Ethically Justified, Practical Guidance for the Professionally Responsible Investigation of Maternal-Fetal Intervention for Fetal or Neonatal Benefit

Abstract

Abstract. This paper provides ethical guidance for the professionally responsible clinical investigation of maternal-fetal investigation for fetal or neonatal benefit and its transition into clinical practice. We present an ethical framework based on the ethical principles of beneficence, respect for autonomy, and justice, the professional virtue of integrity, and the ethical concept of the fetus as a patient. We identify the implications of this ethical framework for the qualifications that centers for maternal-fetal intervention should satisfy. These centers have the ethical obligation to provide prospective review and oversight of both innovation (an experiment undertaken to benefit an individual patient) and research (an experiment undertaken to create generalizable knowledge). We describe ethically justified criteria for innovation and early-phase research, for randomized clinical trials, and for the responsible transition into clinical practice. We also identify the elements of the informed consent process, including measures to prevent therapeutic misconception by pregnant patients during the informed consent process. The scientific, clinical, and ethical requirements of maternal-fetal investigation are demanding. However, the commitment to safety and quality requires that they be met. Fulfilling this commitment will result in well-documented professionally responsible investigation of maternal-fetal intervention for fetal and neonatal benefit.