Ethical Considerations in Microbial Therapeutic Clinical Trials

• Authors: Michael H. Woodworth, Emory University; Tiffany Wang, Emory University; Kaitlin L. Sitchenko, Emory University; Cynthia Carpentieri, Emory University; Rachel Friedman-Moraco, Emory University; Colleen Kraft, Emory University
• Journal Title: New Bioethics
• Volume: Volume 23, Number 3
• Publisher: Taylor & Francis (Routledge): STM, Behavioural Science and Public Health Titles | 2017-09-02, Pages 210-218
• Type of Work: Article | Post-print: After Peer Review
• Publisher DOI: http://doi.org/10.1080/20502877.2017.1387386
• Subjects: Health Sciences, Pathology
• Keywords: Clostridium difficile; FMT; ethics; fecal microbiota transplant; microbiome; recurrent Clostridium difficile; Clinical Trials as Topic; Clostridium Infections; Clostridium difficile; Fecal Microbiota Transplantation; Gastrointestinal Microbiome; Humans

Abstract

As understanding of the human microbiome improves, novel therapeutic targets to improve human health with microbial therapeutics will continue to expand. We outline key considerations of balancing risks and benefits, optimising access, returning key results to research participants, and potential conflicts of interest.