Cambon-Thomsen Anne, Ducournau Pascal, Gourraud Pierre-Antoine, Pontille David
Inserm U 558, Epidémiologie et Analyses en Santé Publique: Risques, Maladies Chroniques et Handicaps, Faculté de Médecine, 37 Allées Jules Guesde, Toulouse cedex F-31073, France.
Comp Funct Genomics. 2003;4(6):628-34. doi: 10.1002/cfg.333.
Biobanks include biological samples and attached databases. Human biobanks occur in research, technological development and medical activities. Population genomics is highly dependent on the availability of large biobanks. Ethical issues must be considered: protecting the rights of those people whose samples or data are in biobanks (information, autonomy, confidentiality, protection of private life), assuring the non-commercial use of human body elements and the optimal use of samples and data. They balance other issues, such as protecting the rights of researchers and companies, allowing long-term use of biobanks while detailed information on future uses is not available. At the level of populations, the traditional form of informed consent is challenged. Other dimensions relate to the rights of a group as such, in addition to individual rights. Conditions of return of results and/or benefit to a population need to be defined. With 'large-scale biobanking' a marked trend in genomics, new societal dimensions appear, regarding communication, debate, regulation, societal control and valorization of such large biobanks. Exploring how genomics can help health sector biobanks to become more rationally constituted and exploited is an interesting perspective. For example, evaluating how genomic approaches can help in optimizing haematopoietic stem cell donor registries using new markers and high-throughput techniques to increase immunogenetic variability in such registries is a challenge currently being addressed. Ethical issues in such contexts are important, as not only individual decisions or projects are concerned, but also national policies in the international arena and organization of democratic debate about science, medicine and society.
生物样本库包括生物样本及相关数据库。人类生物样本库存在于研究、技术开发和医疗活动中。群体基因组学高度依赖大型生物样本库的可用性。必须考虑伦理问题：保护那些样本或数据存于生物样本库中的人的权利（信息、自主权、保密性、私生活保护），确保人体元素的非商业用途以及样本和数据的最佳利用。它们还要平衡其他问题，比如保护研究人员和公司的权利，在未来用途的详细信息尚不可用时允许对生物样本库的长期使用。在群体层面，传统的知情同意形式受到挑战。除了个人权利之外，其他方面还涉及群体本身的权利。需要界定向群体反馈结果和/或使其受益的条件。随着“大规模生物样本库建设”成为基因组学的一个显著趋势，在沟通、辩论、监管、社会控制以及对此类大型生物样本库的增值利用等方面出现了新的社会层面问题。探索基因组学如何能够帮助卫生部门的生物样本库更合理地组建和利用是一个有趣的视角。例如，评估基因组学方法如何能够利用新的标记物和高通量技术帮助优化造血干细胞供体登记库，以增加此类登记库中的免疫遗传学多样性，这是当前正在应对的一项挑战。在这种背景下的伦理问题很重要，因为不仅涉及个人决策或项目，还涉及国际舞台上的国家政策以及关于科学、医学和社会的民主辩论的组织。
