Addressing the bioethical void: ensuring pharmaceutical safety and efficacy for pregnant people

This thesis examines the routine exclusion of pregnant people from pharmaceutical clinical trials and the resulting lack of evidence regarding medication safety and efficacy during pregnancy. While this exclusion is often justified as a protective response to fetal risk, it has produced a systematic evidence gap that undermines ethical clinical care. This thesis argues that exclusion does not reduce risk, but instead structurally redistributes it into clinical practice, producing a system in which uncertainty itself becomes the central ethical harm. Drawing on the bioethical principles of autonomy, beneficence, nonmaleficence, justice, and health equity, this thesis develops the concept of an ethical paradox in which protection through exclusion generates the very conditions of risk it seeks to avoid. Through conceptual and ethical analysis of historical regulatory responses, contemporary practices, and structural features of biomedical research, it demonstrates how pregnant patients are routinely exposed to medications in the absence of rigorous evidence. This condition constrains informed decision-making, contributes to suboptimal treatment, and disproportionately burdens those navigating medically complex pregnancies. The thesis concludes that the current research framework represents an ethical failure and argues for a shift toward responsible inclusion. This includes earlier integration of pregnant populations into drug development, expansion of pharmacokinetic research, strengthened data collection systems, and structural reforms to clinical trial design. Such changes are necessary to reduce uncertainty, promote equitable evidence generation, and align research practices with the ethical obligations of modern medicine.