In the conduct of clinical trials for pharmaceutical research, access to investigational medicines following clinical trials is often necessary for the continued health and well-being of the trial participants; it is an ethical obligation under some circumstances, as outlined in the Declaration of Helsinki 2013 Article 34. This obligation becomes particularly important in lower-income countries, where access to medical care may be limited. Although there is agreement among global research and bioethics communities that continued access should be provided with prospectively defined parameters and procedures, the process is complex, as many responsible parties and complicated logistics are involved. Roche Pharmaceuticals developed and publicly posted the company’s policy regarding continued access to investigational medicines in 2013. This article provides insights on the policy, including the parameters that determine when continued access is and is not considered to be appropriate, along with an example from an active clinical development program. It also describes how multiple stakeholders, including those in academia, industry, government, and patient advocacy, have worked together to assess approaches to continued access. Continued access plans should be transparent and agreed to by research participants, investigators, and governments prior to the study and reassessed based on clinical trial evidence of safety and efficacy and availability of adequate treatments, along with relevant international laws and customs. Conducting responsible continued access programs requires close partnerships with investigators, health authorities, and third-party research partners.

As new ways of reproducing emerge, advancing technologies are forcing us to rethink our old ideas of what it means to be a genetic parent. Why should some processes qualify as “reproduction” and others should not? To illustrate the practical impact of providing a defensible account of reproduction, the author examines the case of mitochondrial donation (mtDNA) and calls for a philosophical argument to bring clarity to exactly what we mean by ‘reproduction.’

The microbiome is proving to be increasingly important for human brain functioning. A series of recent studies have shown that the microbiome influences the central nervous system in various ways, and consequently acts on the psychological well-being of the individual by mediating, among others, the reactions of stress and anxiety. From a specifically neuroethical point of view, according to some scholars, the particular composition of the microbiome—qua microbial community—can have consequences on the traditional idea of human individuality. Another neuroethical aspect concerns the reception of this new knowledge in relation to clinical applications. In fact, attention to the balance of the microbiome—which includes eating behavior, the use of psychobiotics and, in the treatment of certain diseases, the use of fecal microbiota transplantation—may be limited or even prevented by a biased negative attitude. This attitude derives from a prejudice related to everything that has to do with the organic processing of food and, in general, with the human stomach and intestine: the latter have traditionally been regarded as low, dirty, contaminated and opposed to what belongs to the mind and the brain. This biased attitude can lead one to fail to adequately consider the new anthropological conceptions related to the microbiome, resulting in a state of health, both physical and psychological, inferior to what one might have by paying the right attention to the knowledge available today. Shifting from the ubiquitous high-low metaphor (which is synonymous with superior-inferior) to an inside-outside metaphor can thus be a neuroethical strategy to achieve a new and unbiased reception of the discoveries related to the microbiome.

In this paper, the author argues that Joseph Fins’ mosaic decisionmaking model for brain-injured patients is untenable. He supports this claim by identifying three problems with mosaic decisionmaking. First, that it is unclear whether a mosaic is a conceptually adequate metaphor for a decisionmaking process that is intended to promote patient autonomy. Second, that the proposed legal framework for mosaic decisionmaking is inappropriate. Third, that it is unclear how we ought to select patients for participation in mosaic decisionmaking.

The author considers the role of narratives, specifically end-of-life narratives, in medical education. After addressing the role of indexing and other neurological explanations for the validity of narratives in the classroom, she focuses on one recent memoir that explores the medical experience of an ALS patient. The advantages of using narratives, including the understanding of the patients’ perspective and the development of empathy, are two important reasons to adopt this approach.

Healthy volunteers (HVs) who participate in clinical trials are a vulnerable group that deserves specific protection. We assessed the number and types of studies that involve HVs around the world and outline the methodological barriers to their analysis. We found that tens of thousands of HVs are involved every year in clinical trials in a large variety of countries and that the overwhelming majority of studies are not “first-in-human” but pharmacokinetic studies. The two cornerstones for both ethical and safe participation of HVs in clinical trials are properly obtained informed consent and a minimization of exposure to risk, in particular by avoiding concealed participation in multiple trials. To minimize the risk of exploitation of HVs and their exposure to risk, we propose ways to ensure genuine informed consent, and advocate setting up national healthy volunteer registries as established in France and the U.K.

Research into the development of stem cell-derived (SCD) gametes in humans, otherwise known as in vitro gametogenesis (IVG), is largely motivated by reproductive aims. Especially, the goal of establishing genetic parenthood by means of SCD-gametes is considered an important aim. However, like other applications in the field of assisted reproduction, this technology evokes worries about the possibility of creating so-called ‘designer babies.’ In this paper, we investigate various ways in which SCD-gametes could be used to create such preference-matched offspring, and what this would mean for the acceptability of IVG, if it is premised that it is morally problematic to ‘design’ offspring. We argue that IVG might facilitate the creation of preference-matched offspring, but conclude that this should not undermine the moral acceptability of IVG altogether—even if one concedes the premise that creating ‘designer babies’ is morally problematic. In the light of this, we also point at a possible inconsistency for a position that condemns the creation of ‘designer offspring,’ while accepting the various endeavors to have genetically related offspring.

Health research is generally undertaken to resolve existing health problems or enhance existing solutions. Research ethics committees have been the main governance tool for research for more than half a century. Their role is to ensure that research is undertaken ethically. To close the increasing gap between science and society, other governance tools are required. The European Commission recommends and actively promotes the policy of responsible research and innovation (RRI). In addition to sound research ethics, a key feature of RRI is the involvement of different societal stakeholders throughout the research process.

But how accepted is the involvement of societal stakeholders in the research of small- and medium-sized enterprises (SMEs) in the health care sector? This question is examined based on 18 in-depth interviews with private health care industry representatives from across Europe in companies focusing on developing medical device technology. Findings suggest that SMEs are reluctant to undertake research involving patients, especially in the early stages of the research and innovation process. For some SMEs this is due to concerns about the dangers of raising expectations they cannot meet, while for others the main concerns are increasing costs and producing less competitive products. Implications of the research findings are discussed.

It is commonplace to observe that science often outstrips the ability of society to monitor, supervise and regulate it. A recent challenge in this regard concerns Learning Healthcare Systems, an initiative to collect data and test hypotheses across clinical settings, and therefore to a larger degree than before. Some argue that the line between research and clinical practice is becoming blurred, and that existing regulation seems to obstruct low risk research. They propose the creation of a new ethical framework for Learning Healthcare Systems, to speed up research. This paper opposes that view, and argues that Learning Healthcare Systems do not blur or remove the line between research and practice, and will not result in a single set of regulations for all kinds of biomedical research. The authors suggest that a large proportion of Learning Healthcare System activities resemble public health surveillance to a significant extent. Therefore, they propose that these activities should be organized in accordance with the same ethical principles as public health surveillance, specifically that Learning Healthcare Systems should rest on the principles of comprehensiveness, transparency, and public accountability.

Many teaching hospitals in the United States were founded on philanthropic principles and aimed to aid the urban poor and underserved. However, as times have changed, there has been a divide created between the urban poor and teaching hospitals. There is a plethora of reasons why this is the case. This paper will specifically focus on the histories of ten hospitals and medical schools and the effect that white flight, segregation, elitism, and marginalization had on healthcare institutions all over the United States. It will call for a reexamination of the values of Ivy League and Ivy Plus teaching hospitals and medical schools and for them to take an intentional look into their communities.

Anthony is a fourth-year medical student, currently on service during an away surgery rotation. He is rounding with a first-year intern, Dr. Lovett, and the attending, Dr. Todd. They stop outside the room of Mr. Turpin, a 54-year-old male who has recently had a toe amputation due to uncontrolled diabetes mellitus. His chart lists him as a drug-seeker managed for chronic pain. As such, his analgesics are being closely monitored. Before entering the room, Dr. Lovett mentions that the patient had been irritated the night prior, complaining of uncontrolled pain, and upset at staff for refusing increased pain medication. Dr. Todd knows this, remarking that Mr. Turpin has a history of being a “difficult patient.”

Cross-sectorial, dynamic, and innovative partnerships are essential to resolve the challenges of humankind in the 21st century. At the same time, trust in each other’s integrity and good will is a precondition for the solution of any complex problem, and certainly for the success of the United Nations Sustainable Development Agenda. Experience shows that a nation’s economic and social success is at its greatest if, and when, there is cooperation and even cocreation involving a fair division of labor and responsibility among the different societal stakeholders. This paper uses Ralf Dahrendorf’s seminal work on obligations, as well as the European Commission’s Science with and for Society unit’s definition of responsible research and innovation (RRI), to motivate industry responsibilities to make the world a healthier place.

For individuals whose mental illness impair their ability to accept appropriate care—the depressed, acutely suicidal mother, or the psychotic lawyer too paranoid to eat any food—statutes exist to permit involuntary hospitalization, a temporary override of paternalistic benefice over personal autonomy. This exception to the primacy of personal autonomy at the core of bioethics has the aim of restoring the mental health of the temporarily incapacitated individual, and with it, their autonomy.