Congenital bilateral renal agenesis has been considered a uniformly fatal condition. However, the report of using serial amnioinfusions followed by the live birth in 2012 and ongoing survival of a child with bilateral renal agenesis has generated hope, but also considerable controversy over an array of complex clinical and ethical concerns. To assess the ethical concerns associated with using serial amnioinfusions for bilateral renal agenesis, we assembled a multidisciplinary group to map the ethical issues relevant to this novel intervention. The key ethical issues identified were related to 1) potential risks and benefits, 2) clinical care compared with innovation compared with research, 3) counseling of expectant parents, 4) consent, 5) outcome measures, 6) access and justice, 7) conflicts of interest, 8) effects on clinicians, 9) effects on institutions, and 10) long-term societal implications. These ethical issues should be addressed in conjunction with systematic efforts to examine whether this intervention is safe and effective. Future work should capture the experiences of expectant parents, women who undergo serial amnioinfusions, those born with bilateral renal agenesis and their families as well as clinicians confronted with making difficult choices related to it.
Using serial amnioinfusions for the prenatal treatment of bilateral renal agenesis raises clinical and ethical issues that should be addressed when using this intervention.
Berman Institute of Bioethics, the Department of Gynecology and Obstetrics, the Center for Fetal Therapy, the Department of Surgery, Pediatric Palliative Care, the Division of Pediatric Nephrology, the Division of Neonatology, and the Human Research Protection Program, Johns Hopkins School of Medicine and University, Baltimore, Maryland; U.S. House of Representatives, Southwest Washington 3rd District, Washington, DC; the Department of Pediatric Nephrology, Transplantation and Rheumatology, Children’s Hospital of Richmond, the Department of Obstetrics and Gynecology, Virginia Commonwealth University, Richmond, Virginia; the Department of Obstetrics, Gynecology and Reproductive Services, University of California, San Francisco, San Francisco, California; the Department of Pediatrics–Nephrology, Max Rady College of Medicine, Pediatrics and Child Health, University of Manitoba, Winnipeg, Canada; Francis King Carey School of Law, University of Maryland, Baltimore, Maryland; the Division of Nephrology, Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California; the University of Washington School of Law and Institute for Public Health Genetics, Seattle, Washington; the Division of Neonatal-Perinatal Medicine and Program for Biomedical Ethics, Yale University School of Medicine, New Haven, Connecticut; Cincinnati Fetal Center, TriHealth Good Samaritan Hospital, Cincinnati, Ohio; the Department of Obstetrics and Gynecology, Pennsylvania Hospital, Philadelphia, Pennsylvania; and the Division of Nephrology, Boston Children's Hospital and Department of Pediatrics, Harvard Medical School, Boston, Massachusetts.
Corresponding author: Jeremy Sugarman, MD, MPH, Johns Hopkins Berman Institute of Bioethics, 1809 Ashland Avenue, Baltimore, MD 21205; email: firstname.lastname@example.org.
Supported by the Robert H. Levi Leadership Symposium Fund, Johns Hopkins Berman Institute of Bioethics. The sponsor played no role in preparation of this article.
Financial Disclosure Dr. Sugarman serves on Merck KGaA's Bioethics Advisory Panel and Stem Cell Research Oversight Committee and Quintiles' Ethics Advisory Panel. He has also consulted for Novartis. Dr. Desai has received research support from and consultant for Merck. Dr. Neu has research support from Luitpold, Amgen, Genzyme, Sanofi-Pasteur, and Relypsa and has been a consultant for Bayer. The other authors did not report any potential conflicts of interest.
The authors thank Kristen Miller, who provided valuable logistic support, and Alan Regenberg, who facilitated a literature review.
Findings generated at the Robert H. Levi Leadership Symposium: Navigating the Ethical Tensions in Patients' Requests for Innovative Therapies, March 22–23, 2017, Baltimore, Maryland.
Each author has indicated that he or she has met the journal's requirements for authorship.