The principle of respect for human dignity plays a crucial role in the emerging global norms relating to bioethics, in particular in the UNESCO Universal Declaration on Bioethics and Human Rights. This instrument, which is a legal, not merely an ethical document, can be regarded as an extension of international human rights law into the field of biomedicine. Although the Declaration does not explicitly define human dignity, it would be a mistake to see the emphasis put on this notion as (...) a mere rhetorical strategy. Rather, the appeal to dignity reflects a real concern about the need to promote respect both for the intrinsic worth of human beings and for the integrity of the human species. But dignity alone cannot solve most of the dilemmas posed by biomedical practice. This is why international biolaw combines, on the one hand, the appeal to human dignity as an overarching principle with, on the other hand, the recourse to human rights, which provide an effective and practical way forward for dealing with bioethical issues at a global level. (shrink)

The Borg are always confident that humans will be assimilated into their collective hive and therefore that, as they say, “resistance is futile.” In Star Trek, of course, the humans always successfully resist. Elizabeth Fenton and John Arras, like the Borg, resist the idea that humans are uniquely special as well as the utility of the human rights framework for global bioethics. I believe their resistance to human rights is futile, and I explain why in this essay. Let me begin (...) with their subtitle, because we do seem to agree that popular culture is a powerful aid to understanding human actions and motivations. (shrink)

This article summarizes some of the results of the BIOMED II project “Basic Ethical Principles in European Bioethics and Biolaw” connected to a research project of the Danish Research Councils “Bioethics and Law”. The BIOMED project was based on cooperation between 22 partners in most EU countries. The aim of the project was to identify the ethical principles of respect for autonomy, dignity, integrity and vulnerability as four important ideas or values for a European bioethics and biolaw. The research concluded (...) that the basic ethical principles cannot be understood as universal everlasting ideas or transcendental truths but they rather function reflective guidelines and important values in European culture. The method of the research was conceptual, philosophical analysis of the cultural background of the four values or normative ideas that people use and find important in their existence. Moreover, this was combined with analysis of empirical legal material and policy documents. Also, a number of qualitative interviews with relevant experts were carried out. Another important result of the BIOMED project was the partner's Policy Proposals to the European Commission, the Barcelona Declaration, unique as a philosophical and political agreement between experts in bioethics and biolaw from many different countries. The Policy Proposals are reprinted here at the end of the article. (shrink)

The field of bioethics is replete with applications of moral theories such as utilitarianism and Kantianism. For a given dilemma, even if it is not clear how one of these western philosophical principles of right (and wrong) action would resolve it, one can identify many of the considerations that each would conclude is relevant. The field is, in contrast, largely unaware of an African account of what all right (and wrong) actions have in common and of the sorts of factors (...) that for it are germane to developing a sound response to a given bioethical problem. My aim is to help rectify this deficiency by first spelling out a moral theory grounded in the mores of many sub-Saharan peoples, and then applying it to some major bioethical issues, namely, the point of medical treatment, free and informed consent, standards of care and animal experimentation. For each of these four issues, I compare and contrast the implications of the African moral theory with utilitarianism and Kantianism, my overall purposes being to highlight respects in which the African moral theory is distinct and to demonstrate that the field should take it at least as seriously as it does the Western theories. (shrink)

Despite broad agreement that the vulnerable have a claim to special protection, defining vulnerable persons or populations has proved more difficult than we would like. This is a theoretical as well as a practical problem, as it hinders both convincing justifications for this claim and the practical application of required protections. In this paper, I review consent-based, harm-based, and comprehensive definitions of vulnerability in healthcare and research with human subjects. Although current definitions are subject to critique, their underlying assumptions may (...) be complementary. I propose that we should define vulnerability in research and healthcare as an identifiably increased likelihood of incurring additional or greater wrong. In order to identify the vulnerable, as well as the type of protection that they need, this definition requires that we start from the sorts of wrongs likely to occur and from identifiable increments in the likelihood, or to the likely degree, that these wrongs will occur. It is limited but appropriately so, as it only applies to special protection, not to any protection to which we have a valid claim. Using this definition would clarify that the normative force of claims for special protection does not rest with vulnerability itself, but with pre-existing claims when these are more likely to be denied. Such a clarification could help those who carry responsibility for the protection of vulnerable populations, such as Institutional Review Boards, to define the sort of protection required in a more targeted and effective manner. (shrink)

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in (...) the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges. (shrink)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

Concern for human vulnerability seems to be at the heart of bioethical inquiry, but the concept of vulnerability is under-theorized in the bioethical literature. The aim of this article is to show why bioethics needs an adequately theorized and nuanced conception of vulnerability. We first review approaches to vulnerability in research ethics and public health ethics, and show that the bioethical literature associates vulnerability with risk of harm and exploitation, and limited capacity for autonomy. We identify some of the challenges (...) emerging from this literature: in particular, how to reconcile universal human vulnerability with a context-sensitive analysis of specific kinds and sources of vulnerability; and how to reconcile obligations to protect vulnerable persons with obligations to respect autonomy. We then briefly survey some of the theoretical resources available within the philosophical literature to address these challenges, and to assist in understanding the conceptual connections between vulnerability and related concepts such as harm, exploitation, needs, and autonomy. We also sketch out a taxonomy of sources and kinds of vulnerability. Finally, we consider the implications for policy evaluation of making vulnerability an explicit and central focus of bioethics. Our investigation is in the form of a broad survey motivating a research agenda rather than a detailed analysis. (shrink)

The so-called European principles of bioethicsare a welcome enrichment of principlistbioethics. Nevertheless, vulnerability, dignityand integrity can perhaps be moreaccurately understood as anthropologicaldescriptions of the human condition. Theymay inspire a normative language, but they donot contain it primarily lest a naturalisticfallacy be committed. These anthropologicalfeatures strongly suggest the need todevelop deontic arguments in support of theprotection such essential attributes ofhumanity require. Protection is to beuniversalized, since all human beings sharevulnerability, integrity and dignity, thusfundamenting a mandate requiring justice andrespect for fundamental human (...) rights.Being a feature of all humanity, vulnerabilityis improperly extended to designatedestitute individuals and populations. Rather,they are in a state of fallen vulnerability,for they already are harmed in some way, andhave become deprived of their range ofcapabilities. These individuals are destituteand are no longer in command of theirfundamental human rights. They have lost thestatus of unharmed vulnerability;identifying them as susceptible – vulnerated andno longer only vulnerable – stresses thepoint that bioethics demands specific socialaction to palliate or remove their distress.When harm does occur – in the form of disease,for example –, individuals are no longervulnerable – for they have ceased to be intact–, they become susceptible to additionaldeprivations and sickness; integrity isdemeaned and dignity is offended, leading tostates of dysfunction that require specificremedial social practices, aimed at treatingand removing injuries.The main point this paper addresses is thatvulnerability – as well as dignity and integrity – are descriptive characteristics ofhuman beings qua humans, which are not normative in themselves, but fundamental enoughto inspire bioethical requirements of protection and respect for human rights in thewake of social justice. A clear distinction must be made in regard to human beings who areinjured by poverty, sickness, discriminating deprivations or suffer otherdestitutions, having ceased to be only vulnerable for they are no longer intact. Theseindividuals and populations require more than protection, their needs must be met byspecific care and remedial measures to be identified and instigated by bioethics quaapplied ethics. (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)

Within the latter half of the 30-year history of bioethics there has been an increasing pressure to address bioethical issues globally. Bioethics is not traditionally a theory-based enterprise, rather the focus has been problem related. With the introduction of the global perspective, theory has, however, become more important. One of the best known, probably the best known, theory of bioethics is the one presented by Tom L. Beauchamp and James F. Childress in their PrinciplesofBiomedicalEthics in 1979. This theory is known (...) as the or the approach or It is the attempt to create a global framework for bioethics on the four principlesthat I will scrutinize in this paper. (shrink)

Because of cultural differences between East and West, any attempt at outright adaptation of Western ideas in Asia will undoubtly encounter problems, if not rejection. Transferring an idea from one place to another is just like transplanting an organ from a donor to a recipient—rejection is to be expected. Human cultures respond to new ideas from different value systems in very much the same way.Recently, biomedical ethics has received much attention in Asia. Fundamental advances in medicine have motivated medical scientists (...) to look at the ethical issues arising from this progress. Will the principles upheld by the bioethicists in the West meet the challenge in Asia? This article argues that Asian bioethicists must develop a bioethics responding to their own cultural contexts. If Western principles are adopted, then they must be re-interpreted and even modified, if necessary, in light of Asian beliefs. (shrink)

Imagine you are walking down a city street. It is windy and raining. Amidst the bustle you see a young woman. She sits under a railway bridge, hardly protected from the rain and holds a woolen hat containing a small number of coins. You can see that she trembles from the cold. Or imagine seeing an old woman walking in the street at dusk, clutching her bag with one hand and a walking stick with the other. A group of male (...) youths walk behind her without overtaking, drunk and in the mood for mischief. It doesn't need an academic to say what vulnerability is. We can all see it, much more often than we care to. (shrink)

As we look to the future in a world with porous borders and boundaries transgressed by technologies, an inevitable question is:Can there be a single, global bioethics? Intimately intertwined with this question is a second one: How might a global bioethics account for profound - and constantly transforming - sources of cultural difference? Can a uniform, global bioethics be relevant cross-culturally? These are not simple questions, rather, a multi-dimensional answer is required. It is important to distinguish between two meanings of (...) bioethics: the academic discipline of bioethics as opposed to bioethics as a set of practices governing clinical care and scientific research. There is growing evidence to support the notion of a shared global understanding of bioethics as a field of inquiry focused on the moral dimensions of science and biomedicine. (shrink)

In exploring the concept of vulnerability, we do not begin with a blank slate. In research involving human subjects, ethics guidelines typically provide a rough definition of the concept. For example, the commentary on Guideline 13 in the International Ethical Guidelines for Biomedical Research Involving Human Subjects, issued by the Council for International Organizations of Medical Sciences (CIOMS), says that "vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. More formally, they may have insufficient (...) power, intelligence, education, resources, strength, or other needed attributes to protect their own interests" (CIOMS 2002). Because the CIOMS guidelines .. (shrink)

The academic literature in research ethics has been marked in the past decade by a much broader focus on the need for the protection of developing communities subjected to international clinical trials. Because of the proximity of the revision of the Declaration of Helsinki, completed in October 2008, most papers have addressed the issue of a double standard of care following the use of placebo. However, other no less important issues, such as interactions between the lifestyles structures of low-income communities (...) and the efficiency of risk-minimising procedures also deserve attention. The purpose of this paper is to discuss forms of uncertainty involved in clinical trials in poor and low-income countries that are not addressed by conventional methods of risk assessment. Furthermore, the increase in size of risks that are identified by conventional assessment methods will be addressed. Besides, the difficulty in properly applying risk-minimising procedures will be discussed. Finally, this paper proposes the involvement of research ethics committees in the risk evaluation process and the establishment of national ethics evaluation systems. (shrink)

Is there an Asian Bioethics? Some people might consider it blasphemous even to ask this question. But this paper asks it not so much to seek an answer as to clarify what it could actually mean. The idea is to sort out the presuppositions and possible implications of asserting the existence of an Asian bioethics. In the end, this paper makes the following points: (1) In the attempt to assert an Asian identity, one must be careful not to commit the (...) mistake of universalizing (among Asians) a single Asian perspective; and (2) In the face of pluralism and multi‐culturalism, there is some room for a kind of universalist ethics that is founded on a collage of culturally inspired perspectives rather than on a single standard of morality. (shrink)

Today Asia is attracting attention in the area of bioethics. In fact, the potential of bioethics is beginning to be discussed seriously at academic centers across Asia. In Japan, this discussion began a decade ago with the publication The book is one of the principal explorations of biomedical ethics involving Japan to date. Tom Beauchamp, an author of one of the book's chapters, compares Japanese and American standards of informed consent and refutes relativistic positions, concluding that.

Is there an African bioethics? This paper addresses this question by first exploring the ongoing debate on the nature and status of African philosophy. It is argued that if African philosophy exists, then by extension an African bioethics must exist since bioethics is a sub-branch of philosophy. Further, a distinction is made between bioethics as a set of moral principles rooted in a people’s culture which should guide clinical care and scientific research and bioethics as a discipline in the university, (...) with a set of codes, standards, recognized practitioners and customs. It is argued that bioethics in the former sense has always existed in Africa but bioethics in the latter sense is a relatively new development in the continent. (shrink)