The right not to know is often defended on the basis of the principle of respect for personal autonomy. If I choose not to acquire personal information that impacts on my future prospects, such a choice should be respected, because I should be able to decide whether to access information about myself and how to use it. But, according to the incoherence objection to the right not to know in the context of genetic testing, the choice not to acquire genetic (...) information undermines the capacity for autonomous decision making. The claim is that it is incoherent to defend a choice that is inimical to autonomy by appealing to autonomy. In this paper, I suggest that the choice not to know in the context of genetic testing does not undermine self-authorship, which is a key aspect of autonomous decision making. In the light of this, the incoherence objection to the right not to know seems less compelling. (shrink)

This paper will consider the right not to know in the context of psychiatric disorders. It will outline the arguments for and against acquiring knowledge about the results of genetic testing for conditions such as breast cancer and Huntington’s disease, and examine whether similar considerations apply to disclosing to clients the results of genetic testing for psychiatric disorders such as depression and Alzheimer’s disease. The right not to know will also be examined in the context of the diagnosis of psychiatric (...) disorders that are associated with stigma or for which there is no effective treatment. (shrink)

The increasing implementation of next-generation sequencing technologies in the clinical context and the expanding commercial offer of genetic tests directly-toconsumers has increased the availability of previously inaccessible genetic information. A particular concern in both situations is how the volume of novel information will affect the processing of genetic and genomic information from minors. For minors, it is argued that in the provision of genetic testing, their “right not to know” should be respected as much as possible. Testing a minor early (...) in life eliminates the possibility for the minor to make use of his or her “right not to know.” The article discusses the theoretical underpinnings of the right not know, analyzes reasons why various direct-to-consumer companies process samples from minors, and discusses the right not to know in relation to common complex disorders in a pediatric population. (shrink)

In the last few decades, great progress has been made in both genetic and genomic research. The development of the Human Genome Project has increased our knowledge of the genetic basis of diseases and has given a tremendous momentum to the development of new technologies that make widespread genetic testing possible and has increased the availability of previously inaccessible genetic information. Two examples of this exponential evolution are the increasing implementation of next-generation sequencing technologies in the clinical context and the (...) expanding commercial offer of genetic tests directly-to-consumers.Firstly, the rapid development of next generation sequencing technologies has substantially reduced both the cost and the time required to sequence an entire human genome. These technologies are increasingly being used in the clinical setting with the goal of diagnosing conditions of presumed genetic origin that cannot be explained by targeted sequencing approaches. (shrink)

Along with many jurisdictions, Australia is struggling with the unique issues raised by genetic information in the context of privacy laws and medical ethics. Although the consequences of disclosure of most private information are generally confined to individuals, disclosure of genetic information has far-reaching consequences, with a credible argument that genetic relatives have a right to know about potential medical conditions. In 2006, the Privacy Act was amended to permit disclosure of an individual's genetic information, without their consent, to genetic (...) relatives, if it was to avoid or mitigate serious illness. Unfortunately, additional amendments required for operation of the disclosure amendment were overlooked. Public Interest Determinations —delegated legislation issued by the privacy commissioner—have, instead, been used to exempt healthcare providers from provisions which would otherwise make disclosure unlawful. This paper critiques the PIDs using documents obtained under the Freedom of Information Act—specifically the impact of both the PIDs and the disclosure amendment on patients and relatives—and confidentiality and the procedural validity of subordinate laws regulating medical privacy. (shrink)

In this article, I argue that the Canadian government’s position against screening for hepatitis C virus and publicly funding HCV treatment is ethically unjustifiable. Cost of medication and likelihood of widening existing health inequality are the government’s argument for not funding HCV treatment and for also not having a screening program. I object to this position and argue in favour of a screening program and public funding of HCV treatment. I argue that these barriers are ethically unjust. Conclusively, being denied (...) screening and early treatment is to be denied the best possible outcome. (shrink)

Works of art can be difficult in several ways. One important way is by making us face up to unsettling truths. Such works typically receive praise. I maintain, however, that sometimes they deserve moral censure. The crux of my argument is that, just as we have a right to know the truth in certain contexts, so too we have a right not to know it. Provided our ignorance does not harm or seriously endanger others, the decision about whether to know (...) the truth ought to be left to us. Within this limit, therefore, difficult art is morally problematic if it intentionally targets those who have chosen not to know. To illustrate the problem, I discuss the literary writings of Søren Kierkegaard, which aim to deceive readers into seeing unpleasant truths about themselves that they seek to ignore. (shrink)

The right not to know is underappreciated in policy-making. Despite its articulation in medical law and ethics, policy-makers too easily let other concerns override the right not to know. This observation is triggered by a recent decision of the Dutch government on embryo selection for Huntington’s disease. This is a monogenetic debilitating disease without cure, leading to death in early middle age, and thus is a likely candidate for preimplantation genetic diagnosis. People possibly affected with the Huntington gene do not (...) always want to know their genetic status themselves, which is very burdensome knowledge. For prospective parents, this creates a difficulty in having unaffected children through embryo selection without knowing their own genetic status. A solution is provided by the exclusion test: it allows embryo selection while honouring the parents’ right not to know. The Dutch government however disallowed the exclusion test and chose to allow PGD on Huntington only for parents who test themselves first. To avoid “unnecessary” in-vitro fertilisation procedures for unaffected parents, prospective parents are “forced to know” before they can conceive through embryo selection. This article analyses the scope of the right not to know in the context of embryo selection against Huntington’s disease. It concludes that the right not to know implies that PGD against Huntington should be allowed by means of the exclusion test. (shrink)

In this article, we explore the concept of a “right not to know” on a population rather than individual level. We argue that a population level “right not to know” is a useful concept for helping to define the appropriate boundaries of public engagement initiatives in the emerging public health genomics context.

While the realm of bioethics has traditionally focused on the rights of the individual and held autonomy as a defining principle, public health ethics has at its core a commitment to the promotion of the common good. While these two domains may at times conflict, concepts arising in one may also be informative for concepts arising in the other. One example of this is the concept of a “right not to know.” Recent debate suggests that just as there is a (...) “right to know” information about one's genetic status, there is a parallel “right not to know” when it comes to genetic information that if communicated, could be detrimental to an individual's social or psychological well-being. As new genetic technologies continue to change the nature of genetic testing and screening, it is crucial that normative frameworks to guide and assess genetic public health initiatives be developed. In this context, the question of whether a “right not to know” may also be said to exist for populations on a public health level merits attention. (shrink)

Individual research results from population-based genetic and genomic research are traditionally not disclosed to research participants. Current practices of non-disclosure are, however, being challenged by an increasing number of scientists, ethicists and policy-makers who make arguments in favour of disclosing at least individual results of potential health or lifestyle significance to research participants. Simultaneously, research participants are expressing greater interest in accessing their results. This article first provides an overview of main arguments for and against the disclosure of individual research (...) results to research participants. Next, it discusses the need for a move from the current ethical framework under which researchers operate, which is rather protective of research participants and does not encourage disclosure, to a new ethical framework that would better cope with current developments within the field. Comparative analysis of existing and potential ethical frameworks favours implementation of an ethical framework aimed at enhancing the autonomy of research participants through the disclosure of individual research results. Finally, this article explores practical models of disclosure that could be used under such a new framework. A model of disclosure that takes into account the two key criteria of communicability of research results and the research participant’s preferences to determine which results to disclose is found to comply best with the selected ethical framework. (shrink)

In this short essay I intent to discuss the moral standing of autonomy in the field of Medical Ethics and the way it affects individual decision making as well as health care policies. To this purpose I will employ a real life scenario, namely administering placebo medication to a patient without letting him know, by means of which I will challenge not only the effectiveness and the feasibility of autonomy in the Kantian sense, but also its desirability. I will argue (...) that the Kantian notion of autonomy when it comes to Medical Ethics is in some cases self-defeating and, therefore, confusing and misleading. I will conclude with the view that, at least as Medical Ethics is concerned, we should rethink and, maybe, revise the meaning we usually assign to autonomy, so as to take into account the particular nature of the doctor-patient relationship. (shrink)

Personal autonomy is often lauded as a key value in contemporary Western bioethics. Though the claim that there is an important relationship between autonomy and rationality is often treated as uncontroversial in this sphere, there is also considerable disagreement about how we should cash out the relationship. In particular, it is unclear whether a rationalist view of autonomy can be compatible with legal judgments that enshrine a patient's right to refuse medical treatment, regardless of whether the reasons underpinning the choice (...) are known and rational, or indeed whether they even exist. Jonathan Pugh brings recent philosophical work on the nature of rationality to bear on the question of how we should understand personal autonomy in contemporary bioethics. In doing so, he develops a new framework for thinking about the concept of autonomy, one that is grounded in an understanding of the different roles that rational beliefs and rational desires have to play in it. Pugh's account allows for a deeper understanding of d the relationship between our freedom to act and our capacity to decide autonomously. His rationalist perspective is contrasted with other prominent accounts of autonomy in bioethics, and the revisionary implications it has for practical questions in biomedicine are also outlined. (shrink)

Action can only be spontaneous and impulsive if not guided by contemplation; contemplation, on the other hand, may only be luxurious playfulness if not either purposed - or suitable - to motivate action. This volume seeks to prove what may seem self-evident to common sense, but adhering to common sense is never pointless nor excessive. Next to this, Thinking in Action is the offspring of friendship, respect and commitment between two academic communities, the Hellenic and the Serbian philosophical communities, that (...) admittedly have a lot in common, especially with regard to philosophy, and hopefully as many differences as needed in order to secure a long-lasting and fertile exchange of ideas; it is also the natural-born child of necessity: philosophy is about argumentation, debate and confrontation. Thinking in Action inaugurates Hellenic-Serbian Philosophical Dialogue Series that entertains no hesitation in being as ambitious as any philosophical series could be: it seeks to establish a permanent, wide and rich channel of fruitful philosophical interaction between the two philosophical communities. Having high aspirations is one thing; meeting these aspirations as well as the expectations of the reader is a totally different one. We wish Thinking in Action, the first volume of the Hellenic-Serbian Philosophical Dialogue Series, apart from being the initial step of a long journey, will also be a fascinating one to the reader. (shrink)

The paper discusses the current medical practice of "gender verification" in sports from an ethical point of view. It takes the recent public discussion about 800-meter runner Caster Semenya as a starting point. At the World Championships in Athletics 2009 in Berlin, Germany, Semenya was challenged by competitors as being a so called "sex impostor". A medical examination to verify her sex ensued. The author analyses whether athletes like Semenya could claim a right not to know that is generally acknowledged (...) in human genetics and enforced by international and national genetic privacy laws. The relevance of this right for genetic diagnosis in sports is discussed. To this end, the interests of the athlete concerned and of third parties are balanced according to the expected benefits and harms. Harm is documented in a number of cases and includes unjustified disqualification, severe sex and gender identity crisis, demeaning reactions, social isolation, depression and suicide. Benefits are dubious as most cases of intersex are considered irrelevant for sports competition. It has to be concluded that the benefits to be gained from "gender verification" in sports via genetic testing do not outweigh the grave individual disadvantages. The current practice of athletic associations to largely ignore the right of competitors not to know does not comply with prevailing ethical provisions on the protection of sensitive personal data. Therefore, genetic "gender verification" in sports should be abolished. (shrink)

While bioethics as a field has concerned itself with methodological issues since the early years, there has been no systematic examination of how ethics is incorporated into research on the Ethical, Legal and Social Implications of the Human Genome Project. Yet ELSI research may bear a particular burden of investigating and substantiating its methods given public funding, an explicitly cross-disciplinary approach, and the perceived significance of adequate responsiveness to advances in genomics. We undertook a qualitative content analysis of a sample (...) of ELSI publications appearing between 2003 and 2008 with the aim of better understanding the methods, aims, and approaches to ethics that ELSI researchers employ. We found that the aims of ethics within ELSI are largely prescriptive and address multiple groups. We also found that the bioethics methods used in the ELSI literature are both diverse between publications and multiple within publications, but are usually not themselves discussed or employed as suggested by bioethics method proponents. Ethics in ELSI is also sometimes undistinguished from related inquiries. (shrink)

Unconsented episiotomies and other procedures during labour are commonly reported by women in several countries, and often highlighted in birth activism. Yet, forced caesarean sections aside, the ethics of consent during labour has received little attention. Focusing on episiotomies, this paper addresses whether and how consent in labour should be obtained. We briefly review the rationale for informed consent, distinguishing its intrinsic and instrumental relevance for respecting autonomy. We also emphasise two non-explicit ways of giving consent: implied and opt-out consent. (...) We then discuss challenges and opportunities for obtaining consent in labour and birth, given its unique position in medicine.We argue that consent for procedures in labour is always necessary, but this consent does not always have to be fully informed or explicit. We recommend an individualised approach where the antenatal period is used to exchange information and explore values and preferences with respect to the relevant procedures. Explicit consent should always be sought at the point of intervening, unless women antenatally insist otherwise. We caution against implied consent. However, if a woman does not give a conclusive response during labour and the stakes are high, care providers can move to clearly communicated opt-out consent. Our discussion is focused on episiotomies, but also provides a useful starting point for addressing the ethics of consent for other procedures during labour, as well as general time-critical medical procedures. (shrink)

Definition of the problem The umbrella term “explicability” refers to the reduction of opacity of artificial intelligence (AI) systems. These efforts are challenging for medical AI applications because higher accuracy often comes at the cost of increased opacity. This entails ethical tensions because physicians and patients desire to trace how results are produced without compromising the performance of AI systems. The centrality of explicability within the informed consent process for medical AI systems compels an ethical reflection on the trade-offs. Which (...) levels of explicability are needed to obtain informed consent when utilizing medical AI? Arguments We proceed in five steps: First, we map the terms commonly associated with explicability as described in the ethics and computer science literature, i.e., disclosure, intelligibility, interpretability, and explainability. Second, we conduct a conceptual analysis of the ethical requirements for explicability when it comes to informed consent. Third, we distinguish hurdles for explicability in terms of epistemic and explanatory opacity. Fourth, this then allows to conclude the level of explicability physicians must reach and what patients can expect. In a final step, we show how the identified levels of explicability can technically be met from the perspective of computer science. Throughout our work, we take diagnostic AI systems in radiology as an example. Conclusion We determined four levels of explicability that need to be distinguished for ethically defensible informed consent processes and showed how developers of medical AI can technically meet these requirements. (shrink)

The possibilities of non-invasive prenatal testing (NIPT) are expanding, and the use of NIPT for adult-onset conditions may become widely available in the near future. If parents use NIPT to test for these conditions, and the pregnancy is continued, they will have information about the child’s genetic predisposition from birth. In this paper, we argue that prospective parents should be able to access NIPT for an adult-onset condition, even when they have no intention to terminate the pregnancy. We begin by (...) outlining the arguments against testing in such a situation, which generally apply the same considerations that apply in the predictive testing of a minor to the fetus in utero. We then contend, firstly, that there are important practical considerations that support availability of testing for prospective parents regardless of their stated intentions. Secondly, we object to the ethical equation of a fetus in utero with a minor. We base our analysis on a view of pregnancy that conceptualises the fetus as a part of the gestational parent, as opposed to the more common ‘container’ model of pregnancy. We suggest that fetal information is best conceptualised as shared information between the gestational parent and future child. Thus, it should be approached in similar ways as other kinds of shared information (such as genetic information with implications for family members), where a person has a claim over their own information, but should be encouraged to consider the interests of other relevant parties. (shrink)

Labeling of food consumption is related to food safety, food quality, environmental, safety, and social concerns. Future politics of food will be based on a redefinition of commodity food consumption as an expression of citizenship. “Citizen-consumers” realize that they could use their buying power in order to develop a new terrain of social agency and political action. It takes for granted kinds of moral selfhood in which human responsibility is bound into human agency based on knowledge and recognition. This requires (...) new kinds of food labeling practices. Existing research on consumer’s preferences often fails to recognize the full complexity of the motivations and intentions through which the identity of the moral self is built up in relation to food consumption practices. For citizens, not only food production practices matter but also the impact of what we eat on who we are and the ecological foot print of our food stuff. Two major drivers for this are the idea that we ourselves have to take care of our own bodies (“We are what we eat”) and that we are responsible for Planet Earth. Since both obesity and climate change have become major public concerns, also governments develop an increasing interest in defining how citizens ought to behave as consumers and how retailers and producers should facilitate such responsible behavior. Since they are supposed to defend the “bonum commune,” e.g., the public health of their citizens and a sound common future for all, a new consensus on “appropriate” consumption choices has to be found, balancing beneficence and autonomy. (shrink)

In the near future developments in non-invasive prenatal testing may soon provide couples with the opportunity to test for and diagnose a much broader range of heritable and congenital conditions than has previously been possible. Inevitably, this has prompted much ethical debate on the possible implications of NIPT for providing couples with opportunities for reproductive choice by way of routine prenatal screening. In view of the possibility to test for a significantly broader range of genetic conditions with NIPT, the European (...) Society of Human Genetics and American Society of Human Genetics recommend that, pending further debate, prenatal screening for reproductive choice should only be offered where concerning serious congenital conditions and childhood disorders. In support of this recommendation, the ESHG and ASHG discuss a number of ethical issues on which they prompt further debate: the informational privacy of the future child, the trivialization of abortion, the risk of information overload, and issues of distributive justice. This paper responds to this call with further reflection on each ethical issue and how it relates to the moral justification of providing couples with opportunities for meaningful reproductive choice. The paper concludes that whilst there may be good reasons for qualifying the scope of any unsolicited prenatal screening offer to serious congenital conditions and childhood disorders, if prenatal screening is justified for providing couples with opportunities for meaningful reproductive choice, then health services may have obligations to empower couples with the same opportunity where concerning other conditions. (shrink)

Prenatal diagnosis challenges the issue of parental autonomy. Two ethical aspects of the parental decision making process with reference to PND have been taken into consideration: the duty to know and the right not to know. Whilst the first approach has been widely discussed in literature, the latter seems to be overlooked. In order to find good moral reasons supporting the right not to know, firstly the duty to know approach was critically analysed. Subsequently, the emphasis was put on the (...) unconditional parental love and the issue of child’s best interests as the features supporting parental right not to know. The clarification of what is good parenthood was presented as the best normative approach supporting the parental right not to know in case of PND. Apart from parental autonomy, raising the question of the right not to know is important in the debate about the place and role of people with disabilities in society. (shrink)

The “best-medical-interests” standard for reporting findings does not go far enough. Research subjects have a right to know about any comprehensible piece of information about them that is generated by research in which they are participating. An even broader standard may sometimes be appropriate: if subjects agree to accept information that they may not understand, then all information may be disclosed.

Incidental findings and secondary findings, being results that are unrelated to the diagnostic question, are the subject of an important debate in the practice of clinical genomic medicine. Arguments for reporting these results or not doing so typically relate to the principles of autonomy, non-maleficence and beneficence. However, these principles frequently conflict and are insufficient by themselves to come to a conclusion. This study investigates empirically how ethical principles are considered when actually reporting IFs or SFs and how value conflicts (...) are weighed. A qualitative focus group study has been undertaken, including a multidisciplinary group of professionals from Belgian centres for medical genetics. The data were analysed thematically. All eight Belgian centres participated in this study. Ethical values were frequently referred to for disclosure policies on IFs and SFs. Participants invoked respect for patient autonomy to support the disclosure of IFs and opt-out options for IFs and SFs, non-maleficence for the professional delineation of reportable IFs and opt-out options for IFs and SFs and beneficence for the mandatory reporting of actionable IFs, the delineation of reportable IFs and a current decline of actively pursued SFs. Professional assumptions about patients’ genetic literacy were an important factor in the weighing of values. In line with the traditional bioethical discourse, the mandatory reporting of actionable IFs might be interpreted as a “technological, soft paternalism”. Restricting patients’ choices might be acceptable, but then its motives should be valid and its beneficent outcomes highly plausible. Hence, the presuppositions of technological, soft paternalism - patients’ inability to make informed decisions, normative rationality, the efficacy of beneficent outcomes and the delineated spectrum of beneficence - should be approached critically. Moreover, distributive justice should be considered an important value in the delineation of the current scope of the ethical debate on IFs and SFs. This study of guiding values may stimulate the debate on the ethical grounds for a solid policy on IFs and SFs internationally. (shrink)

Disclosure in clinical practice is aimed at promoting patient autonomy, usually culminating in patient choice (e.g., to consent to an operation or not, or between different medications). In medical ethics, there is an implicit background assumption that knowing more about (X) automatically translates to greater, or more genuine, autonomy with respect to one's choices involving (X). I challenge this assumption by arguing that in rare cases, withholding information can promote a patient's autonomy (understood as the capacity for rational choice in (...) alignment with one's values and goals). (shrink)

This article provides a conceptual and normative framework through which we may understand the potentially ethically significant roles that information generated by neurotechnologies about our brains and minds may play in our construction of our identities. Neuroethics debates currently focus disproportionately on the ways that third parties may (ab)use these kinds of information. These debates occlude interests we may have in whether and how we ourselves encounter information about our own brains and minds. This gap is not yet adequately addressed (...) by most allusions in the literature to potential identity impacts. These lack the requisite conceptual or normative foundations to explain why we should be concerned about such effects or how they might be addressed. This article seeks to fill this gap by presenting a normative account of identity as constituted by embodied self-narratives. It proposes that information generated by neurotechnologies can play significant content-supplying and interpretive roles in our construction of our self-narratives. It argues, to the extent that these roles support and detract from the coherence and inhabitability of these narratives, access to information about our brains and minds engages non-trivial identity-related interests. These claims are illustrated using examples drawn from empirical literature reporting reactions to information generated by implantable predictive BCIs and psychiatric neuroimaging. The article concludes by highlighting ways in which information generated by neurotechnologies might be governed so as to protect information subjects’ interests in developing and inhabiting their own identities. (shrink)

Direct-to-consumer genetic testing is a growing phenomenon, fuelled by the notion that knowledge equals control. One ethical question that arises concerns the proband’s duty to share information indicating genetic risks in their relatives. However, such duties are unenforceable and may result in the realisation of anticipated harm to relatives. We argue for a shift in responsibility from proband to provider, placing a duty on test providers in the event of identified actionable risks to relatives. Starting from Parker and Lucassen’s 'joint (...) account model', we adapt Kilbride’s application of the rule of rescue and balance it against the relative’s right not to know, placing responsibility on the providers of direct-to-consumer genetic testing. Where the risk of disease to a relative is actionable, we argue providers ought to share results even in the face of the proband’s objections. Confidentiality issues are navigated by a pre-emptive consent model, whereby consumers agree to the sharing of certain information with their relatives ahead of testing and as a condition of testing. When a relative is informed, the proband’s privacy is protected by maximal deidentification, and the rights of the relative are met by a stepwise approach to informing that allows them to decide how much information they receive. (shrink)

The debate on the ‘right to know’ has simmered on for over 30 years. New examples where a right to be informed is contrasted to a right to be kept in ignorance occasionally surface and spark disagreement on the extent to which patients and research subjects have a right to be self-determining concerning the health related information they receive. Up until now, however, this debate has been unsatisfactory with regard to the question what type of rights—if any—are in play here (...) and to what extent they can provide a normative basis for informed consent. This paper provides an analysis of informed consent in the context of ‘epistemic interventions’: interventions which involve the communication of information. First, I offer an analysis of the concept of a ‘right not to know’ in the context of consent to epistemic interventions. I argue that the scope of the consent is determined by the extent to which this intervention can be seen as an infringement of the private sphere. After that I show how this analysis affects the scope and standards of informed consent. (shrink)

‘Disease interception’ describes the treatment of a disease in its clinically inapparent phase and is increasingly used in medical literature. However, no precise definition, much less an ethical evaluation, has been developed yet. This article starts with a definition of ‘disease interception’ by distinguishing it from other preventions. It then analyses the ethical and social implications of the concept in light of the four principles of medical ethics by Beauchamp and Childress. The term ‘disease interception’ refers to a form of (...) secondary prevention applied in a short interception window intended to prevent a preclinical disease from developing further. We propose the definition ‘early and targeted secondary prevention by treatment’. The ethical evaluation of the concept shows that while it promises to be beneficial, it raises a number of ethical and social challenges regarding patient autonomy and justice. In order to ensure decision-making that respects patient autonomy, commercially motivated metaphors such as ‘disease interception’ should make way for precise definitions. Future research should not only focus on how to detect clinically inapparent diseases but also on the ethical question, when this is justifiable and what consequences it has for the individual and society as a whole. (shrink)

This article highlights the limitations of the tendency to frame health- and wellbeing-related digital tools (mHealth technologies) as empowering devices, especially as they play an increasingly important role in the National Health Service (NHS) in the UK. It argues that mHealth technologies should instead be framed as digital companions. This shift from empowerment to companionship is advocated by showing the conceptual, ethical, and methodological issues challenging the narrative of empowerment, and by arguing that such challenges, as well as the risk (...) of medical paternalism, can be overcome by focusing on the potential for mHealth tools to mediate the relationship between recipients of clinical advice and givers of clinical advice, in ways that allow for contextual flexibility in the balance between patiency and agency. The article concludes by stressing that reframing the narrative cannot be the only means for avoiding harm caused to the NHS as a healthcare system by the introduction of mHealth tools. Future discussion will be needed on the overarching role of responsible design. (shrink)

Advances in DNA sequencing technology open new possibilities for public health genomics, especially in the form of general population preventive genomic sequencing. Such screening programs would sit at the intersection of public health and preventive health care, and thereby at once invite and resist the use of clinical ethics and public health ethics frameworks. Despite their differences, these ethics frameworks traditionally share a central concern for individual rights. We examine two putative individual rights—the right not to know, and the child’s (...) right to an open future—frequently invoked in discussions of predictive genetic testing, in order to explore their potential contribution to evaluating this new practice. Ultimately, we conclude that traditional clinical and public health ethics frameworks, and these two rights in particular, should be complemented by a social justice perspective in order adequately to characterize the ethical dimensions of general population PGS programs. (shrink)

This paper examines how the application of legal fiduciary principles , can serve as a framework to promote management of clinical genomic “incidental” or secondary target findings that is patient-centered and consistent with recognized patient autonomy rights. The application of fiduciary principles to the clinical genomic testing context gives rise to at least four physician fiduciary duties in conflict with recent recommendations by the American College of Medical Genetics and Genomics . These recommendations have generated much debate among lawyers, clinicians, (...) and bioethicists hence I believe this publication will be of value and interest to your readership. (shrink)

Advances in genomics have led to calls for developing population-based preventive genomic sequencing programs with the goal of identifying genetic health risks in adults without known risk factors. One critical issue for minimizing the harms and maximizing the benefits of PGS is determining the kind and degree of control individuals should have over the generation, use, and handling of their genomic information. In this article we examine whether PGS programs should offer individuals the opportunity to selectively opt out of the (...) sequencing or analysis of specific genomic conditions or whether PGS should be implemented using an all-or-nothing panel approach. We conclude that any responsible scale-up of PGS will require a menu approach that may seem impractical to some, but that draws its justification from a rich mix of normative, legal, and practical considerations. (shrink)

This article argues for the importance of conceptual clarity in the debate about the so-called right not to know. This is vital both at the theoretical and the practical level. It is suggested that, unlike many formulations and attempts to give effect to this right, what is at stake is not merely an aspect of personal autonomy and therefore cannot and should not be reduced only to a question of individual choice. Rather, it is argued that the core interests that (...) can be protected by the right not to know are better conceived of as privacy interests rather than autonomy interests. This not only helps us to understand what is in play but also informs regulatory, professional, and legal responses to handling information and taking decisions about whether or not to disclose information to persons about themselves. The practical implications of this conceptualization are explored in the context of feedback policies in health-related research. (shrink)

The right not to know is a contested matter. This can be because the inversion of the normal framing of entitlement to information about one's own health is thought to be illogical and inconsistent with self-authorship and/or because the very idea of claiming a right not to know information is an inappropriate appeal to the discourse of rights that places impossible responsibilities on others. Notwithstanding, there has been a sustained increase in this kind of appeal in recent years fueled in (...) large part by the rise and rise of the importance of personal autonomy in health care ethics, and by domestic and international health law. The right not to know has been acknowledged in at least two important international legal instruments. For example, the UNESCO Universal Declaration on the Human Genome and Human Rights, Article 5c provides: “The right of every individual to decide whether or not to be informed of the results of genetic examination and the resulting consequences should be respected.”. (shrink)

While an ethical obligation to report findings of clinical research to trial participants is increasingly recognised, the academic debate is often vague about what kinds of data should be fed back and how such a process should be organised. In this article, we present a classification of different actors, processes and data involved in the feedback of research results pertaining to an individual. In a second step, we reflect on circumstances requiring further ethical consideration. In regard to a concrete research (...) setting—the one of clinico-genomic research—we discuss what kinds of difficulties have to be faced when returning individual research results to trial participants. In a last step, we elaborate on a stepwise model to trigger the individual feedback process. Hence, this paper gives guidance on how to feedback individual research results in a specific research setting and responds at the same time to new challenges in the debate on the duty to return individual research findings. (shrink)

BackgroundAlthough the “right not to know” is well established in international regulations, it has been heavily debated. Ubiquitous results from extended exome and genome analysis have challenged the right not to know. American College of Medical Genetics and Genomics Recommendations urge to inform about incidental findings that pretend to be accurate and actionable. However, ample clinical cases raise the question whether these criteria are met. Many incidental findings are of uncertain significance. The eager to feedback information appears to enter the (...) field of IFUS and thereby threaten the right not to know. This makes it imperative to investigate the arguments for and against a right not to know for IFUS.DiscussionThis article investigates how the various arguments for and against a right not to know hold for IFUS. The main investigated arguments are: hypothetical utilitarianism, the right-based argument, the feasibility argument, the value of knowledge argument, the argument from lost significance, the empirical argument, the duty to disclose argument, the avoiding harm argument; the argument from principle, from autonomy, from privacy, as well as the argument from the right to an open future. The analysis shows that both sides in the debate have exaggerated the importance of incidental findings.SummaryOpponents of a right not to know have exaggerated the importance of IFUS, while proponents have exaggerated the need to be protected from something that is not knowledge. Hence, to know or not to know is not the question. The question is whether we should be able to stay ignorant of incidental findings of uncertain significance, if we want to. The answer is yes: As long as the information is not accurate and/or actionable: ignorance is bliss. When answering questions that are not asked, we need to think twice. (shrink)

Individual autonomy is a concept highly appreciated in modern Western societies. Its significance is reflected by the central importance and broad use of the model of informed consent in all fields of medicine. In predictive genetic testing, individual autonomy gains particular importance, for what is in focus here is not so much a concrete medical treatment but rather options for taking preventive measures and the influence that the test results have on long-term lifestyle and preferences. Based on an analysis of (...) autonomy-related issues in predictive genetic diagnosis and genetic screening programmes, this contribution stresses the central relevance of a broad notion of autonomy for the discussion of ethical issues raised in connection with predictive genetic testing and genetic screening programmes. Only against the background of such a broad notion of autonomy, which stresses not only free and informed decision-making but also the relevance of long-term prospects for leading a self-determined life in familial and social contexts, can the manifold autonomy-related issues linked to predictive genetic testing be given adequate consideration. (shrink)

This paper defends the right not to know personal health information, while it discards the right of research participants to receive individual research results. Disagreement regarding the right not to know stems from two different conceptions of autonomy, leading to opposing normative conclusions. Researchers occasionally have good reason to inform research participants about incidental findings in spite of the absence of a right to know such information. Such decisions have to be made by health care personnel and researchers on a (...) case by case basis, although external support for the decisions may be available. (shrink)

Bioethicists have for quite some time discussed the right to know and the right not to know personal health information, such as genetic information acquired in health care and incidental health-related findings in research. Several international ethical guidelines explicitly defend these rights.My own interest in these matters stems from my participation in ethics-related research tied to a longitudinal screening study on Type I diabetes involving young children. A few of the participating parents did not want to be informed if the (...) study revealed their child had a high risk of developing diabetes. This response was troublesome, not least since the information would concern the child's and not the parents’ health. Our inclination was that there cannot be a right not to know that should be granted without qualifications. Furthermore, other contextual factors, e.g., that parents experienced pressure to participate and felt concern about some of the personal data handled in the study, gave reason to question whether autonomous decisions were made regarding participation. The autonomy of their expressed desire not to know was therefore questionable. (shrink)

Recent scientific advances in the field of gene editing have led to a renewed discussion on the moral acceptability of human germline modifications. Gene editing methods can be used on human embryos and gametes in order to change DNA sequences that are associated with diseases. Modifying the human germline, however, is currently illegal in many countries but has been suggested as a ‘last resort’ option in some reports. In contrast, preimplantation genetic diagnosis is now a well-established practice within reproductive medicine. (...) Both methods can be used to prevent children from being born with severe genetic diseases. This paper focuses on four moral concerns raised in the debate about germline gene editing and applies them to the practice of PGD for comparison: Violation of human dignity, disrespect of the autonomy and the physical integrity of the future child, discrimination of people living with a disability and the fear of slippery slope towards immoral usage of the technology, e.g. designing children for specific third party interests. Our analysis did not reveal any fundamental differences with regard to the four concerns. We argue that with regard to the four arguments analyzed in this paper germline gene editing should be considered morally as acceptable as the selection of genomes on the basis of PGD. However, we also argue that any application of GGE in reproductive medicine should be put on hold until thorough and comprehensive laws have been implemented to prevent the abuse of GGE for non-medical enhancement. (shrink)

Background Genetic testing is moving from targeted investigations of monogenetic diseases to broader testing that may provide more information. For example, recent health economic studies of genetic testing for an increased risk of breast cancer suggest that it is associated with higher cost-effectiveness to screen for pathogenic variants in a seven gene panel rather than the usual two gene test for variants in BRCA1 and BRCA2. However, irrespective of the extent to which the screening of the panel is cost-effective, there (...) may be ethical reasons to not screen for pathogenic variants in a panel, or to revise the way in which testing and disclosing of results are carried out. Main text In this paper we discuss the ethical aspects of genetic testing for an increased risk of breast cancer with a special focus on the ethical differences between screening for pathogenic variants in BRCA1/2 and a seven gene panel. The paper identifies that the panel increases the number of secondary findings as well as the number of variants of uncertain significance as two specific issues that call for ethical reflection. Conclusions We conclude that while the problem of handling secondary findings should not be overstated with regard to the panel, the fact that the panel also generate more variants of uncertain significance, give rise to a more complex set of problems that relate to the value of health as well as the value of autonomy. Therefore, it is insufficient to claim that the seven gene panel is preferable by only referring to the higher cost effectiveness of the panel. (shrink)