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)
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)
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)
Bayefsky and Berkman argue in favor of evidence-based policy development for expanded prenatal genetic testing. They propose to identify what kinds of information pregnant persons, their par...
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)
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)
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)
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)
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.
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)
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)
In "Implementing Expanded Prenatal Genetic Testing: Should Parents Have Access to Any and All Fetal Genetic Information?," Bayefsky and Berkman argue in favor of establishing three categorie...
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)
Background: With multiple options available today to become a parent, how does the matter of genetic relatedness factor into adolescent cancer patients’ fertility preservation decision making? This study reports on and normatively analyzes this aspect of FP decision making. Methods: A convenience sample of Israeli adolescent cancer survivors and their parents were invited to participate in individual, semi-structured interviews. Results: In discussing the importance of genetic relatedness to future children or grandchildren, participants repeatedly brought up the interrelated issues of nature, (...) normalcy, and personal identity. Regardless of preference or ambivalence for genetic relatedness, the majority of participants were aware of alternative parenting options and noted both their advantages and disadvantages. However, knowledge of alternative parenting options was not uniform. Conclusions: To ensure that adolescent patients and their parents make informed FP decisions that meet their personal goals and values, it is important for physicians to discuss alternative parenting options with them in a culturally sensitive manner. Greater credence also should be given to those who question the importance of genetic relatedness. (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)
Les recherches scientifiques sur la COVID-19 sont à la fois menées et diffusées à une cadence effrénée. Bien qu’il soit inspirant de voir la communauté de la recherche répondre avec autant de vigueur à la crise causée par la pandémie, toute cette activité a par ailleurs engendré un chaos de mauvaises données, de résultats contradictoires et de manchettes exagérées. Alors que la polarisation, la déformation et la médiatisation des résultats scientifiques s’intensifient chaque jour, les inquiétudes se font de plus en (...) plus sentir quant à la perspective que la science pertinente soit présentée au public d’une manière qui puisse causer de la confusion, créer de fausses attentes et éroder la confiance du public. Dans cette note, nous explorons les principaux enjeux associés à la présentation de la science dans le contexte de la pandémie de la COVID-19. Plusieurs de ces enjeux ne sont pas nouveaux. Mais la pandémie de la COVID-19 a braqué les projecteurs sur le processus de la recherche biomédicale et a amplifié les ramifications néfastes des problèmes de communication publique. Nous devons faire mieux. À ce titre, nous conclurons ce rapport en formulant dix recommandations qui s’adressent aux acteurs clés qui interviennent dans la communication de la science sur la COVID-19, notamment les gouvernements, les bailleurs de fonds, les universités, les éditeurs, les médias et les communautés de recherche. (shrink)
COVID science is being both done and circulated at a furious pace. While it is inspiring to see the research community responding so vigorously to the pandemic crisis, all this activity has also created a churning sea of bad data, conflicting results, and exaggerated headlines. With representations of science becoming increasingly polarized, twisted and hyped, there is growing concern that the relevant science is being represented to the public in a manner that may cause confusion, inappropriate expectations, and the erosion (...) of public trust. Here we explore some of the key issues associated with the representations of science in the context of the COVID-19 pandemic. Many of these issues are not new. But the COVID-19 pandemic has placed a spotlight on the biomedical research process and amplified the adverse ramifications of poor public communication. We need to do better. As such, we conclude with ten recommendations aimed at key actors involved in the communication of COVID-19 science, including government, funders, universities, publishers, media and the research communities. (shrink)
A rich literature in bioethics argues against the use of anonymous gamete donation in the name of the ‘interest in knowing one’s genetic origins’. This interest stems from medical as well as psychosocial and identity reasons. The term ‘genealogical bewilderment’ has been coined to express the predicament of those deprived of access to information about their origins. Another rich body of literature in bioethics discusses arguments for and against posthumous-assisted reproduction, with a recent focus on PAR that is initiated by (...) the parents of a deceased man. This paper revisits arguments against PAR, in light of arguments regarding the interest in knowing one’s genetic origins. Limiting the discussion to the specific context of parent-initiated PAR, we argue that the use of cryopreserved sperm from a deceased identifiable man in the context of PIPAR may be ethically preferable when compared with the use of anonymous donor sperm, since it allows genealogical certainty, that is, giving the prospective child access to information about the identity, life story and ancestry of the genetic progenitor as well as genealogical embeddedness, that is, close relationship with extended family members. (shrink)
Background Chemotherapy and/or radiotherapy treatments may cause premature ovarian failure and irreversible loss of fertility. In the context of childhood cancers, it is now acknowledged that possible negative effects of therapies on future reproductive autonomy are a major concern. While a few options are open to post-pubertal patients, the only immediate option currently open to pre-pubertal girls is cryopreservation of ovarian tissue and subsequent transplantation. The aim of the study was to address a current gap in knowledge regarding the offer (...) of fertility preservation by Ovarian Tissue Cryopreservation for prepubescent girls with cancer, and to explore current practices and attitudes of Canadian, French and Moroccan pediatric heme oncologists. The comparative perspective is relevant since legal frameworks surrounding fertility preservation and funding offered by the healthcare system vary greatly. Methods An online survey was sent to the 45 pediatric oncology centers in Canada, France and Morocco. Results A total of 39 centers responded. OTC is offered by almost all pediatric heme oncologists in France, very few in Canada, and none in Morocco. For pediatric hematologists/oncologists who do not propose fertility preservation in Canada, the reasons are: the technique is still experimental, it is not available locally and cost of the technique for the family. 97% of Canadian and 100% of Moroccan pediatric hematologists/oncologists think OTC should be funded by the healthcare system as it is in France and in the province of Quebec in Canada. Conclusions The results of this study show tremendous diversity in the provision of OTC across countries, whereby its offer is correlated with legislation and funding. We argue that the current reality, in which this technology is often not offered to families, raises ethical issues related to justice and equity of access, as well as informed consent and future reproductive autonomy. (shrink)
