Ethical Issues in Fecal Microbiota Transplantation in Practice

Abstract

Fecal microbiota transplantation (FMT) has demonstrated efficacy and is increasingly being used in the treatment of patients with recurrent Clostridium difficile infection. Despite a lack of high-quality trials to provide more information on the long-term effects of FMT, there has been great enthusiasm about the potential for expanding its applications. However, FMT presents many serious ethical and social challenges that must be addressed as part of a successful regulatory policy response. In this article, we draw on a sample of the scientific and bioethics literatures to examine clusters of ethical and social issues arising in five main areas: (1) informed consent and the vulnerability of patients; (2) determining what a “suitable healthy donor” is; (3) safety and risk; (4) commercialization and potential exploitation of vulnerable patients; and (5) public health implications. We find that these issues are complex and worthy of careful consideration by health care professionals. Desperation of a patient should not be the basis for selecting treatment with FMT, and the patient's interests should always be of paramount concern. Authorities must prioritize development of appropriate and effective regulation of FMT to safeguard patients and donors, promote further research into safety and efficacy, and avoid abuse of the treatment.

Keywords:

• confidential
• fecal microbiota transplantation
• privacy
• risk/benefit analysis
• vulnerability

ACKNOWLEDGMENTS

We thank Prof. Richard Oliver from the University of Cardiff, who provided insight and expertise that greatly improved the article. We are also grateful to Prof. Yanglin Pan for his suggestions on an earlier version of the article. We also appreciated the constructive and helpful comments of three anonymous reviewers.

FUNDING

This study was supported by National Social Science Foundation of China(16CZX064).