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. 2022 Mar;22(3):45-61.
doi: 10.1080/15265161.2020.1867932. Epub 2021 Jan 16.

A New Ethical Framework for Assessing the Unique Challenges of Fetal Therapy Trials

Saskia Hendriks  1 , Christine Grady  1 , David Wasserman  1 , David Wendler  1 , Diana W Bianchi  1 , Benjamin E Berkman  1
Affiliations

A New Ethical Framework for Assessing the Unique Challenges of Fetal Therapy Trials

Saskia Hendriks et al. Am J Bioeth. 2022 Mar.

Abstract

New fetal therapies offer important prospects for improving health. However, having to consider both the fetus and the pregnant woman makes the risk-benefit analysis of fetal therapy trials challenging. Regulatory guidance is limited, and proposed ethical frameworks are overly restrictive or permissive. We propose a new ethical framework for fetal therapy research. First, we argue that considering only biomedical benefits fails to capture all relevant interests. Thus, we endorse expanding the considered benefits to include evidence-based psychosocial effects of fetal therapies. Second, we reject the commonly proposed categorical risk and/or benefit thresholds for assessing fetal therapy research (e.g., only for life-threatening conditions). Instead, we propose that the individual risks for the pregnant woman and the fetus should be justified by the benefits for them and the study's social value. Studies that meet this overall proportionality criterion but have mildly unfavorable risk-benefit ratios for pregnant women and/or fetuses may be acceptable.

Keywords: Fetal therapies; ethics, research; fetal diseases; pregnancy; risk benefit assessment; therapies, investigational.

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Figures

Figure 1.
Figure 1.
Proposed elements of risk-benefit analysis for fetal therapy trials
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