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?

In brief

This article examines ethical frameworks for clinical trials involving in utero therapies, including stem cell, protein, mRNA, and gene-based interventions for fetal disease. It addresses the unique ethical considerations when both mother and fetus are research participants in prenatal treatment protocols.

• 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.

Written by the GCMD Library team from the article.