Research to improve the health of pregnant and fetal patients presents ethical challenges to clinical investigators, institutional review boards, funding agencies, and data safety and monitoring boards. The Common Rule sets out requirements that such research must satisfy but no ethical framework to guide their application. We provide such an ethical framework, based on the ethical concept of the fetus as a patient. We offer criteria for innovation and for Phase I and II and then for Phase III clinical trials (...) to improve the health of pregnant patients and of fetal patients and also criteria to responsibly manage the transition from investigation to clinical practice. Basing ethical criteria for research involving pregnant women on the ethical concept of the fetus as a patient insulates the proposed ethical framework and therefore research on pregnant women from the divisive and politicized concepts and discourses of personhood, fetal rights, and unborn child. (shrink)

The Human Fertilisation and Embryology Authority’s recent restrictive recommendations on sex selection have highlighted the need for consideration of the plausibility of ethical arguments against sex selection. In this paper, the author suggests a parental virtues approach to some questions of reproductive ethics as a superior alternative to an exclusively harm focused approach such as the procreative liberty framework. The author formulates a virtue ethics argument against sex selection based on the idea that acceptance is a character trait of the (...) good parent. It is concluded that, because the argument presented posits a wrong in the sex selecting agent’s action that is not a harm, the argument could not function as a justification of the HFEA’s restrictive position in light of their explicit commitment to procreative liberty; it does, however, suggest that ethical approaches focused exclusively on harm fail to capture all the relevant moral considerations and thus that we should look beyond such approaches. (shrink)

New fetal therapies offer important prospects for improving health. However, having to consider both the fetus and the pregnant woman makes the risk–benefit analysis of fetal therapy trials challenging. Regulatory guidance is limited, and proposed ethical frameworks are overly restrictive or permissive. We propose a new ethical framework for fetal therapy research. First, we argue that considering only biomedical benefits fails to capture all relevant interests. Thus, we endorse expanding the considered benefits to include evidence-based psychosocial effects of fetal therapies. (...) Second, we reject the commonly proposed categorical risk and/or benefit thresholds for assessing fetal therapy research. Instead, we propose that the individual risks for the pregnant woman and the fetus should be justified by the benefits for them and the study’s social value. Studies that meet this overall proportionality criterion but have mildly unfavorable risk–benefit ratios for pregnant women and/or fetuses may be acceptable. (shrink)