There is recent empirical evidence that personal identity is constituted by one’s moral traits. If true, this poses a problem for those who advocate for moral enhancement, or the manipulation of a person’s moral traits through pharmaceutical or other biological means. Specifically, if moral enhancement manipulates a person’s moral traits, and those moral traits constitute personal identity, then it is possible that moral enhancement could alter a person’s identity. I go a step further and argue that under the right conditions, (...) moral enhancement can constitute murder. I then argue that these conditions are not remote. (shrink)

This paper explores the ethics of introducing genome-editing technologies as a new reproductive option. In particular, it focuses on whether genome editing can be considered a morally valuable alternative to preimplantation genetic diagnosis. Two arguments against the use of genome editing in reproduction are analysed, namely safety concerns and germline modification. These arguments are then contrasted with arguments in favour of genome editing, in particular with the argument of the child’s welfare and the argument of parental reproductive autonomy. In addition (...) to these two arguments, genome editing could be considered as a worthy alternative to PGD as it may not be subjected to some of the moral critiques moved against this technology. Even if these arguments offer sound reasons in favour of introducing genome editing as a new reproductive option, I conclude that these benefits should be balanced against other considerations. More specifically, I maintain that concerns regarding the equality of access to assisted reproduction and the allocation of scarce resources should be addressed prior to the adoption of genome editing as a new reproductive option. (shrink)

This paper analyses recent calls for so called “neurorights”, suggested novel human rights whose adoption is allegedly required because of advances in neuroscience, exemplified by a proposal of the Neurorights Initiative. Advances in neuroscience and technology are indeed impressive and pose a range of challenges for the law, and some novel applications give grounds for human rights concerns. But whether addressing these concerns requires adopting novel human rights, and whether the proposed neurorights are suitable candidates, are a different matter. This (...) paper argues that the proposed rights, as individuals and a class, should not be adopted and lobbying on their behalf should stop. The proposal tends to promote rights inflationism, is tainted by neuroexceptionalism and neuroessentialism, and lacks grounding in relevant scholarship. None of the proposed individual rights passes quality criteria debated in the field. While understandable from a moral perspective, the proposal is fundamentally flawed from a legal perspective. Rather than conjuring up novel human rights, existing rights should be further developed in face of changing societal circumstances and technological possibilities. (shrink)

Debates over the politicization of science have led some to claim that scientists have or should have a “right to research.” This article examines the political meaning and implications of the right to research with respect to different historical conceptions of rights. The more common “liberal” view sees rights as protections against social and political interference. The “republican” view, in contrast, conceives rights as claims to civic membership. Building on the republican view of rights, this article conceives the right to (...) research as embedding science more firmly and explicitly within society, rather than sheltering science from society. From this perspective, all citizens should enjoy a general right to free inquiry, but this right to inquiry does not necessarily encompass all scientific research. Because rights are most reliably protected when embedded within democratic culture and institutions, claims for a right to research should be considered in light of how the research in question contributes to democracy. By putting both research and rights in a social context, this article shows that the claim for a right to research is best understood, not as a guarantee for public support of science, but as a way to initiate public deliberation and debate about which sorts of inquiry deserve public support. (shrink)

The proper role, if any, for religion-based arguments is a live and sometimes heated issue within the field of bioethics. The issue attracts heat primarily because bioethical analyses influence the outcomes of controversial court cases and help shape legislation in sensitive biopolicy areas. A problem for religious bioethicists who seek to influence biopolicy is that there is now widespread academic and public acceptance, at least within liberal democracies, that the state should not base its policies on any particular religion’s metaphysical (...) claims or esoteric moral system. In response, bioethicists motivated by religious concerns have adopted two identifiable strategies. Sometimes they rely on slippery-slope arguments that, sometimes at least, have empirically testable premises. A more questionable response is the manipulation and misuse of secular-sounding moral language, such as references to “human dignity,” and the plights of groups of people labeled “vulnerable.”. (shrink)

Since the human genome was decoded, great emphasis has been placed on the unique, personal nature of the genome, along with the benefits that personalized medicine can bring to individuals and the importance of safeguarding genetic privacy. As a result, an equally important aspect of the human genome – its common nature – has been underappreciated and underrepresented in the ethics literature and policy dialogue surrounding genetics and genomics. This article will argue that, just as the personal nature of the (...) genome has been used to reinforce individual rights and justify important privacy protections, so too the common nature of the genome can be employed to support protections of the genome at a population level and policies designed to promote the public's wellbeing. In order for public health officials to have the authority to develop genetics policies for the sake of the public good, the genome must have not only a common, but also a public, dimension. This article contends that DNA carries a public dimension through the use of two conceptual frameworks: the common heritage framework and the common resource framework. Both frameworks establish a public interest in the human genome, but the CH framework can be used to justify policies aimed at preserving and protecting the genome, while the CR framework can be employed to justify policies for utilizing the genome for the public benefit. A variety of possible policy implications are discussed, with special attention paid to the use of large-scale genomics databases for public health research. (shrink)

This paper aims to argue for the thesis that it is not a priori morally justified that the first phase of space colonisation is based on sexual reproduction. We ground this position on the argument that, at least in the first colonisation settlements, those born in space may not have a good chance of having a good life. This problem does not depend on the fact that life on another planet would have to deal with issues such as solar radiation (...) or with the decrease or entire absence of the force of gravity. These issues could plausibly be addressed given that the planets or settlements we will feasibly colonise could be completely transformed through geoengineering processes. Likewise, the ability of humans to live in space could be enhanced through genetic modification interventions. Even if, however, the problems concerning survival in space were solved, we think that, at least in the first period of colonisation of space or other planets, giving birth to children in space could be a morally irresponsible choice since we argue, the life we ​​could give them might not be good enough. We contend that this is the case since when we decide to have a baby. We argue that it is not morally right to be content that our children have a minimally sufficient life worth living; before we give birth to children in space, we should make sure we can give them a reasonable chance of having a good life. This principle applies both on Earth - at least where you can choose - and for space travel. (shrink)

Human rights may be the most globalized political value of our times. The rights paradigm has been criticized, however, for being theoretically unsound, legalistic, individualistic and based on the assumption that there is a given and universal humanness. Its use in the area of health is relatively new. Proponents point to its power to frame health as an entitlement rather than a commodity. The problems and the possibilities of a rights approach in addressing health ethics issues are explored in this (...) article. (shrink)

Human rights legislation pertaining to applications of human genetic science is still lacking at an international level. Three international human rights documents now serve as guidelines for countries wishing to develop such legislation. These were drafted and adopted by the United Nations Educational, Scientific and Cultural Organization, the Human Genome Organization, and the Council of Europe. It is critically important that the international nursing community makes known its philosophy and practice-based knowledge relating to ethics and human rights, and contributes to (...) the globalization of genetics. Nurses have particular expertise because they serve in a unique role at grass roots level to mediate between genetic science and its application to public health policies and medical interventions. As a result, nurses worldwide need to focus a constant eye on human rights ideals and interpret these within social, cultural, economic and political contexts at national and local levels. The purpose of this article is to clarify and legitimate the need for an international declaration on nursing, human rights, human genetics and public health policy. Because nurses around the world are the professional workforce by which genetic health care services and genetic research protocols will be delivered in the twenty-first century, members of the discipline of nursing need to think globally while acting locally. Above all other disciplines involved in genetics, nursing is in a good position to articulate an expanded theory of ethics beyond the principled approach of biomedical ethics. Nursing is sensitive to cultural diversity and community values; it is sympathetic to and can introduce an ethic of caring and relational ethics that listen to and accommodate the needs of local people and their requirements for public health. (shrink)

In this chapter, the focus is on robotics development and its ethical implications, especially on some particular applications or interaction principles. In recent years, such developments have happened very quickly, based on the advances achieved in the last few decades in industrial robotics. The technological developments in manufacturing, with the implementation of Industry 4.0 strategies in most industrialized countries, and the dissemination of production strategies into services and health sectors, enabled robotics to develop in a variety of new directions. Policy (...) making and ethical awareness addressed these issues using socio-economic knowledge and also in an effort to solve some of the application problems raised in a range of different circumstances and sectoral environments. (shrink)

The prospect of human genetic enhancement requires an institutional response, and probably the creation of new institutions. The governance of genetic enhancement technologies, moreover, needs to be global in scope. In this article, I analyze the debate on the global governance of human genetic enhancement. I begin by offering a philosophical justification for the need to adopt a global framework for governance of technologies that would facilitate the improvement of non-pathological genetic traits. I then summarize the main concrete proposals that (...) have recently emerged to govern genome editing at the global level. Finally, I develop some impediments that limit the impetus for global governance of genetic enhancement. (shrink)

Paediatric genomic research raises particularly challenging questions on whether and under what circumstances to return research results. In the paediatric context, decision-making is guided by the best interests of the child framework, as enshrined in the 1989 international Convention on the Rights of the Child. According to this Convention, rights and responsibilities are shared between children, parents, researchers, and the state. These "relational" obligations are further complicated in the context of genetic research.

This article addresses the child’s right to know their genetic origins in mitochondrial donation. It focuses on the UK’s public debate on mitochondrial replacement techniques and examines the claims-making activities that shaped the donor information regulations. During the public consultation, downplaying the significance of the mitochondria helped distinguish mitochondria donors from gamete donors and determine their relational status with the resulting child. As a result, according to the Mitochondrial Donation regulations, mitochondria donors, unlike gamete donors, will not be required to (...) be identifiable to the resulting child. I argue that, in the UK, similar to donor conception, public understanding of mitochondrial donation is shaped by a “calculus of genes”: simplified accounts of how genes determine the resulting child’s characteristics and identity. While the donor conception regulations ascribe social meaning to the passage of genes, the mitochondria regulations strip the social meaning away from the donation based on the assumption that the genetic contribution made by the donor is quantitatively insignificant in influencing the identity of the resultant offspring. The nature of the genetic material itself should not be considered as a privileged standpoint from which to decide on social meaning of the donation or the rights attached to it. (shrink)

In the last decade, biodiversity became a central concept of ecology, as important as the concepts of sustainable development, right for future generations, global changes for instance. Biodiversity received a recognition through, the Brundtland report (1987) and the Earth Summit of Rio de Janeiro (1992). Protection of biodiversity represents nowadays a ethical and political obligation.If the concept is rather clear and is applied at three levels, genes (intraspecific and interspecific), species and ecosystems, if we know that the diversity is unequally (...) distributed, concentrated in tropical areas, if it is clear that ecologists have still the immense task to describe this diversity, the ethical foundations of protection of biodiversity are unclear by the high variability of concepts in use.Environmental ethics and protection of biodiversity are often placed in aKind of antagonism, between technocratism or neo-liberralism and fundamentalism of Nature or even eco-fascism. But, in fact, there is no need for an “either-or” attitude, for an “all-or- nothing” thought for an opposition between “natural” and “artificial” or between anthropocentrism and biocentrism: we have here perhaps not incompatible opposites but poles on an spectrum allowing for many degrees.We must manage that the needs of the present are met without compromising the ability of future generations to meet their own needs. Sustainability is:* socially desirable, fulfilling people's cultural, material and spiritual needs in equitable ways, *economically viable, paying for itself with costs not exceeding income, ecologically viable, maintaining the long-term viability of supporting ecosystems.The “business-as-usual” activity resulted in low rigorous protection of biodiversity, we need an increasing part of ethical considerations in the environmental discussion. (shrink)

The new dilemmas and responsibilities which arise in bioethics both because of the unprecedented pace of scientific development and of growing moral pluralism are more and more difficult to grapple with. At the ‘global’ level, the call for the universal nature at least of some fundamental moral values and principles is often being contended as a testament of arrogance, if not directly as a new kind of subtler imperialism. The human rights framework itself, which provided the basis for the most (...) relevant international declarations and documents, is not exempt from the charge. However, the refusal of a top-down conception of the universal as a sort of product for exportation should not be confused with a relativistic landscape, where all the cows can be indifferently black or white. This contribution aims at outlining an approach, which reconciles universalism as enshrined in founding human rights declarations with respect for cultural diversity. In order to do so, two conceptual frameworks are discussed: the ‘tool-kit’ model and the morals/ethics difference. The example of the right to quality health care confirms the argument that striking a balance between cherishing pluralism and defending some fundamental rights and obligations does not amount to an assertion of moral imperialism. (shrink)

BackgroundClustered Regularly Interspaced Short Palindromic Repeats-associated technology may allow for efficient and highly targeted gene editing in single-cell embryos. This possibility brings human germline editing into the focus of ethical and legal debates again.Main bodyAgainst this background, we explore essential ethical and legal questions of interventions into the human germline by means of CRISPR-Cas: How should issues of risk and uncertainty be handled? What responsibilities arise regarding future generations? Under which conditions can germline editing measures be therapeutically legitimized? For this (...) purpose, we refer to a scenario anticipating potential further development in CRISPR-Cas technology implying improved accuracy and exclusion of germline transmission to future generations. We show that, if certain concepts regarding germline editing are clarified, under such conditions a categorical prohibition of one-generation germline editing of single-cell embryos appears not to be ethically or legally justifiable.ConclusionThese findings are important prerequisites for the international debate on the ethical and legal justification of germline interventions in the human embryo as well as for the harmonization of international legal standards. (shrink)

The global development of human embryonic stem cell science and its therapeutic applications are dependent on the nature of its engagement at national and international levels with key cultural values and beliefs concerning the moral status of the early human embryo. This article argues that the political need to reconcile the promise of new health technologies with the cultural costs of scientific advance, dependent in this case on the use of the human embryo, has been met by the evolution of (...) bioethics as a political community, transnational network, and bureaucratic device. Bioethics has become the political means for the creation of a global moral economy where the trading and exchange of values is normalized and legitimated. As a result of such trading, value compromises are produced capable of legitimizing the regulatory policies necessary for maintaining public trust in the new science. (shrink)

In its governance activities for genetic resources, the international community has adopted various approaches to their ownership, including: free access; common heritage of mankind; intellectual property rights; and state sovereign rights. They have also created systems which combine elements of these approaches. While governance of plant and animal genetic resources is well-established internationally, there has not yet been a clear approach selected for human genetic resources. Based on assessment of the goals which international governance of human genetic resources ought to (...) serve, and the implications for how they will be accessed and utilised, it is argued that common heritage of mankind will be the most appropriate approach to adopt to their ownership/control. It does this with the aim of stimulating discussion in this area and providing a starting point for deeper consideration of how a common heritage of mankind, or similar, regime for human genetic resources would function and be implemented. (shrink)

This article examines the assertion that human embryonic stem cells patents are immoral because they violate human dignity. After analyzing the concept of human dignity and its role in bioethics debates, this article argues that patents on human embryos or totipotent embryonic stem cells violate human dignity, but that patents on pluripotent or multipotent stem cells do not. Since patents on pluripotent or multipotent stem cells may still threaten human dignity by encouraging people to treat embryos as property, patent agencies (...) should carefully monitor and control these patents to ensure that patents are not inadvertently awarded on embryos or totipotent stem cells. (shrink)

This paper applies aspects of Hugo Grotius's theologically informed theory of property to contemporary issues concerning access to the human DNA sequence and patenting practices. It argues that Christians who contribute to public debate in these areas might beneficially employ some of the concepts with which he worked--notably "common right," the "right of necessity," and "use right." In the seventeenth century, wars were fought over trading rights and access to the sea. In the twenty-first century, information and intellectual property are (...) the issues of the day. Grotius's writings serve to correct the overemphasis in modern liberalism on individual rights, and have practical application to the debate concerning the reduction of the human genome to the status of private property. (shrink)

ABSTRACT This essay focuses on two underlying presumptions that impinge on the effort of UNESCO to engender universal agreement on a set of bioethical norms: the conception of universality that pervades much of the document, and its disregard of structural inequalities that significantly impact health. Drawing on other UN system documents and recent feminist bioethics scholarship, we argue that the formulation of universal principles should not rely solely on shared ethical values, as the draft document affirms, but also on differences (...) in ethical values that obtain across cultures. UNESCO's earlier work on gender mainstreaming illustrates the necessity of thinking from multiple perspectives in generating universal norms. The declaration asserts the ‘fundamental equality of all human beings in dignity and rights’1 and insists that ‘the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition’2 yet it does not explicitly recognize disparities of power and wealth that deny equal dignity and rights to many. Without attention to structural (as opposed to merely accidental) inequities, UNESCO's invocation of rights is so abstract as to be incompatible with its avowed intention. (shrink)

The paper suggests an application of the precautionary principle to the use of genetics in psychiatry focusing on scientific uncertainty. Different levels of uncertainty are taken into consideration—from the acknowledgement that the genetic paradigm is only one of the possible ways to explain psychiatric disorders, via the difficulties related to the diagnostic path and genetic methods, to the value of the results of studies carried out in this field. Considering those uncertainties, some measures for the use of genetics in psychiatry (...) are suggested. Some of those measures are related to the conceptual limits of the genetic paradigm; others are related to present knowledge and should be re-evaluated. (shrink)

The notion of “integrity” is currently quite common and broadly recognized as complex, mostly due to its recurring and diverse application in various distinct domains such as the physical, psychic or moral, the personal or professional, that of the human being or of the totality of beings. Nevertheless, its adjectivation imprints a specific meaning, as happens in the case of “scientific integrity”. This concept has been defined mostly by via negativa, by pointing out what goes against integrity, that is, through (...) the identification of its infringements, which has also not facilitated the elaboration of an overarching and consensual code of scientific integrity. In this context, it is deemed necessary to clarify the notion of “integrity”, first etymologically, recovering the original meaning of the term, and then in a specifically conceptual way, through the identification of the various meanings with which the term can be legitimately used, particularly in the domain of scientific research and innovation. These two steps are fundamental and indispensable for a forthcoming attempt at systematizing the requirements of “scientific integrity”. (shrink)

BackgroundGenetics and genomics research (GGR) is increasingly being conducted around the world; yet, researchers and research oversight entities in many countries have struggled with ethical challenges. A range of ethics and regulatory issues need to be addressed through comprehensive policy frameworks that integrate with local environments. While important efforts have been made to enhance understanding and awareness of ethical dimensions of GGR in Africa, including through the H3Africa initiative, there remains a need for in-depth policy review, at a country-level, to (...) inform and stimulate local policy development and revision on the continent.MethodsTo identify and characterize existing ethics-related guidelines and laws applicable to GGR across much of Africa, we conducted a scoping review of English language policy documents identified through databases, repositories, and web searches. Thirty-six documents were included and coded using a framework that contained a range of themes across five analytical categories: (1) respect, (2) beneficence, (3) justice, (4) independent oversight, and (5) bans and prohibitions. Data analysis software (NVivo 12) was used to organize, code, and tabulate information according to document characteristics and topics. Illustrative examples of policy requirements were selected for inclusion.ResultsDocuments that met inclusion criteria spanned 20 years; published between 1996 and 2018, with the majority (58%) published after 2009. About two-thirds were denoted as “guidelines,” and slightly more than half were non-exclusive to GGR. Very few (six) country-level documents identified were specific to GGR. Requirements related to the principle of “respect” appeared most often across all documents, relative to other principles and processes. The most commonly stated ban was on reproductive cloning. Other prohibitions applied to germline editing, undue inducements in research, sample use for commercial purposes, employee mandatory DNA testing, fetal sex selection, stem cell use, eugenics, and research without public health benefits.ConclusionsEnforceable policies that are indispensable to the ethical conduct and review of GGR are either deficient or missing in many African countries. Existing international, GGR-specific ethics guidelines can be used to inform GGR policy development at a country-level, in conjunction with insight from country specific ethics committees and other local stakeholders. (shrink)

An analysis of the policy, research and historical documents was performed to better understand the regulatory context within which the Japanese government has come to address the social control of human genome research and the measures it has taken, with regard to the handling of personal data, an area where innovations in the life sciences and in information and communication technology overlap. Our study revealed a shift in policy over time from a rigid to a more collaborative approach to regulation. (...) From the 1980s to the 2000s, security control measures were developed to prevent leakage of personal data to external entities, using methods such as anonymisation, which can be applied in a linkable or unlinkable fashion. However, by the 2010s, de-identification measures have been introduced. They make it possible to utilise personal data that is de-identified in certain types of genomic research. This also involved the establishment of an independent data protection authority that controls the utilisation of data in collaboration with other stakeholders. Through this process, bioethics policy has become an established science and technology policy in Japan; and in recent years, bioethics policy has also gained relevance in areas outside the life sciences. (shrink)

There is growing interest for a communitarian approach to the governance of genomics, and for such governance to be grounded in principles of justice, equity and solidarity. However, there is a near absence of conceptual studies on how communitarian-based principles, or values, may inform, support or guide the governance of genomics research. Given that solidarity is a key principle in Ubuntu, an African communitarian ethic and theory of justice, there is emerging interest about the extent to which Ubuntu could offer (...) guidance for the governance of genomics research in Africa. To this effect, we undertook a conceptual analysis of Ubuntu with the goal of identifying principles that could inform equity-oriented governance of genomics research. Solidarity, reciprocity, open sharing, accountability, mutual trust, deliberative decision-making and inclusivity were identified as core principles that speak directly to the different macro-level ethical issues in genomics research in Africa such as: the exploitation of study populations and African researchers, equitable access and use of genomics data, benefit sharing, the possibility of genomics to widen global health inequities and the fair distribution of resources such as intellectual property and patents. We use the identified the principles to develop ethical guidance for genomics governance in Africa. (shrink)

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

In this article, the authors review some contemporary cases where biotechnologies have been employed, where they have had global implications, and where there has been considerable debate. The authors argue that the concept of dignity, which lies at the center of such documents as the 2005 Universal Declaration on Bioethics and Human Rights, the International Declaration on Human Genetic Data (2003) and the Universal Declaration on the Human Genome and Human Rights (1997) is useful, if not necessary, in engaging in (...) decision making in relation to the moral evaluation of biotechnologies on a global scale. (shrink)

The expansion of the corpus of international human rights to include the right to water and sanitation has implications both for the process of recognizing human rights and for future developments in the relationships between technology, engineering and human rights. Concerns with threats to human rights resulting from developments in science and technology were expressed in the early days of the United Nations (UN), along with the recognition of the ambitious human right of everyone “to enjoy the benefits of scientific (...) progress and its applications.” This comment explores the hypothesis that the emerging concepts most likely to follow recognition of the human right to water primarily involve issues of science and technology, such as access to medicines or clean and healthy environment. Many threats to human rights from advances in science, which were identified in the past as potential, have become real today, such as invasion of privacy from electronic recording, deprivation of health and livelihood as a result of climate change, or control over individual autonomy through advances in genetics and neuroscience. This comment concludes by urging greater engagement of scientists and engineers, in partnership with human rights specialists, in translating normative pronouncements into defining policy and planning interventions. (shrink)

Biobanks are repositories that store human biological materials and their associated data. They are rapidly becoming part of national and international networks and give rise to unique ethico-regulatory issues. Whether consent is informed and whether this term should be used when specimens are collected for biobank research is questionable. Where risks occur, they are usually social and relate to identifiability. Public trust and confidence are important for the success of this type of research. Consensus is growing that governance of biobanks (...) should be harmonised. Controlled specimen and data access agreements are essential. The South African National Health Act and its Regulations, that provide the foundation for the legal framework with regard to human tissue and research in South Africa, are silent on the issue of biobanks and the law lags behind while science and technology advance rapidly. The use of biobank assets will lead to significant benefits in human health and should be encouraged while taking account of the associated ethical, legal and social issues and working towards a balance between these two positions. (shrink)

Human dignity is grounded in basic human attributes such as life and self-respect. When people cannot stand up for themselves they may lose their dignity towards themselves and others. The aim of this study was to elucidate if dignity remains intact for family members during care procedures in a children’s hospital. A qualitative approach was adopted, using open non-participation observation. The findings indicate that dignity remains intact in family-centred care where all concerned parties encourage each other in a collaborative relationship. (...) Dignity is shattered when practitioners care from their own perspective without seeing the individual in front of them. When there is a break in care, family members can restore their dignity because the interruption helps them to master their emotions. Family members’ dignity is shattered and remains damaged when they are emotionally overwhelmed; they surrender themselves to practitioners’ care, losing their self-esteem and self-respect. (shrink)

Industry control over the production and distribution of pharmaceutical safety and efficacy data has become a serious public health and health care funding concern. Various recent scandals, several involving the use of flawed representations of scientific data in the most influential medical journals, highlight the urgency of enhancing pharmaceutical knowledge governance. This paper analyzes why this is a human rights concern and what difference a human rights analysis can make. The paper first identifies the challenges associated with the current knowledge (...) deficit. It then discusses, based on an analysis of case law, how various human rights associated interests can be invoked to support the claim that states have an obligation to actively contribute to independent knowledge governance, for example through ensuring clinical trials transparency. The paper further discusses a conceptual use of human rights, as a methodology which requires a comprehensive analysis of the different interwoven historical, economic, cultural, and social factors that contribute to the problem. Such an analysis reveals that historically grown drug regulations have, in fact, contributed directly to industry control over pharmaceutical knowledge production. This type of finding should inform needed reforms of drug regulation. The paper ends with a recommendation for a comprehensive global response to the problem of pharmaceutical knowledge governance. (shrink)

In recent years, the development process of pharmaceuticals, medical devices, and related products and the overall market of these products have become increasingly global. This paper discusses the need for better governance of one aspect of this market: the production, distribution, and use of pharmaceutical knowledge. Various controversies, some of which will be described in this paper, highlight how industry control over pharmaceutical data production has resulted in very serious threats to public health. Different practices and regulatory fields that affect (...) what I will refer to in this paper as “pharmaceutical knowledge production” are all too often artificially separated and dealt with in isolation, which seriously affects the quality of the available information on the safety and effectiveness of products. I will examine here how a human rights-based approach should inspire us to look more carefully not only at the significant human rights-related interests that are at stake, but also at the relations between the different interwoven regulatory, cultural, and social factors and how these play out at the various stages of knowledge production. (shrink)

This focus issue considers the normative implications of the recent emergence in genome editing technology known as CRISPR (clustered regularly interspaced short palindromic repeats) or CRISPR‐associated protein 9. Originally discovered in the adaptive immune systems of bacteria and archaea, CRISPR enables researchers to make efficient and site‐specific modifications to the genomes of cells and organisms. More accessible, precise, and economic than previous gene editing technologies, CRISPR holds the promise of not only transforming the fields of genetics, agriculture, and human medicine, (...) but also heralding a new era of democratized biotechnology. However, the speed with which developments in the field have progressed threatens to overwhelm our normative sensibilities about the long‐term practical and ethical implications. The contributors to this focus issue attempt to think through some of the more salient moral and practical consequences of CRISPR in the context of religious ethics, particularly as they relate to themes of autonomy, human flourishing, social justice, and the ethics of enhancement. (shrink)

In Canada, the Assisted Human Reproduction Act received royal assent on 29 March 2004. The approach proposed by the federal government responds to Canadians’ strong desire for an enforceable legislative framework in the field of reproduction technologies through criminal law. As a result of the widening gap between the rapid pace of technological change and governing legislation, a distinct need was perceived to create a regulatory framework to guide decisions regarding reproductive technologies.In this article the three main topics covered in (...) the new legislation are commented on: cloning, germline therapy, and purchase of gametes and embryos. Some important issues also covered in the new legislation, such as privacy and access to information, data protection, identity of donors, and inspection, will not be addressed. (shrink)

While the socio-ethical and legal issues surrounding clinical genetics have long been the subject of international interest, the thorny questions of genetic research and biobanking are more recent. Add to this the fact that national guidelines and laws usually precede international policymaking, and the delay in international approaches is understandable. In that regard, the United Nations Educational, Scientific and Cultural Organization’s 1997 Universal Declaration on the Human Genome and Human Rights is unique in its prospective guidance on genetic research. Also, (...) it is in the very nature of international normative instruments to be general, except on specific issues considered to be in the interest of humanity, such as research into human reproductive cloning or access to AIDS drugs. (shrink)

While the socio-ethical and legal issues surrounding clinical genetics have long been the subject of international interest, the thorny questions of genetic research and biobanking are more recent. Add to this the fact that national guidelines and laws usually precede international policymaking, and the delay in international approaches is understandable. In that regard, the United Nations Educational, Scientific and Cultural Organization’s 1997 Universal Declaration on the Human Genome and Human Rights is unique in its prospective guidance on genetic research. Also, (...) it is in the very nature of international normative instruments to be general, except on specific issues considered to be in the interest of humanity, such as research into human reproductive cloning or access to AIDS drugs. (shrink)

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

The development and use of advanced and innovative neuroscience, neurotechnology and some forms of artificial intelligence have exposed potential threats to the human condition, including human rights. As a result, reconceptualizing or creating human rights (i.e. neurorights) has been proposed to address specific brain and mind issues like free will, personal identity and cognitive liberty. However, perceptions, interpretations and meanings of these issues—and of neurorights—may vary between countries, contexts and cultures, all relevant for an international-consensus definition and implementation of neurorights. (...) Thus, we encourage reflecting on the proactive inclusion of transnational, cross-cultural and contextual considerations and concerns to contribute to the global discourse. This inclusion does not mean endorsing ethical relativism but rather a call to foster a universal understanding of key concepts and concerns. Including contextual and cultural perspectives may truly anticipate global concerns which could be addressed while developing and implementing neurorights. Consequently, any ethical and/or legal regulatory framework(s) for the translational and transnational use of advanced neuroscience, neurotechnology and some forms of artificial intelligence intended to protect and safeguard human dignity should be contextually and culturally mindful, responsible, respectful and inclusive of not only human rights and fundamental freedoms but also of neurocognitive cultural diversity. (shrink)

Emergence of novel genome engineering technologies such as clustered regularly interspaced short palindromic repeat has refocused attention on unresolved ethical complications of synthetic biology. Biosecurity concerns, deontological issues and human right aspects of genome editing have been the subject of in-depth debate; however, a lack of transparent regulatory guidelines, outdated governance codes, inefficient time-consuming clinical trial pathways and frequent misunderstanding of the scientific potential of cutting-edge technologies have created substantial obstacles to translational research in this area. While a precautionary principle (...) should be applied at all stages of genome engineering research, the stigma of germline editing, synthesis of new life forms and unrealistic presentation of current technologies should not arrest the transition of new therapeutic, diagnostic or preventive tools from research to clinic. We provide a brief review on the present regulation of CRISPR and discuss the translational aspect of genome engineering research and patient autonomy with respect to the “right to try” potential novel non-germline gene therapies. (shrink)

The article analyses the three terms autonomy, dignity and vulnerability. The relevance and practical application of the terms is tested in two spheres. First, as guiding principles in the area of ethics of medicines and science. Second, as human rights principles, serving to guide the conduct of public policies for an effective realization of human rights. The article argues that all human beings have the same dignity, but that the autonomy—and therefore vulnerability—differs considerably. Simply said, with reduced autonomy comes increased (...) vulnerability, implying extra attention to the protective dimensions. The article finds that the three terms approach the protection of human beings in different ways and that all are relevant and applicable in both spheres, but that an isolated notion of autonomy and a ‘group-based’ notion of vulnerability are not adequate. (shrink)

Two genetic technologies capable of making heritable changes to the human genome have revived interest in, and in some quarters a very familiar panic concerning, so-called germline interventions. These technologies are: most recently the use of CRISPR/Cas9 to edit genes in non-viable IVF zygotes and Mitochondrial Replacement Therapy the use of which was approved in principle in a landmark vote earlier this year by the United Kingdom Parliament. The possibility of using either of these techniques in humans has encountered the (...) most violent hostility and suspicion. However it is important to be aware that much of this hostility dates back to the fears associated with In Vitro Fertilization and other reproductive technologies and by cloning; fears which were baseless at the time concerning both IVF and cloning the use of both of which have proved to be highly beneficial to humanity and which have been effectively regulated and controlled. This paper argues that CRISPR should by pursued through res.. (shrink)

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