When Subjects Violate the Research Covenant: Lessons Learned from a Failed Clinical Trial of Fecal Microbiota Transplantation

1Inflammatory Bowel Disease Center, The University of Chicago Medicine, Chicago, Illinois, USA 2The MacLean Center for Clinical Medical Ethics, The University of Chicago Medicine, Chicago, Illinois, USA 3Section of Pediatric Gastroenterology, Hepatology, & Nutrition, The University of Chicago Medicine, Chicago, Illinois, USA Correspondence: Stacy A. Kahn, MD, The University of Chicago Medicine, Section of Pediatric Gastroenterology, Hepatology and Nutrition, 5841 S. Maryland Avenue, MC 4065, Chicago, Illinois 60637, USA. E-mail: [email protected] Guarantor of the article: Stacy A. Kahn, MD. Specific author contributions: Study concept, design and conduct, data interpretation, drafting, and critical revision of the manuscript: Stacy A. Kahn; study concept and design, data interpretation, critical revision of the manuscript: David T. Rubin. Both authors have approved the final draft submitted. Financial support: Mutchnik Family Foundation; Gastro-Intestinal Research Foundation; and Digestive Diseases Research Core Center (DDRCC): NIDDK P30DK42086. Potential competing interests: None.