As members of the fetal surgery advisory board at a large tertiary care center, we read with great interest Hendriks’ et al. target article proposing a new ethical framework for fetal therap...

We were interested to read the current target article, given our admiration for the senior author’s comprehensive coverage of these same topics a decade ago (Donley, Hul...

Noninvasive prenatal screening using cell-free DNA, which analyzes placental DNA circulating in maternal blood to provide information about fetal chromosomal disorders early in pregnancy and without risk to the fetus, has been hailed as a potential “paradigm shift” in prenatal genetic screening. Commercial provision of cell-free DNA screening has contributed to a rapid expansion of the tests included in the screening panels. The tests can include screening for sex chromosome anomalies, rare subchromosomal microdeletions and aneuploidies, and most recently, the entire (...) fetal genome. The benefits of this screening tool are generally framed, by both providers and commercial laboratories, as enhancing reproductive autonomy and choice by providing an earlier, simpler, and more accurate screening while potentially reducing the need for invasive follow-up testing. The majority of the literature has explored these issues empirically or conceptually from a European or North American vantage point, one that assumes normative priorities such as individual reproductive autonomy and the clinical availability of maternal health care or prenatal screening programs within which cell-free DNA screening is offered. While its implementation has raised both challenges and opportunities, very little is known about real-world experiences and the implications of the rapid introduction of cell-free DNA screening outside of North America and Europe, especially in low- and middle-income countries. To begin addressing this gap in knowledge, we organized a four-day international workshop to explore the ethical, legal, social, economic, clinical, and practical implications of the global expansion of cell-free DNA screening. We describe eight key insights that arose from the workshop. (shrink)

We are grateful to Friesen and colleagues for drawing attention to the tension between the protection of populations that may experience vulnerability with their inclusion in research (Friesen et a...

This book brings together an international collection of experts in reproductive ethics, law, disability studies, and medicine to explore the challenging future of reproduction and children. From the medical to the social and from the financial to the legal, the authors explore the expanding impact of reproductive genetics on our society. New advances in genetic technologies are revolutionizing the practice of reproductive medicine. We have expanded our ability to detect genetic changes in embryos and fetuses in ways that potentially allow (...) to identify, treat, or prevent a growing range of diseases. The development of gene-editing technologies raises questions about the possibility of removing disease-causing variants from embryos before pregnancy implantation. The growing sophistication of prenatal genomic sequencing offers us glimpses into the whole genome of the developing fetus. And, the increasingly sophisticated science of 'gene matching' allows us greater and greater foreknowledge of how the genomes of two individuals will combine in a future child. This is an indispensable book on the newest developments in bioethics caused by the sciences. Chapter 5 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com. (shrink)

While the 2022 Supreme Court of the United States decision in Dobbs v Jackson Women’s Health Organization may bring the contingent rights of pregnant people to refuse interventions into sharper foc...

Objective The study evaluated patient informed consent for the Quad screen and examined differences in IC between test acceptors and test refusers. A multidimensional model of IC was used. Methods Women seeking prenatal care at nine obstetrics clinics in a large Midwestern city completed surveys between February and December 2006. Surveys contained measures for three dimensions of IC: intention, understanding and controlling influence. Results 56.2% of women did not meet criteria for all three of our dimensions of IC and therefore (...) failed to give it. The failure rate was higher among women who choose to screen than women who choose not screen. Women who met all criteria for IC were over three times less likley to choose to screen ) than women who did not meet criteria for IC. Conclusion The decision to screen for fetal anomalies is less of a deliberated action than the decision not to screen. Women who lack a fundamental understanding of the purpose and nature of the screen may be operating on the belief that the screen is part of standard care and presents no need to deliberate. (shrink)

In 2011, the Department of Health and Human Services proposed changes to the regulations that govern human subjects protection in federally funded research. The proposed changes involve modifying inclusion standards for minimal-risk research and removing the necessity of review from certain categories of noninvasive research. All studies would instead be required to comply with privacy protections as initiated by the Health Information Portability and Accountability Act . We argue that relying on HIPAA to protect participants from participation-related risks in noninvasive (...) research is insufficient to protect the autonomy and psychological health of potential research participants. Instead, we suggest a streamlined review format for these categories of research. (shrink)

In their target article, Conley et al. (2023) appropriately highlight the ongoing conceptual and practical opacity of public engagement (PE) in the translation of human gene editing (HGE) (Conley e...

Bioethicists in healthcare institutions have the skills and insights and can and must facilitate and promote measures that address deeply ingrained structural issues that exacerbate health inequity...