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A comparative ethical analysis of the Egyptian clinical research 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.ORCID iD: 0000-0002-3706-7669
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.ORCID iD: 0000-0001-5748-0672
Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.ORCID iD: 0000-0002-5621-8485
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.ORCID iD: 0000-0001-6691-7549
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. Vol. 25, no 1, article id 48
Keywords [en]
Biomedical laws, Ethical principles, Egypt, Clinical trials, Social value
National Category
Medical Ethics
Research subject
Ethics
Identifiers
URN: urn:nbn:se:uu:diva-527433DOI: 10.1186/s12910-024-01040-0ISI: 001210808900001PubMedID: 38689214OAI: oai:DiVA.org:uu-527433DiVA, id: diva2:1855474
Funder
Uppsala UniversityAvailable from: 2024-05-01 Created: 2024-05-01 Last updated: 2024-05-17Bibliographically approved

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Martin, SylviaAncillotti, MirkoSlokenberga, SantaMatar, Amal

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