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. 2024 Feb;44(2):180-186.
doi: 10.1002/pd.6474. Epub 2023 Dec 9.

Precarious hope: Ethical considerations for offering experimental fetal therapies outside of research after initial studies in humans

Saskia Hendriks  1 , Janyne Althaus  2 , Meredith A Atkinson  3 , Ahmet A Baschat  4 , Benjamin E Berkman  1   5 , Christine Grady  1 , David Wasserman  1 , David Wendler  1 , Jena L Miller  4
Affiliations

Precarious hope: Ethical considerations for offering experimental fetal therapies outside of research after initial studies in humans

Saskia Hendriks et al. Prenat Diagn. 2024 Feb.

Abstract

Objective: Risks and benefits of experimental fetal therapies can remain uncertain after initial clinical studies, especially long-term effects. Nevertheless, pregnant individuals may request them, hoping to benefit their future child. Guidance about offering experimental fetal therapies outside research (as "innovative therapy") is limited, despite their ethical complexity. We propose points for clinicians and reviewers to consider when deciding whether and how to offer experimental fetal therapies as innovative therapies after initial clinical studies.

Method: We used conceptual analysis and a current case to develop points for consideration, grounded in broader debates on innovative therapy and the unique challenges associated with experimental fetal therapies.

Results: Clinicians should evaluate whether offering experimental fetal therapies as innovative therapy is appropriate for a pregnant individual and their fetus. The anticipated risk-benefit ratio for the fetus should be favorable. For the pregnant individual, risks may outweigh benefits, within reasonable limits. Medical resources should be sufficient to ensure appropriate care. Clinicians should support pregnant individuals in making informed choices. Clinicians offering innovative therapies with more than minimal risk should collect and report data on outcomes. Independent review should take place.

Conclusion: Considering these points may advance the interests of fetuses, future children, and their families.

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Conflict of interest statement

Conflict of interest statement: No conflicts of interest

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