Moving forward rapidly in the clinical research phase, uterus transplantation may be a future treatment option for women with uterine factor infertility, which accounts for three per cent of all infertility in women. This new method of treatment would allow women, who currently rely on gestational surrogacy or adoption, to gestate and birth their own genetic offspring. Since uterus transplantation carries significant risk when compared with surrogacy and adoption as well as when compared with other organ transplants, it requires greater (...) justification because its goals are quality of life, not life-saving, in their scope. It is important to address questions regarding the physical, psychosocial and ethical risks and benefits of uterus transplantation for all three parties involved—the patient, the donor and the potential child—as well as discuss the regulatory implications as research on uterus transplantations moves forward. (shrink)

The first baby has successfully been born by uterus transplantation (UTx) in the United States and the procedure is swiftly becoming a viable clinical option for patients with uterine factor infertility (UFI). This raises a practical ethical question: should health insurers finance UTx and what issues should they consider in coming to this decision? The article lays forth some of the factors that shape the decision over whether to finance UTx in the United States, including what procedures must be covered, (...) whether UTx is more like organ transplantation or infertility treatment (which are treated differently in the United States), and the benefits and alternatives of the procedure. Then, the article explores arguments around why UTx should be financed, or at least considered along with other important medical needs. The paper argues that UTx ought to be considered along with other competing claims for healthcare services. In countries that generously cover other infertility services, it may logically follow that medical services that enable gestation should be insured when the healthcare system covers services to conceive. In the United States, however, many groups have long suffered inadequate access to medical care, in the context of infertility and more broadly. U.S. healthcare may need to be made more widely equitable, before covering UTx is seen as financially or politically possible. (shrink)

As practicing clinicians, physicians are expected to uphold the ethical norms of their profession, including fidelity to patients and respect for patients’ self-determination. At the same time, as individuals, physicians are moral agents in their own right and, like their patients, are informed by and committed to diverse cultural, religious, and philosophical traditions and beliefs. In some circumstances, the expectation that physicians will put patients’ needs and preferences first may be in tension with the need to sustain the sense of (...) moral integrity and continuity that grounds a physician’s personal and professional life. This article examines the implications for patients, physicians, and the medical profession when tensions arise between a physician’s professional commitments and his or her deeply held personal moral beliefs. It offers guidance on when a physician’s professional commitments should outweigh personal beliefs as well as when physicians should have freedom to act according to the dictates of conscience while still protecting patients’ interests. (shrink)

The Food and Drug Administration and the European Medicines Agency have launched a recent initiative to enhance collaboration in research, with the intent to “ensure that clinical trials submitted in drug marketing applications in the United States and European Union are conducted uniformly, appropriately, and ethically.” This initiative recalls efforts from two decades ago when the United States, the European Union and Japan formed the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use as a (...) mechanism for harmonizing clinical research regulations. The intent of harmonization was to improve patients’ “access to new drugs, to prevent unnecessary global development delays and to avoid animal and human study duplications” through policy reconciliation.FDA/EMA efforts at collaboration call for a reassessment of past harmonization efforts: to what extent are ICH member policies already synchronized and to what extent can they be harmonized in the future? This paper will focus on these questions through the lens of pediatric investigation. (shrink)

Federal law often avoids setting minimum standards for women’s health and reproductive rights issues, leaving legislative and regulatory gaps for the states to fill as they see fit. This has mixed results. It can lead to state innovation that improves state-level health outcomes, informs federal health reform, and provides data on best practices for other states. On the other hand, some states may use the absence of a federal floor to impose draconian policies that pose risks to women’s and maternal (...) health. Health reforms at the federal level must trod carefully to enable state innovation, while imposing foundational safeguards for promoting women’s health nationwide. (shrink)

Oocyte donation raises conflicts of interest and commitment for physicians but little attention has been paid to how to reduce these conflicts in practice. Yet the growing popularity of assisted reproduction has increased the stakes of maintaining an adequate oocyte supply and minimizing conflicts. A growing body of professional guidelines, legal challenges to professional self-regulation, and empirical research on the practice of oocyte donation all call for renewed attention to the issue. As empirical findings better inform existing conflicts and their (...) potential harms, we can better attempt to reduce these conflicts. To that end, the article first describes the nature of conflicts in oocyte donation and relevant regulations and professional guidelines. We then describe studies on conflicts at four phases of oocyte donation: recruitment, screening, stimulation, and post-stimulation monitoring. Next we consider three models for conflict reduction in medicine generally: improved professional self-regulation, outright restriction like Stark anti-referral laws, or the use of conflict mediators, like in living organ donation. We ultimately conclude that improved professional self-regulation is a reasonable starting place for oocyte donation. (shrink)

This commentary proposes the need for greater normative debate about when, if ever, it is appropriate for insurers to access genetic information of insureds to combat anti-selection.