Ethical Challenges in First-in-Human Trials of the Artificial Placenta and Artificial Womb: Not all Technologies Are Created Equally, Ethically

Artificial placenta (AP) and artificial womb (AW) technologies to support extremely premature neonates are advancing toward first in human trials. Currently, minimal recommendations exist to guide ethical study design. We will present an overview of ethical issues for each modality and provide recommendations to adhere to principles of research ethics for initial human translation. These technologies have important differences impacting research methodology. AP may be offered as initial therapy in place of conventional neonatal therapy (early application) or rescue therapy when conventional neonatal therapy fails (late application). AW is intended for only early application. Though the early application of AP and AW both rely on antenatal enrollment, only AW requires delivery via classical C-section, altering risk profile to pregnant parent. For both modalities, there are ethical challenges in determining the proper fetal/neonatal population for first in human trials. For example, known population-based (but not individualized) risks of prematurity may be difficult to weigh against the unknown risk profile of AP/AW. Additionally, decision-making may be impacted by heightened emotional states of expectant parents and therapeutic misconception. In this session, we will propose guidance on considering the proper population for first in human trials and the extra attention that must be paid to the recruitment and consent process. Recruitment should involve a multidisciplinary team including a neonatologist experienced in antenatal consultation and a Maternal Fetal Medicine specialist in addition to the study team.

George Mychaliska, MD – Professor, Surgery, University of Michigan; Elliott Weiss, MD, MSME – Associate Professor of Pediatrics, Neonatology, Pediatrics, University of Washington Treuman Katz Center for Pediatric Bioethics/Seattle Children’s Hospital & Research Institute