Biobanking for human gut microbiome: Ethical and regulatory considerations
- 生命科学－已发表论文 
人体微生物组与健康和疾病的关系是重要的科学问题。而人体微生物样本库的建立是人体微生物组研究的重要基础,这个新兴领域迫切要求对已建立的价值体系和伦; 理规范进行调整和变革。本文讨论人体微生物样本库建设中的知情同意、样本和数据的所有权、隐私和风险等;并以粪菌库和粪菌移植为典型案例,分析选择"最佳; 、健康供体所面临的医学和伦理困难;提出了人体微生物样本库监管的政策建议。Human microbiome research and its relationship with health and disease; have increasingly become a hot area in biomedical science. Biobanking; human microbiome is fundamental for the development of human microbiome; research. However, human microbiome research and biobank are facing many; serious ethical, social and regulatory challenges that must be; addressed. In this article, we examine three core ethical and social; issues, i.e., informed consent, ownership, privacy and risks. Next, we; employ fecal microbiota bank and fecal microbiota transplantation as a; case study to discuss how to determine a suitable healthy donor. We; conclude the article by providing some regulatory and governance; suggestions for policy makers to develop successful policy response.