TY  - JOUR
T1  - A Comparative Study of Ethical Issues in the Egyptian Clinical Research Law
A1  - Anna Bratt
A1  - Aron Naimi-Akbar
JF  - Asian Journal of Ethics in Health and Medicine
JO  - Asian J Ethics Health Med
SN  - 3108-5059
Y1  - 2023
VL  - 3
IS  - 1
DO  - 10.51847/mjnPnkn27U
SP  - 66
EP  - 80
N2  - This study investigates the ethical dimensions of Egypt’s newly enacted clinical trial legislation, employing the ethical framework of Emanuel et al. for evaluation and situating it within a comparative context alongside national and supranational laws. Given Egypt’s emergence as a high-growth pharmaceutical market, the country has become a prime location for clinical research. Its extensive population, well-established healthcare system, and largely treatment-naïve patients provide a valuable setting for examining how bioethical regulations are applied in practice. We performed a comparative review of Egyptian law alongside regulations from Sweden, France, and the EU Clinical Trials Regulation. Using established criteria for ethical human subject research, a directed qualitative content analysis was conducted to systematically interpret the legal frameworks. The analysis was reinforced through rigorous peer review, repeated debriefing sessions, and consultation with legal experts experienced in international research law to ensure validity and depth. Across the seven ethical principles—social and scientific values, scientific validity, fair participant selection, risk-benefit ratio, independent review, informed consent, and respect for participants—the Egyptian framework displayed comparable alignment with French and EU regulations. Certain principles, including Social Value, Scientific Value, and Fair Selection of Participants, were difficult to assess directly due to their being addressed implicitly rather than through explicit legal statements. The study demonstrates that Egypt’s clinical trial law broadly reflects internationally recognized ethical standards as outlined by Emanuel et al., comparable to French, Swedish, and EU frameworks. Nonetheless, findings underscore the need for ongoing refinement, particularly regarding the definition and operationalization of social value and the expertise and neutrality of ethical review boards. These considerations suggest a continuing agenda for strengthening research ethics practices in Egypt and beyond.
UR  - https://smerpub.com/article/a-comparative-study-of-ethical-issues-in-the-egyptian-clinical-research-law-ft6p0vlwnlx8vtl
ER  -