de Montgolfier Sandrine, Moutel Grégoire, Duchange Nathalie, Theodorou Ioannis, Hervé Christian, Leport Catherine
Laboratoire d'Ethique Médicale, de Droit de la Santé et de Santé Publique, Faculté Necker, 156, rue de Vaugirard, 75730 Paris cedex 15, France.
Pharmacogenetics. 2002 Dec;12(9):667-75. doi: 10.1097/00008571-200212000-00001.
The aim of this study was to analyse ethical issues concerning the storage of human biological samples to be used in genetic analyses and pharmacogenetic research based on a French experience of DNA banking in a cohort of human immunodeficiency virus (HIV)-infected patients started on a protease inhibitor-containing treatment. We describe the ethical issues raised during the establishment of a DNA bank, including questions dealing with autonomy, benefit to the patient, information sharing and confidentiality as well as guarantees concerning the storage and use of DNA. The practical applications of themes illustrated theoretically in the literature are discussed. Most of the points raised are not specific to HIV, but some of them may be more accurate due to the characteristics of the HIV population, which is more involved in the social debate through the community life and the increased risk of stigmatization. Our results are summarized in the memorandum and consent form presented in the Appendices. One issue still open to discussion is the way the results of genetic data will be given to the patients. This work should allow other researchers and members of evaluation committees to enrich their considerations and should stimulate discussion on this topic.
本研究的目的是基于在一群开始接受含蛋白酶抑制剂治疗的人类免疫缺陷病毒（HIV）感染患者中建立DNA库的法国经验，分析与用于基因分析和药物遗传学研究的人类生物样本储存相关的伦理问题。我们描述了在建立DNA库过程中出现的伦理问题，包括涉及自主权、对患者的益处、信息共享和保密以及DNA储存和使用保证等问题。讨论了文献中理论阐述的主题的实际应用。提出的大多数观点并非HIV所特有，但其中一些观点可能因HIV人群的特征而更为确切，该人群通过社区生活更多地参与社会辩论，且遭受污名化的风险增加。我们的结果总结在附录中呈现的备忘录和同意书中。一个仍有待讨论的问题是如何将基因数据结果告知患者。这项工作应能让其他研究人员和评估委员会成员丰富他们的思考，并应激发对该主题的讨论。
