Legal personhood and frozen embryos: implications for fertility patients and providers in post-Roe America.

The demise of Roe v. Wade has prompted some state lawmakers to try to redefine legal personhood to begin before birth and even before pregnancy. The sweeping abortion bans passed and pending in the wake of Dobbs pose a threat to reproductive rights that extends beyond abortion. That threat spills over into in vitro fertilization (IVF) and other assisted reproductive technologies (ART). If legislatures designate embryos as legal persons, fertility clinics will be forced to change how they manage embryos, including current standard practices such as pre-implantation genetic testing, storage of unused embryos, and the disposal of those unlikely to have reproductive potential. This essay examines the many ways in which conferring the status of persons under private and public law is likely to impact patients pursuing IVF and clinics practicing ART.

Expanding Paid Sick Leave Laws: The Public Health Imperative.

A key public health measure has received far too little attention over the course of the Covid-19 pandemic: paid sick leave policies that encourage people at risk of spreading disease to stay home rather than come to work. The United States is one of the only developed countries that fails to guarantee paid sick leave at the federal level, leaving a patchwork of state and private policies that undersupply time off when people are contagious and protect top wage earners at wildly disproportionate rates compared with what workers with lower incomes experience. Other countries have shown that sick leave mandates are neither unjustified burdens on employers nor gratuitous giveaways to employees. In fact, sick leave saves on health care costs by making employees less likely to infect coworkers, to be absent for longer themselves, or to need treatment in expensive hospital emergency departments. Nationally guaranteed sick leave is urgently needed to promote public health.

Rethinking nomenclature for interspecies cell fusions.

Cell fusions have a long history of supporting biomedical research. These experimental models, historically referred to as 'somatic cell hybrids', involve combining the plasma membranes of two cells and merging their nuclei within a single cytoplasm. Cell fusion studies involving human and chimpanzee pluripotent stem cells, rather than somatic cells, highlight the need for responsible communication and a revised nomenclature. Applying the terms 'hybrid' and 'parental' to the fused and source cell lines, respectively, evokes reproductive relationships that do not exist between humans and other species. These misnomers become more salient in the context of fused pluripotent stem cells derived from different but closely related species. Here, we propose a precise, versatile and generalizable framework to describe these fused cell lines. We recommend the term 'composite cell line', to distinguish cell lines that are experimentally created through fusions from both reproductive hybrids and natural cell fusion events without obscuring the model in overly technical terms. For scientific audiences, we further recommend technical nomenclature that describes the contributing species, ploidy and cell type.

The Legal Challenge of Abortion Stigma-and Government Restrictions on the Practice of Medicine.

During the 2016 election, Donald Trump won conservative support by promising that he would, if elected, nominate "pro-life" justices to the U.S. Supreme Court. Whether President Trump makes good on his campaign promise to restrict abortion rights may come down to competing impulses of the chief justice, John Roberts. These dueling dispositions-from the man whom many see as the new "swing justice"-hold the key to a blockbuster new case that legal historians call "the most unpredictable the Supreme Court has been on abortion in decades." The case, June Medical Services v. Russo, turns on arduous new requirements that Louisiana has imposed on facilities and clinicians that provide abortion. But the case is not just about abortion access. The Court will have to decide whether a clinic has a right to challenge the law in the first place.

Lawsuit frequency and claims basis over lost, damaged, and destroyed frozen embryos over a 10-year period.

OBJECTIVE: To review the claims, claims basis, and frequency of lawsuits over lost or damaged frozen embryos and to estimate their frequency over a 10-year interval. DESIGN: Retrospective analysis of case law. SETTING: Private in vitro fertilization clinic and school of law. PATIENTS: None. INTERVENTIONS: Case law identified using Bloomberg Law, Westlaw, and Lexis Nexis databases for coverage of court dockets regarding allegations and claims. MAIN OUTCOME MEASURES: Lawsuits brought and settled in state and federal court, with data extracted included claims basis and location in federal or state courts. RESULTS: We reviewed case law from January 1, 2009, to April 22, 2019, using the terms frozen, discarded, lost, and damaged embryo/s, and calculated clinical cases using frozen embryos from Centers for Disease Control and Prevention data. We identified 133 cases: 122 and 11 lawsuits in the state and federal court dockets, respectively. Of these, 87 cases involved alleged freezer tank failure in California and Ohio in 2018-2019. In the remaining 44 cases, the majority (37 cases) were brought for personal injury, breach of contract or warranty, product liability, professional negligence, unfair business practices, and miscellaneous tort. A minority (7 cases) were brought for medical malpractice. During this interval, a total of 398,256 embryo-thaw procedures were reported nationally. CONCLUSIONS: Allegations range from business practices to product liability and are seldom for medical malpractice. Our results suggest that best practices in storage of frozen embryos should include not only improvements in hardware and monitoring of storage conditions of specimens but also setting standards for communications among patients, providers, and embryology laboratories regarding disposition of embryos.

Returning Results to Family Members: Professional Duties in Genomics Research in the United States.

 This article critically appraises the ethical and legal duties to disclose findings to the family members of research participants. These family members stand to benefit in important ways from discoveries that can inform their own health and reproductive risks. However, careful appreciation of how medical research differs from clinical practice and of the uncertainties at stake in genomic research complicates any warning to relatives. Research laboratories should generally be immune from liability for failing to diagnose or disclose a genetic disorder in time to prevent adverse outcomes for a participant's family members or to return properly interpreted test results for even direct findings under investigation, let alone incidental ones. The only exception is where warning relatives of medical risks is very likely to prevent imminent harm and would not override known participant wishes. Genomic autopsy studies for sudden death satisfy these conditions of life-saving potential for relatives without disrespect to subjects. These are among the rare instances in which we conclude that offering results to family members is not just permissible but obligatory, not just as a moral matter but as a legal one.

Privatizing procreative liberty in the shadow of eugenics.

The late John Robertson is renowned for the theory of 'procreative liberty' that he expounded in his pioneering book, Children of Choice. Procreative liberty captures the 'freedom to reproduce without sex' above and beyond the 'freedom to have sex without reproduction' that are recognized by constitutional rights to abortion and birth control. Most controversial among Robertson's work on procreative liberty was its application to prenatal selection. Unless the state had very good reasons, he argued, people should be free to access reproductive medicine or technology to have a child who or would be born with particular traits. Prospective parents in the USA today face no official limits in using sperm banks, egg vendors, IVF clinics, or surrogacy agencies with an eye toward choosing for certain characteristics. But should they be protected, this essay asks, when mix-ups or misdiagnoses thwart the selection of offspring traits? The best answer to this question extends the theory of procreative liberty from government restrictions to professional negligence. It also demands sensitivity to genetic uncertainty, the limits of private law, and the history of eugenics in America. Or so I argue in this tribute to the inimitable John Robertson.

A community effort to protect genomic data sharing, collaboration and outsourcing.

The human genome can reveal sensitive information and is potentially re-identifiable, which raises privacy and security concerns about sharing such data on wide scales. In 2016, we organized the third Critical Assessment of Data Privacy and Protection competition as a community effort to bring together biomedical informaticists, computer privacy and security researchers, and scholars in ethical, legal, and social implications (ELSI) to assess the latest advances on privacy-preserving techniques for protecting human genomic data. Teams were asked to develop novel protection methods for emerging genome privacy challenges in three scenarios: Track (1) data sharing through the Beacon service of the Global Alliance for Genomics and Health. Track (2) collaborative discovery of similar genomes between two institutions; and Track (3) data outsourcing to public cloud services. The latter two tracks represent continuing themes from our 2015 competition, while the former was new and a response to a recently established vulnerability. The winning strategy for Track 1 mitigated the privacy risk by hiding approximately 11% of the variation in the database while permitting around 160,000 queries, a significant improvement over the baseline. The winning strategies in Tracks 2 and 3 showed significant progress over the previous competition by achieving multiple orders of magnitude performance improvement in terms of computational runtime and memory requirements. The outcomes suggest that applying highly optimized privacy-preserving and secure computation techniques to safeguard genomic data sharing and analysis is useful. However, the results also indicate that further efforts are needed to refine these techniques into practical solutions.

PRINCESS: Privacy-protecting Rare disease International Network Collaboration via Encryption through Software guard extensionS.

Motivation: We introduce PRINCESS, a privacy-preserving international collaboration framework for analyzing rare disease genetic data that are distributed across different continents. PRINCESS leverages Software Guard Extensions (SGX) and hardware for trustworthy computation. Unlike a traditional international collaboration model, where individual-level patient DNA are physically centralized at a single site, PRINCESS performs a secure and distributed computation over encrypted data, fulfilling institutional policies and regulations for protected health information. Results: To demonstrate PRINCESS' performance and feasibility, we conducted a family-based allelic association study for Kawasaki Disease, with data hosted in three different continents. The experimental results show that PRINCESS provides secure and accurate analyses much faster than alternative solutions, such as homomorphic encryption and garbled circuits (over 40 000× faster). Availability and Implementation: https://github.com/achenfengb/PRINCESS_opensource. Contact: shw070@ucsd.edu. Supplementary information: Supplementary data are available at Bioinformatics online.