Clinical trials of xenotransplantation may begin early in the next decade, with kidneys from genetically modified pigs transplanted into adult humans. If successful, transplanting pig hearts into children with advanced heart failure may be the next step. Typically, clinical trials have a specified end date, and participants are aware of the amount of time they will be in the study. This is not so with XTx. The current ethical consensus is that XTx recipients must consent to lifelong monitoring. While this (...) presents challenges to the right to withdraw in the adult population, additional and unanswered questions also linger in the paediatric population. In paediatric XTx, parents or guardians consent not only to the initial treatment of the child but also to lifelong monitoring, thus making a decision whose consequences will remain present as the child develops the capacity for assent, and finally the capacity for informed consent or refusal. This article presents and evaluates unanswered paediatric ethical questions in regard to the right to withdraw from XTx follow-up in the paediatric population. (shrink)

The socio-ethical concerns regarding exploitation in commercial surrogacy are premised on asymmetric vulnerability and the commercialization of women’s reproductive capacity to suit individualistic motives. In examining the exploitation argument, this article reviews the social contract theory that describes an individual as an ‘economic man’ with moral and/or political motivations to satisfy individual desires. This study considers the critique by feminists, who argue that patriarchal and medical control prevails in the surrogacy contracts. It also explores the exploitative dynamics amongst actors in (...) the light of Baier’s conceptualization of trust and human relationship, within which both justice and exploitation thrive, and Foucault’s concept of bio-power. Drawing on these concepts, this paper aims to investigate the manifestations of exploitation in commercial surrogacy in the context of trust, power and experiences of actors, using a case study of one clinic in India. The actors’ experiences are evaluated at different stages of the surrogacy process: recruitment, medical procedures, living in the surrogate home, bonding with the child and amongst actors, financial dealings, relinquishment and post-relinquishment. (shrink)

To be made aware of bioethical issues related to their disciplines, undergraduate students in biology and pharmaceutical sciences at the University of Basel are required to enroll in the bioethics course called “Introduction to Bioethics”. This article describes the chances and challenges faced when teaching a large number of undergraduate biology and pharmaceutical sciences students. Attention is drawn to the relevance and specific ethical issues that biology and pharmaceutical sciences students may be confronted with and to how these could be (...) integrated into ethics curricula. Results from a survey addressing the knowledge and opinion of students taking the course in spring semester 2012, 2013, and 2014 are presented and discussed. Finally, we describe the lessons learned and how we have improved the course based on students’ feedback throughout the following years. (shrink)

I seek to advance enquiry into the philosophical question of in virtue of what human beings have a dignity of the sort that grounds human rights. I first draw on values salient in sub-Saharan African moral thought to construct two theoretically promising conceptions of human dignity, one grounded on vitality, or liveliness, and the other on our communal nature. I then argue that the vitality conception cannot account for several human rights that we intuitively have, while the community conception can (...) do so. I conclude that, of plausible theories of human dignity with an African pedigree, the field ought to favour a community-based view and critically compare it in future work with the Kantian, autonomy-based view that dominates Western thinking about dignity. (shrink)

In this article, we seek to contribute to the debate on the requirement of disclosure in the context of informed consent for research. We defend the subjective standard of disclosure and describe ways to implement this standard in research practice. We claim that the researcher should make an effort to find out what kinds of information are likely to be relevant for those consenting to research. This invites researchers to take empirical survey information seriously, attempt to understand the cultural context, (...) talk to patients to be better able to understand what can be potentially different concerns and interests prevalent in the target population. The subjective standard of disclosure should be seen as a moral ideal that perhaps can never be perfectly implemented but still can and should be used as a normative ideal guiding research practice. In the light of these discussions, we call for more empirical research on what considerations are likely to be perceived as relevant by potential research participants recruited from different socio-economic and cultural groups. (shrink)

This issue of The Journal of Medicine and Philosophy brings together an international group of scholars from Hong Kong, Mainland China, and North America, critically to explore whole-body/head transplantation. The proposed procedure raises significant philosophical, ethical, and social/political questions. For example, assuming transplant is successful, who survives the surgery? Does personal identity necessarily follow the head? The contributors to this special thematic issue explore the nature and ground of personal identity, what it would mean to preserve personal identity, given such (...) a significant set of physical changes, as well as the morality of such a procedure. As the authors make clear, careful conceptual philosophical analysis is essential for understanding whether whole-body/head transplantation is a life-saving/life-enhancing technological innovation, or a bioethical morass that should not be attempted. How we come to terms with such conceptual and moral concerns will have a significant impact on the future of medicine and medical technological innovation. (shrink)

BackgroundCountries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.DiscussionResearch ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs (...) can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices.The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals.ConclusionOutcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed? (shrink)

Non-beneficial paediatric research is vital to improving paediatric healthcare. Nevertheless, it is also ethically controversial. By definition, subjects of such studies are unable to give consent and they are exposed to risks only for the benefit of others, without obtaining any clinical benefits which could compensate those risks. This raises ethical concern that children participating in non-beneficial research are treated instrumentally; that they are reduced to mere instruments for the benefit of science and society. But this would make the research (...) incompatible with the widely endorsed principle of the primacy of the human subject, which stipulates that the interests of the participating individual should prevail over the interests of science and society. This paper deals with this conflict. It analyses solutions to this problem developed in the literature, and shows that they are unsuccessful. Finally, it offers a new idea of how to reconcile the conduct of non-beneficial paediatric research with the PP. The paper argues for a new formula of the PP, and shows that it implies a specific non-comparative definition of the minimal risk threshold. (shrink)

Many countries in Africa, and more generally those in the Global South with tropical areas, are plagued by illnesses that the wealthier parts of the world (mainly ‘the West’) neither suffer from nor put systematic effort into preventing, treating or curing. What does an ethic with a recognizably African pedigree entail for the ways various agents ought to respond to such diseases? As many readers will know, a characteristically African ethic prescribes weighty duties to aid on the part of those (...) in a position to do so, and it therefore entails that there should have been much more contribution from the Western, ‘developed’ world. However, what else does it prescribe, say, on the part of sub-Saharan governments and the African Union, and are they in fact doing it? I particularly seek to answer these questions here, by using the 2013-16 Ebola crisis in West Africa to illustrate what should have happened but what by and large did not. (shrink)

Clinicians sometimes disagree about how much to honor surrogates’ deeply held cultural values or traditions when they differ from those of the host country. Such a controversy arose when parents requested a cultural accommodation to let their infant die by withdrawing life saving care. While both the parents and clinicians claimed to be using the Best Interests Standard to decide what to do, they were at an impasse. This standard is analyzed into three necessary and jointly sufficient conditions and used (...) to resolve the question of how much to accommodate cultural preferences and how to treat this infant. The extreme versions of absolutism and relativism are rejected. Properly understood, the Best Interests Standard can serve as a powerful tool in settling disputes about how to make good decisions for those who cannot decide for themselves. (shrink)

Increasing privacy concerns are arising from expanding use of aggregated personal information in health practices. Conversely, in light of the promising benefits of data driven healthcare, privacy...

There is a global shortage of nurses that affects healthcare delivery, which will be exacerbated with the increasing demand for healthcare professionals by the aging population. The growing shortage requires an ethical exploration on the issue of nurse migration. In this article, we discuss how migration respects the autonomy of nurses, increases cultural diversity, and leads to improved patient satisfaction and health outcomes. We also discuss the potential for negative impacts on public health infrastructures, lack of respect for cultural diversity, (...) and ethical concerns related to autonomy and justice, including coercion and discrimination. This analysis is written from a rights-based ethics approach by referring to rights held by nurses and patient populations. Nurse migration highlights conflicts between nurses and between nurses and healthcare systems. Increased awareness of ethical challenges surrounding nurse migration must be addressed to enhance the well-being of nurses and patient populations. (shrink)

In order to continue to maintain public trust and confidence in human research, participants must be treated with respect. Researchers and Human Research Ethics Committee members need to be aware that modern considerations of this value include: the need for a valid consenting process, the protection of participants who have their capacity for consent compromised; the promotion of dignity for participants; and the effects that human research may have on cultures and communities. This paper explains the prominence of respect as (...) a value when considering the ethics of human research and provides practical advice for both researchers and Human Research Ethics Committee members in developing respectful research practices. (shrink)

The article we present aims to discuss the appropriateness of terms such as vulnerability and vulnerable pregnancy in medical practice, as well as the attempt to recognize the specific contribution of bioethics in this discussion. Starting from a historical trajectory of the concept of vulnerability, the current confusing situation of the use of the category of vulnerable pregnancy is exposed. Finally, the relevance of the notion of vulnerability in the understanding of clinical practice from medical anthropology is acknowledged, and more (...) rigorous interdisciplinary research is encouraged. (shrink)

In October 2005, UNESCO (the United Nations Educational, Scientific and Cultural Organization) adopted the Universal Declaration on Bioethics and Human Rights. This was the culmination of nearly 2 years of deliberations and negotiations. As a non-binding instrument, the declaration must be incorporated by UNESCO’s member states into their national laws, regulations or policies in order to take effect. Based on documentary evidence and data from interviews, this paper compares the declaration’s universal principles with national bioethics guidelines and practice in Kenya (...) and South Africa. It concentrates on areas of particular relevance to developing countries, such as protection of vulnerable persons and social responsibility. The comparison demonstrates the need for universal principles to be contextualised before they can be applied in a meaningful sense at national level. The paper also assesses the ‘added value’ of the declaration in terms of biomedical research ethics, given that there are already well-established international instruments on bioethics, namely the World Medical Association Declaration of Helsinki and the CIOMS (Council for International Organizations of Medical Sciences) guidelines on biomedical research. It may be that the added value lies as much in the follow-up capacity building activities being initiated by UNESCO as in the document itself. (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)

A collaborative team of environmental sociologists, community psychologists, religious studies scholars, environmental studies/science researchers and engineers has been working together to design and implement new training in research ethics, culture and community-based approaches for place-based communities and cultural groups. The training is designed for short and semester-long graduate courses at several universities in the northeastern US. The team received a 3 year grant from the US National Science Foundation’s Ethics Education in Science and Engineering in 2010. This manuscript details the (...) curriculum topics developed that incorporate ethical principles, particularly for group protections/benefits within the field practices of environmental/engineering researchers. (shrink)