背景:在这项研究中,我们研究了埃及新临床试验法的伦理含义,采用伊曼纽尔等人提出的伦理框架。并将其与各种国家和超国家法律进行比较。作为埃及,这一分析至关重要,被认为是一个高增长的医药市场,已经成为临床试验的一个有吸引力的地点,在一个拥有强大的医疗保健基础设施和主要是初治患者的人口大国中,提供对生物伦理法规的伦理实施的见解。
方法:我们对埃及法律与瑞典和法国的法规进行了比较分析,包括欧盟临床试验条例,考虑伦理人类主题研究标准,并采用定向方法进行定性内容分析,以考察法律法规。这项研究涉及广泛的同行审查,频繁的汇报情况,并与具有相关国际法律专业知识的法律专家合作,以确保对法律进行严格的分析和解释。
结果:关于七个不同原则(社会和科学价值,科学有效性,公平选择参与者,风险收益比,独立审查,知情同意和对参与者的尊重)埃及,法国,和欧盟法规有可比的分数。具体原则(社会价值、科学价值,和公平选择参与者)由于某些法规体现了“隐含”原则而不是明确陈述的原则,因此直接识别具有挑战性。
结论:分析强调了埃及与国际公认的道德原则的一致性,正如伊曼纽尔等人概述的那样。,通过与法语的比较,瑞典语,和欧盟法规,强调埃及迫切需要不断完善其道德法规,以保障参与者的保护和研究诚信。确定的关键问题包括在研究中澄清和规范社会价值概念的必要性,除了对道德审查委员会的专业知识和公正性的担忧之外,指出了加强埃及及其他地区研究伦理的更广泛议程。
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.
CONCLUSIONS: 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.