.
    Slokenberga, Santa
    et al.
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Olsena, Solvita
    Nobeigums2022In: Medicīnas tiesības: Otrais papildinātais izdevums / [ed] Agnese Gusarova; Aldis Lieljuksis; Aleksandrs Potaičuks; Laura Šāberte; Santa Slokenberga; Solvita Olsena; Ronalds Rožkalns; Liene Elizabete Tauriņa; Ilze Vilka; Niāra Zālīte; Anita Slokenberga; Karina Palkova; Laura Kadile; Olga Šķerberga; Signe Mežinska, Tiesu namu aģentūra , 2022, 2, p. 718-719Chapter in book (Other academic)
  • 49.
    Slokenberga, Santa
    et al.
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Olsena, Solvita
    Pacientu tiesības2022In: Medicīnas tiesības: Otrais papildinātais izdevums / [ed] Agnese Gusarova; Aldis Lieljuksis; Aleksandrs Potaičuks; Laura Šāberte; Santa Slokenberga; Solvita Olsena; Ronalds Rožkalns; Liene Elizabete Tauriņa; Ilze Vilka; Niāra Zālīte; Anita Slokenberga; Karina Palkova; Laura Kadile; Olga Šķerberga; Signe Mežinska, Tiesu namu aģentūra , 2022, 2, p. 165-227Chapter in book (Other academic)
  • 50.
    Slokenberga, Santa
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Lund Univ, Fac Law, Lund, Sweden.
    Reichel, Jane
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Stockholm Univ, Fac Law, Stockholm, Sweden.
    Niringiye, Rachel
    Aegis Advocates, Kampala, Uganda.
    Croxton, Talishiea
    Univ Maryland, Baltimore, MD 21201 USA.
    Swanepoel, Carmen
    Stellenbosch Univ, Fac Med & Hlth Sci, Natl Hlth Lab Serv, Div Heamatol,Dept Pathol, Stellenbosch, South Africa.
    Okal, June
    Univ Nairobi, Nairobi, Kenya.
    EU data transfer rules and African legal realities: is data exchange for biobank research realistic?2019In: International Data Privacy Law, ISSN 2044-3994, E-ISSN 2044-4001, Vol. 9, no 1, p. 30-48Article in journal (Refereed)
    Abstract [en]

    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 Regulation (GDPR) avenues for data transfer exist, the ones feasible for transcontinental data exchange for biobank research rely on EU enforcement which in essence means limited oversight possibilities and, consequently, considerable risks to the EU data subject’s privacy.

    • To ensure effective data protection for data subjects in biobanking, raising the data protection bar in data recipient countries is crucial. Although Kenya, Nigeria, South Africa, and Uganda have taken considerable steps towards developing data protection frameworks, only that of South Africa and Nigeria’s Protection of Personal Information Bill seem to be such to meet the protection level set out by the GDPR. The legislative initiatives in Kenya and Uganda require revisions to ensure that protection of privacy is not undermined when data are being sent to these countries.

    • Currently, considerable responsibility is placed in the hands of the legislatures in the countries of concern—and notably in Kenya, and Uganda—to set foundations for ending research and research integrity-harming practices. In Nigeria, these foundations are defined in the Protection of Personal Information Bill, but not adopted yet. South Africa, however, has taken a big step towards building routes for genuine biobank capacity-building in the country and collaboration in that regard.

12 1 - 50 of 63
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