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Ethical challenges in first-in-human trials of the artificial placenta and artificial womb: not all technologies are created equally, ethically

Journal of Perinatology volume 43, pages 1337–1342 (2023)Cite this article

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Abstract

Artificial placenta and artificial womb technologies to support extremely premature neonates are advancing toward clinical testing in humans. Currently, no recommendations exist comparing these approaches to guide study design and optimal enrollment eligibility adhering to principles of research ethics. In this paper, we will explore how scientific differences between the artificial placenta and artificial womb approaches create unique ethical challenges to designing first-in-human trials of safety and provide recommendations to guide ethical study design for initial human translation.

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Author information

Authors and Affiliations

  1. Division of Neonatology, Department of Pediatrics, Children’s Mercy Hospital, Kansas City, MO, USA

    Stephanie K. Kukora

  2. Children’s Mercy Bioethics Center, Children’s Mercy Hospital, Kansas City, MO, USA

    Stephanie K. Kukora

  3. Department of Surgery, Section of Pediatric Surgery, Fetal Diagnosis and Treatment Center, University of Michigan, Michigan Medicine, Ann Arbor, MI, USA

    George B. Mychaliska

  4. Division of Neonatology, Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, USA

    Elliott Mark Weiss

  5. Treuman Katz Center for Pediatric Bioethics, Seattle Children’s Research Institute, Seattle, WA, USA

    Elliott Mark Weiss

Authors
  1. Stephanie K. Kukora
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  2. George B. Mychaliska
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  3. Elliott Mark Weiss
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Contributions

Dr SKK co-conceptualized the project, drafted the initial paper and critically revised it, contributed content expertize in neonatal bioethics and antenatal counseling. Dr GBM critically revised the paper and contributed content expertize on artificial placenta and artificial womb technology. Dr EW co-conceptualized the project, critically revised the paper, and contributed content expertize on neonatal research ethics.

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Correspondence to Stephanie K. Kukora.

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The authors declare no competing interests.

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Kukora, S.K., Mychaliska, G.B. & Weiss, E.M. Ethical challenges in first-in-human trials of the artificial placenta and artificial womb: not all technologies are created equally, ethically. J Perinatol 43, 1337–1342 (2023). https://doi.org/10.1038/s41372-023-01713-5

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