دورية أكاديمية
A comparative ethical analysis of the Egyptian clinical research law.
| العنوان: | A comparative ethical analysis of the Egyptian clinical research law. |
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| المؤلفون: | Martin S; Center for Research and Bioethics, Uppsala University, Uppsala, Sweden. sylvia.martin@crb.uu.se., Ancillotti M; Center for Research and Bioethics, Uppsala University, Uppsala, Sweden., Slokenberga S; Department of Law, Uppsala University, Uppsala, Sweden., Matar A; Center for Research and Bioethics, Uppsala University, Uppsala, Sweden.; Clinical Immunology and Transfusion Medicine Department, Uppsala University Hospital, Uppsala, Sweden. |
| المصدر: | BMC medical ethics [BMC Med Ethics] 2024 Apr 30; Vol. 25 (1), pp. 48. Date of Electronic Publication: 2024 Apr 30. |
| نوع المنشور: | Journal Article; Comparative Study; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: BioMed Central Country of Publication: England NLM ID: 101088680 Publication Model: Electronic Cited Medium: Internet ISSN: 1472-6939 (Electronic) Linking ISSN: 14726939 NLM ISO Abbreviation: BMC Med Ethics Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: London : BioMed Central, [2000- |
| مواضيع طبية MeSH: | Ethical Analysis* , Biomedical Research*/ethics , Biomedical Research*/legislation & jurisprudence, Egypt ; Humans ; Sweden ; Ethics, Research ; France ; Informed Consent/ethics ; Informed Consent/legislation & jurisprudence ; Clinical Trials as Topic/ethics ; Clinical Trials as Topic/legislation & jurisprudence ; Social Values ; Research Subjects/legislation & jurisprudence ; Human Experimentation/ethics ; Human Experimentation/legislation & jurisprudence ; European Union ; Ethics Committees, Research |
| مستخلص: | 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. (© 2024. The Author(s).) |
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| فهرسة مساهمة: | Keywords: Biomedical laws; Clinical trials; Egypt; Ethical principles; Social value |
| تواريخ الأحداث: | Date Created: 20240430 Date Completed: 20240430 Latest Revision: 20240503 |
| رمز التحديث: | 20240503 |
| مُعرف محوري في PubMed: | PMC11059645 |
| DOI: | 10.1186/s12910-024-01040-0 |
| PMID: | 38689214 |
| قاعدة البيانات: | MEDLINE |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 1472-6939 |
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| DOI: | 10.1186/s12910-024-01040-0 |