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.

human microbiome  /  biobank  /  bioethics  /  regulation