Andanda Pamela, Machinya Johannes, Mutomba Takudzwa
Professor of law at the University of the Witwatersrand, Johannesburg.
Lecturer of Health Sociology at the University of the Witwatersrand, Johannesburg.
Ethics Hum Res. 2025 May-Jun;47(3):40-45. doi: 10.1002/eahr.60023.
Clinical research is essential for establishing the safety, efficacy, and contextualized effectiveness of medical products. Data from multiple sources such as representative target population studies and health and demographic data obtained through health surveillance systems are required for designing clinical research protocols and for recruitment of participants. In this essay, we review barriers from a complex interplay of ethical, legal, and practical challenges in data governance that hamper sharing health data from these sources in Sub-Saharan Africa. We suggest that a translational bioethics approach offers a valuable framework for addressing these challenges to bridge the gap between theory and practical application of ethical principles in data governance.
临床研究对于确定医疗产品的安全性、有效性和情境有效性至关重要。设计临床研究方案和招募参与者需要来自多个来源的数据，如代表性目标人群研究以及通过健康监测系统获得的健康和人口数据。在本文中，我们审视了数据治理中伦理、法律和实际挑战之间复杂相互作用所带来的障碍，这些障碍阻碍了撒哈拉以南非洲地区分享来自这些来源的健康数据。我们认为，转化生物伦理学方法提供了一个有价值的框架，以应对这些挑战，弥合数据治理中伦理原则理论与实际应用之间的差距。
