Paternal consent in prenatal research: ethical aspects

Abstract

The role of mothers in prenatal research has been discussed extensively. Significantly less work has been done on the father's role. In this article, focusing on ethical issues, we seek to redress this imbalance. Examining the father's position in research conducted on pregnant women, we ask whether or not paternal consent ought to be required in addition to that of the pregnant woman. Having distinguished between different concepts of father and mother, we proceed by giving an overview of the reasons for requiring consent of the woman who is carrying the child. We then examine which of these reasons apply to the biological father, and show that some of them are relevant to the father. The case, roughly speaking, revolves around privacy issues, the father's future legal responsibilities, and the likelihood that he will care about the health and wellbeing of his future child. These factors in the decision problem should all be recognized, as should the fact that they can in principle be trumped by other considerations.

Fetal gene therapy

“…169 The father/partner should also not be forgotten, as in most jurisdictions, they will share parental responsibility after the baby is born and therefore should be recognized as having an important contribution to decisions as to whether to proceed with fetal gene therapy. 170 The benefit of fetal therapy should be weighed against the alternative, either delivery at term with immediate neonatal treatment or elective early cesarean section and disease management at birth. The later case is exemplified by the management of large sacrococcygeal teratomas which place the fetus at risk of heart failure due to a vascular steal scenario.…”

“…Fetal gene therapy presents a very challenging situation regarding how to inform the mother of all the potential risks and has been considered extensively 169 . The father/partner should also not be forgotten, as in most jurisdictions, they will share parental responsibility after the baby is born and therefore should be recognized as having an important contribution to decisions as to whether to proceed with fetal gene therapy 170 . The benefit of fetal therapy should be weighed against the alternative, either delivery at term with immediate neonatal treatment or elective early cesarean section and disease management at birth.…”

Maternal–Fetal Drug Development: An Industry Perspective

“…The potential consents required could include but are not limited to a parental consent (maternal and/or maternal and paternal consent) and a separate consent for the fetus, as well as a new consent once the infant is born (eg, for safety and development assessments). 54 Additionally, the clinical trials consent requirements could vary by the type of study, age of participant(s), and country. Some therapeutics such as vaccines and neonatalspecific medications may be more straightforward to study.…”

“…Conducting trials that include pregnant women and their fetus may include consenting questions such as the number of consents needed for the participants (eg, pregnant woman and fetus), number of consents needed for each phase of the study, and the country requirements for who is eligible to provide consent for the study. The potential consents required could include but are not limited to a parental consent (maternal and/or maternal and paternal consent) and a separate consent for the fetus, as well as a new consent once the infant is born (eg, for safety and development assessments) 54 . Additionally, the clinical trials consent requirements could vary by the type of study, age of participant(s), and country.…”

Fetal and Maternal Safety Considerations for In Utero Therapy Clinical Trials: iFeTiS Consensus Statement

“…The 10 potential for a lethal disorder to be partially treated, resulting in survival of a neonate with an extremely poor quality of life, is highly relevant to informed consent discussions . Paternal consent and the role of the father in the ongoing care of a neonate treated as a fetus are also important 12 . Interventions that are commenced in utero with a further postnatal application, for example a postnatal stem cell booster, will require reconfirmation of parental consent after birth to allow ongoing neonatal participation in the clinical trial.…”