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.

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.

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.

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.

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.

Gene editors such as CRISPR could be used to create stronger, faster, or more resilient nonhuman animals. This is of keen interest to people who breed, train, race, and profit off the millions of animals used in sport that contribute billions of dollars to legal and illegal economies across the globe. People have tried for millennia to perfect sport animals; CRISPR proposes to do in one generation what might have taken decades previously. Moreover, gene editing may facilitate enhancing animals’ capacities beyond their typical limits. This paper describes the state of animal use and engineering for sport, examines the moral status of animals, and analyzes current and future ethical issues at the intersection of animal use, gene editing, and sports. We argue that animal sport enthusiasts and animal welfarists alike should be concerned about the inevitable use of CRISPR in sport animals. Though in principle CRISPR could be used to improve sport animals’ well-being, we think it is unlikely in practice to do so.

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.

The advent of CRISPR-Cas9 technology has increased attention, and contention, regarding the use and regulation of genome editing technologies. Public discussions continue to give evidence of this debate falling back into the previous polarized positions of technological enthusiasts versus those who are more cautious in their approach. One response to this contentious relapse could be to view this promising and problematic new technology from a radically different perspective that embraces both the excitement of this technological advance and the prudence necessary to use it well. The thought of Teilhard de Chardin provides this desired perspective, and some insights that may help carry forward public discussions to achieve widely accepted uses and regulations.

This paper considers the relevance of the concept of “eugenics,”—a term associated with some of the most egregious crimes of the twentieth century—to the possibility of editing human genomes. The author identifies some uses of gene editing as eugenics but proposes that this identification does not suffice to condemn them. He proposes that we should distinguish between “morally wrong” practices, which should be condemned, and “morally problematic” practices that call for solutions, and he suggests that eugenic uses of gene editing fall into this latter category. Although when we choose the characteristics of future people we are engaging in morally dangerous acts, some interventions in human heredity should nevertheless be acknowledged as morally good. These morally good eugenic interventions include some uses of preimplantation genetic diagnosis. The author argues that we should think about eugenic interventions in the same way that we think about morally problematic interventions in public health. When we recognize some uses of gene editing as eugenics, we make the dangers of selecting or modifying human genetic material explicit.

In Catholic doctrine, church and state are two different and autonomous institutional subjects, but they are mutually linked. Therefore, a believer, as a citizen, is a subject simultaneously of two legal systems; the state is bound to recognize the confessional dimension of its own members, and the church is called to realize its proper ends within a precise political-social context. The Second Vatican Council (1962–1965) constitutes for the Catholic Church a point of change and renewal. It did not limit itself to affirming the coexistence of the two systems in their independence, but it declared the necessity of a mutual alliance for the good of citizens and believers.

Therefore, the church offers its own contribution to the state, favoring in this way the right to religious liberty; and the state allows the church to establish itself and carry out its proper mission in an institutional form, guaranteeing the protection of the rights of citizens as believers for the free expression of their faith, whether in a private dimension or in an organized form. Vatican II abandons, therefore, the concept of “state religion” in the classic sense of the term, and thus the privilege reserved to one among numerous religious expressions, and opens an authentic collaboration between parties as a prerequisite for the good not only for individual believers and religious organizations, but also for society itself. In particular, religious liberty finds its foundation no longer in the concept of truth (that legitimized the exclusion of other confessions in that they were “not true”), but in the concept of the dignity of the person, which must be protected as such.

During excavations of the Iron Age ringfort of Sandby borg (ad 400–550), the remains of twenty-six unburied bodies were encountered inside and outside the buildings. The skeletons and the archaeological record indicate that after the individuals had died the ringfort was deserted. An osteological investigation and trauma analysis were conducted according to standard anthropological protocols. The osteological analysis identified only men, but individuals of all ages were represented. Eight individuals (31 per cent) showed evidence of perimortem trauma that was sharp, blunt, and penetrating, consistent with interpersonal violence. The location of the bodies and the trauma pattern appear to indicate a massacre rather than a battle. The ‘efficient trauma’ distribution (i.e. minimal but effective violence), the fact that the bodies were not manipulated, combined with the archaeological context, suggest that the perpetrators were numerous and that the assault was carried out effectively. The contemporary sociopolitical situation was seemingly turbulent and the suggested motive behind the massacre was to gain power and control.