Regulation and clinical practices regarding end of human life care differ among the nations and countries. These differences reflect the history of the development of state health systems, different societal values, and different understandings of dignity and what it means to protect or respect dignity. The result is variation in the ethical, legal, and practical approaches to end-of-life issues. The article analyzes the diversity of strategies to strengthen dignity at the end of life of terminally ill patients and to highlight (...) the legal preconditions and limitations for implementing these strategies in independent Lithuania, as a former state of the Soviet Union. It is based on the critical analysis of philosophical literature, legal national and international documents and scientific evidence related to the issue. The author argues that the legal system in Lithuania is not sufficient to ensure the patient’s dignity at the end of life and remains far behind other Western European countries. Legal regulations in Lithuania do not guarantee the right of the patient to express his or her will regarding the future treatment, including the refusal of resuscitation, do not regulate the termination of burdensome, non-viable and meaningless treatment that is undesired by the patient, and limit the accessibility of palliative care with its necessary quality and comfort. (shrink)

Biobanks act as the custodians for the access to and responsible use of human biological samples and related data that have been generously donated by individuals to serve the public interest and scientific advances in the health research realm. Risk assessment has become a daily practice for biobanks and has been discussed from different perspectives. This paper aims to provide a literature review on risk assessment in order to put together a comprehensive typology of diverse risks biobanks could potentially face. (...) Methodologically set as a typology, the conceptual approach used in this paper is based on the interdisciplinary analysis of scientific literature, the relevant ethical and legal instruments and practices in biobanking to identify how risks are assessed, considered and mitigated. Through an interdisciplinary mapping exercise, we have produced a typology of potential risks in biobanking, taking into consideration the perspectives of different stakeholders, such as institutional actors and publics, including participants and representative organizations. With this approach, we have identified the following risk types: economic, infrastructural, institutional, research community risks and participant’s risks. The paper concludes by highlighting the necessity of an adaptive risk governance as an integral part of good governance in biobanking. In this regard, it contributes to sustainability in biobanking by assisting in the design of relevant risk management practices, where they are not already in place or require an update. The typology is intended to be useful from the early stages of establishing such a complex and multileveled biomedical infrastructure as well as to provide a catalogue of risks for improving the risk management practices already in place. (shrink)

There is significant controversy over whether patients have a ‘right not to know’ information relevant to their health. Some arguments for limiting such a right appeal to potential burdens on others that a patient’s avoidable ignorance might generate. This paper develops this argument by extending it to cases where refusal of relevant information may generate greater demands on a publicly funded healthcare system. In such cases, patients may have an ‘obligation to know’. However, we cannot infer from the fact that (...) a patient has an obligation to know that she does not also have a right not to know. The right not to know is held against medical professionals at a formal institutional level. We have reason to protect patients’ control over the information that they receive, even if in individual instances patients exercise this control in ways that violate obligations. (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)

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)

Because of the development towards community care, care providers not only exchange information in a team, but increasingly also in networks. This is a challenge to confidentiality. The ethical question is how care providers can keep information about the care receiver confidential, whilst at the same time exchanging information about that care receiver in a team or network? Can shared confidentiality be extended from a team to a network? To clarify this question, the article refers to the advice of an (...) expert ethics committee in mental health care. The advice regards exchange of information in a network as a further step in enhancing collaboration among care providers. Therefore, the good and evident practice of shared confidentiality in a team can be extended to a network if the same conditions are met. First, the care providers participate in a clearly defined and identifiable team or network. Secondly, they have a shared care responsibility. Thirdly, they have a duty of confidentiality. Fourth, they dialogue with the care receiver and obtain his or her consent. Finally, they apply the filter of relevance. Hence, conditional shared confidentiality is an ethical justification for the exchange of information in a team or network. (shrink)

Among the various experiments in ‘new governance’, the model of Responsible Research and Innovation is emerging in the European landscape as quite promising. Up to now, there have been two versions of RRI: a socio-empirical version which tends to underline the role of democratic processes aimed at identifying values on which governance needs to be anchored and a normative version which stresses the role of EU goals as ‘normative anchor points’ of both governance strategies and policy making. Both versions are (...) unsatisfactory. The first since it suggests movable anchorage which could clash with prefixed values, such as individual rights. The second since it does not safeguard fundamental rights in the process of balancing ‘anchor points’. This result is counterintuitive because it exposes governance to the risk of facing adverse court decisions in the defense of individual rights, thus losing its anticipative attitude. In order to avoid this outcome, the paper argues that it is only through better integration between the system of human rights and that of EU fundamental rights that the anticipative feature of RRI can be preserved. (shrink)

Alzheimer’s disease is a very common, progressive and still incurable disease. Future possibilities for its cure lie in the promotion of research that will increase our knowledge of the disorder’s causes and lead to the discovery of effective remedies. Such research will necessarily involve individuals suffering from Alzheimer’s disease. This raises the controversial issue of whether patients with Alzheimer’s disease are competent to give their consent for research participation.

In accordance with a recent statement released by the World Health Organization, the Canadian province of Ontario is moving to ban payment for plasma donation. This is partially based on contentions that remuneration for blood and blood products undermines autonomy and personal dignity. This paper is dedicated to evaluating this claim. I suggest that traditional autonomy-based arguments against commodification of human body parts and substances are less compelling in the context of plasma donation in Canada, but that there is another (...) autonomy-based objection to paid plasma donation that has not received sufficient attention. Namely, the stigma that surrounds exchanging plasma for payment makes it difficult to make an autonomous decision to engage in this activity. I suggest that this problem can be overcome in one of two ways; by banning payment for plasma, or by reducing the stigma surrounding this practice. I provide an indication of how we might work to achieve the latter, contending that this possibility should be taken seriously, due to the difficulties in achieving a sufficient supply of plasma without remuneration. (shrink)

Historically, the care of hospitalized children has evolved from being performed in isolation from parents to a situation where the parents and the child are regarded as a unit, and parents and nurses as equal partners in the child’s care. Parents are totally dependent on professionals’ knowledge and expertise, while nurses are dependent on the children’s emotional connection with their parents in order to provide optimal care. Even when interdependency exists, nurses as professionals hold the power to decide whether and (...) to what extent parents should be involved in their child’s care. This article focuses on nurses’ responsibility to act ethically and reflectively in a collaborative partnership with parents. To illuminate the issue of nurses as moral practitioners, we present an observation of contemporary child care, and discuss it from the perspective of the Danish moral philosopher KE Løgstrup and his book The ethical demand. (shrink)

Free and informed choice is an oft-acknowledged ethical basis for living kidney donation, including parental living kidney donation. The extent to which choice is present in parental living kidney donation has, however, been questioned. Since parents can be expected to have strong emotional bonds to their children, it has been asked whether these bonds make parents unable to say no to this donation. This article combines a narrative analysis of parents’ stories of living kidney donation with a philosophical discussion of (...) conditions for parental decision-making. Previous research has shown that parents often conclude that it is “natural” to donate. Our study shows that this naturalness needs to be understood as part of a story where parental living kidney donation is regarded as natural and as a matter of non-choice. Our study also highlights the presence of a parenthood moral imperative of always putting one’s child’s needs before one’s own. On the basis of these results, we discuss conditions for decision-making in the context of parental LKD. We argue that the presence of a parenthood moral imperative can matter with regard to the decision-making process when parents consider whether to volunteer as living kidney donors, but that it need not hamper choice. We emphasise the need for exploring relational and situational factors in order to understand parental decision-making in the context of parental LKD. (shrink)

The publication of the Report of the International Bioethics Committee of Unesco on Social responsibility and health provides an opportunity to reshape the conceptual framework of the right to health care and its practical implications. The traditional distinctions between negative and positive, civil-political and economic-social, legal and moral rights are to be questioned and probably overcome if the goal is to pursue ‘the highest attainable standard of health’ as a fundamental human right, that should as such be guaranteed to every (...) human being. What we are called upon to, is the commitment not to exclude now and forever anyone from having access to the ‘excellence’ of scientific and medical progress. Therefore, the addressees of this ‘responsibility’ cannot be just the governments and the states within the limits of their ‘jurisdiction’. The challenge is to tackle at the same time the social and global determinants of health. (shrink)

On 19 December 2008 the Official Journal of Belgium published the ‘Law regarding the procurement and use of human body material destined for human medical applications or for scientific research purposes’. This paper will comment on various aspects of the Law: its scope of application (what is understood by ‘body material’?); its concept of ‘residual human body material’ (with far-reaching implications for the type of consent required for research); the nature of actions with and uses of human body material that (...) are explicitly prohibited; the right of donors to be informed of relevant information revealed by the use of their body material; and the special responsibilities placed on hospital ethics committees. As will be argued in this paper, several of these provisions are highly problematic from an ethical point of view, especially those relating to consent. Meanwhile, the Minister of Public Health has asked the Belgian Advisory Committee on Bioethics for advice on the incorporation of the ‘presumed consent’ model, that applies to post mortem organ donation, into the biobank Law’s provisions on post mortem removal and use of body material. This aspect of the Law effectively extends the ‘presumed consent’ regime, both from organs to body material in general, and from therapeutic uses to research uses. (shrink)

Statements on issues in biomedical ethics, purporting to represent international interests, have been put forth by numerous groups. Most of these groups are composed of thinkers in the tradition of European secularism, and do not take into account the values of other ethical systems. One fifth of the world’s population is accounted for by Islam, which is a universal religion, with more than 1400 years of scholarship. Although many values are held in common by secular ethical systems and Islam, their (...) inferences are different. The question, “Is it possible to derive a truly universal declaration of biomedical ethics?” is discussed here by examining the value and extent of personal autonomy in Western and Islamic biomedical ethical constructs. These constructs are then tested vis-à-vis the issue of abortion. It is concluded that having a universal declaration of biomedical ethics in practice is not possible, although there are many conceptual similarities and agreements between secular and Islamic value systems, unless a radical paradigm shift occurs in segments of the world’s deliberative bodies. The appellation “universal” should not be used on deliberative statements unless the ethical values of all major schools of thought are satisfied. (shrink)

This collection of papers were originally presented during conferences on ethics in science and technology that UNESCO’s Regional Unit for Social and Human Sciences (RUSHSAP) has been convening since 2005. Since intercultural communication and information-sharing are essential components of these deliberations, the books also provide theme-related discourse from the conferences.

Since the 1990s, numerous studies on the relationship between parents and their children have been reported on in the literature and implemented as a philosophy of care in most paediatric units. The purpose of this article is to understand the process of nurses' care for children in a paediatric setting by using Noddings's caring ethics theory. Noddings's theory is in part described from a theoretical perspective outlining the basic idea of the theory followed by a critique of her work. Important (...) conceptions in her theory are natural caring (reception, relation, engrossment, motivational displacement, reciprocity) and ethical caring (physical self, ethical self, and ethical ideal). As a nurse one holds a duty of care to patients and, in exercising this duty, the nurse must be able to develop a relationship with the patient including giving the patient total authenticity in a 'feeling with' the patient. Noddings's theory is analysed and described in three examples from the paediatrics. In the first example, the nurse cared for the patient in natural caring while in the second situation, the nurse strived for the ethical caring of the patient. In the third example, the nurse rejected the impulse to care and deliberately turned her back to ethics and abandoned her ethical caring. According to the Noddings's theory, caring for the patient enables the nurse to obtain ethical insights from the specific type of nursing care which forms an important contribution to an overall increase of an ethical consciousness in the nurse. (shrink)

The possibility of editing the genomes of human embryos has generated significant discussion and interest as a matter of science and ethics. While it holds significant promise to prevent or treat disease, research on and potential clinical applications of human embryo editing also raise ethical, regulatory, and safety concerns. This systematic review included 223 publications to identify the ethical arguments, reasons, and concerns that have been offered for and against the editing of human embryos using CRISPR-Cas9 technology. We identified six (...) major themes: risk/harm; potential benefit; oversight; informed consent; justice, equity, and other social considerations; and eugenics. We explore these themes and provide an overview and analysis of the critical points in the current literature. (shrink)

Case studies are used to reflect on the treatment of patients with dementia hospitalized at the Geriatric Department of the Faculty hospital in Prešov, emphasizing human dignity in clinical practice. The discussion is focused on the palliative care of patients with severe dementia. The biomedical method, which respects human dignity is defined by means of inductive, deductive, and normative bioethical methods. They make it possible to provide guidelines for palliative care and individualized prognosis strategy. An analysis of health status of (...) individuals with severe dementia enables us to offer a clinical definition of purposeful treatment based on normative justice and decision-making that reflects the patient’s best interest, thus respecting their dignity. An evaluation of a patient’s care is based on a biomedical method that considers the dementia stage. Applying a bioethical model in a holistic context preconditions the human rights of patients with dementia. (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)

This paper targets an orphan topic in research ethics, namely the so called principle of the primacy of the human being, which states that the interests of the human subject should always take precedence over the interests of science and society. Although the principle occupies the central position in the majority of international ethical and legal standards for biomedical research, it has been commented in the literature mainly in passing. With a few notable exceptions, there is little in-depth discussion about (...) the meaning and role of the principle. Several authors note that the principle is vogue, ambiguous and apparently conflicting with the accepted practice of conducting non-beneficial research on individuals unable to give consent. There are opinions that it is just “a vacuous figure of speech” and should be abandoned. This paper argues that the primacy principle is far from being “a vacuous figure of speech”, rather it should be seen as a threefold concept: a fundamental interpretative rule, a procedural rule, and a substantive rule aimed at protecting research subjects from instrumental treatment and unacceptable risks. This interpretation tracks back to the principle regulatory and normative origins in the Declaration of Helsinki of 1975, but also acknowledges changes in research ethics and practice, which took place at the turn on the twentieth and twenty-first centuries. Thus, the proposed reading of the principle is not only original, but also historically grounded and normatively fruitful. It provides a fresh and ethically rich perspective on extensively debated, but still controversial problem of an upper limit of permissible risks in non-beneficial studies. (shrink)

BackgroundSharing de-identified individual-level health research data is widely promoted and has many potential benefits. However there are also some potential harms, such as misuse of data and breach of participant confidentiality. One way to promote the benefits of sharing while ameliorating its potential harms is through the adoption of a managed access approach where data requests are channeled through a Data Access Committee (DAC), rather than making data openly available without restrictions. A DAC, whether a formal or informal group of (...) individuals, has the responsibility of reviewing and assessing data access requests. Many individual groups, consortiums, institutional and independent DACs have been established but there is currently no widely accepted framework for their organization and function.Main textWe propose that DACs, should have the role of both promotion of data sharing and protection of data subjects, their communities, data producers, their institutions and the scientific enterprise. We suggest that data access should be granted by DACs as long as the data reuse has potential social value and provided there is low risk of foreseeable harms. To promote data sharing and to motivate data producers, DACs should encourage secondary uses that are consistent with the interests of data producers and their own institutions. Given the suggested roles of DACs, there should be transparent, simple and clear application procedures for data access. The approach to review of applications should be proportionate to the potential risks involved. DACs should be established within institutional and legal frameworks with clear lines of accountability, terms of reference and membership. We suggest that DACs should not be modelled after research ethics committees (RECs) because their functions and goals of review are different from those of RECs. DAC reviews should be guided by the principles of public health ethics instead of research ethics.ConclusionsIn this paper we have suggested a framework under which DACs should operate, how they should be organised, and how to constitute them. (shrink)

As Next Generation Sequencing technologies are increasingly implemented in biomedical research and care, the number of study participants and patients who ask for release of their genomic raw data is set to increase. This raises the question whether research participants and patients have a legal and moral right to receive their genomic raw data and, if so, how this right should be implemented into practice. In a first step we clarify some central concepts such as “raw data”; in a second (...) step we sketch the international legal framework. The third step provides an extensive ethical analysis which comprehends two parts: an evaluation of whether there is a prima facie moral right to receive one’s raw data, and a contextualization and discussion of the right in light of potentially conflicting interests and rights of the data subject herself and third parties; in a last fourth step we emphasize the main practical consequences of the ethical analyses and propose recommendations for the release of raw data. In several legislations like the new European General Data Protection Regulation, patients do in principle have the right to receive their raw data. However, the procedural implementation of this right and whether it involves genetic counselling is at the discretion of the Member States. Even more questions remain with respect to the research context. The ethical analysis suggests that patients and research subjects have a moral right to receive their genomic raw data and addresses aspects which are also of relevance for the legal discussion such as the costs of release of raw data and its impact on academic freedom. Taking into account the specific nature and implications of genomic raw data and the contexts of research and health care, several concerns and potentially conflicting interests of the data subjects themselves and involved researchers, physicians, biomedical institutions and relatives arise. Instead of using them to argue in favor of restrictions of the data subjects’ legal and moral right to genomic raw data, the concerns should be addressed through provision of information and other measures. To this end, we propose relevant recommendations. (shrink)

Increased knowledge of the gene–disease associations contributing to common cancer development raises the prospect of population stratification by genotype and other risk factors. Individual risk assessments could be used to target interventions such as screening, treatment and health education. Genotyping neonates, infants or young children as part of a systematic programme would improve coverage and uptake, and facilitate a screening package that maximises potential benefits and minimises harms including overdiagnosis. This paper explores the potential justifications and risks of genotyping children (...) for genetic variants associated with common cancer development within a personalised screening programme. It identifies the ethical and legal principles that might guide population genotyping where the predictive value of the testing is modest and associated risks might arise in the future, and considers the standards required by population screening programme validity measures . These are distinguished from the normative principles underpinning predictive genetic testing of children for adult-onset diseases—namely, to make best-interests judgements and to preserve autonomy. While the case for population-based genotyping of neonates or young children has not yet been made, the justifications for this approach are likely to become increasingly compelling. A modified evaluative and normative framework should be developed, capturing elements from individualistic and population-based approaches. This should emphasise proper communication and genuine parental consent or informed choice, while recognising the challenges associated with making unsolicited approaches to an asymptomatic group. Such a framework would be strengthened by complementary empirical research. (shrink)

In the trauma surrounding mass disasters, the need to identify victims accurately and as soon as possible is critical. DNA identification testing is increasingly used to identify human bodies and remains where the deceased cannot be identified by traditional means. This form of testing compares DNA taken from the body of the deceased with DNA taken from their personal items or from close biological relatives. DNA identification testing was used to identify the victims of the terrorist attack on the World (...) Trade Center in New York on September 11, 2001, and of the victims of the Tsunami that hit Asia on December 26, 2004. Shortly after the 9/11 attack, police investigators asked the victims' families for personal items belonging to the missing, and for DNA samples from family members themselves. The New York medical examiner's office coordinated the DNA identification testing program; however, some of the identification work was contracted out to private laboratories. (shrink)

Background: The relationship between healthcare professionals and patients in the Spanish health sector has undergone dramatic change. One aspect of this is that the use of informed consent has become a key factor in the delivery of adequate healthcare. But although a certain period of time has already passed since informed consent started to be used, in Spain there is still doubt about how adequately informed consent is being used. Objectives: (a) To look at how patients understand the notion and (...) purpose of informed consent, and (b) how the informed consent is applied – the way patients receive such information affects their level of participation and decision making during the time they receive medical care. Methodology: We use interpretative description of interviews with patients. We developed guiding questions for the interviews with patients in two preliminary and exploratory focus groups. Then, we carried out 20 personal open-ended interviews with 20 purposive selected patients with illnesses that had a serious impact on their lives. Ethical considerations: Permission from ethical committees and institutions involved in the study, and consent and confidentiality were ensured before conducting the research. Results: The findings show that while patients agreed that their consent should be necessary for health professionals to be able to intervene, they had serious difficulty obtaining and then understanding information offered to them at the moment when they were being asked to sign informed consent documents. The participants were critical of the consent documents, which they considered were treated as merely a formality and even some of them had felt coerced to sign. Discussion: Participants confirmed that the informed consent documents that they signed did not meet their ethical objectives. Their perception of the purpose of consent indicates that informed consent document may still be largely understood as a formality rather an ethical obligation. (shrink)

BackgroundGlobal collaboration in genomic research is increasingly both a scientific reality and an ethical imperative. This past decade has witnessed the emergence of six new, interconnected areas of ethical consensus and emphasis for policy in genomics: governance, security, empowerment, transparency, the right not to know, and globalization.DiscussionThe globalization of genomic research warrants an approach to governance policies grounded in human rights.SummaryA human rights approach activates the ethical principles underpinning genomic research. It lends force to the right of all citizens to (...) benefit from scientific progress, and to the right of all scientists to be recognized for their contributions. (shrink)

Recent advances in genomic research have led to the development of new diagnostic tools, including tests which make it possible to predict the future occurrence of monogenetic diseases (e.g. Chorea Huntington) or to determine increased susceptibilities to the future development of more complex diseases (e.g. breast cancer). The use of such tests raises a number of ethical, legal and social issues which are usually discussed in terms of rights. However, in the context of predictive genetic tests a key question arises (...) which lies beyond the concept of rights, namely, What should we want to know about our future? In the following I shall discuss this question against the background of Kant’s Doctrine of Virtue. It will be demonstrated that the system of duties of virtue that Kant elaborates in the second part of his Metaphysics of Morals offers a theoretical framework for addressing the question of a proper scope of future knowledge as provided by genetic tests. This approach can serve as a source of moral guidance complementary to a justice perspective. It does, however, not rest on the – rather problematic – claim to be able to define what the “good life” is. (shrink)

Pediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences of the unprecedented integration of research and care in pediatric oncology from the perspective of parents and physicians. An empirical ethical approach, combining (1) a narrative review of (primarily) qualitative studies on parents' and physicians' experiences of the pediatric (...) oncology research practice, and (2) comparison of these experiences with existing theoretical ethical concepts about (pediatric) research. The use of empirical evidence enriches these concepts by taking into account the peculiarities that ethical challenges pose in practice. Analysis of the 22 studies reviewed revealed that the integration of research and care has consequences for the informed consent process, the promotion of the child's best interests, and the role of the physician (doctor vs. scientist). True consent to research is difficult to achieve due to the complexity of research protocols, emotional stress and parents' dependency on their child's physician. Parents' role is to promote their child's best interests, also when they are asked to consider enrolling their child in a trial. Parents are almost never in equipoise on trial participation, which leaves them with the agonizing situation of wanting to do what is best for their child, while being fearful of making the wrong decision. Furthermore, a therapeutic misconception endangers correct assessment of participation, making parents inaccurately attribute therapeutic intent to research procedures. Physicians prefer the perspective of a therapist over a researcher. Consequently they may truly believe that in the research setting they promote the child's best interests, which maintains the existence of a therapeutic misconception between them and parents. Due to the integration of research and care, their different ethical perspectives become intertwined in the daily practice of pediatric oncology. Increasing awareness of what this means for the communication between parents and physicians is essential. Future research should focus on efforts that overcome the problems that the synchronicity of research and care evokes. (shrink)

This article presents an overview ofregulations, guidelines and societal debates ineight member states of the EC about a)embryonic and fetal tissue transplantation(EFTT), and b) the use of human embryonic stemcells (hES cells) for research into celltherapy, including `therapeutic' cloning. Thereappears to be a broad acceptance of EFTT inthese countries. In most countries guidance hasbeen developed. There is a `strong' consensusabout some of the central conditions for `goodclinical practice' regarding EFTT.International differences concern, amongstothers, some of the informed consent issuesinvolved, and the (...) questions whether anintermediary organisation is necessary, whetherthe methods of abortion may be influenced bythe possible use of EFT, and whether EFTTshould only be used for the experimentaltreatment of rare disorders. The potential useof hES cells for research into cell therapy hasgiven a new impetus to the debate about (human)embryo research. The therapeutic prospects withregard to the retrieval and research use of hEScells appear to function as a catalyst for theintroduction of less restrictive regulationsconcerning research with spare embryos, atleast in some European countries. It remains tobe seen whether the prospect of treatingpatients suffering from serious disorders withtransplants produced by therapeutic cloningwill decrease the societal and moral resistanceto allowing the generation of embryos for`instrumental' use. (shrink)

As a part of a research project on Dignity and Older Europeans Programme) I explore in this paper a set of notions of human dignity. The general concept of dignity is introduced and characterized as a position on a value scale and it is further specified through its relations to the notions of right, respect and self-respect. I present four kinds of dignity and spell out their differences: the dignity of merit, the dignity of moral or existential stature, the dignity (...) of identity and the universal human dignity. Menschenwürde pertains to all human beings to the same extent and cannot be lost as long as the persons exist. The dignity of merit depends on social rank and position. There are many species of this kind of dignity and it is very unevenly distributed among human beings. The dignity of merit exists in degrees and it can come and go. The dignity of moral stature is the result of the moral deeds of the subject; likewise it can be reduced or lost through his or her immoral deeds. This kind of dignity is tied to the idea of a dignified character and of dignity as a virtue. The dignity of moral stature is a dignity of degree and it is also unevenly distributed. The dignity of identity is tied to the integrity of the subject's body and mind, and in many instances, although not always, also dependent on the subject's self-image. This dignity can come and go as a result of the deeds of fellow human beings and also as a result of changes in the subject's body and mind. (shrink)

Prohibition on sex selection may well be unnecessary and oppressive as well as posing risks to women’s lives The urge to select children’s sex is not new. The Babylonian Talmud, a Jewish text completed towards the end of the fifth century of the Christian era, advises couples on means to favour the birth of either a male or a female child.1 The development of amniocentesis alerted the public in the mid-1970s to the scientific potential for prenatal determination of fetal sex,2 (...) and progressive decriminalisation of abortion afforded choice about continuation of pregnancy. The more recent emergence of preimplantation genetic diagnosis (PGD) obviates resort to abortion, and improved techniques of sperm sorting and diagnosis permit creation of zygotes that will ensure the sex of a future child. Growth of biomedical means to select the sex of future children has been accompanied by fear that such means will be employed to favour births of sons, and so perpetuate devaluation of girl children and women’s inferior family and social status. A reaction to this fear has been the demand for legal and medical professional prohibition of sex selection techniques. For instance, the Council of Europe’s Convention on Human Rights and Biomedicine3 provides in article 14 that: The use of techniques of medically assisted procreation shall not be allowed for the purpose of choosing a future child’s sex, except where serious hereditary sex-related disease is to be avoided. Legislation has been enacted in a number of countries, and proposed in others, to prohibit sex selection on non-medical grounds, such as the Prenatal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 in India. In Canada, for instance, government draft legislation introduced in May 2002 proposes to make it a crime for any person, for the purpose of creating a human …. (shrink)

In this paper I analyse who should be able to control the use of human embryonic stem cell lines. I distinguish between different kinds of control and analyse a set of arguments that purport to show that the donors of gametes and embryos should not be able to control the use of stem cell lines derived from their embryos. I show these arguments to be either deficient or of so general a scope that they apply not only to donors but (...) also to those who derived the stem cell lines. Since we normally think that stem cell derivers have the right to control the use of the cell lines they derived, we have no justification for denying donors similar rights of control. In the final section I briefly discuss why informed consent is not an appropriate vehicle for transferring or alienating control rights. (shrink)

Background Several authors have shown that children and adolescents have limited understanding of critical elements of the research studies in which they are participating. The inclusion of graphic elements is a promising approach to increase the understandability of assent forms of clinical trials. Objectives To design a new assent form in comic strip format for minors participating in clinical trials and to compare the comprehension of this new document with a traditional assent form. Methods This study included an assessment of (...) the readability of standard informed assents, the evaluation of the comprehension of one of these documents, the development of a new (comic format) informed assent from the original document previously evaluated, and the analysis of readability and comprehension of the new informed assent. The readability of the documents was assessed using previously validated formulas, whereas comprehension analyses were performed through a questionnaire taken by two groups of 12-year-old students of secondary schools. Ethical considerations: All procedures involving human participants were in accordance with the ethical standards of the 1964 Helsinki Declaration and its later amendments. Findings Compared with the original document, the comic assent form improved the grammatical readability of the “Aims, Risks and Benefits and How to Get More Information” sections, the comprehension scores in the Aims and Procedure sections, the understanding of ideas, and the formation of macro-ideas. The benefits of the comic strip format were more noticeable among participants in the lower percentiles of the comprehension score. Conclusions Our results show that the comic assent form has high readability and comprehensibility compared with its original form, particularly in the domains of knowledge-based inferences and macro-ideas formation. The use of forms that combine text and comic strips may help the comprehension of minors participating of a clinical trial, supporting their autonomy in decision-making. (shrink)

In the last few decades, assisted reproduction has introduced new challenges to the way people conceive and build their families. While the numbers of donor-conceived individuals have increased worldwide, there are still many controversies concerning access to donor information. Is there a fundamental moral right to know one’s genetic background? What does identity in DC families mean? Is there any relationship between identity formation and disclosure of genetic origins? These questions are addressed by analysing core regulatory discourse. This analysis shows (...) that the notion of narrative identity is suitable for defining and answering these questions. This review analyses the meaning of resemblance in DC families and the way donors are selected following affinity-ties and discusses disclosure strategies and agreements. As a preliminary conclusion, it could be said that, in the field of third-party reproduction, knowing about the donor conception significantly contributes towards the development of a narrative identity and also serves as a moral basis for the child’s right to know. (shrink)

In recent years, neuroscience has been a particularly prolific discipline stimulating many innovative treatment approaches in medicine. However, when it comes to the brain, new techniques of intervention do not always meet with a positive public response, in spite of promising therapeutic benefits. The reason for this caution clearly is the brain’s special importance as “organ of the mind”. As such it is widely held to be the origin of mankind’s unique position among living beings. Likewise, on the level of (...) the individual human being, the brain is considered the material substrate of those traits that in combination render each person unique. In view of this preeminent significance of the brain, it is understandable that, in general, interventions into the brain are considered a delicate issue and that new techniques of intervention are scrutinised with particular care. However, in doing so it is important not to go to the opposite extreme and shy away from promising new therapeutic approaches for debilitating disorders of the brain. With respect to the new techniques of brain intervention a broad interdisciplinary perspective is required to discern irrational fear from justified concern. Hence, the Europäische Akademie established a project group consisting, on the one hand, of experts from different fields of medicine who have got first-hand experience of applying the techniques at issue and, on the other hand, of philosophers and a legal expert. The task of this team was to review the state of the art with respect to each single technique of intervening in the brain, to indicate future developments, and to address the ethical and legal issues common to all of them. The project’s outcome is the book at hand. (shrink)

Biobanks, collecting human specimen, medical records, and lifestyle-related data, face the challenge of having contradictory missions: on the one hand serving the collective welfare through easy access for medical research, on the other hand adhering to restrictive privacy expectations of people in order to maintain their willingness to participate in such research. In this article, ethical frameworks stressing the societal value of low-privacy expectations in order to secure biomedical research are discussed. It will turn out that neither utilitarian nor communitarian (...) or classical libertarian ethics frameworks will help to serve both goals. Instead, John Rawls’ differentiation of the “right” and the “good” is presented in order to illustrate the possibility of “serving two masters”: individual interests of privacy, and societal interests of scientific progress and intergenerational justice. In order to illustrate this counterbalancing concept with an example, the five-pillar concept of the German Ethics Council will be briefly discussed. (shrink)

The intriguing issue of pain and suffering in patients with disorders of consciousness (DOCs), particularly in Unresponsive Wakefulness Syndrome/Vegetative State (UWS/VS) and Minimally Conscious State (MCS), is assessed from a theoretical point of view, through an overview of recent neuroscientific literature, in order to sketch an ethical analysis. In conclusion, from a legal and ethical point of view, formal guidelines and a situationist ethics are proposed in order to best manage the critical scientific uncertainty about pain and suffering in DOCs (...) and ensure the best possible care for the patient. (shrink)

Genomic research is an expanding and subversive field, leaking into various others, from environmental protection to food production to healthcare delivery, and in doing so, it is reshaping our relationship with them. The international community has issued various declaratory instruments aimed at the human genome and genomic research. These soft law instruments stress the special nature of genomics and our genetic heritage, and attempt to set limits on our activities with respect to same, as informed by the human rights paradigm. (...) This paper examines the primary thrust and, more importantly, the joint value position of the Universal Declaration on the Human Genome and Human Rights and the Universal Declaration on Bioethics and Human Rights, concluding that, though important legal instruments from the human rights paradigm, these instruments, or rather the values contained therein, must find a more influential hard law voice and a broader policy environment. (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)

The professional regulatory system known as medical ethics has been one of the most visionary and socially valuable creations of the medical profession. Its beneficial influence has extended beyond physician/patient relations, to the shaping of many key humanistic and egalitarian features of the world’s legal and political institutions. The continued existence of medical ethics as a professionally influential normative system, however, is being challenged by international human rights. The UNESCO Universal Declaration on Bioethics and Human Rights, is likely to be (...) an important point of intersection in this process. (shrink)

Direct-to-consumer genetic testing is a growing phenomenon, fuelled by the notion that knowledge equals control. One ethical question that arises concerns the proband’s duty to share information indicating genetic risks in their relatives. However, such duties are unenforceable and may result in the realisation of anticipated harm to relatives. We argue for a shift in responsibility from proband to provider, placing a duty on test providers in the event of identified actionable risks to relatives. Starting from Parker and Lucassen’s 'joint (...) account model', we adapt Kilbride’s application of the rule of rescue and balance it against the relative’s right not to know, placing responsibility on the providers of direct-to-consumer genetic testing. Where the risk of disease to a relative is actionable, we argue providers ought to share results even in the face of the proband’s objections. Confidentiality issues are navigated by a pre-emptive consent model, whereby consumers agree to the sharing of certain information with their relatives ahead of testing and as a condition of testing. When a relative is informed, the proband’s privacy is protected by maximal deidentification, and the rights of the relative are met by a stepwise approach to informing that allows them to decide how much information they receive. (shrink)

This paper examines the ability of countries in Central and Eastern Europe to ensure appropriate protection of research participants in the field of increasingly globalizing biomedical research. By applying an analytical framework for identifying gaps in policies and programs for human subjects protection to four countries of CEE—Belarus, Latvia, Lithuania, and Poland, substantial gaps in the scope and content of relevant policies and major impediments to program performance have been revealed. In these countries, public policies on the protection of research (...) participants lack consistency and reliable mechanisms for their implementation. Impediments to program performance most often relate to inadequacies in the national research ethics systems with regard to organizational structure, budgetary support, supervision, and training. The level of research ethics capacity varies from country to country and depends on socio-economic and political factors of post-communist transition. The breadth and depth of the problems identified suggest that the current level of protection for research participants in CEE might be inadequate to the challenges posed by the globalization of biomedical research. In CEE countries, there is a need for strengthening research ethics capacity through modification of relevant policies and improvement of program management. The differences among the countries call for further research on identifying the best approaches for filling the gaps in the policies and programs aimed at ensuring effective protection of research participants. (shrink)

In this article, the question is discussed if and how Healthcare Ethics Committees (HECs) should be regulated. The paper consists of two parts. First, authors from eight EC member countries describe the status quo in their respective countries, and give reasons as to the form of regulation they consider most adequate. In the second part, the country reports are analysed. It is suggested that regulation of HECs should be central and weak. Central regulation is argued to be apt to improve (...) HECs’ accountability, relevance and comparability. To facilitate biomedical citizenship and ethical reflection, regulation should at the same time be weak rather than strict. Independence of HECs to deliberate about ethical questions, and to give solicited and unsolicited advice, should be supported and only interfered with by way of exception. One exception is when circumstances become temporary adversarial to ethical deliberation in healthcare institutions. In view of European unification, steps should be taken to develop consistent policies for both Eastern and Western European countries. (shrink)

(No abstract is available for this citation).

The paper argues that the idea of gift-giving and its associated imagery, which has been founding the ethics of organ transplants since the time of the first successful transplants, should be abandoned because it cannot effectively block arguments for (regulated) markets in human body parts. The imagery suggests that human bodies or their parts are transferable objects which belong to individuals. Such imagery is, however, neither a self-evident nor anthropologically unproblematic construal of the relation between a human being and their (...) body. The paper proposes an alternative conceptualization of that relation, the identity view according to which a human being is identical with their living body. This view, which offers a new ethical perspective on some central concepts of transplant medicine and its ethical and legal standards and institutions, supports widely shared intuitive ethical judgments. On this proposal, an act of selling a human body or one of its parts is an act of trade in human beings, not in owned objects. Transfers of human body parts for treatment purposes are to be seen as sharing in another human being’s misfortune rather than as giving owned objects. From the perspective of policy-making, the proposal requires, first, that informed consent for removal of transplant material be obtained from the potential benefactor. Secondly, explicit consent by the prospective benefactor is obligatory in the case of removal of transplant material from a living benefactor. Thirdly, in the case of posthumous retrieval, informed consent by the potential benefactor during their life is not ethically indispensable. Additionally, while refusal of posthumous retrieval expressed by a potential benefactor during their life must be respected, such a refusal needs ethical justification and explanation. (shrink)