Fecal Microbiota Transplantation: Ethical Challenges and Regulatory Hurdles

Kahn

Tuesday, March 8, 2016 - 11:30am to 1:00pm

Mississippi Room, Coffman Union

Fecal Microbiota Transplantation (FMT) has emerged as an important yet controversial therapy for Clostridium difficile (C. difficile), a painful and sometimes life-threatening form of colitis. While there is a great deal of enthusiasm about the treatment, there remain many unanswered questions. Dr. Kahn described her pioneering work using FMT with pediatric patients and outlined critical ethical, social, and regulatory issues, including implications of the FDA’s decision to designate FMT as both a biologic and a drug.

Co-sponsored by the University of Minnesota’s BioTechnology Institute and the Microbiota Therapeutics Program

Commentator:
Dr. Byron Vaughn, MD
Microbiota Therapeutics Program
University of Minnesota

Attorneys
1.5 standard CLE credits are approved. Event ID: 215667.

American Medical Association/PRA
The University of Minnesota is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Physicians
The University of Minnesota designates this live educational activity for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Other Health Care Professionals: Research coordinators, nurse practitioners, nurses, and other health care professionals who participate in this CE activity may submit their Statements of Participation to their appropriate accrediting organizations or state boards for consideration of credit. The participant is responsible for determining whether this activity meets the requirements for acceptable continuing education.

Stacy A. Kahn, MD, is Assistant Professor of Pediatrics and Medicine, and Director of the Transitional Inflammatory Bowel Diseases (IBD) Clinic at the University of Chicago. Dr. Kahn specializes in the evaluation and treatment of digestive diseases in children, adolescents and young adults. Her clinical work and research focus is on IBD and fecal microbiota transplantation (FMT). She performed the first colonoscopic FMT in a pediatric patient with refractory Clostridium difficile and has built a national reputation as an expert in pediatric FMT. She is a founding member and Co-chair of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) FMT Special Interest Group and a member of the American Gastroenterolgical Society FMT Registry Steering Committee. Dr. Kahn also serves on the ethics faculty at the University of Chicago MacLean Center for Clinical Medical Ethics and has a particular interest in the ethical, legal, social, and regulatory issues related to FMT.