Paternal Consent And Research During Pregnancy: A Comparison With Dual-Parent Consent In Pediatric Research

INTRODUCTION: The US regulation on research with pregnant women, “Subpart B”, requires paternal consent, in addition to the woman’s (i.e. dual-parent consent), if the research offers the prospect of direct benefit (PDB) to the fetus but not to her. We sought to investigate the ethical underpinnings of this requirement by exploring dual-parent consent requirements for research with children in “Subpart D,” which governs pediatric research. METHODS: We reviewed the requirements for dual-parent consent in Subparts B and D to analyze the ethical underpinnings of each regulation. Consent requirements were assessed in using conceptual methods from ethical theory and research ethics literature. RESULTS: We identified a critical difference between the considerations for dual-parent consent in Subparts B and D. Subpart D requires dual-parent consent when research offers no prospect of direct benefit to the child and presents greater than minimal risk, presumably as an extra measure of protection to the future offspring; research offering the prospect of direct benefit to the child requires only one parent’s consent. Conversely, Subpart B requires dual-parent consent when, and only when, research offers potential benefit to the fetus while not the woman. CONCLUSION: The requirement for paternal consent in research with pregnant women does not mirror the requirement for dual-parent consent for research with children. The regulations problematically burden access to the direct benefit that research might offer a future child in a way that they do not burden access to such benefit with born children.