Abstract:Therapeutic misconception (TM)—when clinical research participants fail to adequately grasp the difference between participating in a clinical trial and receiving ordinary clinical care—has long been recognized as a significant problem in consent to clinical trials. We suggest that TM does not primarily reflect inadequate disclosure or participants’ incompetence. Instead, TM arises from divergent primary cognitive frames. The researchers’ frame places the clinical trial in the context of scientific designs for assessing intervention efficacy. In contrast, most participants have a cognitive frame (...) that is personal and focused primarily on their medical problems. To illustrate this, we draw on interview material from both clinical researchers and participants in clinical trials. We suggest that reducing TM requires encouraging subjects to adjust their frame, not just add information to their existing frame. What is necessary is ascientific reframingof participation in a clinical trial. (shrink)

Since the early 1980’s, with the clinical advent of in vitro fertilization resulting in so-called “test tube babies,” a wide array of ethical considerations and concerns regarding artificial womb technology (AWT) have been described. Recent breakthroughs in the development of extracorporeal neonatal life support by means of AWT have reinitiated ethical interest about this topic with a sense of urgency. Most of the recent ethical literature on the topic, however, pertains not to the more imminent scenario of a physiologically improved (...) method of neonatal care through AWT, but instead to the remote scenario of “complete ectogenesis” that imagines human gestation occurring entirely outside of the womb. This scoping review of the ethical literature on AWT spans from more abstract concerns about complete ectogenesis to more immediate concerns about the soon-to-be-expected clinical life support of what we term the fetal neonate or fetonate. Within an organizing framework of different stages of human gestational development, from conception to the viable premature infant, we discuss both already identified and newly emerging ethical considerations and concerns regarding AWT and the care of the fetonate. (shrink)

Subjects of ectogenesis—human beings that are developing in artificial wombs (AWs)—share the same moral status as newborns. To demonstrate this, I defend two claims. First, subjects of partial ectogenesis—those that develop in utero for a time before being transferred to AWs—are newborns (in the full sense of the word). Second, subjects of complete ectogenesis—those who develop in AWs entirely—share the same moral status as newborns. To defend the first claim, I rely on Elizabeth Chloe Romanis’s distinctions between fetuses, newborns and (...) subjects of ectogenesis. For Romanis, the subject of partial ectogenesis ‘is neither a fetus nor a baby’ but is, instead, a ‘new product of human reproduction’. In this essay, I begin by, expanding upon Romanis’s argument that subjects of partial ectogenesis are not fetuses while arguing that those subjects are newborns. Next, I show that the distinction that Romanis draws between subjects of partial ectogenesis and newborns needs to be revised. The former is a kind of the latter. This leads us to an argument that shows why different moral statuses cannot be justifiably assigned to subjects of partial ectogenesis and subjects of complete ectogenesis, respectively. As subjects of partial ectogenesis share the same moral status as newborns, it follows that subjects of complete ectogenesis share the same moral status as newborns as well. I conclude by considering implications that this essay may have for the research and development of AW technology and conceptual links between a subject’s moral status and birth. (shrink)

In this paper I argue that we can no longer afford to ignore technology’s so-called ‘soft’ impacts, as this type of impact is becoming increasingly prominent in affluent societies where people have sufficient resources to pursue self-realization and where technologies are becoming more and more ‘intimate’ as they pervade our life world. These soft impacts come with their own type of normative challenges. The first challenge is to acknowledge the mutual shaping of technology and morality that causes soft impacts to (...) be fundamentally morally ambiguous. The second challenge is to anticipate soft impacts, which requires a rich and thick description of our morally laden current practices in the light of plausible technomoral change provoked by emerging technologies. The third and last challenge is to avoid both relativism and foundationalism, by opting for an open and learning attitude vis à vis the ways new and emerging technologies put our current morals into question. (shrink)

In 2017, a Philadelphia research team revealed the closest thing to an artificial womb the world had ever seen. The ‘biobag’, if as successful as early animal testing suggests, will change the face of neonatal intensive care. At present, premature neonates born earlier than 22 weeks have no hope of survival. For some time, there have been no significant improvements in mortality rates or incidences of long-term complications for preterms at the viability threshold. Artificial womb technology, that might change these (...) odds, is eagerly anticipated for clinical application. We need to understand whether AWT is an extension of current intensive care or something entirely new. This question is central to determining when and how the biobag should be used on human subjects. This paper examines the science behind AWT and advances two principal claims. First, AWT is conceptually different from conventional intensive care. Identifying why AWT should be understood as distinct demonstrates how it raises different ethico-legal questions. Second, these questions should be formulated without the ‘human being growing in the AW’ being described with inherently value laden terminology. The ‘human being in an AW’ is neither a fetus nor a baby, and the ethical tethers associated with these terms could perpetuate misunderstanding and confusion. Thus, the term ‘gestateling’ should be adopted to refer to this new product of human reproduction: a developing human being gestating ex utero. While this paper does not attempt to solve all the ethical problems associated with AWT, it makes important clarifications that will enable better formulation of relevant ethical questions for future exploration. (shrink)

Ethical concerns about therapeutic misconception have been raised since the early 1980s. This concept was originally described as research participants' assumptions that decisions relating to research interventions are made on the basis of their individual therapeutic needs. The term has since been used to refer to a range of ‘misunderstandings’ that research participants may have. In this paper, we describe a new concept—therapeutic appropriation. Therapeutic appropriation occurs when patients, or clinicians, actively reframe research participation as an opportunity to enhance patients' (...) clinical care, while simultaneously acknowledging the generalised research aims. To illustrate the concept of therapeutic appropriation, we draw on data from an interview study which we conducted to investigate the experiences of patients and general practitioners involved in clinical trials in primary care. We argue that therapeutic appropriation has two key elements: comprehension that the research project is not necessarily aiming to benefit participants and the deliberate use of incidental features of the research for personal therapeutic benefit of various kinds. We conclude that therapeutic appropriation is a useful concept that refines understanding of potential ethical problems in clinical research, and points to strategies to address them. (shrink)