Merz Jon F, McGee Glenn E, Sankar Pamela
Center for Bioethics, University of Pennsylvania, Philadelphia, PA 19104-3308, USA.
Soc Sci Med. 2004 Mar;58(6):1201-9. doi: 10.1016/s0277-9536(03)00256-9.
A detailed analysis of the Icelandic commercial population-wide genomics database project of deCODE Genetics was performed for the purpose of providing ethics insights into public/private efforts to develop genetic databases. This analysis examines the moral differences between the general case of governmental collection of medical data for public health purposes and the centralized collection planned in Iceland. Both the process of developing the database and its design vary in significant ways from typical government data collection and analysis activities. Because of these differences, the database may serve the interests of deCODE more than it serves the interests of the public, undermining the claim that presumed consent for this data collection and its proprietary use is ethical. We believe that there is an evolving consensus that informed consent of participants must be secured for population-based genetics databases and research. The Iceland model provides an informative counterexample that holds key ethics lessons for similar ventures.
为了深入了解公私合作开发基因数据库项目中的伦理问题，我们对 deCODE 基因公司在冰岛开展的全商业人口基因组数据库项目进行了详细分析。本分析探讨了政府为公共卫生目的收集医疗数据的一般情况与冰岛计划进行的集中式数据收集之间的道德差异。该数据库的开发过程及其设计在许多重要方面与典型的政府数据收集和分析活动不同。由于这些差异，该数据库可能更多地服务于 deCODE 公司的利益，而非公众利益，这削弱了关于对该数据收集及其专有使用的推定同意是符合伦理的这一主张。我们认为，对于基于人群的基因数据库和研究，必须获得参与者的知情同意，这一共识正在不断发展。冰岛模式提供了一个具有参考价值的反例，为类似项目提供了关键的伦理教训。
