In a study of fetoscopic laser surgery to benefit the fetus, who must give consent according to Subpart B?

In the context of research involving fetuses, Subpart B of the Department of Health & Human Services (DHHS) regulations provides specific guidelines regarding consent. For studies like fetoscopic laser surgery that could affect both the fetus and the pregnant woman, it is essential to obtain informed consent from both parties involved.

The rationale for this requirement stems from the ethical principle of respect for persons, which underscores the importance of acknowledging the roles and rights of both parents in decision-making for the fetus. By requiring the consent of both the pregnant woman and the father, except in cases where the father cannot provide consent (due to incapacity or other valid reasons), the regulation ensures that all interested parties are involved in the decision that impacts the health and welfare of the fetus.

This requirement promotes shared responsibility and supports family dynamics, acknowledging that the decision to participate in research involving a fetus is not solely the domain of the pregnant woman. It recognizes the potential interests and concerns of the father as well, thereby ensuring a comprehensive ethical approach to obtaining informed consent.