利益相关者对埃塞俄比亚审判后访问安排的观点:定性研究
Gudina Terefe Tucho1, Cynthia Khamala Wangamati2, Diribe Makonene Kumsa3
1Department of Environmental Health Sciences and Technology Institute of Health, Jimma University, Jimma, Ethiopia.
Global bioethics = Problemi di bioetica
|May 7, 2025
概括
埃塞俄比亚的利益相关者希望临床试验参与者和社区从研究中受益. 然而,他们认为缺乏指导方针和担心成本上升是审判后访问 (PTA) 的障碍.
科学领域:
- 临床试验 临床试验
- 生物伦理学生物伦理学
- 全球健康 全球健康
背景情况:
- 临床试验后获取 (PTA) 在临床试验中获益共享方面具有伦理重要性,特别是在低收入和中等收入国家 (LMICs).
- 撒哈拉以南非洲对PTA的研究有限,尽管它对分配正义的重要性很大.
- 埃塞俄比亚在临床研究中缺乏关于PTA的实际指导和经验.
研究的目的:
- 探讨在埃塞俄比亚临床试验中有关试验后访问 (PTA) 的利益相关者的观点.
- 评估在埃塞俄比亚背景下实施PTA的可行性.
主要方法:
- 采用了一种探索性定性研究设计.
- 与22个参与临床试验研究和审查的利益相关者进行了深入采访.
- 演性主题分析被用来分析采访数据.
主要成果:
- 研究参与者对PTA的认识有限.
- 利益相关者认为,试验参与者和社区都应该从临床试验中受益.
- 埃塞俄比亚PTA可行性的关键障碍包括缺乏立法,法规和指导方针,以及由于潜在成本增加而对赞助商保留的担忧.
结论:
- 埃塞俄比亚应该制定具体的立法和指导方针来管理PTA.
- 多方利益相关者参与对于有效的PTA规划和实施至关重要.
- 所有当事人之间的共同责任对于有意义的审判后访问至关重要.
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