Investigators and institutional review boards should integrate plans about the appropriate disclosure of individual genetic results when designing research studies. The ethical principles of beneficence, respect, reciprocity, and justice provide justification for routinely offering certain results to research participants. We propose a result-evaluation approach that assesses the expected information and the context of the study in order to decide whether results should be offered. According to this approach, the analytic validity and the clinical utility of a specific result determine whether (...) it should be offered routinely. Different results may therefore require different decisions even within the same study. We argue that the threshold of clinical utility for disclosing a result in a research study should be lower than the threshold used for clinical use of the same result. The personal meaning of a result provides additional criteria for evaluation. Finally, the context of the study allows for a more nuanced analysis by addressing the investigators' capabilities for appropriate disclosure, participants' alternative access to the result, and their relationship with the investigators. This analysis shows that the same result may require different decisions in different contexts. (shrink)
A rich literature in public health has demonstrated that health is strongly influenced by a host of environmental factors that can vary according to social, economic, geographic, cultural or physical contexts. Bioethicists should, we argue, recognize this and – where appropriate – work to integrate environmental concerns into their field of study and their ethical deliberations. In this article, we present an argument grounded in scientific research at the molecular level that will be familiar to – and so hopefully more (...) persuasive for – the biomedically-inclined in the bioethics community. Specifically, we argue that the relatively new field of molecular epigenetics provides novel information that should serve as additional justification for expanding the scope of bioethics to include environmental and public health concerns. We begin by presenting two distinct visions of bioethics: the individualistic and rights-oriented and the communitarian and responsibility-oriented. We follow with a description of biochemical characteristics distinguishing epigenetics from genetics, in order to emphasize the very close relationship that exists between the environment and gene expression. This then leads to a discussion of the importance of the environment in determining individual and population health, which, we argue, should shift bioethics towards a Potterian view that promotes a communitarian-based sense of responsibility for the environment, in order to fully account for justice considerations and improve public health. (shrink)
In Western countries today, a growing number of women delay motherhood until their late 30s and even 40s, as they invest time in pursuing education and career goals before starting a family. This social trend results from greater gender equality and expanded opportunities for women and is influenced by the availability of contraception and assisted reproductive technologies. However, advanced maternal age is associated with increased health risks, including infertility. While individual medical solutions such as ART and elective egg freezing can (...) promote reproductive autonomy, they entail significant risks and limitations. We thus argue that women should be better informed regarding the risks of advanced maternal age and ART, and that these individual solutions need to be supplemented by a public health approach, including policy measures that provide women with the opportunity to start a family earlier in life without sacrificing personal career goals. (shrink)
Recent findings in epigenetics have been attracting much attention from social scientists and bioethicists because they reveal the molecular mechanisms by which exposure to socioenvironmental factors, such as pollutants and social adversity, can influence the expression of genes throughout life. Most surprisingly, some epigenetic modifications may also be heritable via germ cells across generations. Epigenetics may be the missing molecular evidence of the importance of using preventive strategies at the policy level to reduce the incidence and prevalence of common diseases. (...) But while this “policy translation” of epigenetics introduces new arguments in favor of public health strategies and policy-making, a more “clinical translation” of epigenetics is also emerging. It focuses on the biochemical mechanisms and epigenetic variants at the origin of disease, leading to novel biomedical means of assessing epigenetic susceptibility and reversing detrimental epigenetic variants. In this paper, we argue that the impetus to create new biomedical interventions to manipulate and reverse epigenetic variants is likely to garner more attention than effective social and public health interventions and therefore also to garner a greater share of limited public resources. This is likely to happen because of the current biopolitical context in which scientific findings are translated. This contemporary neoliberal “regime of truth,” to use a term from Michel Foucault, greatly influences the ways in which knowledge is being interpreted and implemented. Building on sociologist Thomas Lemke's Foucauldian “analytics of biopolitics” and on literature from the field of science and technology studies, we present two sociological trends that may impede the policy translation of epigenetics: molecularization and biomedicalization. These trends, we argue, are likely to favor the clinical translation of epigenetics—in other words, the development of new clinical tools fostering what has been called “personalized” or “precision” medicine. In addition, we argue that an overemphasized clinical translation of epigenetics may further reinforce this biopolitical landscape through four processes closely related to neoliberal pathways of thinking: the internalization and isolation of socioenvironmental determinants of health and increased opportunities for commodification and technologicalization of health care interventions. (shrink)
Current advances in assisted reproductive technologies aim to promote the health and well-being of future children. They offer the possibility to select embryos with the greatest potential of being born healthy and may someday correct faulty genes responsible for heritable diseases in the embryo ). Most laws and policy statements surrounding HGGM refer to the notion of ‘serious’ as a core criterion in determining what genetic diseases should be targeted by these technologies. Yet, this notion remains vague and poorly defined, (...) rendering its application challenging and decision making subjective and arbitrary. By way of background, we begin by briefly presenting two conceptual approaches to ‘health’ and ‘disease’: objectivism and constructivism. The basic challenge under both is sorting out whether and to what extent social and environmental factors have a role in helping to define what qualifies as a ‘serious’ disease beyond the medical criteria. We then focus on how a human rights framework could integrate the concepts of objectivism and constructivism so as to provide guidance for a more actionable consideration of ‘serious’. Ultimately, it could be argued that a human rights framework, by way of its legally binding nature and its globally accepted norms and values, provides a more universal foundation for discussions of the ethical, legal and social implications of emerging or disruptive technologies. (shrink)
Noninvasive prenatal screening using cell-free DNA, which analyzes placental DNA circulating in maternal blood to provide information about fetal chromosomal disorders early in pregnancy and without risk to the fetus, has been hailed as a potential “paradigm shift” in prenatal genetic screening. Commercial provision of cell-free DNA screening has contributed to a rapid expansion of the tests included in the screening panels. The tests can include screening for sex chromosome anomalies, rare subchromosomal microdeletions and aneuploidies, and most recently, the entire (...) fetal genome. The benefits of this screening tool are generally framed, by both providers and commercial laboratories, as enhancing reproductive autonomy and choice by providing an earlier, simpler, and more accurate screening while potentially reducing the need for invasive follow-up testing. The majority of the literature has explored these issues empirically or conceptually from a European or North American vantage point, one that assumes normative priorities such as individual reproductive autonomy and the clinical availability of maternal health care or prenatal screening programs within which cell-free DNA screening is offered. While its implementation has raised both challenges and opportunities, very little is known about real-world experiences and the implications of the rapid introduction of cell-free DNA screening outside of North America and Europe, especially in low- and middle-income countries. To begin addressing this gap in knowledge, we organized a four-day international workshop to explore the ethical, legal, social, economic, clinical, and practical implications of the global expansion of cell-free DNA screening. We describe eight key insights that arose from the workshop. (shrink)
While many experts and organizations have recognized infertility as a public health issue, most governments have not yet adopted a public health approach to infertility. This article argues in favor of such an approach by discussing the various implications of infertility for public health. We use a conceptual framework that focuses on the dual meaning of the term ‘public’ in this context: the health of the public, as opposed to that of individuals, and the public/collective nature of the required interventions. (...) This analysis highlights the need for a comprehensive public health approach toward infertility, points to some initiatives that are already in place and demonstrates that prevention is currently a neglected—yet much needed—element. We move on to discuss the sensitive nature of prevention initiatives as a probable explanation for their scarcity. We illustrate the complexity of prevention through an analysis of an infertility prevention campaign previously conducted in the United States, which provoked significant controversy. We use a public health communication ethics framework to expose the strengths and the shortcomings of this campaign, and conclude that prevention initiatives targeting infertility can indeed be conducted in a sensible way that promotes autonomy while improving public health. (shrink)
Mitochondrial/nuclear transfer to avoid the transmission of serious mitochondrial disease raises complex and challenging ethical, legal and social issues. In February 2015, the United Kingdom became the first country in the world to legalize M/NT, making the heated debate surrounding this technology even more relevant. This critical interpretive review identified 95 relevant papers discussing the ELSI of M/NT, including original research articles, government-commissioned reports, editorials, letters to editors and research news. The review presents and synthesizes the arguments present in the (...) literature in relation to the most commonly raised themes: terminology; identity, relationships and parenthood; potential harm; reproductive autonomy; available alternatives; consent; impact on specific interest groups; resources; “slippery slope”; creation, use and destruction of human embryos; and beneficence. The review concludes by identifying those ELSI that are specific to M/NT and by calling for follow-up longitudinal clinical and psychosocial research in order to equip future ELSI debate with empirical evidence. (shrink)
Unlike most Western nations, Israel does not recognize full separation of church and state but seeks instead a gentle fusion of Jewish and democratic values. Inasmuch as important religious norms such as sanctity of life may clash with dignity, privacy, and self-determination, conflicts frequently arise as Israeli lawmakers, ethicists, and healthcare professionals attempt to give substance to the idea of a Jewish-democratic state. Emerging issues in Israeli bioethics—end-of-life treatment, fertility, genetic research, and medical ethics during armed conflict—highlight this conflict vividly.
Chronic shortage in organs for transplantation worldwide is leading many policy-makers to consider various incentives that may increase donation rates.1 These range from giving holders of donor cards some priority on the transplant waiting list or a discount on health insurance premiums, to giving families who consent to donation a medal of honour, reimbursement of funeral expenses, tax incentives or even financial compensation.2–4 Of the various proposed incentive mechanisms, the one that has consistently garnered the most criticism and objection in (...) the literature is that of paying families who consent to donate the organs of a deceased loved one.Arguments against such a policy abound: it could exploit the poor, influence the family to prematurely withdraw care, encourage families to withhold medical information that would result in transplant-transmission of disease, and finally, it would commercialise the value of human life and result in the perception of human organs as commodities. Indeed, to date no Western country has adopted a policy of financial compensation to families for consenting to organ donation.2Recently, a country suffering from severe shortage in organs has implemented a policy of financial incentives that uses cash payments. Wu and Fang5 describe a recent pilot programme in China that compensates families for postmortem donation, through an independent third party and based on consent or presumed consent of the deceased. The particular context within which this programme is implemented validates and even exacerbates some ethical concerns that have been voiced in the Western medical and bioethics …. (shrink)
Over the last decade there has been a noticeable increase in attention, on the part of public health scholars and professionals, to the important ethical challenges that arise in the context of public health policy, practice and research. This has arguably been a driver for the development of public health ethics as both a specialized field of study in bioethics and a subject for professional education. But how is PHE taught in public health programs and schools? Are current educational approaches (...) sufficient to provide future professionals with the necessary tools to address the diverse ethical challenges they will encounter? In this article, we examine the international public health and bioethics literatures regarding PHE education in public health programs and schools. Specifically, we 1) summarize the results from studies that describe PHE education in the United States, Europe, Canada and in some developing countries, 2) explore current attitudes and educational approaches toward ethics curricula in public health, and 3) identify and discuss reported barriers to PHE education. We conclude with some general recommendations and a research agenda to guide future work on implementing PHE into different public health programs. (shrink)
In this reply, we wish to defend our original position and address several of the points raised by two excellent responses. The first response questions the relevance of the notion of ‘serious’ within the context of human germline genome modification. We argue that the ‘serious’ factor is relevant and that there is a need for medical and social lenses to delineate the limits of acceptability and initial permissible applications of HGGM. In this way, ‘serious’ acts as a starting point for (...) further discussions and debates on the acceptability of the potential clinical translation of HGGM. Therefore, there is a pressing need to clarify its scope, from a regulatory perspective, so as to prevent individuals from using HGGM for non-therapeutic or enhancement purposes. The second response criticizes the narrow interpretation of the objectivist approach and the apparent bias towards material innovations when discussing the right to benefit from scientific advancements. As an in-depth discussion of the objectivist and constructivist approaches was beyond the scope of our original paper, we chose to focus on one specific objectivist account, one which focuses on biological and scientific facts. We agree, however, with the critique that material innovations should not be the sole focus of the right to benefit from scientific advancements, which also incorporates freedom of scientific research and access to scientific knowledge scientific freedom and knowledge, including the influence of these on ethical thinking and cultures. (shrink)
With the world's population aging, hospitals are facing pressure to adequately meet the needs of a growing number of frail older patients. For this population, comorbidities combined with a limited ability to face stressful situations contribute to frailty whereby a small injury or illness can lead to significant loss of function. It is widely recognized that hospitalized older patients are more vulnerable to physical or cognitive functional decline and require increased assistance in activities of daily living (Creditor 1993; Sager et (...) al. 1996; Mahoney, Sager, and Jalaluddin 1998; Kortebein et al. 2008; English and PaddonJones 2010; Covinsky, Pierluissi, and Johnston 2011; Zisberg et al. 2011;... (shrink)
The ethics of safe sex in the gay community has, for many years, been focused on debates surrounding the responsibility regarding the use of condoms to prevent HIV transmission, once the only tool available. With the development of Truvada as a pre-exposure prophylaxis for HIV, for the first time in the history of the HIV/AIDS epidemic there is the potential to significantly reduce the risk of HIV transmission during sex without the use of condoms. The introduction of PrEP necessitates a (...) renewed discussion about the politics and ethics of safe sex for men who have sex with men. We present the arguments of authors who hold radically opposite positions with regard to the ethics of condom use by gay men, but who currently both criticize the use of PrEP. We offer a critique of their arguments and advance the position that the use of PrEP, even without condoms, can be acceptable and part of a safe sex ethics framework for MSM. (shrink)
Investigators and institutional review boards should integrate plans about the appropriate disclosure of individual genetic results when designing research studies. The ethical principles of beneficence, respect, reciprocity, and justice provide justification for routinely offering certain results to research participants. We propose a result-evaluation approach that assesses the expected information and the context of the study in order to decide whether results should be offered. According to this approach, the analytic validity and the clinical utility of a specific result determine whether (...) it should be offered routinely. Different results may therefore require different decisions even within the same study. We argue that the threshold of clinical utility for disclosing a result in a research study should be lower than the threshold used for clinical use of the same result. The personal meaning of a result provides additional criteria for evaluation. Finally, the context of the study allows for a more nuanced analysis by addressing the investigators' capabilities for appropriate disclosure, participants' alternative access to the result, and their relationship with the investigators. This analysis shows that the same result may require different decisions in different contexts. (shrink)
BackgroundThe clinical introduction of non-invasive prenatal testing for fetal aneuploidies is currently transforming the landscape of prenatal screening in many countries. Since it is noninvasive, safe and allows the early detection of abnormalities, NIPT expanded rapidly and the test is currently commercially available in most of the world. As NIPT is being introduced globally, its clinical implementation should consider various challenges, including the role of the surrounding social and cultural contexts. We conducted a qualitative study with healthcare professionals in Lebanon (...) and Quebec as case studies, to highlight the relevance of cultural contexts and to explore the concerns that should be taken into account for an ethical implementation of NIPT.MethodsWe conducted semi-structured interviews with 20 healthcare professionals, 10 from each country, practicing in the field of prenatal screening and follow up diagnostic testing, including obstetricians and gynecologists, nurses, medical geneticists and, genetic counselors. We aimed to 1) explore HCPs’ perceptions and views regarding issues raised by NIPT and 2) to shed light on ways in which the introduction of the same technology in two different contexts raises common and different challenges that are influenced by the cultural norms and legal policies in place.ResultsWe identified challenges to the ethical implementation of NIPT. Some are common to both contexts, including financial/economic, social, and organizational/ educational challenges. Others are specific to each context. For example, challenges for Lebanon include abortion policy and financial profit, and in Quebec challenges include lobbying by Disability rights associations and geographical access to NIPT.ConclusionsOur findings highlight the need to consider specific issues related to various cultural contexts when developing frameworks that can guide an ethically sound implementation of NIPT. Further, they show that healthcare professional education and training remain paramount in order to provide NIPT counseling in a way that supports pregnant women and couples’ choice. (shrink)
