In their article, Pavarani and colleagues offer a vision of evolutionary bioethics that focuses on innovation and empirical research as a means to enrich the field of bioethics. Empirical bi...

This study’s objective was to understand Colombian adolescents’ experiences and preferences regarding access to sexual and reproductive health services (SRHS), either alone or accompanied. A mixed-method approach was used, involving a survey of 812 participants aged eleven to twenty-four years old and forty-five semi-structured interviews with participants aged fourteen to twenty-three. Previous research shows that adolescents prefer privacy when accessing SRHS and often do not want their parents involved. Such findings align with the longstanding tendency to frame the ethical principle (...) of autonomy as based on independence in decision-making. However, the present study shows that such a conceptualization and application of autonomy does not adequately explain Colombian adolescent participants’ preferences regarding access to SRHS. Participants shared a variety of preferences to access SRHS, with the majority of participants attaching great importance to having their parents involved, to varying degrees. What emerges is a more complex and non-homogenous conceptualization of autonomy that is not inherently grounded in independence from parental involvement in access to care. We thus argue that when developing policies involving adolescents, policymakers and health professionals should adopt a nuanced “relational autonomy” approach to better respect the myriad of preferences that Colombian (and other) adolescents may have regarding their access to SRHS. (shrink)

With closer interactions between academic and commercial entities the role of the university is expanding to also include knowledge transferIn the biomedical and health sciences , close interactions between academic and commercial entities are now common place. Funds from pharmaceutical and biotechnology companies have helped finance major bioscience projects and research centres, graduate students are receiving training in commercial laboratories, and university scientists are translating their ‘intellectual property’ by patenting their research and launching start-up companies. And this is happening with (...) the blessing of universities, who see the commercialisation of research – and the royalties brought in from ‘technology transfer’ – as part of their new mission.The result is that no longer are universities simply places of higher learning, where academics are dedicated to teaching and research, traditionally the ‘first’ and ‘second’ missions of universities; universities now have a ‘third’ mission, to engage in knowledge transfer. Governments and research-intensive industries , are keen to translate university research into marketable products. Facilitated by policies and laws to protect intellectual property rights and aid commercialisation, universities are transforming into ‘entrepreneurial’ institutions.1 University administrators seek to generate new funding streams, while governments see universities as drivers of technology development and economic growth. In such a climate, it should not be surprising that researchers in many disciplines are facing pressure to collaborate …. (shrink)

In seeking to clarify the concept of conflict of interest (COI) in debates about physician–industry relationships, Howard Brody (2011) highlights the extent to which the prob- lem turns on a common pejorative understanding of COI. Whether it is the academic or public policy “pharmapologists” or “pharmascolds” talking about COI, there is often a straightforward and overly simplistic correlation made: that is, a conflict of interest—by definition—leads to fraudulent or corrupt behavior. The same type of reasoning is com- monly found in (...) discussions about COI outside the health sciences, most notably in news stories about the awarding of government contracts or the behaviour of corporate executives. The problem is that in focusing on dramatic failures to manage COI (e.g., around Vioxx), there is a tendency to strongly associate COI with extreme forms of financial and even criminal misconduct, leaving the public, policymakers, academics, and professionals with a skewed and limited understanding of the concept. (shrink)

While there has been significant discussion in the health sciences and ethics literatures about problems associated with publication practices (e.g., ghost- and gift-authorship, conflicts of interest), there has been relatively little practical guidance developed to help researchers determine how they should fairly allocate credit for multi-authored publications. Fair allocation of credit requires that participating authors be acknowledged for their contribution and responsibilities, but it is not obvious what contributions should warrant authorship, nor who should be responsible for the quality and (...) content of the scientific research findings presented in a publication. In this paper, we review arguments presented in the ethics and health science literatures, and the policies or guidelines proposed by learned societies and journals, in order to explore the link between author contribution and responsibility in multi-author multidisciplinary health science publications. We then critically examine the various procedures used in the field to help researchers fairly allocate authorship. (shrink)

In the United Kingdom, there are moves to extend formal ethical review of research involving human subjects beyond the traditional oversight by NHS local or multi-centre research ethics committees of medical or clinical research, to also encompass all ‘non-clinical’ research involving human subjects. This paper describes and analyses the development and implementation of a model for ethical review within the university sector. At Cardiff University, a devolved or two-tiered system of ethics review has been created in which a top-level university (...) research ethics committee provides policy advice to and oversight of school-based research ethics committees that engage in formal ethics review of research conducted in their respective schools. We describe the system and reflect on the challenges and benefits of implementing such a coordinated and comprehensive university-wide system of ethics review. (shrink)

Scientific authorship serves to identify and acknowledge individuals who “contribute significantly” to published research. However, specific authorship norms and practices often differ within and across disciplines, labs, and cultures. As a consequence, authorship disagreements are commonplace in team research. This study aims to better understand the prevalence of authorship disagreements, those factors that may lead to disagreements, as well as the extent and nature of resulting misbehavior. Methods include an international online survey of researchers who had published from 2011 to (...) 2015. Of the 6673 who completed the main questions pertaining to authorship disagreement and misbehavior, nearly half reported disagreements regarding authorship naming; and discipline, rank, and gender had significant effects on disagreement rates. Paradoxically, researchers in multidisciplinary teams that typically reflect a range of norms and values, were less likely to have faced disagreements regarding authorship. Respondents reported having witnessed a wide range of misbehavior including: instances of hostility, undermining of a colleague’s work during meetings/talks, cutting corners on research, sabotaging a colleague’s research, or producing fraudulent work to be more competitive. These findings suggest that authorship disputes may contribute to an unhealthy competitive dynamic that can undermine researchers’ wellbeing, team cohesion, and scientific integrity. (shrink)

Research on research ethics—regarding both the governance and practice of the ethical review of human subjects research—has a tumultuous history in North America and Europe. Much of the academic literature focuses on issues to do with regulating the conduct and quality of ethics review of research protocols by ethics committees (research ethics boards (REBs) in Canada and institutional review boards (IRBs) in the United States). In addition, some of the literature attends to issues particular to the review of qualitative research, (...) and still other literature addresses the challenges posed by and the need for research on REBs/IRBs. It is this third group of literature within which our article is situated. (shrink)

For Van Rensselaer Potter (1911–2001), Global Bio-Ethics is about building on the legacy of Aldo Leopold (1887–1948), one of the most notable forest managers of the twentieth century who brought to light the importance of pragmatism in the sciences and showed us a new way to proceed with environmental ethics. Following Richard Huxtable and Jonathan Ives's methodological 'Framework for Empirical Bioethics Research Projects' called 'Mapping, framing, shaping,' published in BMC Medicine Ethics (2019)), we propose operationalizing a framework for Global Bio-Ethics (...) by hybridizing approaches in empirical bioethics and ecosystem management. We explain this framework using the metaphor of forest management. This mixed approach is articulated through three phases: (1) mapping the “landscape” to build a working theory, (2) framing the “scene” to prepare the fieldwork, and (3) shaping bioethics “tools” to stimulate cooperation. Applying this methodology, an adaptive management cycle is outlined to help ensure that political processes are sustainable and socially acceptable, still based on strategic and ethical thinking, but also capable of reshaping failing policies. (shrink)

: Decisions about funding health services are crucial to controlling costs in health care insurance plans, yet they encounter serious challenges from intellectual property protection—e.g., patents—of health care services. Using Myriad Genetics' commercial genetic susceptibility test for hereditary breast cancer (BRCA testing) in the context of the Canadian health insurance system as a case study, this paper applies concepts from social contract theory to help develop more just and rational approaches to health care decision making. Specifically, Daniels's and Sabin's "accountability (...) for reasonableness" is compared to broader notions of public consultation, demonstrating that expert assessments in specific decisions must be transparent and accountable and supplemented by public consultation. (shrink)

Public discussions of ethical issues related to the biotechnology industry tend to treat "biotechnology" as a single, undifferentiated technology. Similarly, the pros and cons associated with this entire sector tend to get lumped together, such that individuals and groups often situate themselves as either "pro-" or "anti-" biotechnology as a whole. But different biotechnologies and their particular application context pose very different challenges for ethical corporate decision-making. Even within a single product category, different specialty products can pose strikingly different ethical (...) challenges. In this paper, we focus on the single over-arching category of "genetic testing" and compare tests for disease susceptibility and drug response. We highlight the diversity of ethical challenges - grouped under the broad categories of "truth in advertising" and "protecting intellectual property" - raised by the commercialization and marketing of these technologies. By examining social and technical differences between genetic tests, and the associated corporate ethics challenges posed by their commercialization, our intent is to contribute to the nascent business ethics literature examining issues raised by the development and marketing of genetic tests. (shrink)

Dans notre société de plus en plus digitalisée, avons-nous vraiment le choix d’adopter ou non les technologies? Comment cette digitalisation impacte-t-elle les personnes âgées en particulier et son écosystème? Quels sont les enjeux éthiques soulevés par cette digitalisation? Ce texte vise à amener des éléments de réflexions en lien avec ces enjeux selon le point de vue de divers experts des domaines de la technologie, du vieillissement et de la bioéthique. Ces experts se sont rencontrés lors d’un symposium ayant eu (...) lieu à Angers, France, en octobre 2019. Le texte est un compte-rendu des échanges et points de vue de ces experts, ainsi que des discussions ouvertes qu’ils ont eues avec l’assistance, portant sur les principaux enjeux soulevés par cette digitalisation selon la perspective des personnes âgées, des proches-aidants, des soignants, de la société et de la recherche. (shrink)

L’érosion actuelle de la confiance du public envers les campagnes de vaccination et les décisions de politiques publiques qui y sont associées, aggravée par des scandales comme ceux relatifs à la pandémie H1N1 et l’utilisation du Tamiflu™, risque de diminuer de façon significative l’efficacité de ces interventions importantes pour la santé publique. Un manque de confiance de la population envers les acteurs de santé publique peut conduire à une méfiance accrue face aux interventions, pouvant ainsi compromettre l’atteinte des objectifs recherchés (...) par une intervention spécifique et, conséquemment, avoir un impact important sur les bénéfices attendus pour la population visée par cette intervention. Dans la production des avis d’experts, les membres des comités consultatifs d’experts en immunisation (CCEI) peuvent avoir une influence importante sur la prise de décision publique, notamment, sur la sélection par les décideurs de santé publique de vaccins en particulier et la façon dont les campagnes de vaccination seront déployées. En contrepartie de cette influence sur les décisions publiques, une indépendance et une transparence sont attendues de leur part puisque des mécanismes de divulgation et de gestion de conflits d’intérêts (CI) imparfaits peuvent affecter négativement la confiance du public à l’égard de telles décisions. Il apparaît donc important de s’assurer que des mécanismes de gestion des CI, transparents et robustes, existent pour ces comités. Dans cette étude, les avis ou rapports d’évaluation de la pertinence de la vaccination préparés par un CCEI au Québec ont été examinés pour quatre types de maladies évitables par la vaccination (infections invasives à méningocoques et à pneumocoques, coqueluche et virus du papillome humain). Le but était de : 1) identifier les CI divulgués par les membres du CCEI dans leurs rapports comparativement à ceux déclarés dans leurs publications scientifiques pour ces mêmes infections ; 2) analyser la nature des CI (réel, potentiel, apparent, personnel, financier, institutionnel, etc.) et l’impact potentiel (risque) sur la prise de décision impartiale et sur la confiance du public ; et 3) évaluer les mécanismes de gestion de CI actuellement utilisés par ce CCEI. Les résultats de cette étude montrent que très peu de rapports du CCEI contiennent une section sur les CI par rapport à la pléthore divulguée dans les publications scientifiques publiées par les membres du CCEI. De plus, les CI divulgués dans les rapports fréquemment ne correspondent pas à ceux décrits dans les publications scientifiques. Il serait donc important d’introduire des mesures visant à accroître la transparence des experts en immunisation et d’améliorer les mécanismes de divulgation et de gestion des CI afin de veiller à ce que la confiance du public envers les décideurs en santé publique soit maintenue et améliorée. (shrink)

Public discussions of ethical issues related to the biotechnology industry tend to treat “biotechnology” as a single, undifferentiated technology. Similarly, the pros and cons associated with this entire sector tend to get lumped together, such that individuals and groups often situate themselves as either “pro-” or “anti-” biotechnology as a whole. But different biotechnologies and their particular application context pose very different challenges for ethical corporate decision-making. Even within a single product category, different specialty products can pose strikingly different ethical (...) challenges. In this paper, we focus on the single over-arching category of “genetic testing” and compare tests for disease susceptibility and drug response. We highlight the diversity of ethical challenges – grouped under the broad categories of “truth in advertising” and “protecting intellectual property” – raised by the commercialization and marketing of these technologies. By examining social and technical differences between genetic tests, and the associated corporate ethics challenges posed by their commercialization, our intent is to contribute to the nascent business ethics literature examining issues raised by the development and marketing of genetic tests. (shrink)

Background There has been debate on whether a global or unified field of bioethics exists. If bioethics is a unified global field, or at the very least a closely shared way of thinking, then we should expect bioethicists to behave the same way in their academic activities anywhere in the world. This paper investigates whether there is a 'global bioethics' in the sense of a unified academic community. Methods To address this question, we study the web-linking patterns of bioethics institutions, (...) the citation patterns of bioethics papers and the buying patterns of bioethics books. Results All three analyses indicate that there are geographical and institutional differences in the academic behavior of bioethicists and bioethics institutions. Conclusion These exploratory studies support the position that there is no unified global field of bioethics. This is a problem if the only reason is parochialism. But these regional differences are probably of less concern if one notices that bioethics comes in many not always mutually understandable dialects. (shrink)

Antimicrobial resistance is a growing public health concern and is associated with the over - or inappropriate use of antimicrobials in both humans and agriculture. While there has been recognition of this problem on the part of agricultural and public health authorities, there has nonetheless been significant difficulty in translating policy recommendations into practical guidelines. In this paper, we examine the process of public health policy development in Quebec agriculture, with a focus on the case of pork production and the (...) role of food animal veterinarians in policy making. We argue that a tendency to employ strictly techno- scientific risk analyses of antimicro- bial use ignores the fundamental social, economic and political realities of key stakeholders and so limits the applicability of policy recommendations developed by government advisory groups. In particular, we suggest that veterinarians’ personal and professional interests, and their ethical norms of practice, are key factors to both the problem of and the solution to the current over -reliance on antimicrobials in food production. (shrink)

Antimicrobial resistance is a growing public health concern and is associated with the over- or inappropriate use of antimicrobials in both humans and agriculture. While there has been reco- gnition of this problem on the part of agricultural and public health authorities, there has none- theless been significant difficulty in translating policy recommendations into practical guidelines. In this paper, we examine the process of public health policy development in Quebec agriculture, with a focus on the case of pork production and (...) the role of food animal veterinarians in policy making. We argue that a tendency to employ strictly techno-scientific risk analyses of antimicro- bial use ignores the fundamental social, economic and political realities of key stakeholders and so limits the applicability of policy recommendations developed by government advisory groups. In particular, we suggest that veterinarians’ personal and professional interests, and their ethi- cal norms of practice, are key factors to both the problem of and the solution to the current over-reliance on antimicrobials in food production. (shrink)

There are conceptual and ethical challenges to defining adolescents’ autonomy to access health care, and these can lead to health care norms and practices that could be maladjusted to the needs and preferences of adolescents. Particularly sensitive is access to sexual and reproductive health care services (SRHS). Yet, while there has been substantial conceptual work to conceptualize autonomy (e.g., as independence), there is a lack of empirical research that documents the perceptions of adolescents regarding on how they access or wish (...) to access health care services. The main objectives of this research were to (a) understand how adolescents in Colombia interpret the concept of “autonomy,” (b) describe how these adolescents articulate their autonomy (i.e., preferences) in accessing SRHS, and (c) analyze the ethical issues emerging from these data. Forty-five semi-structured interviews were conducted with participants aged 14 to 23 years old in the Departments of Antioquia and Valle del Cauca in Colombia. Our study showed that participants’ understanding of autonomy was context-based and highly dependent on personal experiences, and these influenced their choice in how to access SRHS. Seen through the ethical lens of a reproductive justice framework, our results highlight the unequal opportunities for adolescents in terms of autonomy to access SRHS. (shrink)

Van Rensselaer Potter (1911-2001), le biologiste à l’origine du terme « bioéthique » dans les écrits nord-américains, considère que « real bioethics falls in the context of the ideals of […] Aldo Leopold », un forestier, philosophe et poète ayant marqué le XXe siècle. Associer Leopold à Potter a pour effet de placer la bioéthique dans la famille des éthiques de l’environnement, ce qui la différencie du sens conventionnel retenu en médecine et en recherche depuis le Rapport Belmont (1979), une (...) déclaration ayant propulsé l’institutionnalisation de la bioéthique en Amérique du Nord. Cependant, diviser la bioéthique entre le médical et l’environnemental est réducteur. Potter propose au contraire une bioéthique globale s’intéressant aux enjeux situés à leur interface, dont ceux concernant la terre, la vie sauvage, la surpopulation, la consommation, etc. Cet article vise à amorcer un nouveau chantier d’analyse de la pensée de Potter en s’appuyant sur l’héritage de Leopold en biologie. Une synthèse de cette vision potterienne est proposée de manière à considérer son œuvre comme un tout cohérent s’intégrant aux grands débats qui transcendent les XXe et XXIe siècles. Sa vision apparaît comme une sagesse collective et prospective sous la forme d’une science de la survie et d’un code de bioéthique. Dépassant l’éthique de l’environnement, son association avec Leopold offre un modèle de la complexité s’imposant comme cas indissociable du contexte qui l’englobe, en améliorant nos façons d’intervenir en pratique dans un monde en constante transformation, à titre de gouvernance adaptative et de sagesse de la responsabilité. (shrink)

Imagine that you are part of the editorial board of a young bioethics journal committed to publishing open access (OA) and to ensuring accessibility to high quality and innovative scholarship. To support junior and interna- tional scholars who might not otherwise find places for their work in the leading Western bioethics journals, you do not charge author fees. Imagine also that you have no financial resources to pay for a professional website, auto- mated submissions manager, or even a part-time coordina- (...) tor: Your government has cut all grants for journals, you cannot go to industry for private funding because of the evident risk of apparent conflicts of interest, and your strapped-for-cash institution cannot afford to offer you any support. If one of the major publishers were to approach you to sign a deal, the temptation would be strong to accept. However, this would likely mean putting aside your ideals: It would be impossible to stay a “Green OA” publication (i.e., free of author publication charges) or supportive of junior and international scholars (because of pressures to “increase credibility” through artificially high rejection rates, for example). (shrink)

Authorship is commonly used as the basis for the measurement of research productivity. It influences career progression and rewards, making it a valued commodity in a competitive scientific environment. To better understand authorship practices amongst collaborative teams, this study surveyed authors on collaborative journal articles published between 2011 and 2015. Of the 8364 respondents, 1408 responded to the final open-ended question, which solicited additional comments or remarks regarding the fair distribution of authorship in research teams. This paper presents the analysis (...) of these comments, categorized into four main themes: disagreements, questionable behavior, external influences regarding authorship, and values promoted by researchers. Results suggest that some respondents find ways to effectively manage disagreements in a collegial fashion. Conversely, others explain how distribution of authorship can become a “blood sport” or a “horror story” which can negatively affect researchers’ wellbeing, scientific productivity and integrity. Researchers fear authorship discussions and often try to avoid openly discussing the situation which can strain team interactions. Unethical conduct is more likely to result from deceit, favoritism, and questionable mentorship and may become more egregious when there is constant bullying and discrimination. Although values of collegiality, transparency and fairness were promoted by researchers, rank and need for success often overpowered ethical decision-making. This research provides new insight into contextual specificities related to fair authorship distribution that can be instrumental in developing applicable training tools to identify, prevent, and mitigate authorship disagreement. (shrink)

This case study examines some of the challenges, and in particular conflicts of interest, that professors face in writing letters of reference for their students.

The case of Andrew Gobea, the first child to receive experimental gene therapy for SCID, and a reflection on the associated ethical implications of gene therapy research.

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)

This case study examines the conflicts of interest that can arise in the selection of jury members to evaluate a PhD thesis, and the costs associated with trying to avoid COI.

Ongoing research in the fields of genetics and biotechnology hold the promise of improved diagnosis and treatment of genetic diseases, and potentially the development of individually tailored pharmaceuticals and gene therapies. Difficulty, however, arises in determining how these services are to be evaluated and integrated equitably into public health care systems such as Canada's. The current context is one of increasing fiscal restraint on the part of governments, limited financial resources being dedicated to health care, and rising costs for new (...) health care services and technologies. This has led to increasing public debate in the last few years about how to reform public health care, and whether we should prohibit, permit or perhaps even encourage private purchase of health care services. ;In Canada, some of these concerns have crystallized around the issue of gene patents and commercial genetic testing, in particular as illustrated by the case of Myriad Genetics' patented BRACAnalysis test for hereditary breast and ovarian cancer. While most Canadians who currently access genetic services do so through the public health care system, for those with the means, private purchase is becoming an option. This situation raises serious concerns---about justice in access to health care; about continued access to safe and reliable genetic testing supported by unbiased patient information; and about the broader effects of commercialization for ongoing research and the Canadian public health care system. Commercial genetic testing presents a challenge to health care professionals, policy analysts, and academics concerned with the social, ethical and policy implications of new genetic technologies. Using the Myriad case as an exemplar, tools from moral philosophy, the social sciences, and health policy and law will be brought to bear on the larger issues of how as a society we should regulate commercial research and product development, and more coherently decide which services to cover under public health insurance and which to leave to private purchase. Generally, the thesis is concerned with the question of "how best to bring capital, morality, and knowledge into a productive and ethical relationship". (shrink)

Conflicts of interest in the university context are receiving growing attention, but the focus has been largely on problematic financial COI arising from university-industry relations, which clearly need to be avoided. The result, unfortunately, is a pejorative perception of COI as being equivalent to fraud and thus an issue of academic misconduct. In this paper, the aim is to show that while some financial and non-financial COI are particularly problematic and so should be avoided, many are pervasive and actually the (...) norm in academia even if they are still largely ignored and misunderstood. Through a reflection on my own experiences as a university professor, I describe a diversity of common financial, non-financial and institutional COI of varying degrees of risk, that arise in the day-to-day activities of a professor, in order to then consider how these COI can and should be managed in practice. It is essential to attend to the full range of COI and to think about appropriate policies, procedures, or guidelines to prohibit some COI and mitigate the risks of others; but these “hard” mechanisms are only part of the solution. This paper will focus on elucidating the various “soft” mechanisms – such as education, self-awareness, humility, and dialogue – that can empower professors to manage those COI that cannot be prevented or avoided. (shrink)

The rapid advances made in genetic research and technology over the last few decades have led to a host of important discoveries that have allowed for the detection (and hopefully soon the treatment) of a number of genetic conditions and diseases. Not surprisingly, these advances have also raised numerous ethical concerns about how result­ ing technologies will be implemented, and the impact they will have on different com­ munities. One particular concern is the enormous costs involved in conducting genetic research (...) and the fact that the private sector has become heavily involved; the desire to commercialize the results and technology derived from genetic research is considered problematic. In September 1998, the Second International Conference on DNA Sampling, titled "The Commercialization of Genetic Research: Ethical, Legal and Policy Issues," was held of the conference, and of this book, was to in Edmonton, Alberta, Canada. The goal facilitate an interdisciplinary discussion of the legal, ethical, and policy implications arising from the commercialization of genetic research. We solicited contributions for the book from authors in fields as diverse as ethics, law, medicine, health policy, and the social sciences. The papers included, while based on presentations given at the conference, have been substantially expanded and enhanced by the commentary received and discussions held at the conference. (shrink)

This case study examines the conflicts of interest that arise when university professors use as required course readings their own textbooks.

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)

Genetic testing in the workplace is a technology both full of promise and fraught with ethical peril. Though not yet common, it is likely to become increasingly so. We survey the key arguments in favour of such testing, along with the most significant ethical worries. We further propose a set of pragmatic criteria, which, if met, would make it permissible for employers to offer (but not to require) workplace genetic testing.

While every health care system stakeholder would seem to be concerned with obtaining the greatest value from a given technology, there is often a disconnect in the perception of value between a technology’s promoters and those responsible for the ultimate decision as to whether or not to pay for it. Adopting an empirical ethics approach, this paper examines how five Canadian medical device manufacturers, via their websites, frame the corporate “value proposition” of their innovation and seek to respond to what (...) they consider the key expectations of their customers. Our analysis shows that the manufacturers’ framing strategies combine claims that relate to valuable socio-technical goals and features such as prevention, efficiency, sense of security, real-time feedback, ease of use and flexibility, all elements that likely resonate with a large spectrum of health care system stakeholders. The websites do not describe, however, how the innovations may impact health care delivery and tend to obfuscate the decisional trade-offs these innovations represent from a health care system perspective. Such framing strategies, we argue, tend to bolster physicians’ and patients’ expectations and provide a large set of stakeholders with powerful rhetorical tools that may influence the health policy arena. Because these strategies are difficult to counter given the paucity of evidence and its limited use in policymaking, establishing sound collective health care priorities will require solid critiques of how certain kinds of medical devices may provide a better (i.e., more valuable) response to health care needs when compared to others. (shrink)

There is a widely acknowledged shortage of and an increasing demand for transplantable human organs and tissues (e.g., kidney, heart, lung, liver, cornea) in developed and developing countries around the world. In response to this need, Lott and Savulescu (2007) propose the creation of a human embryonic stem (hESC) bank to facilitate the equitable and efficient dissemination of human leukocyte anti- gen (HLA) matched tissues and organs to patients in need of replacement. Although not an unreasonable proposal, the authors go (...) on to make a much stronger claim. They argue that hESCs are such important tools for addressing the massive unmet global need for organs that it is ethically justified to require mandatory banking of spare embryos, and they argue for the use of financial (or other) inducements to procure embryos for the derivation of hESCs. (shrink)

In Canada, there are currently no guidelines at either the federal or provincial level regarding the provision of kidney transplantation services to foreign nationals (FN). Renal transplant centres have, in the past, agreed to put refugee claimants and other FNs on the renal transplant waiting list, in part, because these patients (refugee claimants) had health insurance through the Interim Federal Health Programme to cover the costs of medication and hospital care. However, severe cuts recently made to this programme have forced (...) clinicians to question whether they should continue with transplants for FNs, for financial and ethical reasons. This paper first examines different national policies (eg, in Canada, USA, France and the UK) to map the diversity of approaches regarding transplantation for FNs, and then works through different considerations commonly used to support or oppose the provision of organs to these patients: (1) the organ shortage; (2) the free-rider problem; (3) the risk of becoming a transplant destination; (4) the impact on organ donation rates; (5) physicians’ duties; (6) economic concerns; (7) vulnerability. Using a Canadian case as a focus, and generalising through a review of various national policies, we analyse the arguments for and against transplantation for FNs with a view to bringing clarity to what is a sensitive political and clinical management issue. Our aim is to help transplant centres, clinicians and ethicists reflect on the merits of possible options, and the rationales behind them. (shrink)

Promotion of prescription drugs may appear to be severely limited in some jurisdictions due to restrictions on direct-to-consumer advertising. However, in most jurisdictions, strategies exist to raise consumer awareness about prescription drugs, notably through the deployment of direct-to-consumer information campaigns that encourage patients to seek help for particular medical conditions. In Canada, DTCI is presented by industry and regulated by Health Canada as being purely informational activities, but their design and integration in broader promotional campaigns raise very similar ethical concerns (...) as those associated with DTCA. Specifically, DTCI can be an effective means of familiarizing the public with the scope and benefits of a particular prescription drug and so, like DTCA, can promote increased patient-consumer demand and thus a problematic rise in the prescribing and use of medications that may be neither the most appropriate nor the most cost-effective. Yet, with DTCI the industry is playing within the existing rules and regulations set by health regulators. To respond appropriately to this regulatory incoherence, we argue that DTCI should be regulated as a type of direct-to-consumer indirect advertising. Even if the case and specific regulations presented here are Canadian, the implications extend to every country that has a partial or total prohibition on DTCA. (shrink)

Concern about the ethics of clinical drug trials research on patients and healthy volunteers has been the subject of significant ethical analysis and policy development—protocols are reviewed by Research Ethics Committees and subjects are protected by informed consent procedures. More recently attention has begun to be focused on DNA banking for clinical and pharmacogenetics research. It is, however, surprising how little attention has been paid to the commercial nature of such research, or the unique issues that present when subjects are (...) asked to consent to the storage of biological samples. Our contention is that in the context of pharmacogenetic add-on studies to clinical drug trials, the doctrine of informed consent fails to cover the broader range of social and ethical issues. Applying a sociological perspective, we foreground issues of patient/subject participation or ‘work’, the ambiguity of research subject altruism, and the divided loyalties facing many physicians conducting clinical research. By demonstrating the complexity of patient and physician involvement in clinical drug trials, we argue for more comprehensive ethical review and oversight that moves beyond reliance on informed consent to incorporate understandings of the social, political and cultural elements that underpin the diversity of ethical issues arising in the research context. (shrink)

Military physicians are often perceived to be in a position of ‘dual loyalty’ because they have responsibilities towards their patients but also towards their employer, the military institution. Further, they have to ascribe to and are bound by two distinct codes of ethics, each with its own set of values and duties, that could at first glance be considered to be very different or even incompatible. How, then, can military physicians reconcile these two codes of ethics and their distinct professional/institutional (...) values, and assume their responsibilities towards both their patients and the military institution? To clarify this situation, and to show how such a reconciliation might be possible, we compared the history and content of two national professional codes of ethics: the Defence Ethics of the Canadian Armed Forces and the Code of Ethics of the Canadian Medical Association. Interestingly, even if the medical code is more focused on duties and responsibility while the military code is more focused on core values and is supported by a comprehensive ethical training program, they also have many elements in common. Further, both are based on the same core values of loyalty and integrity, and they are broad in scope but are relatively flexible in application. While there are still important sources of tension between and limits within these two codes of ethics, there are fewer differences than may appear at first glance because the core values and principles of military and medical ethics are not so different. (shrink)

Nanotechnology research is beginning to see widespread coverage in the media and popular science literatures, but discussions of hopes and fears about nanotechnology have already become polarised into utopian and dystopian visions. More moderate discussions focus on the near-term applications of nanotechnologies, and on potential benefits and harms. However, in exploring the social and ethical implications of nanotechnology, important lessons should be learned from experiences in other fields. In particular, studies of the ethical, legal, and social issues of genetics research (...) have successfully mapped out many of the issues that arise when new technologies are deployed. It is our contention that, for the most part, the ethical and social issues arising in nanomedicine are not altogether new, and thus do not require novel ethical principles or frameworks, nor a massive investment in ‘NELSI’ research. Instead, what is needed is support for the development of a culture of ethics amongst scientists and clinicians, basic scientific and medical knowledge for bioethicists, and a social competency for citizens to participate actively in debates about the implications of new technologies in general. (shrink)

Lee (2017) calls for greater attention to the shared epistemological and normative grounds of both public health ethics and environmental ethics, and to Potter’s original conception of bioethics, which, as she rightly observes, has been largely disregarded in contemporary North American bioethics scholarship and practice. In a previous publication we also argued in favor of reviving the Potterian approach to bioethics; we built a case grounded in “the relatively new field of molecular epigenetics [that] provides novel information that should serve (...) as additional justification for expanding the scope of bioethics to include environmental and public health concerns.”. (shrink)

The case study presented by Winch and Sinnott (2011) shows not only how difficult it is for clinicians and researchers to identify conflicts of interest (COI), but also how damaging it can be when there are unin- formed and uncoordinated policy responses by senior administrators.

University research ethics boards, although well established in North American since the 1980s, sometimes still have a poor reputation among researchers. They may be seen by members of the academic community as a bureaucratic system designed to prevent or slow down research, and one that does not understand the reality of researchers. This negative view is often the result of misunderstanding by 1) researchers and 2) some REBs about what an REB’s mandate is and how it should work. Based on (...) the experience of an REB President and a bioethicist, this series of Frequently Asked Questions aims to demystify research ethics so that researchers and REBs can collaborate in the advancement of knowledge, while ensuring the ethical and responsible conduct of research. (shrink)

University research ethics boards, although well established in North American since the 1980s, sometimes still have a poor reputation among researchers. They may be seen by members of the academic community as a bureaucratic system designed to prevent or slow down research, and one that does not understand the reality of researchers. This negative view is often the result of misunderstanding by 1) researchers and 2) some REBs about what an REB’s mandate is and how it should work. Based on (...) the experience of an REB President and a bioethicist, this series of Frequently Asked Questions aims to demystify research ethics so that researchers and REBs can collaborate in the advancement of knowledge, while ensuring the ethical and responsible conduct of research. (shrink)

A current advance within the agricultural industry is the use of genetic engineering to produce novel crops for food production. This technology raises questions about how societies should position themselves with respect to genetically modified (GM) crop development and implementation; namely, how should the potentials and risks of this technology be evaluated? We argue that current methods to evaluate the risks and benefits of GM crops are inadequate and not conducive to the strategic development of this technology, where a way (...) to ameliorate technology assessments for GM crops is to include farmers in the research process of evaluating these crops prior to their commercialization. However, particularities concerning the ethical status of such research require special consideration and vigilance. For example, in such technology assessment initiatives, farmers would occupy both the roles of research participant and research investigator. Other particularities surface due to factors related to the nature of GM crops. These particularities are examined with reference to concepts drawn from the field of research ethics, namely informed consent, compensatory decisions, and issues of participant inclusion/exclusion. (shrink)

Concern about the ethics of clinical drug trials research on patients and healthy volunteers has been the subject of significant ethical analysis and policy development—protocols are reviewed by Research Ethics Committees and subjects are protected by informed consent procedures. More recently attention has begun to be focused on DNA banking for clinical and pharmacogenetics research. It is, however, surprising how little attention has been paid to the commercial nature of such research, or the unique issues that present when subjects are (...) asked to consent to the storage of biological samples. Our contention is that in the context of pharmacogenetic add-on studies to clinical drug trials, the doctrine of informed consent fails to cover the broader range of social and ethical issues. Applying a sociological perspective, we foreground issues of patient/subject participation or ‘work’, the ambiguity of research subject altruism, and the divided loyalties facing many physicians conducting clinical research. By demonstrating the complexity of patient and physician involvement in clinical drug trials, we argue for more comprehensive ethical review and oversight that moves beyond reliance on informed consent to incorporate understandings of the social, political and cultural elements that underpin the diversity of ethical issues arising in the research context. (shrink)