In biomedical ethics, there is widespread acceptance of moral realism, the view that moral claims express a proposition and that at least some of these propositions are true. Biomedical ethics is also in the business of attributing moral obligations, such as “S should do X.” The problem, as we argue, is that against the background of moral realism, most of these attributions are erroneous or inaccurate. The typical obligation attribution issued by a biomedical ethicist fails (...) to truly capture the person's actual obligations. We offer a novel argument for rife error in obligation attribution. The argument starts with the idea of an epistemic burden. Epistemic burdens are all of those epistemic obstacles one must surmount in order to achieve some aim. Epistemic burdens shape decision-making such that given two otherwise equal options, a person will choose the option that has the lesser of epistemic burdens. Epistemic burdens determine one's potential obligations and, conversely, their non-obligations. The problem for biomedical ethics is that ethicists have little to no access to others' epistemic burdens. Given this lack of access and the fact that epistemic burdens determine potential obligations, biomedical ethicists often can only attribute accurate obligations out of luck. This suggests that the practice of attributing obligations in biomedical ethics is rife with error. To resolve this widespread error, we argue that this practice should be abolished from the discourse of biomedical ethics. (shrink)

Ontologies describe reality in specific domains in ways that can bridge various disciplines and languages. They allow easier access and integration of information that is collected by different groups. Ontologies are currently used in the biomedical sciences, geography, and law. A Biomedical Ethics Ontology would benefit members of ethics committees who deal with protocols and consent forms spanning numerous fields of inquiry. There already exists the Ontology for Biomedical Investigations (OBI); the proposed BMEO would interoperate (...) with OBI, creating a powerful information tool. We define a domain ontology and begin to construct a BMEO, focused on the process of evaluating human research protocols. Finally, we show how our BMEO can have practical applications for ethics committees. This paper describes ongoing research and a strategy for its broader continuation and cooperation. (shrink)

Addressing the question in the form of Kant’s maxim, this paper moves on to a more controversial topic in biomedical ethics, physician-assisted suicide. However, my conclusion is tentative, and what is worse, negative: I partially approve suicide. It does not imply a moral hazard. The situation is opposite: in the present times, terminal patients seriously wish it. I, as an author, put an emphasis on this very respect. Now suicide is, for certain circles, nothing but justice. The arguments (...) of thinkers who approve suicide are also cited from this angle. (shrink)

Publication ethics is an important aspect of both the research and publication enterprises. It is particularly important in the field of biomedical science because published data may directly affect human health. In this article, we examine publication ethics policies in biomedical journals published in Central and Eastern Europe. We were interested in possible differences between East European countries that are members of the European Union (Eastern EU) and South-East European countries (South-East Europe) that are not members (...) of the European Union.The most common ethical issues addressed by all journals in the region were redundant publication, peer review process, and copyright or licensing details. Image manipulation, editors’ conflicts of interest and registration of clinical trialswere the least common ethical policies. Three aspects were significantly morecommon in journals published outside the EU: statements on the endorsement of international editorial standards, contributorship policy, and image manipulation.On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences amongbiomedical journals’ ethical policies calls for further research and active measuresto harmonize policies across journals. On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences among biomedical journals’ ethical policies calls for further research and active measures to harmonize policies across journals. (shrink)

What proper role should considerations of risk, particularly to research subjects, play when it comes to conducting research on human enhancement in the military context? We introduce the currently visible military enhancement techniques (1) and the standard discussion of risk for these (2), in particular what we refer to as the ‘Assumption’, which states that the demands for risk-avoidance are higher for enhancement than for therapy. We challenge the Assumption through the introduction of three categories of enhancements (3): therapeutic, preventive, (...) and pure enhancements. This demands a revision of the Assumption (4), alongside which we propose some further general principles bearing on how to balance risks and benefits in the context of military enhancement research. We identify a particular type of therapeutic enhancements as providing a more responsible path to human trials of the relevant interventions than pure enhancement applications. Finally, we discuss some possible objections to our line of thought (5). While acknowledging their potential insights, we ultimately find them to be unpersuasive, at least provided that our proposal is understood as fully non-coercive towards the candidates for such therapeutic enhancement trials. (shrink)

What proper role should considerations of risk, particularly to research subjects, play when it comes to conducting research on human enhancement in the military context? We introduce the currently visible military enhancement techniques and the standard discussion of risk for these, in particular what we refer to as the ‘Assumption’, which states that the demands for risk-avoidance are higher for enhancement than for therapy. We challenge the Assumption through the introduction of three categories of enhancements : therapeutic, preventive, and pure (...) enhancements. This demands a revision of the Assumption, alongside which we propose some further general principles bearing on how to balance risks and benefits in the context of military enhancement research. We identify a particular type of therapeutic enhancements as providing a more responsible path to human trials of the relevant interventions than pure enhancement applications. Finally, we discuss some possible objections to our line of thought. While acknowledging their potential insights, we ultimately find them to be unpersuasive, at least provided that our proposal is understood as fully non-coercive towards the candidates for such therapeutic enhancement trials. (shrink)

The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining ‘ethics regulation system for biomedical research’ as a set of actors, institutions, codes and laws involved in overseeing the (...) class='Hi'>ethics of biomedical research on humans. This framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and research ethics committees, but the Brazilian system has strong and noteworthy specificities. (shrink)

Biomedical technologies can increasingly be used not only to combat disease, but also to augment the capacities or traits of normal, healthy people – a practice commonly referred to as biomedical enhancement. Perhaps the best‐established examples of biomedical enhancement are cosmetic surgery and doping in sports. But most recent scientific attention and ethical debate focuses on extending lifespan, lifting mood, and augmenting cognitive capacities.

central claim is that anti-love biomedical intervention can be justified without the “simultaneous consent” of recipients (where the simultaneous consent of a person S is understood as S’s consent at time t to an intervention at t) when it contributes to increased autonomy. We begin with an overview of earlier discussions of the ethics of anti-love biomedical intervention, focusing on the pioneering work of Earp and colleagues. We then present some cases in which paternalistic intervention may be (...) effective. We will then present an argument for the idea of anti-love biomedical intervention without simultaneous consent, based on an analogy between (biomedical intervention in) addiction and (biomedical intervention in) love. One premise of this argument is that love and addiction are importantly similar in that they can compromise the autonomous capacity for self-governing. The other premise of this argument is that biomedical intervention in addiction without simultaneous consent can be justified if the intervention is expected to restore the compromised capacity for self-governing. We will propose the “Ulysses contract”, a contract to enforce anti-love biomedical intervention when the recipient refuses it, as a possible measure of such paternalistic intervention and discuss its possible risks. (shrink)

Background: Use of patients’ medical data for secondary purposes such as health research, audit, and service planning is well established in the UK. However, the governance environment, as well as public understanding about this work, have lagged behind. We aimed to systematically review the literature on UK and Irish public views of patient data used in research, critically analysing such views though an established biomedical ethics framework, to draw out potential strategies for future good practice guidance and inform (...) ethical and privacy debates. Methods: We searched three databases using terms such as patient, public, opinion, and electronic health records. Empirical studies were eligible for inclusion if they surveyed healthcare users, patients or the public in UK and Ireland and examined attitudes, opinions or beliefs about the use of patient data for medical research. Results were synthesised into broad themes using a framework analysis. Results: Out of 13,492 papers and reports screened, 20 papers or reports were eligible. While there was a widespread willingness to share patient data for research for the common good, this very rarely led to unqualified support. The public expressed two generalised concerns about the potential risks to their privacy. The first of these concerns related to a party’s competence in keeping data secure, while the second was associated with the motivation a party might have to use the data. Conclusions: The public evaluates trustworthiness of research organisations by assessing their competence in data-handling and motivation for accessing the data. Public attitudes around data-sharing exemplified several principles which are also widely accepted in biomedical ethics. This provides a framework for understanding public attitudes, which should be considered in the development in any guidance for regulators and data custodians. We propose four salient questions which decision makers should address when evaluating proposals for the secondary use of data. (shrink)

Background: Transgender health care is a subject of much debate among clinicians, political commentators, and policy-makers. While the World Professional Association of Transgender Health (WPATH) Standards of Care (SOC) establish clinical standards, these standards contain implied ethics but lack explicit focused discussion of ethical considerations in providing care. An ethics chapter in the SOC would enhance clinical guidelines. Aims: We aim to provide a valuable guide for healthcare professionals, and anyone interested in the ethical aspects of clinical support (...) for gender diverse and transgender people of all ages. Recognizing that the WPATH is a global association, we address broad challenges. We offer a reflection on general ethical principles, providing conceptual tools for healthcare providers, patients, and families to navigate the specific challenges they might encounter in transgender health care, in line with WPATH’s worldwide mission and scope. Method: This article employs a descriptive analysis, and our framework of reference is the four principles of biomedical ethics: respect for autonomy, beneficence, nonmaleficence, and justice. Results: The article presents a discussion on the four ethical principles as applied to transgender health care. We address issues such as respect for patient autonomy in decision-making, the role of beneficence and nonmaleficence in clinical interventions, and the importance of justice in equitable treatment and access to care. Some of the ethical concerns we address in this article pertain to the current sociopolitical climate, where there has been increasing legal interference, internationally, for transgender and nonbinary people, particularly youth, seeking medical care. Discussion: We highlight the interplay between ethical principles and clinical practice, underscoring the need for ethical guidance in addressing the diverse challenges faced by healthcare providers and patients in transgender health care. We advocate for continuous refinement of ethical thinking to ensure that transgender health care is not only medically effective but also ethically sound. (shrink)

While there is a steadily growing literature on epistemic injustice in healthcare, there are few discussions of the role that biomedical technologies play in harming patients in their capacity as knowers. Through an analysis of newborn and pediatric genetic and genomic sequencing technologies (GSTs), I argue that biomedical technologies can lead to epistemic injustice through two primary pathways: epistemic capture and value partitioning. I close by discussing the larger ethical and political context of critical analyses of GSTs and (...) their broader implications for just and equitable healthcare delivery. (shrink)

It is widely believed that a conservative moral outlook is opposed to biomedical forms of human enhancement. In this paper, I argue that this widespread belief is incorrect. Using Cohen’s evaluative conservatism as my starting point, I argue that there are strong conservative reasons to prioritise the development of biomedical enhancements. In particular, I suggest that biomedical enhancement may be essential if we are to maintain our current evaluative equilibrium (i.e. the set of values that undergird and (...) permeate our current political, economic, and personal lives) against the threats to that equilibrium posed by external, non-biomedical forms of enhancement. I defend this view against modest conservatives who insist that biomedical enhancements pose a greater risk to our current evaluative equilibrium, and against those who see no principled distinction between the forms of human enhancement. (shrink)

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

Background: Smart sensors have been developed as diagnostic tools for rehabilitation to cover an increasing number of geriatric patients. They promise to enable an objective assessment of complex movement patterns. -/- Objective: This research aimed to identify and analyze the conflicting ethical values associated with smart sensors in geriatric rehabilitation and provide ethical guidance on the best use of smart sensors to all stakeholders, including technology developers, health professionals, patients, and health authorities. -/- Methods: On the basis of a systematic (...) literature search of the scientific databases PubMed and ScienceDirect, we conducted a qualitative document analysis to identify evidence-based practical implications of ethical relevance. We included 33 articles in the analysis. The practical implications were extracted inductively. Finally, we carried out an ethical analysis based on the 4 principles of biomedical ethics: autonomy, beneficence, nonmaleficence, and justice. The results are reported in categories based on these 4 principles. -/- Results: We identified 8 conflicting aims for using smart sensors. Gains in autonomy come at the cost of patient privacy. Smart sensors at home increase the independence of patients but may reduce social interactions. Independent measurements performed by patients may result in lower diagnostic accuracy. Although smart sensors could provide cost-effective and high-quality diagnostics for most patients, minorities could end up with suboptimal treatment owing to their underrepresentation in training data and studies. This could lead to algorithmic biases that would not be recognized by medical professionals when treating patients. -/- Conclusions: The application of smart sensors has the potential to improve the rehabilitation of geriatric patients in several ways. It is important that patients do not have to choose between autonomy and privacy and are well informed about the insights that can be gained from the data. Smart sensors should support and not replace interactions with medical professionals. Patients and medical professionals should be educated about the correct application and the limitations of smart sensors. Smart sensors should include an adequate representation of minorities in their training data and should be covered by health insurance to guarantee fair access. (shrink)

In the near future, our society may develop a vast array of medical enhancements. There is a large debate about enhancements, and that debate has identified many possible harms. This paper describes a harm that has so far been overlooked. Because of some particular features of enhancements, we could come to place more value on them than we actually should. This over-valuation would lead us to devote time, energy, and resources to enhancements that could be better spent somewhere else. That (...) mistake might not be trivial. By spending too much time, energy, and resources on enhancements, we could set back our pursuit of our deepest goals such as living happily and leading ethical lives. (shrink)

The recent progression in AI, nanomedicine and robotics have increased concerns about ethics, policy and law. The increasing complexity and hybrid nature of AI and nanotechnologies impact the functionality of “law in action” which can lead to legal uncertainty and ultimately to a public distrust. There is an immediate need of collaboration between Central Asian biomedical scientists, AI engineers and academic lawyers for the harmonization of AI, nanomedicines and robotics in Central Asian legal system.

Background Genomic research on neurodevelopmental disorders (NDDs), particularly involving minors, combines and amplifies existing research ethics issues for biomedical research. We performed a review of the literature on the ethical issues associated with genomic research involving children affected by NDDs as an aid to researchers to better anticipate and address ethical concerns. Results Qualitative thematic analysis of the included articles revealed themes in three main areas: research design and ethics review, inclusion of research participants, and communication of (...) research results. Ethical issues known to be associated with genomic research in general, such as privacy risks and informed consent/assent, seem especially pressing for NDD participants because of their potentially decreased cognitive abilities, increased vulnerability, and stigma associated with mental health problems. Additionally, there are informational risks: learning genetic information about NDD may have psychological and social impact, not only for the research participant but also for family members. However, there are potential benefits associated with research participation, too: by enrolling in research, the participants may access genetic testing and thus increase their chances of receiving a (genetic) diagnosis for their neurodevelopmental symptoms, prognostic or predictive information about disease progression or the risk of concurrent future disorders. Based on the results of our review, we developed an ethics checklist for genomic research involving children affected by NDDs. Conclusions In setting up and designing genomic research efforts in NDD, researchers should partner with communities of persons with NDDs. Particular attention should be paid to preventing disproportional burdens of research participation of children with NDDs and their siblings, parents and other family members. Researchers should carefully tailor the information and informed consent procedures to avoid therapeutic and diagnostic misconception in NDD research. To better anticipate and address ethical issues in specific NDD studies, we suggest researchers to use the ethics checklist for genomic research involving children affected by NDDs presented in this paper. (shrink)

In this paper, I examine the ethics of e - trust and e - trustworthiness in the context of health care, looking at direct computer-patient interfaces (DCPIs), information systems that provide medical information, diagnosis, advice, consenting and/or treatment directly to patients without clinicians as intermediaries. Designers, manufacturers and deployers of such systems have an ethical obligation to provide evidence of their trustworthiness to users. My argument for this claim is based on evidentialism about trust and trustworthiness: the idea that (...) trust should be based on sound evidence of trustworthiness. Evidence of trustworthiness is a broader notion than one might suppose, including not just information about the risks and performance of the system, but also interactional and context-based information. I suggest some sources of evidence in this broader sense that make it plausible that designers, manufacturers and deployers of DCPIs can provide evidence to users that is cognitively simple, easy to communicate, yet rationally connected with actual trustworthiness. (shrink)

This article discusses the role and validity of arguments of culture in biomedical ethics. It is often maintained that any fundamental bioethical consensus is ruled out by the existence of incommensurable value axioms rooted in the different traditions, above all with regard to diverging conceptions of the human being. For example, it is argued that the <Christian>Western culture leads to more restrictive and the <Confucian> Chinese culture to more permissive stances with regard to consumptive embryo research. However, what (...) a <culture> says has always been a matter of interpretation and debate. Confucianism, too, offers more than just one option to answer crucial bioethical questions. There is no established cultural position that would absolve one from a responsible decision. Rather than exerting a one-sided impact on ethics, culture can also be reshaped and changed in view of ethical challenges. (shrink)

Health data processing fields face ethical and legal problems regarding fundamental rights. As we know, patients can benefit in the Digital Era from having health or medical information available, and medical decisions can be more effective with a better understanding of clinical histories, medical and health data thanks to the development of Artificial Intelligence, Internet of Things and other Digital technologies. However, at the same time, we need to guarantee fundamental rights, including privacy ones. The complaint about ethical and legal (...) requirements – including constitutional ones – is particularly relevant in the processing of health data. This paper is focused on the problem of the consent required to the processing of health data and the exceptions established in the new European Union General Data Regulation, which cover the processing of this special data -within other aims- for scientific, historical and statistical research as legitimate purposes, which include biomedical research. The conclusion is that these open concepts are problematic both for the protection of privacy rights and for the legal security/certainty of research. On one hand there are several interpretation problems, regarding the processing of health data and the protection of information privacy. On the other hand, professionals must follow the Multilevel legal framework and to guarantee fundamental rights in the processing of health data, so there are also problems of interpretation for researchers. Therefore, we need a clearer legal framework for biomedical research. (shrink)

Much of contemporary research ethics was developed in the latter half of the twentieth century as a response to the unethical treatment of human beings in biomedical research. Research ethical considerations have subsequently been extended to cover topics in the sciences and technology such as data handling, precautionary measures, engineering codes of conduct, and more. However, moral issues in the humanities have gained less attention from research ethicists. This article proposes an ethical principle for reading for research purposes: (...) Respect the author. (shrink)

A new world has probably emerged through the progression of technology which has led to significant debates on social, cultural, legal, and ethical issues, especially in the biomedical field in this century. Application of physician-patient relationship, principles of pluralism, autonomy, democracy, human dignity, and human rights is being challenged within the medicine and health-care system of today. Development of technology-based remedies has fostered greater degrees of medicalization. Hence, the automatic application of such technologies risks distorting the nature of medicine. (...) To be sure, there is a cultural shift that is affecting the society that is increasingly unable to adapt to traditional legal systems. This cultural shift, perhaps, demands new ethics. This entry aims to evaluate the gap between traditional deontological nature of medicine and the emerging new ethics and assess why bioethical reflection is needed. (shrink)

Having scandalous unethical research practices in the mid and late 20th century, study protocols of biomedical research reviewed by the Ethics Committee (EC) has become the accepted international standard. The Declaration of Helsinki uniformly requires that all biomedical research involving human participants, including research on identifiable human material or data, should be approved by the EC. Today, concerns over the quality of the EC functions worldwide. There are research globally in this regard but no data are available (...) from Bangladesh. Hence, we conducted a questionnaire based pilot study on knowledge and attitude of EC members on bioethics and structure & function of EC in Bangladesh. (shrink)

Deep brain stimulation (DBS), a surgical procedure involving the implantation of electrodes in the brain, has rekindled the medical community’s interest in psychosurgery. Whereas many researchers argue DBS is substantially different from psychosurgery, we argue psychiatric DBS—though a much more precise and refined treatment than its predecessors—is nevertheless a form of psychosurgery, which raises both old and new ethical and legal concerns that have not been given proper attention. Learning from the ethical and regulatory failures of older forms of psychosurgery (...) can help shed light on how to address the regulatory gaps that exist currently in DBS research. To show why it is important to address the current regulatory gaps within psychiatric DBS, we draw on the motivations underlying the regulation of earlier forms of psychosurgery in the US. We begin by providing a brief history of psychosurgery and electrical brain stimulation in the US. Against this backdrop, we introduce psychiatric DBS, exploring current research and ongoing clinical trials. We then draw out the ethical and regulatory similarities between earlier forms of psychosurgery and psychiatric DBS. As we will show, the factors that motivated strict regulation of earlier psychosurgical procedures mirror concerns with psychiatric DBS today. We offer three recommendations for psychiatric DBS regulation, which echo earlier motivations for regulating psychosurgery, along with new considerations that reflect the novel technologies used in DBS. (shrink)

Andrea Wiggins and John Wilbanks’ article (2019) presents us with a welcome overview of the neglected, novel ethical issues raised by the advent of citizen science in health and biomedical contexts. This contribution takes a rather different approach, focusing on a very specific (yet also overlooked) problem in this context - the ethical implications of self-administered genetic testing. This problem, however, is particularly illustrative of the “ethics gap” between traditional medical settings and new public-driven scientific practices, emphasized by (...) Wiggins and Wilbanks in their more wide-ranging treatment. (shrink)

Background If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical - trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the (...) 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. (shrink)

Perez-Rodriguez and de la Fuente (2017) assume that although human races do not exist in a biological sense (“geneticists and evolutionary biologists generally agree that the division of humans into races/subspecies has no defensible scientific basis,” they exist only as “sociocultural constructions” and because of that maintain an illusory reality, for example, through “racialized” practices in medicine. Agreeing with the main postulates formulated in the article, we believe that the authors treat this problem in a superficial manner and have failed (...) to capture the current state of the field of knowledge in science and the humanities. In our commentary, we want to highlight two main omissions, and to notice three important implications for “a postracial medicine.”. (shrink)

The Human Genome Project is regarded by many as one of the major scientific achievements in recent science history, a large-scale endeavour that is changing the way in which biomedical research is done and expected, moreover, to yield considerable benefit for society. Thus, since the completion of the human genome sequencing effort, a debate has emerged over the question whether this effort merits to be awarded a Nobel Prize and if so, who should be the one to receive it, (...) as no more than three individuals can be selected. In this article, the HGP is taken as a case study to consider the ethical question to what extent it is still possible, in an era of big science, of large-scale consortia and global team work, to acknowledge and reward individual contributions to important breakthroughs in biomedical fields. Is it still viable to single out individuals for their decisive contributions in order to reward them in a fair and convincing way? Whereas the concept of the Nobel prize as such seems to reflect an archetypical view of scientists as solitary researchers who, at a certain point in their careers, make their one decisive discovery, this vision has proven to be problematic from the very outset. Already during the first decade of the Nobel era, Ivan Pavlov was denied the Prize several times before finally receiving it, on the basis of the argument that he had been active as a research manager rather than as a researcher himself. The question then is whether, in the case of the HGP, a research effort that involved the contributions of hundreds or even thousands of researchers worldwide, it is still possible to “individualise” the Prize? The “HGP Nobel Prize problem” is regarded as an exemplary issue in current research ethics, highlighting a number of quandaries and trends involved in contemporary life science research practices more broadly. (shrink)

Most current dental ethics curricula use a deontological approach to biomedical and dental ethics that emphasizes adherence to duties and principles as properties that determine whether an act is ethical. But the actual ethical orientation of students is typically unknown. The purpose of the current study was to determine the ethical orientation of dental students in resolving clinical ethical dilemmas. First-year students from one school were invited to participate in an electronic survey that included eight vignettes featuring (...) ethical conflicts common to the health care setting. The Multidimensional Ethics Scale was used to evaluate the students’ ethical judgments of these conflicts. Students rated each vignette along 13 ethically relevant items using a 7-point scale. Nine of the thirteen items were analyzed because they represent the dominant ethical theories, including deontology. One hundred sixteen dental students successfully completed the survey. Of the analyzed items, those associated with deontology had comparatively weak associations with whether students judged the action to be ethical and whether students judged themselves likely to perform the action. Whether an action was judged to be caring had the strongest association with whether the action was judged to be ethical and whether students judged themselves likely to perform the action. These results suggest that adherence to duties or principles has weaker association with students’ ethical judgments and behavior compared to caring, which was found to be more influential in their ethical judgments and behavior. Current dental school curricula with a primary focus on deontology may no. (shrink)

The context of international health research involving human subjects, and this should appear obvious, is the human community. As such, basic questions of how human beings should be treated by other human beings, particularly in situations of unequal power – e.g., in the form of control, choice, or opportunity – lay at the foundations of related ethical discourse when ethics are discussed at all. I trace a narrative that follows upon a recent revision process of international guidelines for (...) class='Hi'>biomedical research involving human subjects. I focus in particular upon the issue of a standard of care. In the second section, I draw upon philosophers John Rawls, Claudia Card, and Allen Buchanan to discuss concerns regarding the 'least advantaged members of society' in the context of global inequality. The paper includes reflections upon pedagogy in courses focused upon international health research involving human subjects. (shrink)

The paper discusses the possibility that the benefits of pharmacogenomics will not be distributed equally and will create orphan populations. I argue that since these inequalities are not substantially different from those produced by ‘traditional’ drugs and are not generated with the intention to discriminate, their production needs not be unethical. Still, the final result is going against deep-seated moral feelings and intuitions, as well as broadly accepted principles of just distribution of health outcomes and healthcare. I thus propose two (...) provisos that would prevent the most offensive outcomes and moderate the scope of the produced inequalities. The first proviso rejects pharmacogenomics innovations that worsen existing group inequalities and aggravate the disadvantage of communities with a history of discrimination. The second proviso requires that there is a strategy in place to even out as much as possible the distribution of benefits in the future and that a system of compensations is in place for pharmacogenomic orphans. Given that only one moral problem generated by pharmacogenomics has been tackled, the list of provisos might be expanded when other issues are considered. (shrink)

This project considers whether and how research ethics can contribute to the provision of cost-effective medical interventions. Clinical research ethics represents an underexplored context for the promotion of cost-effectiveness. In particular, although scholars have recently argued that research on less-expensive, less-effective interventions can be ethical, there has been little or no discussion of whether ethical considerations justify curtailing research on more expensive, more effective interventions. Yet considering cost-effectiveness at the research stage can help ensure that scarce resources such (...) as tissue samples or limited subject popula- tions are employed where they do the most good; can support parallel efforts by providers and insurers to promote cost-effectiveness; and can ensure that research has social value and benefits subjects. I discuss and rebut potential objections to the consideration of cost-effectiveness in research, including the difficulty of predicting effectiveness and cost at the research stage, concerns about limitations in cost-effectiveness analysis, and worries about overly limiting researchers’ freedom. I then consider the advantages and disadvantages of having certain participants in the research enterprise, including IRBs, advisory committees, sponsors, investigators, and subjects, consider cost-effectiveness. The project concludes by qualifiedly endorsing the consideration of cost-effectiveness at the research stage. While incorporating cost-effectiveness considerations into the ethical evaluation of human subjects research will not on its own ensure that the health care system realizes cost-effectiveness goals, doing so nonetheless represents an important part of a broader effort to control rising medical costs. (shrink)

Gender affirming hormone treatment is an important part of the care of trans adolescents which enables them to develop the secondary sexual characteristics congruent with their identified genders. There is an increasing amount of empirical evidence showing the benefits of gender affirming hormone treatment for psychological health and social well-being in this population. However, in several countries, access to gender affirming hormone treatment for trans adolescents has recently been severely restricted. While much of the opposition to gender affirming hormone treatment (...) for trans adolescents has in part been ideologically motivated, it also reflects a debate about whether there are harms that outweigh the benefits of the treatment. Accordingly, a systematic and comprehensive philosophical analysis of the ethics of gender affirming hormone treatment for trans adolescents is needed. Herein, I offer such an analysis that draws on the four principles of biomedical ethics by Tom Beauchamp and James Childress. Based on the considerations of beneficence, nonmaleficence, autonomy, and justice, I argue that the provision of access to gender affirming hormone treatment for consenting trans adolescents is ethically required and that the current restrictions to such treatment are ethically wrong. (shrink)

Weighing competing obligations and achieving the “greatest balance” of right over wrong guides an individual, an agency or a country in determining what ought to be done in an ethically challenging situation. Conducting controlled human infection model (CHIM) studies in India is one such situation. The ethical challenge in conducting a CHIM study lies in completing the difficult task of introducing standardised, attenuated strains of micro-organisms into normal healthy volunteers, at the same time ensuring the safety of these healthy individuals (...) from potential and completely informed risks in a fashion that is transparent and accountable. The bar is further raised against the background of already fragile public confidence in biomedical research in India; especially when “deliberate” introduction of microbial agents into healthy individuals is involved, with the larger altruistic objective of gain to society as a whole. -/- This paper discusses the uses of CHIM studies with respect to the larger scientific Indian research enterprise of the 21st century. It further explores etic and emic perspectives in conducting such trials in India and seeks to generate an ethical coherence to the justification for conducting CHIM studies in India. The paper deliberates on ethical issues arising out of conducting CHIM studies and reflects on how developing the capacity for CHIM studies in India is likely to strengthen the health research and development sector in the country. -/- . (shrink)

We argue that the fragility of contemporary marriages—and the corresponding high rates of divorce—can be explained (in large part) by a three-part mismatch: between our relationship values, our evolved psychobiological natures, and our modern social, physical, and technological environment. “Love drugs” could help address this mismatch by boosting our psychobiologies while keeping our values and our environment intact. While individual couples should be free to use pharmacological interventions to sustain and improve their romantic connection, we suggest that they may have (...) an obligation to do so as well, in certain cases. Specifically, we argue that couples with offspring may have a special responsibility to enhance their relationships for the sake of their children. We outline an evolutionarily informed research program for identifying promising biomedical enhancements of love and commitment. (shrink)

Background: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research (...) in Germany, Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods: For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results: The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions: The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. (shrink)

To address some questions in global biomedical ethics, three problems about cultural moral differences and alleged differences in Eastern and Western cultures are addressed: The first is whether the East has fundamentally different moral traditions from those in the West. Concentrating on Japan and the United States, it is argued that theses of profound and fundamental East-West differences are dubious because of many forms of shared morality. The second is whether human rights theory is a Western invention with (...) no firm traditions in Eastern moral traditions. It is argued that this thesis is unsupported both historically and in contemporary bioethics. The third problem is whether multiculturalist theory casts doubt on claims of universal principles and rights. It is argued that the reverse is true: multiculturalism is a universalistic theory. The argument throughout supports common morality theory. (shrink)

An abundance of data unequivocally shows that exercise can be an effective tool in the fight against obesity and its associated co-morbidities. Indeed, physical activity can be more effective than widely-used pharmaceutical interventions. Whilst metformin reduces the incidence of diabetes by 31% (as compared with a placebo) in both men and women across different racial and ethnic groups, lifestyle intervention (including exercise) reduces the incidence by 58%. In this context, it is notable that a group of prominent medics and exercise (...) scientists recently sent a well-publicised letter to the General Medical Council and Medical Schools Council calling for the introduction of evidence-based lifestyle education into all medical curricula. The letter warns that there is a lack of understanding of the impact that exercise and nutrition can have on physical health amongst doctors. In the absence of an educational overhaul, the signatories warn that the government is likely to fail to reach its goal of preventing tens of thousands of premature deaths from heart disease and cancer by 2020. Whilst we agree with the need to address this apparent lack of understanding, we argue that the ethical justification of doing so is not limited to this broadly beneficence-based justification. There is also a justification grounded in the duty of non-maleficence, that is, the duty to avoid unreasonably harming patients. This duty requires that doctors refrain from (i) preventing patients from undergoing beneficial treatment without good reason, (ii) exposing patients to unreasonable risks and (iii) reducing the therapeutic effect of an effective medical intervention. This requires an understanding of the physical impact of exercise. (shrink)

Animal rights activists are often accused of caring more about animals than about human beings. How, it is asked, can activists condemn the use of animals in biomedical research—research that improves human health and saves human lives? In this article, I argue that even if animal experimentation might eventually provide cures for many serious diseases, given the present state of the world, we are not justified supporting this research; rather, we ought to devote our limited resources to other forms (...) of humanitarian assistance. (shrink)

Until recently, the problem of traumatic brain injury in sports and the problem of performance enhancement via hormone replacement have not been seen as related issues. However, recent evidence suggests that these two problems may actually interact in complex and previously underappreciated ways. A body of recent research has shown that traumatic brain injuries, at all ranges of severity, have a negative effect upon pituitary function, which results in diminished levels of several endogenous hormones, such as growth hormone and gonadotropin. (...) This is a cause for concern for many popular sports that have high rates of concussion, a mild form of TBI. Emerging research suggests that hormone replacement therapy is an effective treatment for TBI-related hormone deficiency. However, many athletic organizations ban or severely limit the use of hormone replacing substances because many athletes seek to use them solely for the purposes of performance enhancement. Nevertheless, in the light of the research linking traumatic brain injury to hypopituitarism, this paper argues that athletic organizations’ policies and attitudes towards hormone replacement therapy should change. We defend two claims. First, because of the connection between TBI and pituitary function, it is likely many more athletes than previously acknowledged suffer from hormone deficiency and thus could benefit from hormone replacement therapy. Second, athletes’ hormone levels should be tested more rigorously and frequently with an emphasis on monitoring TBI and TBI-related issues, rather than simply monitoring policy violations. (shrink)

Introduction In 2013, Dr. J. Muizelaar and Dr. R. Schrot, two neurosurgeons at the University of California Davis Medical Center (UCDMC), were found guilty of research misconduct due to failure to comply with institutional policies as well as Food and Drug Administration (FDA) regulations governing human subjects research. At issue here, however, is the difference between research and innovative therapy in the clinical setting of patient care where clinical judgment is reasonably to be privileged. Methods The UCDMC investigative document is (...) reviewed along with standard literature on clinical ethics and clinical data about glioblastoma multiforme (GBM) cancer. Results In this paper I argue that, by tendentiously focusing on policies, regulations, and procedures governing human subjects research, the UCDMC investigation failed to account for the centrality of clinical judgment and clinical ethics pertinent to judicious review of this matter, especially given the unique clinical context of terminally ill patients having exhausted standard care treatment options for glioblastoma multiforme (GBM) cancer. Conclusions The UCDMC investigation raises serious problems for clinicians who are engaged in innovative therapy in the clinical setting, requiring a regulatory framework separate from the normal Institutional Review Board (IRB) process. (shrink)

Suppose a fire broke out in a fertility clinic. One had time to save either a young girl, or a tray of ten human embryos. Would it be wrong to save the girl? According to Michael Sandel, the moral intuition is to save the girl; what is more, one ought to do so, and this demonstrates that human embryos do not possess full personhood, and hence deserve only limited respect and may be killed for medical research. We will argue, however, (...) that no relevant ethical implications can be drawn from the thought experiment. It demonstrates neither that one always ought to let the embryos die, nor does it allow for any general conclusion concerning the moral status of human embryos. (shrink)

In this chapter, we describe three areas within the broad field of ecogenomics or postgenomics: epigenetics, proteomics, and microbiomics. We argue that these fields challenge traditional bioethics in different ways. Since epigenetic, proteomic, and microbiomic data may contain phenotypical information, they may intensify discussions about consent, privacy, and return of results. But these fields also firmly position organisms, including human beings, as deeply entangled with their environments, as constituted by context, history, and experiences as much as genes. This yields new (...) insights into concepts of health and development. We discuss precision medicine as an example of a systemic approach to health. We argue that acknowledging the entanglement of organism and environment also means recognizing the importance of interdisciplinarity for bioethics and thinking together biomedical ethics and environmental ethics. (shrink)

Disorders of consciousness include coma, the vegetative state and the minimally conscious state. Such patients are often regarded as unconscious. This has consequences for end of life decisions for these patients: it is much easier to justify withdrawing life support for unconscious than conscious patients. Recent brain imaging research has however suggested that some patients may in fact be conscious.

Biomedical diagnostic science is a great deal less successful than we've been willing to acknowledge in bioethics, and this fact has far-reaching ethical implications. In this article I consider the surprising prevalence of medically unexplained symptoms, and the term's ambiguous meaning. Then I frame central questions that remain answered in this context with respect to informed consent, autonomy, and truth-telling. Finally, I show that while considerable attention in this area is given to making sure not to provide biological care (...) to patients without a need, comparatively little is given to the competing, ethically central task of making sure never to obstruct access to biological care for those with diagnostically confusing biological conditions. I suggest this problem arises from confusion about the philosophical value of vagueness when it comes to the line between biological and psychosocial needs. (shrink)

Response to the paper “The Biomedical Ethics Ontology Proposal: Excellent Aims, Questionable Methods" by James DuBois, published in the Journal of Empirical Research on Human Research Ethics.