The analysis of data from electronic health records aspires to facilitate healthcare efficiencies and biomedical innovation. There are also ethical, legal and social implications from the handling of sensitive patient information. The paper explores the concerns, expectations and implications of the National Health Service England care.data programme: a national data sharing initiative of linked electronic health records for healthcare and other research purposes. Using Nissenbaum’s contextual integrity of privacy framework through a critical Science and Technology Studies lens, it examines the (...) way technologies and policies are developed to promote sustainability, governance and economic growth as the de facto social values, while reducing privacy to an individualistic preference. The state, acting as a new, central data broker reappropriates public ownership rights and establishes those information flows and transmission principles that facilitate the assetisation of NHS datasets for the knowledge economy. Various actors and processes from other contexts attempt to erode the public healthcare sector and privilege new information recipients. However, such data sharing initiatives in healthcare will be resisted if we continue to focus only on the monetary and scientific values of these datasets and keep ignoring their equally important social and ethical values. (shrink)

The intellectual property regimes we have currently in place are heavily under attack. One of the points of criticism is the interaction between two elements of article 27 of the Universal Declaration of Human Rights, the widely discussed issue of being able to benefit from scientific progress and the less argued for position of having a right to take part in scientific enterprises. To shine light on the question if we should balance the two elements or prioritize one of them, (...) an exploration will be offered on how benefiting from scientific progress and the ability to participate in the advancement of science relate to securing human capabilities. A different perspective to the question will be gained by identifying the problem as an issue of misrecognition, especially the failure to recognize many willing collaboration partners in scientific research as peers. Lastly, I will argue that cooperative justice requires that if we have an innovation incentive system that disproportionally benefits one particular group, a certain duty to counterbalance this advantage exists when we are relying on mutual cooperation for the recognition of intellectual property rights. (shrink)

The World Health Organisation encourages that blood donation becomes voluntary and unremunerated, a system already operated in the UK. Drawing on public documents and videos, this paper argues that blood donation is regarded and presented as altruistic and supererogatory. In advertisements, donation is presented as something undertaken for the benefit of others, a matter attracting considerable gratitude from recipients and the collecting organisation. It is argued that regarding blood donation as an act of supererogation is wrongheaded, and an alternative account (...) of blood donation as moral obligation is presented. Two arguments are offered in support of this position. First, the principle of beneficence, understood in a broad consequentialist framework obliges donation where the benefit to the recipient is large and the cost to the donor relatively small. This argument can be applied, with differing levels of normativity, to various acts of donation. Second, the wrongness of free riding requires individuals to contribute to collective systems from which they benefit. Alone and in combination these arguments present moral reasons for donation, recognised in communication strategies elsewhere. Research is required to evaluate the potential effects on donation of a campaign which presents blood donation as moral obligation, but of wider importance is the recognition that other-regarding considerations in relation to our own as well as others’ health result in a range not only of choices but also of obligations. (shrink)

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

:This essay brings together work I have done over the past 10 years: on the nature of ethics, on the purpose of ethics, and on its foundations in a way that, I hope, as E.M. Forster put it, connects “the prose and the passion.” I deploy lessons learned in this process to identify and face what I believe to be crucial challenges to science and to freedom. Finally I consider threats to freedom of a different sort, posed by the creation (...) and dissemination of “alternative facts” and by what is sometimes called “super” or “full” artificial intelligence. (shrink)

This paper reflects on some amendments to the Declaration of Helsinki in 2008. It focuses on former paragraphs 5 (now 6) and 19 (now 17). Paragraph 5 suggested that the wellbeing of research participants should take precedence over the interests of science and society. Paragraph 6 now proposes that it should take precedence over all other interests. Paragraph 19, and the new paragraph 17, suggest that research involving the members of a disadvantaged population is only justified if the clinical trial (...) is likely to benefit them. In both cases, the recommendation is that the interests of the research subjects should prevail over the interests of third parties. This paper assesses the plausibility of these statements, and in order to do so, considers debates on the moral duty to participate in biomedical research. It is argued that, even if seen in the context of the Declaration as a whole, the statements contained in these paragraphs risk offering a misleading portrait of science and risk eroding some of the ethical principles that should form the basis of a satisfactory shared life, such as altruism and responsibility for our fellows. (shrink)

Our starting point in this article is the debate between John Harris and Iain Brassington on whether or not there is a duty to take part in scientific research. We consider the arguments that have been put forward based on fairness and a duty to rescue, and suggest an alternative justification grounded in a hypothetical agreement: that is, because effective healthcare cannot be taken for granted, but requires continuous medical research, and nobody knows what kind of healthcare they will need, (...) participating in research should be viewed from the perspective of a social contract, based on our mutual need for medical advances. (shrink)

Biomedical research has brought to the fore the issue of which rights and duties we have to each other and society. Several scholars have advocated reframing the notion of participation, arguing that we have a moral duty to participate in research from which we all benefit. However, less attention has been paid to how we justify and defend the concept of self-determination and what the implications are in a biomedical setting. The author discusses the value and importance of self-determination on (...) the basis of the framework of the liberal-communitarian debate. Biobank research is used as an example of a project wherein, through our participation, we confirm our sense of belonging to society and acknowledge our mutual dependence on each other. We need a richer concept of self-determination that encompasses both liberal and communitarian insights in order to make sense of the value we attach to self-determination. (shrink)

New health technologies are rapidly emerging from various areas of bioscience research, such as gene editing, regenerative medicine and synthetic biology. These technologies raise promising medical possibilities but also a range of ethical considerations. Apart from the issues involved in considering whether novel health technologies can or should become part of mainstream medical treatment once established, the process of research translation to develop such therapies itself entails particular ethical concerns. In this paper I use synthetic biology as an example of (...) a new and largely unexplored area of health technology to consider the ways in which novel health technologies are likely to emerge and the ethical challenges these will present. I argue that such developments require us to rethink conventional attitudes towards clinical research, the roles of doctors/researchers and patients/participants with respect to research, and the relationship between science and society; and that a broader framework is required to address the plurality of stakeholder roles and interests involved in the development of treatments based on novel technologies. (shrink)

Biomedical research involving human participants is highly regulated and subject to stringent ethical requirements. Clinical research ethics, regulation and policy have tended to focus almost exclusively on the protection of participants' interests against harms that might result from taking part in research. Less consideration, however, has been given to the interests that patients may themselves have in research participation, even in trials that may be beyond the bounds of current clinical research practice. In this paper, we consider the case of (...) a suggested extension to clinical trial protocols to explore the ethics of participation in ‘risky’ research. We argue that patients may have a strong interest in taking part in research, and that even when greater-than-usual risks may be present, such research can be both ethically and scientifically justified. Finally, we suggest that there might be scope in some cases to assert a right to participate in research, and that the possibility of such a right merits further consideration. (shrink)

Background: The internationalization of clinical studies requires a shared understanding of the fundamental ethical values guiding clinical studies. It is important that these values are not only embraced at the legal level but also adopted by clinicians themselves during clinical studies. Objective: Our goal is to provide an insight on how clinicians in Germany and Poland perceive and identify the different ethical issues regarding informed consent in clinical studies. Methods: To gain an understanding of how clinicians view clinical studies in (...) the countries they work in, we carried out semi-structured problem-centered interviews per telephone in Poland (n = 6) and Germany (n = 6). Our interviewees concentrated on three main topics: an appraisal of the normative framework, challenges in the information process and the protection of all participants in clinical studies. Results: Clinicians generally supported the normative framework, even though they considered it quite complex. In the two study countries, a widely noted dilemma in the information process was whether to overburden participants with extensive information or risking leaving out important facts. Clinicians were ready to exclude larger population groups from participating in clinical studies when the information process could not be carried out with standard procedures or when their inclusion was ethically sensitive. Conclusion: Clinicians need to gain a better understanding of the consequences of excluding larger population groups form participating in clinical studies. They should seek assistance in improving the information process for the inclusion of underrepresented groups in clinical studies. (shrink)

Intuitively we feel that we ought (to attempt) to save the lives, or ameliorate the suffering, of identifiable individuals where we can. But this comes at a price. It means that there may not be any resources to save the lives of others in similar situations in the future. Or worse, there may not be enough resources left to prevent others from ending up in similar situations in the future. This chapter asks whether this is justifiable or whether we would (...) be better served focusing on public health in the form of preventative medicine. It looks briefly at the supposed difference between benefiting individuals and benefiting populations by considering the difference between interventions aimed at ‘rescue’ and those which are preventative. It then considers the rule of rescue in the health care setting, and looks at some of the reasons stemming from this that we might have for allocating resources to rescue interventions. If these reasons do not provide adequate justification for preferring these types of interventions, then the implication is that our current mode of resource allocation may need to be revised in favour of a more public health-oriented model. (shrink)