Abstract
State-of-the-art minimally invasive in utero interventions involving stem cell, protein, and nucleic acid-based therapies represent a new frontier in medicine, which offers hope for devastating fetal diagnoses and promises the restoration of lifetimes. Yet they also introduce serious concerns regarding health risks posed to mother, fetus, and future generations. Recent international consensus statements provide general guidance for structuring trials to maximize health and minimize the risk of experimental treatments for both a pregnant mother and fetus. This article offers additional ethical guidance for translating interventions from first-in-human studies by focusing on a more holistic and nondirective consent process and encouraging pretrial publication of proposed studies to increase dialogue, fine-tune protocols, and potentially improve access.