Warwick Heale has recently defended the notion of individualized and personalized Quality-Adjusted Life Years (QALYs) in connection with health care resource allocation decisions. Ordinarily, QALYs are used to make allocation decisions at the population level. If a health care intervention costs £100,000 and generally yields only two years of survival, the cost per QALY gained will be £50,000, far in excess of the £30,000 limit per QALY judged an acceptable use of resources within the National Health Service in the United Kingdom. However, if we know with medical certainty that a patient will gain four extra years of life from that intervention, the cost per QALY will be £25,000. Heale argues fairness and social utility require such a patient to receive that treatment, even though all others in the cohort of that patient might be denied that treatment (and lose two years of potential life). Likewise, Heale argues that personal commitments of an individual (religious or otherwise), that determine how they value a life-year with some medical intervention, ought to be used to determine the value of a QALY for them. I argue that if Heale’s proposals were put into practice, the result would often be greater injustice. In brief, requirements for the just allocation of health care resources are more complex than pure cost-effectiveness analysis would allow.

In recent years, CRISPR-Cas9 has become one of the simplest and most cost-effective genetic engineering techniques among scientists and researchers aiming to alter genes in organisms. As Zika came to the fore as a global health crisis, many suggested the use of CRISPR-Cas9 gene drives in mosquitoes as a possible means to prevent the transmission of the virus without the need to subject humans to risky experimental treatments. This paper suggests that using gene drives or other forms of genome editing in nonhumans (like mosquitos) for the purposes of disease prevention raises important issues about informed consent. Additionally, it examines the consequences this line of inquiry could have for the use of gene drives as a tool in public health and suggests that the guidance offered by informed consent protocols could help the scientific community deploy gene drives in a way that ensures that ongoing research is consistent with our ethical priorities.

Neuroprosthetic speech devices are an emerging technology that can offer the possibility of communication to those who are unable to speak. Patients with ‘locked in syndrome,’ aphasia, or other such pathologies can use covert speech—vividly imagining saying something without actual vocalization—to trigger neural controlled systems capable of synthesizing the speech they would have spoken, but for their impairment.

We provide an analysis of the mechanisms and outputs involved in speech mediated by neuroprosthetic devices. This analysis provides a framework for accounting for the ethical significance of accuracy, control, and pragmatic dimensions of prosthesis-mediated speech. We first examine what it means for the output of the device to be accurate, drawing a distinction between technical accuracy on the one hand and semantic accuracy on the other. These are conceptual notions of accuracy.

Both technical and semantic accuracy of the device will be necessary (but not yet sufficient) for the user to have sufficient control over the device. Sufficient control is an ethical consideration: we place high value on being able to express ourselves when we want and how we want. Sufficient control of a neural speech prosthesis requires that a speaker can reliably use their speech apparatus as they want to, and can expect their speech to authentically represent them. We draw a distinction between two relevant features which bear on the question of whether the user has sufficient control: voluntariness of the speech and the authenticity of the speech. These can come apart: the user might involuntarily produce an authentic output (perhaps revealing private thoughts) or might voluntarily produce an inauthentic output (e.g., when the output is not semantically accurate). Finally, we consider the role of the interlocutor in interpreting the content and purpose of the communication.

These three ethical dimensions raise philosophical questions about the nature of speech, the level of control required for communicative accuracy, and the nature of ‘accuracy’ with respect to both natural and prosthesis-mediated speech.

Facial transplantation is emerging as a therapeutic option for self-inflicted gunshot wounds. The self-inflicted nature of this injury raises questions about the appropriate role of self-harm in determining patient eligibility. Potential candidates for facial transplantation undergo extensive psychosocial screening. The presence of a self-inflicted gunshot wound warrants special attention to ensure that a patient is prepared to undergo a demanding procedure that poses significant risk, as well as stringent lifelong management. Herein, we explore the ethics of considering mechanism of injury in the patient selection process, referring to the precedent set forth in solid organ transplantation. We also consider the available evidence regarding outcomes of individuals transplanted for self-inflicted mechanisms of injury in both solid organ and facial transplantation. We conclude that while the presence of a self-inflicted gunshot wound is significant in the overall evaluation of the candidate, it does not on its own warrant exclusion from consideration for a facial transplantation.

This paper provides an analysis of the statement, made in many papers and reports on the use of gene editing in humans, that we should only use the technology when it is safe. It provides an analysis of what the statement means in the context of nonreproductive and reproductive gene editing and argues that the statement is inconsistent with the philosophical commitments of some of the authors, who put it forward in relation to reproductive uses of gene editing, specifically their commitment to Parfitian nonidentity considerations and to a legal principle of reproductive liberty.

But, if that is true it raises a question about why the statement is made. What is its discursive and rhetorical function? Five functions are suggested, some of which are more contentious and problematic than others. It is argued that it is possible, perhaps even likely, that the “only when it is safe” rider is part of a deliberate obfuscation aimed at hiding the full implications of the arguments made about the ethics of gene editing and their underlying philosophical justifications.

The question as to whether people with an addiction have control (and to what extent) over their addiction, and voluntarily decide to use substances is an ongoing source of controversy in the context of research on addiction, health policy and clinical practice. We describe and discuss a set of five challenges for further research into voluntariness (definition[s], measurement and study tools, first person perspectives, contextual understandings, and connections to broader frameworks) based on our own research experiences and those of others.

There is a role for regulatory oversight over new genetic technologies. Research must ensure the rights of human subjects, and all medical products and techniques should be ensured to be safe and effective. In the United States, these forms of regulation are largely the purview of the National Institutes of Health and the Food and Drug Administration. Some have argued, however, that human genetic therapies require new regulatory agencies empowered to enforce cultural norms, protect against hypothetical social harms, or ensure that the human genome remains unchanged. Focusing on the United States, this essay will briefly review these arguments and argue that the current limited regulatory role over human gene therapies is sufficient to protect public health, bodily autonomy, and reproductive freedom.

Academic Medical Centers (AMCs) offer patient care and perform research. Increasingly, AMCs advertise to the public in order to garner income that can support these dual missions. In what follows, we raise concerns about the ways that advertising blurs important distinctions between them. Such blurring is detrimental to AMC efforts to fulfill critically important ethical responsibilities pertaining both to science communication and clinical research, because marketing campaigns can employ hype that weakens research integrity and contributes to therapeutic misconception and misestimation, undermining the informed consent process that is essential to the ethical conduct of research. We offer ethical analysis of common advertising practices that justify these concerns. We also suggest the need for a deliberative body convened by the Association of American Medical Colleges and others to develop a set of voluntary guidelines that AMCs can use to avoid in the future, the problems found in many current AMC advertising practices.

Since the advent of recombinant DNA technology, expectations (and trepidations) about the potential for altering genes and controlling our biology at the fundamental level have been sky high. These expectations have gone largely unfulfilled. But though the dream (or nightmare) of being able to control our biology is still far off, gene editing research has made enormous strides toward potential clinical use. This paper argues that when it comes to determining permissible uses of gene editing in one important medical context—germline intervention in reproductive medicine—issues about enhancement and eugenics are, for the foreseeable future, a red herring. Current translational goals for gene editing research involve a different kind of editing than would be required to achieve manipulation of complex traits such as intelligence, and there are more pressing (and unresolved) questions that need attention if clinical use of gene editing in reproductive medicine ever becomes a possibility.

Open neural tube defects or myelomeningoceles are a common congenital condition caused by failure of closure of the neural tube early in gestation, leading to a number of neurologic sequelae including paralysis, hindbrain herniation, hydrocephalus and neurogenic bowel and bladder dysfunction. Traditionally, the condition was treated by closure of the defect postnatally but a recently completed randomized controlled trial of prenatal versus postnatal closure demonstrated improved neurologic outcomes in the prenatal closure group. Fetal surgery, or more precisely maternal-fetal surgery, raises a number of ethical issues that we address including who the patient is, informed consent, surgical innovation and equipoise as well maternal assumption of risk. As the procedure becomes more widely adopted into practice, we suggest close monitoring of new fetal surgery centers, in order to ensure that the positive results of the trial are maintained without increased risk to both the mother and fetus.