David Shaw

We analyzed stable patients’ views regarding synthetic biology in general, the medical application of synthetic biology, and their potential participation in trials of synthetic biology in particular. The aim of the study was to find out whether patients’ views and preferences change after receiving more detailed information about synthetic biology and its clinical applications. The qualitative study was carried out with a purposive sample of 36 stable patients, who suffered from diabetes or gout. Interviews were transcribed verbatim, translated and fully anonymized. Thematic analysis was applied in order to examine stable patients’ attitudes towards synthetic biology, its medical application, and their participation in trials. When patients were asked about synthetic biology in general, most of them were anxious that something uncontrollable could be created. After a concrete example of possible future treatment options, patients started to see synthetic biology in a more positive way. Our study constitutes an important first empirical insight into stable patients’ views on synthetic biology and into the kind of fears triggered by the term “synthetic biology.” Our results show that clear and concrete information can change patients’ initial negative feelings towards synthetic biology. Information should thus be transmitted with great accuracy and transparency in order to reduce irrational fears of patients and to minimize the risk that researchers present facts too positively for the purposes of persuading patients to participate in clinical trials. Potential participants need to be adequately informed in order to be able to autonomously decide whether to participate in human subject research involving synthetic biology.

Emergence of novel genome engineering technologies such as clustered regularly interspaced short palindromic repeat has refocused attention on unresolved ethical complications of synthetic biology. Biosecurity concerns, deontological issues and human right aspects of genome editing have been the subject of in-depth debate; however, a lack of transparent regulatory guidelines, outdated governance codes, inefficient time-consuming clinical trial pathways and frequent misunderstanding of the scientific potential of cutting-edge technologies have created substantial obstacles to translational research in this area. While a precautionary principle should be applied at all stages of genome engineering research, the stigma of germline editing, synthesis of new life forms and unrealistic presentation of current technologies should not arrest the transition of new therapeutic, diagnostic or preventive tools from research to clinic. We provide a brief review on the present regulation of CRISPR and discuss the translational aspect of genome engineering research and patient autonomy with respect to the “right to try” potential novel non-germline gene therapies.

A range of interventions in dying patients can improve both the possibility of successful organ donation and the likely long-term success of transplantation. The ethical and legal issues surrounding such interventions, which most frequently occur in the context of donation after circulatory determination of death, are complex, controversial and many remain unresolved. This is true with adults, but even more so with children, where the issue of organ donation and premortem interventions to facilitate it, are highly sensitive. Essentially, such interventions are being undertaken in dying children who cannot medically benefit from them, though arguments have been advanced that becoming a donor might be in a child's extended best interest. However, certain interventions carry a potential risk, although small, of direct harm and of course overall objections to child donation after circulatory determination of death per se are still expressed in the literature. But, unlike the case in critically ill adults, those giving permission for such interventions are normally able to fully participate in decision-making, and indeed to consent, to both donation and premortem interventions. We review the issue of the use of premortem interventions in dying children to facilitate organ donation, including decision-making and ethical justification. Individual interventions are then considered, including an ethical analyse of their use. Finally, we recommend an approach using a combination of welfare checklist strategy, coupled with the establishment of an agreed zone of parental discretion about individual interventions which might be used in dying children to increase the possibility of successful organ donation.

Over the last decade, several European countries and the Council of Europe itself have strongly supported the use of advance directives as a means of protecting patients’ autonomy, and adopted specific norms to regulate this matter. However, it remains unclear under which conditions those regulations should apply to people who are placed in correctional settings. The issue is becoming more significant due to the increasing numbers of inmates of old age or at risk of suffering from mental disorders, all of whom might benefit from using advance directives. At the same time, the closed nature of prisons and the disparate power relationships that characterise them mean that great caution must be exercised to prevent care being withdrawn or withheld from inmates who actually want to receive it. This paper explores the issue of prisoners’ advance directives in the European context, starting with the position enshrined in international and European law that prisoners retain all their human rights, except the right to liberty, and are therefore entitled to self-determination regarding health care decisions.

In this article I argue that vagueness concerning consent to post‐mortem organ donation causes considerable harm in several ways. First, the information provided to most people registering as organ donors is very vague in terms of what is actually involved in donation. Second, the vagueness regarding consent to donation increases the distress of families of patients who are potential organ donors, both during and following the discussion about donation. Third, vagueness also increases the chances that the patient's intention to donate will not be fulfilled due to the family's distress. Fourth, the consequent reduction in the number of donated organs leads to avoidable deaths and increased suffering among potential recipients, and distresses them and their families. There are three strategies which could be used to reduce the harmful effects of this vagueness. First, recategorizing the reasons (commonly referred to as ‘overrules’ under the current system) given by families who refuse donation from registered donors would bring greater clarity to donation discussions. Second, people who wish to donate their organs should be encouraged to discuss their wishes in detail with their families, and to consider recording their wishes in other ways. Finally, the consent system for organ donation could be made more detailed, ensuring both that more information is provided to potential donors and that they have more flexibility in how their intentions are indicated; this last strategy, however, could have the disadvantage of discouraging some potential donors from registering.

Beauchamp and Childress’ definition of autonomous decision‐making includes the conditions of intentionality, understanding, and non‐control. In genetics, however, a relational conception of autonomy has been increasingly recognized. This article aims to empirically assess aspects of social influence in genetic testing decision‐making and to connect these with principlist and relational theories of autonomy. We interviewed 18 adult genetic counsellees without capacity issues considering predictive genetic testing for cancer predisposition for themselves and two counselling physicians in Switzerland. We conducted a qualitative analysis, building on a grounded theory study about predictive genetic testing decision‐making. We found that some participants agreed to predictive genetic testing predominantly because relatives wanted them to do it, with some even acting contrary to their own convictions. Others, in contrast, based their decision on purely individualistic reasons but expressed difficulties in explaining their decision to their social environment. Healthcare professionals had a critical influence on decision‐making in many cases without being manipulative, as perceived by counsellees. Still, cases of coercion and social pressure occurred within social relationships. In conclusion, predictive genetic testing decision‐making includes relational and individualistic aspects, and both are compatible with autonomous decision‐making. While the principlist and relational notions of autonomy compete on a theoretical level, they are two sides of the same coin when used as analytical lenses for genetic testing decision‐making. Social acceptance of refusal of testing should be improved to mitigate social pressure. Individuals should be encouraged to decide for themselves how much their social environment influences their decision regarding predictive genetic testing.

Objectives The study uses a qualitative empirical method to define Health Research for Development. This project explores the perspectives of stakeholders in an international health research partnership operating in Ghana and Tanzania. Methods We conducted 52 key informant interviews with major stakeholders in an international multicenter partnership between GlaxoSmithKline and the global health nonprofit organisation PATH and its Malaria Vaccine Initiative program,. The respondents included teams from four clinical research centres and various collaborating partners. This paper analyses responses to the question: What is Health Research for Development? Results Based on the stakeholders’ experience the respondents offered many ways of defining Health Research for Development. The responses fell into four broad themes: i) Equitable Partnerships; ii) System Sustainability; iii) Addressing Local Health Targets, and iv) Regional Commitment to Benefit Sharing. Conclusion Through defining Health Research for Development six key learning points were generated from the four result themes: 1) Ensure there is local research leadership working with the collaborative partnership, and local healthcare system, to align the project agenda and activities with local research and health priorities; 2) Know the country-specific context - map the social, health, legislative and political setting; 3) Define an explicit development component and plan of action in a research project; 4) Address the barriers and opportunities to sustain system capacity. 5) Support decentralised health system decision-making to facilitate the translation pathway; 6) Govern, monitor and evaluate the development components of health research partnerships. Overall, equity and unity between partners are required to deliver health research for development.

Precision medicine is an emerging approach to individualized care. It aims to help physicians better comprehend and predict the needs of their patients while effectively adopting in a timely manner the most suitable treatment by promoting the sharing of health data and the implementation of learning healthcare systems. Alongside its promises, PM also entails the risk of exacerbating healthcare inequalities, in particular between ethnoracial groups. One often-neglected underlying reason why this might happen is the impact of structural racism on PM initiatives. Raising awareness as to how structural racism can influence PM initiatives is paramount to avoid that PM ends up reproducing the pre-existing health inequalities between different ethnoracial groups and contributing to the loss of trust in healthcare by minority groups. We analyse three nodes of a process flow where structural racism can affect PM’s implementation. These are: the collection of biased health data during the initial encounter of minority groups with the healthcare system and researchers, the integration of biased health data for minority groups in PM initiatives and the influence of structural racism on the deliverables of PM initiatives for minority groups. We underscore that underappreciation of structural racism by stakeholders involved in the PM ecosystem can be at odds with the ambition of ensuring social and racial justice. Potential specific actions related to the analysed nodes are then formulated to help ensure that PM truly adheres to the goal of leaving no one behind, as endorsed by member states of the United Nations for the 2030 Agenda for Sustainable Development. Structural racism has been entrenched in our societies for centuries and it would be naïve to believe that its impacts will not spill over in the era of PM. PM initiatives need to pay special attention to the discriminatory and harmful impacts that structural racism could have on minority groups involved in their respective projects. It is only by acknowledging and discussing the existence of implicit racial biases and trust issues in healthcare and research domains that proper interventions to remedy them can be implemented.

BackgroundA patient who fulfils the due diligence requirements for euthanasia, and is medically suitable, is able to donate his organs after euthanasia in Belgium, the Netherlands and Canada. Since 2012, more than 70 patients have undergone this combined procedure in the Netherlands. Even though all patients who undergo euthanasia are suffering hopelessly and unbearably, some of these patients are nevertheless willing to help others in need of an organ. Organ donation after euthanasia is a so-called donation after circulatory death (DCD), Maastricht category III procedure, which takes place following cardiac arrest, comparable to donation after withdrawal of life sustaining therapy in critically ill patients. To minimize the period of organ ischemia, the patient is transported to the operating room immediately after the legally mandated no-touch period of 5 min following circulatory arrest. This means that the organ donation procedure following euthanasia must take place in the hospital, which appears to be insurmountable to many patients who are willing to donate, since they already spent a lot of time in the hospital. Case presentationThis article describes the procedure of organ donation after euthanasia starting at home (ODAEH) following anesthesia in a former health care professional suffering from multiple system atrophy. This case is unique for at least two reasons. He spent his last conscious hours surrounded by his family at home, after which he underwent general anaesthesia and was intubated, before being transported to the hospital for euthanasia and organ donation. In addition, the patient explicitly requested the euthanasia to be performed in the preparation room, next to the operating room, in order to limit the period of organ ischemia due to transport time from the intensive care unit to the operating room. The medical, legal and ethical considerations related to this illustrative case are subsequently discussed.ConclusionsOrgan donation after euthanasia is a pure act of altruism. This combined procedure can also be performed after the patient has been anesthetized at home and during transportation to the hospital.

In this article, I describe and analyse the proposed new International Committee of Medical Journal Editors form for disclosing conflicts of interest and conclude that it has many flaws. The form does not mention ‘conflicts of interest’ even once in either its body or its title, it introduces a conceptually confused categorisation of different potential conflicts and it ignores future conflicts and intellectual biases. Finally, many of the authors of the new form have themselves failed to declare relevant potential conflicts of interest.

This article provides a systematic analysis of the proposal to use Covid‐19 vaccination status as a criterion for admission of patients with Covid‐19 to intensive care units (ICUs) under conditions of resource scarcity. The general consensus is that it is inappropriate to use vaccination status as a criterion because doing so would be unjust; many health systems, including the UK National Health Service, are based on the principle of equality of access to care. However, the analysis reveals that there are several unique features of Covid vaccination status in the context of a pandemic that make this issue disanalogous to cases (such as lung cancer caused by smoking) discussed previously. First, there is equality in access to care at the point of vaccination; the unvaccinated refuse the offer of preventive care when they decline vaccination, weakening their claim to ongoing care if they become ill (this is qualitatively different from ‘poor lifestyle choices’ such as smoking). Second, the decision of one person to refuse vaccination substantially increases the risk that they will become seriously ill and need ICU care; the person who chooses not to get vaccinated thus potentially increases the pressure on intensive care bed provision, as well as increasing the risk that he or she will infect others who in turn might end up needing ICU care. Third, justice cuts both ways, and giving unvaccinated patients equal priority may itself be unjust when other patients have reduced their risk of ending up on the ICU by getting vaccinated.

Emerging biotechnology may soon allow the creation of genetically human organs inside animals, with non-human primates and pigs being the best candidate species. This prospect raises the question of whether creating organs in primates in order to then transplant them into humans would be more acceptable than using them for research. In this paper, we examine the validity of the purported moral distinction between primates and other animals, and analyze the ethical acceptability of using primates to create organs for human use.

In this Current Controversy article, I describe and analyse the imminent move to a system of deemed consent for deceased organ donation in England and similar planned changes in Scotland, in light of evidence from Wales, where the system changed in 2015. Although the media has tended to focus on the potential benefits and ethical issues relating to the main change from an opt-in default to an opt-out one, other defaults will also change, while some will remain the same. Interaction of these other defaults with the principal one raise several ethical issues that may complicate efforts to use deemed consent to increase donation rates. Most significantly, changing the main default will have the effect of changing the default for patients' families, who play a vital role in the consent process.

Many ethical issues are posed by public health interventions. Although abstract theorizing about these issues can be useful, it is the application of ethical theory to real cases which will ultimately be of benefit in decision-making. To this end, this paper will analyse the ethical issues involved in Childsmile, a national oral health demonstration programme in Scotland that aims to improve the oral health of the nation's children and reduce dental inequalities through a combination of targeted and universal interventions. With Scotland's level of dental caries among the worst in Europe, Childsmile represents one of the largest programmes of work aimed at combating oral health inequalities in the UK. The areas of ethical interest include several contrasting themes: reducing health inequalities and improving health; universal and targeted interventions; political values and evidence base; prevention and treatment; and underlying all of these, justice and utility.

Researchers often refer to “research integrity”, “scientific integrity”, “research misconduct”, “scientific misconduct” and “research ethics”. However, they may use some of these terms interchangeably despite conceptual distinctions. The aim of this paper is to clarify what is signified by several key terms related to research integrity, and to suggest clearer conceptual delineation between them. To accomplish this task, it provides a conceptual analysis based upon definitions and general usage of these phrases and categorization of integrity-breaching behaviours in literature and guidelines, including clarification of the different domains and agents involved. In the first part of the analysis, following some initial clarifications, I explore the distinction between internal and external rules of integrity. In the second part, I explore the distinction between integrity and lack of misconduct, before suggesting a recategorisation of different types of integrity breach. I conclude that greater clarity is needed in the debate on research integrity. Distinguishing between scientific and research integrity, reassessing the relative gravity of different misbehaviours in light of this distinction, and recognising all intentional breaches of integrity as misconduct may help to improve guidelines and education.

In this paper, we discuss the largely neglected topic of semantics in medicine and the associated ethical issues. We analyse several key medical terms from the informed perspective of the healthcare professional, the lay perspective of the patient and the patient’s family, and the descriptive perspective of what the term actually signifies objectively. The choice of a particular medical term may deliver different meanings when viewed from these differing perspectives. Consequently, several ethical issues may arise. Technical terms that are not commonly understood by lay people may be used by physicians, consciously or not, and may obscure the understanding of the situation by lay people. The choice of particular medical terms may be accidental use of jargon, an attempt to ease the communication of psychologically difficult information, or an attempt to justify a preferred course of action and/or to manipulate the decision-making process.

Much of the ethical discourse concerning the coronavirus pandemic has focused on the allocation of scarce resources, be it potentially beneficial new treatments, ventilators, intensive care beds, or oxygen. Somewhat ironically, the more important ethical issues may lie elsewhere, just as the more important medical issues do not concern intensive care or treatment for COVID‐19 patients, but rather the diversion towards these modes of care at the expense of non‐Covid patients and treatment. In this article I explore how ethicists can and should prioritize which ethical issues to deal with, and develop a method of triage for identification and prioritization of ethical issues both in the next public health emergency and in bioethics more widely.

We all now know that the novel coronavirus is anything but a common cold. The pandemic has created many new obligations for all of us, several of which come with serious costs to our quality of life. But in some cases, the guidance and the law are open to a degree of interpretation, leaving us to decide what is the ethical course of action. Because of the high cost of some of the obligations, a conflict of interest can arise between what we want to do and what it is right to do. And so, some people choose to respect only the letter of the law, but not the spirit, or not to respect even the spirit of the guidelines. This paper identifies and describes the new obligations imposed on us all by the pandemic, considers their costs in terms of the good life, and provides an ethical analysis of two personal and two public cases in terms of the letter and spirit of the guidance and legislation.

In this article I argue that vagueness concerning consent to post-mortem organ donation causes considerable harm in several ways. First, the information provided to most people registering as organ donors is very vague in terms of what is actually involved in donation. Second, the vagueness regarding consent to donation increases the distress of families of patients who are potential organ donors, both during and following the discussion about donation. Third, vagueness also increases the chances that the patient's intention to donate will not be fulfilled due to the family's distress. Fourth, the consequent reduction in the number of donated organs leads to avoidable deaths and increased suffering among potential recipients, and distresses them and their families. There are three strategies which could be used to reduce the harmful effects of this vagueness. First, recategorizing the reasons given by families who refuse donation from registered donors would bring greater clarity to donation discussions. Second, people who wish to donate their organs should be encouraged to discuss their wishes in detail with their families, and to consider recording their wishes in other ways. Finally, the consent system for organ donation could be made more detailed, ensuring both that more information is provided to potential donors and that they have more flexibility in how their intentions are indicated; this last strategy, however, could have the disadvantage of discouraging some potential donors from registering.

It is widely accepted in clinical ethics that removing a patient from a ventilator at the patient’s request is ethically permissible. This constitutes voluntary passive euthanasia. However, voluntary active euthanasia, such as giving a patient a lethal overdose with the intention of ending that patient’s life, is ethically proscribed, as is assisted suicide, such as providing a patient with lethal pills or a lethal infusion. Proponents of voluntary active euthanasia and assisted suicide have argued that the distinction between killing and letting die is flawed and that there is no real difference between actively ending someone’s life and "merely" allowing them to die. This paper shows that, although this view is correct, there is even less of a distinction than is commonly acknowledged in the literature. It does so by suggesting a new perspective that more accurately reflects the moral features of end-of-life situations: if a patient is mentally competent and wants to die, his body itself constitutes unwarranted life support unfairly prolonging his or her mental life.

In this chapter I consider the narrow and wider benefits of permitting assisted dying in the specific context of organ donation and transplantation. In addition to the commonly used arguments, there are two other neglected reasons for permitting assisted suicide and/or euthanasia: assisted dying enables those who do not wish to remain alive to prolong the lives of those who do, and also allows many more people to fulfill their wish to donate organs after death. In the first part of this chapter I explore the possibility of allowing those who die with assistance to donate their organs and the potential benefits of doing so in countries where some form of assisted dying is legal; in the second part I consider the added force that organ donation considerations bring to the argument in favour of legalizing assisted dying in countries where such practices remain forbidden.

In this article we summarise some previously described proposals for ethical governance of autonomous vehicles, critique them, and offer an alternative solution. Rather than programming cars to react to crash situations in the same way as humans, having humans program pre-set responses for a wide range of different potential scenarios, or applying particular ethical theories, we suggest that decisions should be made jointly between humans and cars. Given that humans lack the requisite processing capacity, and computers lack the necessary ethical capacity, the medical paradigm of advance care planning can be retooled for this new context. Advance car-crash planning provides a way to combine humans’ ethical preferences with the advanced data processing capacities of computers to enable shared decision making in collision situations.