Modern health data practices come with many practical uncertainties. In this paper, I argue that data subjects’ trust in the institutions and organizations that control their data, and their ability to know their own moral obligations in relation to their data, are undermined by significant uncertainties regarding the what, how, and who of mass data collection and analysis. I conclude by considering how proposals for managing situations of high uncertainty might be applied to this problem. These emphasize increasing organizational flexibility, (...) knowledge, and capacity, and reducing hazard. (shrink)

This thesis addresses the tension in pragmatic cluster-randomized trials between their social value and the requirement to respect the autonomy of research participants. Pragmatic trials are designed to evaluate the effectiveness of treatments in real-world settings to inform clinical decision-making and promote cost-efficient care. These trials are often embedded into clinical settings and ideally include all patients who would receive the treatments under investigation as a part of routine care. Trialists increasingly adopt cluster-randomized designs—in which intact groups, such as hospitals (...) or clinics, are allocated randomly to study interventions—to simplify the inclusion of all patients. But including all-comers conflicts with the requirement to obtain written informed consent from research participants. Since informed consent is central to respecting patient autonomy, the question arises: how can the ends of autonomy and pragmatism be served simultaneously? Some philosophers argue that patients have an obligation to participate in clinical research and that this may negate consent requirements. I argue that while there may be grounds for a prima facie obligation for patients to participate in clinical research, no compelling argument has demonstrated that the obligation is enforceable. Others assert that broad application of a waiver of consent will facilitate the conduct of pragmatic cluster-randomized trials. I demonstrate that this proposal sharply conflicts with the historical origins of the waiver. I articulate a novel moral foundation for the use of a waiver of consent and show that when trials evaluate treatments delivered directly to patients, the autonomy interests at stake for participants are too substantial to permit its use. My solution draws a distinction between consent requirements in existing policy and consent as an autonomous authorization. As many pragmatic cluster-randomized trials are conducted in primary care settings with no research staff, I argue that patient autonomy can be promoted and protected using clinical-style consent, in which health providers seek verbal informed consent from patients and document it in the electronic health record. This approach has been associated with high rates of recruitment and, thus, may satisfy both requirements for social value and respect for autonomy. (shrink)

In discussions about direct-to-consumer availability of genetic testing, much attention has been given to identifying the various risks and benefits that individuals might incur. For example, upon...

The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research but largely (...) silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations of Research Ethics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promote research that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure that research is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connecting research to the goals of a just social order grounds a framework for assessing and managing research risk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceiving research ethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and international research. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (shrink)

Indigenous Peoples, Consent and Benefit Sharing is the first in-depth account of the Hoodia bioprospecting case and use of San traditional knowledge, placing it in the global context of indigenous peoples’ rights, consent and benefit-sharing. It is unique as the first interdisciplinary analysis of consent and benefit sharing in which philosophers apply their minds to questions of justice in the Convention on Biological Diversity (CBD), lawyers interrogate the use of intellectual property rights to protect traditional knowledge, environmental scientists analyse implications (...) for national policies, anthropologists grapple with the commodification of knowledge and, uniquely, case experts from Asia, Australia and North America bring their collective expertise and experiences to bear on the San-Hoodia case. -/- While much of the focus is on bioprospecting and natural product development, Indigenous Peoples, Consent and Benefit-Sharing also draws important lessons about informed consent and benefit-sharing from the health sciences and sectors such as mining. Policymakers around the world are under significant pressure to resolve the challenges of implementing the CBD. This book’s analysis and recommendations will help them. -/- ‘It is good to see philosophers engaging with the UN Convention on Biological Diversity, and doing so by looking in depth at a real situation in which it has been invoked.’ Peter Singer, Ira W. DeCamp Professor of Bioethics in the University Center for Human Values, Princeton University . (shrink)

One proposal to significantly reduce cardiovascular disease is the idea of administering a ‘polypill’—a combination of drugs that reduce the risk of heart disease and carry few side effects—to everyone over the age of 55. Despite their promise, population strategies like the polypill have not been well-accepted. In this article, I defend the polypill by appealing to fairness. The argument focuses on the need to fairly distribute the costs to individuals. While the fact that population strategies like the polypill impose (...) minor costs on everyone has primarily been used to criticize such strategies, I argue that it gives us a reason to support them. I argue that implementing a population strategy with the polypill contributes to the public good of ‘health system capacity’. I then explain that public goods have widely accepted obligations: they carry an obligation to fairly distribute the costs of the goods and prevent free-riding. Thus, we have at least one pro tanto moral reason to implement the polypill. As such, this article challenges the current literature on the topic, which has largely held adopting population strategies like the polypill to be unjustifiable. (shrink)

Commentators tout the societal benefits of research to conclude that people have a civic duty to participate in it. A review of several problems in research demonstrate the contrary and reveal why claims we are duty-bound to participate in research deter urgently needed efforts to tackle multiple entrenched deficiencies in it.

The language of “participant-driven research,” “crowdsourcing” and “citizen science” is increasingly being used to encourage the public to become involved in research ventures as both subjects and scientists. Originally, these labels were invoked by volunteer research efforts propelled by amateurs outside of traditional research institutions and aimed at appealing to those looking for more “democratic,” “patient-centric,” or “lay” alternatives to the professional science establishment. As mainstream translational biomedical research requires increasingly larger participant pools, however, corporate, academic and governmental research programs (...) are embracing this populist rhetoric to encourage wider public participation. We examine the ethical and social implications of this recruitment strategy. We begin by surveying examples of “citizen science” outside of biomedicine, as paradigmatic of the aspirations this democratizing rhetoric was originally meant to embody. Next, we discuss the ways these aspirations become articulated in the biomedical context, with a view to drawing out the multiple and potentially conflicting meanings of “public engagement” when citizens are also the subjects of the science. We then illustrate two uses of public engagement rhetoric to gain public support for national biomedical research efforts: its post-hoc use in the “care.data” project of the National Health Service in England, and its proactive uses in the “Precision Medicine Initiative” of the United States White House. These examples will serve as the basis for a normative analysis, discussing the potential ethical and social ramifications of this rhetoric. We pay particular attention to the implications of government strategies that cultivate the idea that members of the public have a civic duty to participate in government-sponsored research initiatives. We argue that such initiatives should draw from policy frameworks that support normative analysis of the role of citizenry. And, we conclude it is imperative to make visible and clear the full spectrum of meanings of “citizen science,” the contexts in which it is used, and its demands with respect to participation, engagement, and governance. (shrink)

While Specific Informed Consent has been the established standard for obtaining consent for medical research for many years, it does not appear suitable for large-scale biobank and health data research. Thus, alternative forms of consent have been suggested, based on a variety of ethical background assumptions. This article identifies five main ethical perspectives at stake. Even though Tiered Consent, Dynamic Consent and Meta Consent are designed to the demands of the self-determination perspective as well as the perspective of research as (...) a public good, they are still also criticized from both perspectives. In addition, criticisms based on concerns of justice, participation and democratic deliberation, and relational concerns have been levelled at each of the models. As all of these perspectives have valid points to make, the task at hand lies in balancing these ethical perspectives. What constitutes an adequate balancing depends on contextual factors. These factors include digital infrastructure and digital literacy, data safety regulation, good scientific and clinical practice, transparent debates on ethically relevant features of research, social inequalities, anti-discrimination laws and practices, trust in health care institutions and recognition of patient preferences, and consensus on unethical research. We argue that the role of context in determining acceptable models of consent puts the ethical importance of models of consent into perspective. Since altering contextual factors can help to live up to the ethical concerns at stake in debates about models of consent, opting for such a shift of focus comes without ethical loss. (shrink)

Many health care systems include programs that allow patients in exceptional circumstances to access medical interventions of as yet unproven benefit. In this article we consider the ethical justifications for—and demands on—these special access programs (SAPs). SAPs have a compassionate basis: They give patients with limited options the opportunity to try interventions that are not yet approved by standard regulatory processes. But while they signal that health care systems can and will respond to individual suffering, SAPs have several disadvantages, including (...) the potential to undermine regulatory and knowledge-generation structures that constitute significant public goods. The “balance” between these considerations depends in part on how broadly SAPs are used, but also on whether SAPs can be made to contribute to the generation of knowledge about the effects of health interventions. We argue that patients should usually be required to contribute outcome data while using SAPs. (shrink)

Informed consent bears significant relevance as a legal basis for the processing of personal data and health data in the current privacy, data protection and confidentiality legislations. The consent requirements find their basis in an ideal of personal autonomy. Yet, with the recent advent of the global pandemic and the increased use of eHealth applications in its wake, a more differentiated perspective with regards to this normative approach might soon gain momentum. This paper discusses the compatibility of a moral duty (...) to share data for the sake of the improvement of healthcare, research, and public health with autonomy in the field of data protection, privacy and medical confidentiality. It explores several ethical-theoretical justifications for a duty of data sharing, and then reflects on how existing privacy, data protection, and confidentiality legislations could obstruct such a duty. Consent, as currently defined in the General Data Protection Regulation – a key legislative framework providing rules on the processing of personal data and data concerning health – and in the recommendation of the Council of Europe on the protection of health-related data – explored here as soft-law – turns out not to be indispensable from various ethical perspectives, while the requirement of consent in the General Data Protection Regulation and the recommendation nonetheless curtails the full potential of a duty to share medical data. Also other legal grounds as possible alternatives for consent seem to constitute an impediment. (shrink)

Empirical evidence suggests that while people hold the capacity to control their data in high regard, they increasingly experience a loss of control over their data in the online world. The capacity to exert control over the generation and flow of personal information is a fundamental premise to important values such as autonomy, privacy, and trust. In healthcare and clinical research this capacity is generally achieved indirectly, by agreeing to specific conditions of informational exposure. Such conditions can be openly stated (...) in informed consent documents or be implicit in the norms of confidentiality that govern the relationships of patients and healthcare professionals. However, with medicine becoming a data-intense enterprise, informed consent and medical confidentiality, as mechanisms of control, are put under pressure. In this paper we explore emerging models of informational control in data-intense healthcare and clinical research, which can compensate for the limitations of currently available instruments. More specifically, we discuss three approaches that hold promise in increasing individual control: the emergence of data portability rights as means to control data access, new mechanisms of informed consent as tools to control data use, and finally, new participatory governance schemes that allow individuals to control their data through direct involvement in data governance. We conclude by suggesting that, despite the impression that biomedical big data diminish individual control, the synergistic effect of new data management models can in fact improve it. (shrink)

Human body material removed post mortem is a particularly valuable resource for research. Considering the efforts that are currently being made to study the biochemical processes and possible genetic causes that underlie cancer and cardiovascular and neurodegenerative diseases, it is likely that this type of research will continue to gain in importance. However, post mortem procurement of human body material for research raises specific ethical concerns, more in particular with regard to the consent of the research participant. In this paper, (...) we attempt to determine which consent regime should govern the post mortem procurement of body material for research. In order to do so, we assess the various arguments that could be put forward in support of a duty to make body material available for research purposes after death. We argue that this duty does in practice not support conscription but is sufficiently strong to defend a policy of presumed rather than explicit consent. (shrink)

Rosamond Rhodes and John Harris have both recently argued that we all have a general moral duty to participate in medical research. However, neither Rhodes' nor Harris' arguments in support of this obligation stand up to scrutiny, and severe and convincing criticism has been levelled against their case. Still, to refute their arguments is not to refute the conclusion. There seems to be some truth in the view that when people are asked to take part in medical research, their choice (...) is not completely morally neutral. In this article, we argue that the proper question to ask is when, rather than if, a certain moral duty to volunteer for medical research can be appealed to. To answer this question, we need a denser description of relevant research projects and their context rather than just describing medical research in general. Drawing on our study of participants in the Norwegian HUNT biobank, we use the normative implications of the Norwegian concept «dugnad» as an analogy to discuss the requirement of providing neutral information to potential biobank participants in order to promote their free and informed decision as to whether or not to take part. We suggest that normative recruitment is not just a question of principles and ethics. It is also a question of research design and the creation of the common good in the community where the research takes place. (shrink)

The purpose of this paper is to unveil the incompleteness of John Harris' view that parents have a moral obligation to genetically enhance their unborn children. Specifically, here two main conclusions are proposed: (1) at present there exist insufficient empirical data for determining whether prenatal genetic enhancement (PGE) is a moral obligation on prospective parents. Although the purpose of PGE research would be to determine the extent to which PGE is safe and effective, the task of determining the veracity of (...) Harris' premises is impossible to achieve without begging the question; we would be forced to assume the moral permissibility of PGE in order to generate the data that are required for determining its moral standing. So, given this empirical blindness, consequence-based normative frameworks like that of Harris cannot determine the moral standing of PGE, but merely push the question of the moral standing of PGE back a step, without offering any plausible and morally endorsable recourse for how to answer it; (2) even if PGE research were legal, which it is not, parents nevertheless have good reason not to consent to it for their children, especially as participants in the first wave(s) of such research. (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)

This paper highlights the need for researchers and research ethics committees to look at the implications of a research study beyond the immediate research question, and the dignity, safety and wellbeing of research subjects, going on to consider whether the results of the study could be detrimental, for example, to more vulnerable groups in society. Although the case studies described come from workplace-based psychosocial research, it is suggested that the lessons drawn from these could be applied more generally.

In the first five of these articles I have questioned the justice, and effectiveness, of total dependence in clinical research on willing volunteers. I have explored ways that might better and more equitably spread the burden of participating in clinical research as subjects of it. Here I consider this question: if consent is the barrier, must we regard consent as indispensable?

In a series of articles, I set out my belief that investigators and subjects of research should work together in a partnership based in shared aims. Such a relationship – quite different from what is usual today – would impose duties on both partners. In earlier papers I explored the origin and nature of the duties that would fall on patients; here I examine their limits.

In a series of articles, I argue for a different relationship between investigators and subjects of clinical research – one that is based on partnership in shared aims. This would require significant behavioural change since any relationship of this nature requires each partner to recognise their duties within it. This third essay examines the duties that would fall on patients in this partnership.

This series of articles argues for a different relationship between investigators and subjects of clinical research based on partnership in shared aims and recognition, by each, of their duties within this partnership. This second essay describes how those duties arise and explores the basis on which, and by and to whom, they are owed. The conclusion that patients have duties in research raises a number of moral issues which, ultimately, question the concept of consent. Discussion of these will be continued (...) in future articles. (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)

A recent article on the front page of The Independent reported that the genetic ‘manipulation’ of IVF embryos is to start in Britain, using a new revolutionary gene-editing technique, called Crispr/Cas9. About three weeks later, on the front page of the same newspaper, it was reported that the National Health Service faces a one billion pound deficit only 3 months into the new year. The hidden connection between these reports is that gene editing could be used to solve issues related (...) to health care allocation. Improving the health of future generations might coincide with public health goals; it might improve the health of individuals and communities, and, if successful, might be seen as a public good. However, enhancing future generations will require In Vitro Fertilisation and Pre-implantation Genetic Diagnosis. Remarkably, the necessary involvement of women in an enhancing scenario has not been discussed by its proponents. The present discourse on moral obligations of future generations, although not referring to women, seems to imply that women might be required, morally, if not legally, to reproduce with IVF. Enhancing future generations will be gendered, unless the artificial womb is developed. These are challenging issues that require a wider perspective, of both women and men. Despite the lack of a unified feminist conclusion in the discussions about the merits and risks of human genome modification, there is an urgent need to clarify the role of women in this scenario. (shrink)

Two protechnology arguments, the “hopeful principle” and the “automatic escalator”, often used in bioethics, are identified and critically analysed in this paper. It is shown that the hopeful principle is closely related to the problematic precautionary principle, and the automatic escalator argument has close affinities to the often criticised empirical slippery slope argument. The hopeful principle is shown to be really hopeless as an argument, and automatic escalator arguments often lead nowhere when critically analysed. These arguments should therefore only be (...) used with great caution. (shrink)

Using the case of Ebola Virus Disease as an example, this paper shows why patients at high risk for death have a defensible moral claim to access unregistered medical interventions, without having to enrol in randomized placebo controlled trials.A number of jurisdictions permit and facilitate such access under emergency circumstances. One controversial question is whether patients should only be permitted access to UMI after trials investigating the interventions are fully recruited. It is argued that regulatory regimes should not prioritise trial (...) recruitment over patient access, even if this results in drug research and development delays.We describe how the moral duty to rescue impacts on others' duties to oblige patients seeking emergency access to unregistered medical interventions. The view that eligible patients are owed the provision of access to UMI regardless of their willingness to enrol in a randomised controlled trial is defended. (shrink)

There are ethical obligations to conduct research that contributes to generalisable knowledge and improves reproductive health, and this should include embryo research in jurisdictions where it is permitted. Often, the controversial nature of embryo research can alarm ethics committee members, which can unnecessarily delay important research that can potentially improve fertility for patients and society. Such delay is ethically unjustified. Moreover, countries such as the UK, Australia and Singapore have legislation which unnecessarily captures low-risk research, such as observational research, in (...) an often cumbersome and protracted review process. Such countries should revise such legislation to better facilitate low-risk embryo research.We introduce a philosophical distinction to help decision-makers more efficiently identify higher risk embryo research from that which presents no more risks to persons than other types of tissue research. That distinction is between future person embryo research and non-future person embryo research. We apply this distinction to four examples of embryo research that might be presented to ethics committees.Embryo research is most controversial and deserving of detailed scrutiny when it potentially affects a future person. Where it does not, it should generally require less ethical scrutiny. We explore a variety of ways in which research can affect a future person, including by deriving information about that person, and manipulating eggs or sperm before an embryo is created. (shrink)

There are ethical obligations to conduct research that contributes to generalisable knowledge and improves reproductive health, and this should include embryo research in jurisdictions where it is permitted. Often, the controversial nature of embryo research can alarm ethics committee members, which can unnecessarily delay important research that can potentially improve fertility for patients and society. Such delay is ethically unjustified. Moreover, countries such as the UK, Australia and Singapore have legislation which unnecessarily captures low-risk research, such as observational research, in (...) an often cumbersome and protracted review process. Such countries should revise such legislation to better facilitate low-risk embryo research. We introduce a philosophical distinction to help decision-makers more efficiently identify higher risk embryo research from that which presents no more risks to persons than other types of tissue research. That distinction is between future person embryo research and non-future person embryo research. We apply this distinction to four examples of embryo research that might be presented to ethics committees. Embryo research is most controversial and deserving of detailed scrutiny when it potentially affects a future person. Where it does not, it should generally require less ethical scrutiny. We explore a variety of ways in which research can affect a future person, including by deriving information about that person, and manipulating eggs or sperm before an embryo is created. (shrink)

The EU offers a suitable milieu for the comparison and harmonisation of healthcare across different languages, cultures, and jurisdictions, which could provide improvements in healthcare standards across the bloc. There are specific ethico-legal issues with the use of data in healthcare research that mandate a different approach from other forms of research. The use of healthcare data over a long period of time is similar to the use of tissue in biobanks. There is a low risk to subjects but it (...) is impossible to gain specific informed consent given the future possibilities for research. Large amounts of data on a subject present a finite risk of re-identification. Consequently, there is a balancing act between this risk and retaining sufficient utility of the data. Anonymising methods need to take into account the circumstances of data sharing to enable an appropriate balance in all cases. There are ethical and policy advantages to exceeding the legal requirements and thereby securing the social licence for research. This process would require the examination and comparison of data protection laws across the trading bloc to produce an ethico-legal framework compatible with the requirements of all member states. Seven EU jurisdictions are given consideration in this critique. (shrink)

Clinicians and health researchers frequently encounter opportunities to rescue people. Rescue cases can generate a moral duty to aid those in peril. As such, bioethicists have leveraged a duty to rescue for a variety of purposes. Yet, despite its broad application, the duty to rescue is under-analyzed. In this paper, we assess the state of theorizing about the duty to rescue. There are large gaps in bioethicists’ understanding of the force, scope, and justification of the two most cited duties to (...) rescue—the individual duty of easy rescue and the institutional rule of rescue. We argue that the duty of easy rescue faces unresolved challenges regarding its force and scope, and the rule of rescue is indefensible. If the duty to rescue is to help solve ethical problems, these theoretical gaps must be addressed. We identify two further conceptions of the duty to rescue that have received less attention—an institutional duty of easy rescue and the professional duty to rescue. Both provide guidance in addressing force and scope concerns and, thereby, traction in answering the outstanding problems with the duty to rescue. We conclude by proposing and propose research priorities for developing accounts of duties to rescue in bioethics. (shrink)

Researchers increasingly rely on large data sets of health information, often linked with biological specimens. In recent years, the argument has been made that obtaining informed consent for conducting records-based research is unduly burdensome and results in ?consent bias.? As a type of selection bias, consent bias is said to exist when the group giving researchers access to their data differs from the group denying access. Therefore, to promote socially beneficial research, it is argued that consent should be unnecessary. After (...) analyzing the biostatistics evidence and bioethics arguments, the article concludes that (1) claims about the amount of consent bias are overstated; (2) commonly used statistical methods usually can account for consent bias; and (3) any residual effects of consent bias are below an acceptable level of imprecision and constitute a reasonable social cost for conducting ethically responsible research. (shrink)

ZusammenfassungEthische Aspekte von Biobanken-basierter Forschung werden zunehmend kontrovers diskutiert. In diesem Artikel wird die Debatte um ethisch angemessene Formen der Einwilligung in Biobanken-basierte Forschung nachgezeichnet. Nach einer Einführung in etablierte Einwilligungsmodelle skizziert der Beitrag kurz die Entwicklung alternativer Ansätze und diskutiert die damit verbundenen ethischen und regulatorischen Herausforderungen. Dabei wird dargestellt, welche ethischen Prinzipien in diesen Diskussionen eine Rolle spielen. Der Beitrag schließt mit einem Ausblick für Deutschland.

Discussions on the ethics and regulation of clinical research have a great deal to say about the responsibilities of investigators, sponsors, research institutions and institutional review boards, but very little about the responsibilities of research participants. In this article, we discuss the responsibilities of participants in clinical research. We argue that competent adult participants are responsible for complying with study requirements and fulfilling other obligations they undertake when they make an informed choice to enrol in a study. These responsibilities are (...) based on duties related to promise-keeping, avoiding harm to one's self or others, beneficence and reciprocity. Investigators and research staff should inform participants about their responsibilities during the consent process, and should stress the importance of fulfilling study requirements. They should address any impediments to compliance, and they may provide participants with financial incentives for meeting study requirements. In very rare cases, coercive measures may be justified to prevent immanent harm to others resulting from non-compliance with study requirements. (shrink)

Over the past few years, a growing number of people have called for reconceptualizing participation in health research as a moral obligation. John Harris argues that seriously debilitating diseases give rise to important needs, and since medical research is necessary to relieve those needs in many circumstances, people are morally obligated to act as research subjects.1 Rosamond Rhodes claims that research participation is a moral obligation for reasons of justice, beneficence, and self-development: because we all benefit significantly from modern medicine, (...) we are all required to do our part in advancing the state of medical knowledge.2 Individuals who reap the benefits of medical knowledge without contributing .. (shrink)

In this article we attempt to answer the question of how the ethical and conceptual framework (ECF) for a learning health‐care system (LHS) affects some of the main controversies in research ethics by addressing five key problems of research ethics: (a) What is the difference between practice and research? (b) What is the relationship between research ethics and clinical ethics? (c) What is the ethical relevance of the principle of clinical equipoise? (d) Does participation in research require a higher standard (...) of informed consent than the practice of medicine? and (e) What ethical principle should take precedence in medicine? These questions allow us to construct two opposite idealized positions on the distinction between research and practice: the integration model and the segregation model of research and practice. We then compare the ECF for an LHS with these two idealized positions. We argue that the ECF for a LHS does not, in fact, solve these problems, but that it is a third, separate position in the relationship between research ethics and clinical ethics. Moreover, we suggest that the ECF for a LHS raises new ethical problems that require additional ethical analysis and justification. Our article contributes to the discussion on the relationship between research ethics and clinical ethics, revealing that although a learning health‐care system may significantly change the landscape of health care, some ethical dilemmas still require resolving on both theoretical and policy‐making levels. (shrink)

Identifiable excess surgical tissue is an important resource for medical research but we have become overly restrictive about consent requirements. I suggest we devolve consent to ethics committees for ordinary research projects involving human tissue, retaining the requirement for explicit consent only for those sensitive research situations where there is significant risk of harm to individual interests in privacy.

In this article I review the principal arguments in favour of and against the UK government’s recent proposals to allow access to NHS patient records to life sciences companies as part of the NHS–Life Sciences partnership scheme.

The recent desperation to clone human embryos may be seriously undermining accepted ethical principles of medical research, with potentially profound wider consequencesIn her editorial in the February 2005 issue of this journal, Nikola Biller-Andorno questioned whether the effort and resources that have been invested in debates about cloning at the United Nations might have been somewhat disproportionate, if a binding universal agreement on reproductive cloning cannot be reached.1 Although most of the overt disagreement has centred around “therapeutic” cloning, rather than (...) the potential use of nuclear transfer for reproduction, it is none the less clear that the delay and ultimate failure to date in achieving consensus on the former has also increased the likelihood of the latter becoming a foreseeable reality in the absence of a legally binding global convention. Whilst the much heralded promise of therapies has now been severely undermined by scandals of fraud,2 the available evidence from various primate studies3–5 and the history of similar work with other mammalian species6,7 have provided little reason to doubt that human reproductive cloning might be possible in principle . I completely agree with Dr Biller-Andorno’s appeal that we need to “foster a genuine, worldwide discourse on bioethical issues” and not let our debate get completely derailed by vested interests, whether politically or economically motivated. If we don’t, we can probably expect dire consequences for the future of biomedical research and its impact on society at large.Prior to the United Nations’ discussions regarding a ban on human cloning in October 2004, the Human Fertilisation and Embryology Authority in Great Britain announced that they had granted their first licence to clone human embryos by nuclear transfer,8 though no other applications had apparently been made following the legalisation …. (shrink)

Medical artificial intelligence (AI) is considered to be one of the most important assets for the future of innovative individual and public health care. To develop innovative medical AI, it is necessary to repurpose data that are primarily generated in and for the health care context. Usually, health data can only be put to a secondary use if data subjects provide their informed consent (IC). This regulation, however, is believed to slow down or even prevent vital medical research, including AI (...) development. For this reason, a number of scholars advocate a moral civic duty to share electronic health records (EHRs) that overrides IC requirements in certain contexts. In the medical AI context, the common arguments for such a duty have not been subjected to a comprehensive challenge. This article sheds light on the correlation between two normative discourses concerning informed consent for secondary health record use and the development and use of medical AI. There are three main arguments in favour of a civic duty to support certain developments in medical AI by sharing EHRs: the ‘rule to rescue argument’, the ‘low risks, high benefits argument’, and the ‘property rights argument’. This article critiques all three arguments because they either derive a civic duty from premises that do not apply to the medical AI context, or they rely on inappropriate analogies, or they ignore significant risks entailed by the EHR sharing process and the use of medical AI. Given this result, the article proposes an alternative civic responsibility approach that can attribute different responsibilities to different social groups and individuals and that can contextualise those responsibilities for the purpose of medical AI development. (shrink)

The capacity to collect and analyse data is growing exponentially. Referred to as ‘Big Data’, this scientific, social and technological trend has helped create destabilising amounts of information, which can challenge accepted social and ethical norms. Big Data remains a fuzzy idea, emerging across social, scientific, and business contexts sometimes seemingly related only by the gigantic size of the datasets being considered. As is often the case with the cutting edge of scientific and technological progress, understanding of the ethical implications (...) of Big Data lags behind. In order to bridge such a gap, this article systematically and comprehensively analyses academic literature concerning the ethical implications of Big Data, providing a watershed for future ethical investigations and regulations. Particular attention is paid to biomedical Big Data due to the inherent sensitivity of medical information. By means of a meta-analysis of the literature, a thematic narrative is provided to guide ethicists, data scientists, regulators and other stakeholders through what is already known or hypothesised about the ethical risks of this emerging and innovative phenomenon. Five key areas of concern are identified: informed consent, privacy, ownership, epistemology and objectivity, and ‘Big Data Divides’ created between those who have or lack the necessary resources to analyse increasingly large datasets. Critical gaps in the treatment of these themes are identified with suggestions for future research. Six additional areas of concern are then suggested which, although related have not yet attracted extensive debate in the existing literature. It is argued that they will require much closer scrutiny in the immediate future: the dangers of ignoring group-level ethical harms; the importance of epistemology in assessing the ethics of Big Data; the changing nature of fiduciary relationships that become increasingly data saturated; the need to distinguish between ‘academic’ and ‘commercial’ Big Data practices in terms of potential harm to data subjects; future problems with ownership of intellectual property generated from analysis of aggregated datasets; and the difficulty of providing meaningful access rights to individual data subjects that lack necessary resources. Considered together, these eleven themes provide a thorough critical framework to guide ethical assessment and governance of emerging Big Data practices. (shrink)

Observational research involving access to personally identifiable data in medical records has often been conducted without informed consent, owing to practical barriers to soliciting consent and concerns about selection bias. Nevertheless, medical records research without informed consent appears to conflict with basic ethical norms relating to clinical research and personal privacy. This article analyzes the scope of these norms and provides an ethical justification for research using personally identifiable medical information without consent.

Research drawn from data contained in medical records is a common and immensely important means of scientific investigation in epidemiology and health services research. It provides valuable knowledge regarding risk factors for disease, the safety of pharmaceuticals and medical procedures, and the quality of medical care. Electronic information technology has greatly enhanced the capability of conducting research using medical records, but it has also generated increasing concern about invasions of privacy. Both practical and scientific considerations militate against soliciting consent for (...) population-based observational research. Retrospective review of existing medical records, especially with large samples, poses insuperable barriers to locating human subjects in order to obtain their informed consent. When efforts are made to obtain informed consent for prospective research drawn from disease and treatment registries, mounting evidence has accumulated that substantial selection biases are introduced into the data, as those who consent are not necessarily representative of the population of relevant patients. (shrink)

Several feminist philosophers of science have argued that social and political values are compatible with, and may even enhance, scientific objectivity. A variety of normative recommendations have emerged regarding how to identify, manage, and critically evaluate social values in science. In particular, several feminist theorists have argued that scientific communities ought to: 1) include researchers with diverse experiences, interests, and values, with equal opportunity and authority to scrutinize research; 2) investigate or "study up" scientific phenomena from the perspectives, interests, and (...) conditions of marginalized stakeholders potentially affected by the research; and 3) make gender, ethnicity, class, and geographical location "visible," or use them as categories of analysis when appropriate. Yet, more work is needed to determine what exactly these recommendations would require, and the benefits they would yield, in specific research contexts. Using the recent development of the human papillomavirus (HPV) vaccines, we examine how these three feminist recommendations would have applied. We argue that these principles would have yielded several epistemic and social benefits in the HPV case, as well as in biomedical research more generally. That is, biomedical research guided by these principles would not only be epistemically superior, but also more socially responsible. (shrink)

In this paper, the author questions whether the research ethics guidelines and procedures are robust enough to protect groups when conducting genetics research with socially identifiable populations, particularly with Native American groups. The author argues for a change in the federal guidelines in substance and procedures of conducting genetic research with socially identifiable groups.

The genetic revolution is well underway, with genetic research and knowledge expanding at an exponential rate. Much of the new genetics research is focused on population groups, and proponents of “population genomics” argue that such studies are necessary since genetic “variation” among human populations holds the most promise for technological innovations that can improve human health and lead to increased understanding of the origin of human populations. Population genomic research thus targets specific groups to discover variation that could lead to (...) knowledge about genetic disorders, possible cures, and the origin and migration patterns of distinctive peoples. Research on genetic differences among groups or populations, however, raises many pressing ethical and legal questions. For example, focus on biological differences of racial and ethnic groups has in the past lead to assumptions about superiority and inferiority between groups, and in practice resulted in stigmatization and discrimination. Consequently, attention on groups should raise legal and moral red flags and compel us to move cautiously in this area. Pragmatically, targeting population groups as the object of study requires the determination of the nature and scope of “population groups” for purposes of genetics research. (shrink)

This article argues that personal medical data should be made available for scientific research, by enabling and encouraging individuals to donate their medical records once deceased, similar to the way in which they can already donate organs or bodies. This research is part of a project on posthumous medical data donation developed by the Digital Ethics Lab at the Oxford Internet Institute at the University of Oxford. Ten arguments are provided to support the need to foster posthumous medical data donation. (...) Two major risks are also identified—harm to others, and lack of control over the use of data—which could follow from unregulated donation of medical data. The argument that record-based medical research should proceed without the need to secure informed consent is rejected, and instead a voluntary and participatory approach to using personal medical data should be followed. The analysis concludes by stressing the need to develop an ethical code for data donation to minimise the risks, and offers five foundational principles for ethical medical data donation suggested as a draft code. (shrink)