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)

Is abortion a question of personal morality? Liberals and feminists often embrace this idea, but so also do those who are personally opposed to abortion. Someone may claim to believe personally that abortion is wrong without holding the corresponding public belief. I am interested in what exactly one means when one says that abortion is a question of personal morality. In Sec. II, I consider three influential interpretations of the claim that abortion is a question of personal morality. After showing (...) that each of these interpretations is inadequate, I develop a fourth that avoids some of the problems with the first three (in Sec. III). But even on this interpretation, the claim that abortion is a question of personal morality is difficult to defend. This is because we cannot show that abortion is a question of personal morality without first knowing something about the moral status of the fetus. I conclude the paper with some pessimistic remarks concerning our ability to arrive at a compromise position on abortion. (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)

ABSTRACTJohn Harris suggests that participation in or support for research, particularly medical research, is a moral duty. One kind of defence of this position rests on an appeal to the past, and produces two arguments. The first of these arguments is that it is unfair to accept the benefits of research without contributing something back in the form of support for, or participation in, research. A second argument is that we have a social duty to maintain those practices and institutions (...) that sustain us, such as those which contribute to medical knowledge. This argument is related to the first, but it does not rely so heavily on fairness. Another kind of defence of the duty to research rests on an appeal to the future benefits of research: research is an effective way to discharge a duty to rescue others from serious illness or death, therefore we have a duty to research. I suggest that all three of Harris' lines fail to provide a compelling duty to research and spell out why. Moreover, not only do the lines of argument fail in their own terms: in combination, they turn out to be antagonistic to the very position that Harris wants to defend. While it is not my intention here to deny that there might be a duty to research, I claim that Harris' argument for the existence of such a duty is not the best way to establish it. (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)

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)

The current prevailing view is that participation in biomedical research is above and beyond the call of duty. While some commentators have offered reasons against this, we propose a novel public goods argument for an obligation to participate in biomedical research. Biomedical knowledge is a public good, available to any individual even if that individual does not contribute to it. Participation in research is a critical way to support an important public good. Consequently, all have a duty to participate. The (...) current social norm is that individuals participate only if they have a good reason to do so. The public goods argument implies that individuals should participate unless they have a good reason not to. Such a shift would be of great aid to the progress of biomedical research, eventually making society significantly healthier and longer lived. (shrink)

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)

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)

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)

We argue in this essay that (1) the embryo is an irredeemably ambiguous entity and its ambiguity casts serious doubt on the arguments claiming its full protection or, at least, its protection against its use as a means fo research, (2) those who claim the embryo should be protected as "one of us" are committed to a position even they do not uphold in their practices, (3) views that defend the protection of the embryo in virtue of its potentiality to (...) become a person fail, and (4) the embryo does not have any rights or interests to be protected. Given that many are willing to treat the embryo as a means in other practices, and that human embryonic stem cell (hESC) research holds the potential to benefit many people, one cannot but conclude that hESC research is permissible and, because of its immense promise for alleviating human even obligatory. (shrink)

Clinicians have good moral and professional reasons to contribute to pragmatic clinical trials (PCTs). We argue that clinicians have a defeasible duty to participate in this research that takes place in usual care settings and does not involve substantive deviation from their ordinary care practices. However, a variety of countervailing reasons may excuse clinicians from this duty in particular cases. Yet because there is a moral default in favor of participating, clinicians who wish to opt out of this research must (...) justify their refusal. Reasons to refuse include that the trial is badly designed in some way, that the trial activities will violate the clinician’s conscience, or that the trial will impose excessive burdens on the clinician. (shrink)

In today’s online data-driven world, people constantly shed data and deposit digital footprints. When individuals access health services, governments and health providers collect and store large volumes of health information about people that can later be retrieved, linked and analysed for research purposes. This can lead to new discoveries in medicine and healthcare. In addition, when securely stored and de-identified, the privacy risks are minimal and manageable. In many jurisdictions, ethics committees routinely waive the requirement for researchers to obtain consent (...) from data subjects before using and linking these datasets in an effort to balance respect for individuals with research efficiency. In this paper, I explore the ethical justification for using routinely collected health data for research without consent. I conclude that, not only is this morally justified but also that data subjects have a moral obligation to contribute their data to such research, which would obviate the need for ethics committees to consider consent waivers. In justifying this argument, I look to the duty of easy rescue, distributive justice and draw analogies with vaccination ethics. (shrink)

Die Sekundärnutzung klinischer Daten für Forschungs- und Lernaktivitäten hat das Potenzial, medizinisches Wissen und klinische Versorgung erheblich zu verbessern. Zur Realisierung dieses Potenzials bedarf es einer ethischen und rechtlichen Grundlage für die Datennutzung, vorzugsweise in Form der Einwilligung von Patient*innen. Damit stellt sich die grundsätzliche Frage: Haben Patient*innen eine moralische Pflicht, ihre klinischen Daten für Forschungs- und Lernaktivitäten zur Verfügung zu stellen?Auf Basis eines ethischen Ansatzes, der als „sorgender Liberalismus“ bezeichnet werden kann, werden folgende Argumente zur Begründung einer Pflicht von (...) Patient*innen zur Bereitstellung ihrer klinischen Daten für Forschungs- und Lernaktivitäten auf Plausibilität und moralisches Gewicht untersucht: die allgemeine Hilfspflicht; Solidarität; die Pflicht zu gemeinwohlförderlichem Handeln; das Trittbrettfahrerargument; transgenerationale Gerechtigkeit; das Prinzip des Zurückgebens; das Prinzip des Nicht-Schädigens; die Forschungsfreiheit und der Wert der Wissenschaft.Die allgemeine Hilfspflicht und die Pflicht zu gemeinwohlförderlichem Handeln sind gewichtige Gründe für eine moralische Pflicht von Patient*innen zur Bereitstellung ihrer klinischen Daten für Forschungs- und Lernaktivitäten. Das Argument der transgenerationalen Gerechtigkeit und das Prinzip des Zurückgebens sind ethisch schwache Gründe für eine solche Pflicht, können jedoch eine motivationale Rolle spielen. Die anderen Gründe sind nicht geeignet, eine Pflicht zu begründen. Das Ergebnis ist in mehrfacher Hinsicht relevant: für Patient*innen, die um die Einwilligung in die Sekundärnutzung ihrer klinischen Daten gebeten werden; für die ethische Diskussion der Frage, ob und inwieweit Abstriche von der klassischen spezifischen Einwilligung unter bestimmten Bedingungen ethisch akzeptabel sind; für die rechtwissenschaftliche Diskussion der Bedingungen für eine juristisch verhältnismäßige Sekundärnutzung klinischer Daten für Forschungs- und Lernaktivitäten. (shrink)

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)

In light of the magnitude of interpersonal harm and the risk of greater harm in the future, Ingmar Persson and Julian Savulescu have argued for pharmacological enhancement of moral behaviour. I discuss moral bioenhancement as a set of collective action problems. Psychotropic drugs or other forms of neuromodulation designed to enhance moral sensitivity would have to produce the same or similar effects in the brains of a majority of people. Also, a significant number of healthy subjects would have to participate (...) in clinical trials testing the safety and efficacy of these drugs, which may expose them to unreasonable risk. Even if the drugs were safe and effective, a majority of people would have to co-operate in a moral enhancement programme for such a project to succeed. This goal would be thwarted if enough people opted out and decided not to enhance. To avoid this scenario, Persson and Savulescu argue that moral enhancement should be compulsory rather than voluntary. But the collective interest in harm reduction through compulsory enhancement would come at the cost of a loss of individual freedom. In general, there are many theoretical and practical reasons for scepticism about the concept and goal of moral enhancement. (shrink)

The predominant view is that a study using health data is observational research and should require individual consent unless it can be shown that gaining consent is impractical. But recent arguments have been made that citizens have an ethical obligation to share their health information for research purposes. In our view, this obligation is sufficient ground to expand the circumstances where secondary use research with identifiable health information is permitted without explicit subject consent. As such, for some studies the Institutional (...) Review Board/Research Ethics Committee review process should not assess the practicality of gaining consent for data use. Instead the review process should focus on assessing the public good of the research, public engagement and transparency. (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)

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)

This study has a twofold objective: firstly, it aims to examine the main types of argument that have been formulated against human cloning, to identify their presuppositions and to evaluate their strength; secondly, it aims to argue that the most important objections against human cloning are philosophical and religious, in particular the objection that human cloning represents a radical form of disenchantment or an abuse of rationality. The birth of a cloned mammal, a sheep named Dolly, which was announced on (...) 23 February 23 1997, began a wide public debate on the morality of human cloning. I shall try to show that this debate should not be limited only to ethical and legal considerations, since it has more profound ramifications. The science of cloning is rooted in a certain metaphysical background, which, discreetly, but firmly, accompanies its spectacular promises, and which has profound consequences on our metaphysical and religious beliefs. This background needs to be openly discussed and evaluated. Moreover, it warrants the special attention of philosophers and religious thinkers alike. . (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)

Because of the important benefits that biomedical research offers to humans, some have argued that people have a general moral obligation to participate in research. Although the defense of such a putative moral duty has raised controversy, few scholars, on either side of the debate, have attended to the social context in which research takes place and where such an obligation will be discharged. By reflecting on the social context in which a presumed duty to participate in research will obtain, (...) this article shows that decontextualized discussions of this putative moral obligation are problematic. (shrink)

Research Ethics, Volume 18, Issue 2, Page 151-162, April 2022. In today’s online data-driven world, people constantly shed data and deposit digital footprints. When individuals access health services, governments and health providers collect and store large volumes of health information about people that can later be retrieved, linked and analysed for research purposes. This can lead to new discoveries in medicine and healthcare. In addition, when securely stored and de-identified, the privacy risks are minimal and manageable. In many jurisdictions, ethics (...) committees routinely waive the requirement for researchers to obtain consent from data subjects before using and linking these datasets in an effort to balance respect for individuals with research efficiency. In this paper, I explore the ethical justification for using routinely collected health data for research without consent. I conclude that, not only is this morally justified but also that data subjects have a moral obligation to contribute their data to such research, which would obviate the need for ethics committees to consider consent waivers. In justifying this argument, I look to the duty of easy rescue, distributive justice and draw analogies with vaccination ethics. (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)

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)

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)

Since the 1970s, estrogen have sometimes been used in adolescent girls to reduce very tall adult expected height. Worries about long-term effects have led to a proposal to link treatment data with cancer registers. How should one deal with informed consent for such a study? We designed a qualitative study with semi-structured telephone interviews. From 1200 women who were to be followed-up in cancer registers, we randomly selected 22 women. Major themes were a wish to be involved and a positive (...) attitude to the proposed register research. The women did not express worry after reading the study protocol, but did convey considerable frustration that this research had not been initiated earlier. Active consent was not seen as crucial. We found strong interest in a high participation rate and a concern over missing data. The selection of information and consent or the decision to go ahead without consent in register follow-up is a delicate balancing act. Study participants wish to be contacted, but acknowledge the primary goal of answering important questions. Our study provides support for safeguarding privacy in epidemiological linkage studies and in follow-up of medical treatment without losing the scientific value by requesting for informed consent. (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)

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)

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)

Monetary compensation given to study subjects in a clinical trial is an effective tool to increase overall study enrolment, nonetheless it may stimulate some participants to commit fraud and lie about their medical history.A survey-study in 684 Hispanic prospective subjects in Mexico and USA was conducted to evaluate if a high monetary compensation would encourage them to lie about their medical history. Almost half of the subjects considered participating in a clinical trial with no compensation. Younger male individuals were more (...) likely to consider committing fraud in order to receive a relatively high compensation. On the other hand, individuals with either low or high educational backgrounds, as those with higher income, were less likely to consider committing fraud. (shrink)

A recent article on the front page of The Independent (September 18, 2015) 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 (Saturday 10, October 2015), on the front page of the same newspaper, it was reported that the National Health Service (NHS) 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)

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)

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.

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)

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)

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.

Several years ago, the University of Minnesota hosted a lecture by Alan Milstein, a Philadelphia attorney specializing in clinical trial litigation. Milstein, who does not mince words, insisted on calling research studies “experiments.” “Don't call it a study,” Milstein said. “Don't call it a clinical trial. Call it what it is. It's an experiment.” Milstein's comments made me wonder: when was the last time I heard an ongoing research study described as a “human experiment”? The phrase is now almost always (...) associated with abuses. Asking a prospective subject to sign up for a medical experiment would probably get roughly the same response as asking him or her to sign up for a police interrogation. It wasn't always this way. In the early days of American bioethics, scholars used the word “experimentation” in the same neutral way that they later began to use “research study” and “clinical trial.”. (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)

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)