What should ethics guidelines look like for clinical trials of <em>in utero</em> stem cell, protein, mRNA, and gene therapies to treat fetal disease?

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Key takeaways

• Ethics frameworks for in utero therapies must balance maternal autonomy with fetal beneficence given dual-patient considerations.
• Informed consent processes require clear communication of novel risks including long-term effects on fetal development and maternal health.
• Trial design should incorporate rigorous safety monitoring and stopping rules given limited preclinical data for fetal interventions.
• Equity considerations are critical to prevent disparities in access to experimental prenatal treatments across populations.
• Regulatory pathways need adaptation to address unique challenges of fetal therapy trials versus traditional pediatric research.

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