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Martin, S., Ancillotti, M., Slokenberga, S. & Matar, A. (2024). A comparative ethical analysis of the Egyptian clinical research law. BMC Medical Ethics, 25(1), Article ID 48.
Open this publication in new window or tab >>A comparative ethical analysis of the Egyptian clinical research law
2024 (English)In: BMC Medical Ethics, E-ISSN 1472-6939, Vol. 25, no 1, article id 48Article in journal (Refereed) Published
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.

Place, publisher, year, edition, pages
BioMed Central (BMC), 2024
Keywords
Biomedical laws, Ethical principles, Egypt, Clinical trials, Social value
National Category
Medical Ethics
Research subject
Ethics
Identifiers
urn:nbn:se:uu:diva-527433 (URN)10.1186/s12910-024-01040-0 (DOI)001210808900001 ()38689214 (PubMedID)
Funder
Uppsala University
Available from: 2024-05-01 Created: 2024-05-01 Last updated: 2024-07-04Bibliographically approved
Fåhraeus, D., Reichel, J. & Slokenberga, S. (2024). The European Health Data Space: Challenges and Opportunities. Stockholm: Sieps – Swedish Institute for European Policy Studies
Open this publication in new window or tab >>The European Health Data Space: Challenges and Opportunities
2024 (English)Report (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. 

Place, publisher, year, edition, pages
Stockholm: Sieps – Swedish Institute for European Policy Studies, 2024. p. 20
Keywords
European Health Data Space GDPR
National Category
Law and Society
Research subject
European (Integration) Law
Identifiers
urn:nbn:se:uu:diva-525129 (URN)
Available from: 2024-03-17 Created: 2024-03-17 Last updated: 2024-04-19Bibliographically approved
Slokenberga, S. (2023). EVDT regulas priekšlikumsun Datu otrreizējās izmantošanaslikumprojekts. Jurista vārds: una lex - una iustitia omnibus, 32(7), 32-37
Open this publication in new window or tab >>EVDT regulas priekšlikumsun Datu otrreizējās izmantošanaslikumprojekts
2023 (Latvian)In: Jurista vārds: una lex - una iustitia omnibus, ISSN 1691-2462, Vol. 32, no 7, p. 37p. 32-37Article in journal (Other academic) Published
Place, publisher, year, edition, pages
Latvijas Vēstnesis, 2023. p. 37
National Category
Social Sciences
Research subject
Medical Law
Identifiers
urn:nbn:se:uu:diva-512353 (URN)
Available from: 2023-09-25 Created: 2023-09-25 Last updated: 2023-09-25Bibliographically approved
Lind, A.-S., Kindström Dahlin, M., Garland, J., Slokenberga, S. & Singer, A. (Eds.). (2023). Festskrift till Elisabeth Rynning: Integritet och rättssäkerhet inom och bortom den medicinska rätten. Uppsala: Iustus förlag
Open this publication in new window or tab >>Festskrift till Elisabeth Rynning: Integritet och rättssäkerhet inom och bortom den medicinska rätten
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2023 (Swedish)Collection (editor) (Other academic)
Place, publisher, year, edition, pages
Uppsala: Iustus förlag, 2023. p. 420
Keywords
medicinsk rätt, rättssäkerhet, etik, grundläggande fri- och rättigheter, hälso- och sjukvård
National Category
Law
Research subject
Public Law
Identifiers
urn:nbn:se:uu:diva-513461 (URN)978-91-7737-235-6 (ISBN)
Available from: 2023-10-06 Created: 2023-10-06 Last updated: 2023-11-28
Slokenberga, S., Minssen, T. & Nordberg, A. (2023). Introduction: The Significance of ELSPI Perspectives in Governing, Protecting, and Regulating the Future of Genome Editing. In: Santa Slokenberga; Timo Minssen; Ana Nordberg (Ed.), Governing, Protecting, and Regulating the Future of Genome Editing: The Significance of ELSPI Perspectives (pp. 1-14). Leiden; Boston: Brill Nijhoff
Open this publication in new window or tab >>Introduction: The Significance of ELSPI Perspectives in Governing, Protecting, and Regulating the Future of Genome Editing
2023 (English)In: 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)
Place, publisher, year, edition, pages
Leiden; Boston: Brill Nijhoff, 2023
National Category
Law Medical Ethics
Research subject
Medical Law
Identifiers
urn:nbn:se:uu:diva-511983 (URN)10.1163/9789004526136_002 (DOI)978-90-04-52613-6 (ISBN)978-90-04-52608-2 (ISBN)
Available from: 2023-09-19 Created: 2023-09-19 Last updated: 2023-09-25Bibliographically approved
Slokenberga, S. & Gusarova, A. (2023). Veselības datu tiesiskā regulējuma transformācija. Jurista vārds una lex - una iustitia omnibus, 7(1273), 6-7
Open this publication in new window or tab >>Veselības datu tiesiskā regulējuma transformācija
2023 (Latvian)In: Jurista vārds una lex - una iustitia omnibus, ISSN 1691-2462, Vol. 7, no 1273, p. 6-7Article in journal (Other academic) Published
Place, publisher, year, edition, pages
Latvijas Vēstnesis, 2023
National Category
Law Other Medical Sciences not elsewhere specified
Research subject
Medical Law
Identifiers
urn:nbn:se:uu:diva-512356 (URN)
Available from: 2023-09-25 Created: 2023-09-25 Last updated: 2023-09-25Bibliographically approved
Slokenberga, S. (2023). What Would It Take to Enable Germline Editing in Europe for Medical Purposes?. In: Santa Slokenberga; Timo Minssen; Ana Nordberg (Ed.), Governing, Protecting, and Regulating the Future of Genome Editing: The Significance of ELSPI Perspectives (pp. 200-221). Leiden; Boston: Brill Nijhoff
Open this publication in new window or tab >>What Would It Take to Enable Germline Editing in Europe for Medical Purposes?
2023 (English)In: 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.

Place, publisher, year, edition, pages
Leiden; Boston: Brill Nijhoff, 2023
Keywords
Biomedicine Convention Article 13, Clinical Trials Regulation Article 90, gene therapy, germline gene editing
National Category
Law Medical Ethics
Research subject
Medical Law
Identifiers
urn:nbn:se:uu:diva-511985 (URN)10.1163/9789004526136_011 (DOI)978-90-04-52613-6 (ISBN)978-90-04-52608-2 (ISBN)
Available from: 2023-09-19 Created: 2023-09-19 Last updated: 2023-09-25Bibliographically approved
Matar, A., Hansson, M. G., Slokenberga, S., Panagiotopoulos, A., Chassang, G., Tzortzatou, O., . . . Beauvais, M. (2022). A proposal for an international Code of Conduct for data sharing in genomics. Developing World Bioethics, 23(4), 344-357
Open this publication in new window or tab >>A proposal for an international Code of Conduct for data sharing in genomics
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2022 (English)In: Developing World Bioethics, ISSN 1471-8731, E-ISSN 1471-8847, Vol. 23, no 4, p. 344-357Article in journal (Refereed) Published
Abstract [en]

As genomic research becomes commonplace across the world, there is an increased need to coordinate practices among researchers, especially with regard to data sharing. One such way is an international code of conduct. In September 2020, an expert panel consisting of representatives from various fields convened to discuss a draft proposal formed via a synthesis of existing professional codes and other recommendations. This article presents an overview and analysis of the main issues related to international genomic research that were discussed by the expert panel, and the results of the discussion and follow up responses by the experts. As a result, the article presents as an annex a proposal for an international code of conduct for data sharing in genomics that is meant to establish best practices.

Place, publisher, year, edition, pages
John Wiley & Sons, 2022
Keywords
biobanking, cloud computing, code of conduct, data protection, genomics, international data transfers, privacy
National Category
Medical Genetics
Identifiers
urn:nbn:se:uu:diva-487139 (URN)10.1111/dewb.12381 (DOI)000870811900001 ()
Funder
EU, Horizon 2020, 741716
Available from: 2022-10-24 Created: 2022-10-24 Last updated: 2024-05-29Bibliographically approved
Staunton, C., Slokenberga, S., Parziale, A. & Mascalzoni, D. (2022). Appropriate Safeguards and Article 89 of the GDPR: Considerations for Biobank, Databank and Genetic Research. Frontiers in Genetics, 13, Article ID 719317.
Open this publication in new window or tab >>Appropriate Safeguards and Article 89 of the GDPR: Considerations for Biobank, Databank and Genetic Research
2022 (English)In: Frontiers in Genetics, E-ISSN 1664-8021, Vol. 13, article id 719317Article, review/survey (Refereed) Published
Abstract [en]

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 life, the right to protection of personal data, the right to freedom of arts and sciences, and the right to non-discrimination. The use of genetic data and other health-related data in this context must be used in a manner that is rooted in human rights. Owing in part to the General Data Protection Regulation (GDPR) coming into force, the right to the protection of personal data in the context of scientific research has been afforded increasing attention. The GDPR gives effect to the right to data protection, but states that this right must be balanced against other rights and interests. The GDPR applies to all personal data, with specific attention to special categories of data, that includes health and genetic data. The collection, access to, and sharing of such data must comply with the GDPR, and therefore directly impacts the use of such data in research. The GDPR does provide for several derogations and exemptions for research from many of the strict processing requirements. Such derogations are permitted only if there are appropriate safeguards in place. Article 89 states that to be appropriate, safeguards must be "in accordance" with the GDPR "for the rights and freedoms of the data subject". In particular, those safeguards must ensure "respect for the principle of data minimisation". Despite the importance of safeguards, the GDPR is silent as to the specific measures that may be adopted to meet these requirements. This paper considers Article 89 and explores safeguards that may be deemed appropriate in the context of biobanks, databanks, and genetic research.

Place, publisher, year, edition, pages
Frontiers Media S.A.Frontiers Media SA, 2022
Keywords
GDPR-general data protection regulation, biobank, genetic research, safeguards, consent, ethics review and governance
National Category
Computer Sciences
Identifiers
urn:nbn:se:uu:diva-470742 (URN)10.3389/fgene.2022.719317 (DOI)000766588400001 ()35251121 (PubMedID)
Available from: 2022-03-29 Created: 2022-03-29 Last updated: 2024-01-15Bibliographically approved
Slokenberga, S. & Tauriņa, L. E. (2022). Ārstniecība cilvēka dzīves nogalē (2ed.). In: 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 (Ed.), Medicīnas tiesības: Otrais papildinātais izdevums (pp. 485-514). Tiesu namu aģentūra
Open this publication in new window or tab >>Ārstniecība cilvēka dzīves nogalē
2022 (Latvian)In: 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. 485-514Chapter in book (Other academic)
Place, publisher, year, edition, pages
Tiesu namu aģentūra, 2022 Edition: 2
National Category
Law
Research subject
Medical Law
Identifiers
urn:nbn:se:uu:diva-512000 (URN)978-9934-621-01-7 (ISBN)
Available from: 2023-09-19 Created: 2023-09-19 Last updated: 2023-09-25Bibliographically approved
Projects
AI and Automated Systems and the Right to Health – Revisiting Law Accounting for the Exploitation of Users Preferences and Values; Uppsala UniversityEuropean legal perspectives on health-related direct-to-consumer genetic testing'; Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of LawDecision-making for children in a state of medical indeterminacy; Uppsala University; Publications
Slokenberga, S. (2021). 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. BIOLAW JOURNAL-RIVISTA DI BIODIRITTO (1), 223-250
AI and Automated Systems and the Right to Health – Revisiting Law Accounting for the Exploitation of Users Preferences and Values; Uppsala University
Organisations
Identifiers
ORCID iD: ORCID iD iconorcid.org/0000-0002-5621-8485

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