Over the last few decades an increasingly pressing social demand for access to assisted reproductive technologies (ART) has emerged. Alongside the use of reproductive technologies, relevant bioethical and biolegal issues arise, such as the claim of a “right” to have a child, the so-called “reproductive rights”, of the prospective parents and the rights of children. This paper explores these and further challenges, both old and new, calling for a transformation of parenthood and filiation, from the perspective of the different theories (...) of the contemporary pluralistic debate, with a descriptive and critical analysis of the recent Report on ART of the Unesco International Bioethics Committee, the first global document on these topics. (shrink)

The UNESCO International Bioethics Committee is an international body that sets standards in the field of bioethics. This collection represents the contributions of the IBC to global bioethics. The IBC is a body of 36 independent experts that follows progress in the life sciences and its applications in order to ensure respect for human dignity and freedom. Currently, some of the topics of the IBC contributions have been discussed in the bioethics literature, mostly (...) journal articles. However, this is a unique contribution by the scholars who developed these universal declarations and reports. The contributors have not only provided a scholarly up to date discussion of their research topics, but as members of the IBC they have also discussed specific practical challenges in the development of such international documents. This book will be suited to academics within bioethics, health care policy and international law. (shrink)

In the past decade UNESCO has pursued a leadership role in the articulation of general principles for bioethics, as well as an extensive campaign to promulgate these principles globally.1 Since UNESCO's General Conference adopted the Universal Declaration on Bioethics and Human Rights in 2005, UNESCO's Bioethics Section has worked with member states to develop a "bioethics infrastructure." UNESCO also provides an "Ethics Teacher Training Course" to member states and disseminates a "core curriculum," primarily targeting medical students. (...) The core curriculum orients itself by the Universal Declaration on Bioethics and Human Rights and aims to articulate a set of "bioethical principles" that provide a "common global . (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Negotiating International Bioethics: A Response to Tom Beauchamp and Ruth MacklinRobert Baker (bio)AbstractCan the bioethical theories that have served American bioethics so well, serve international bioethics as well? In two papers in the previous issue of the Kennedy Institute of Ethics Journal, I contend that the form of principlist fundamentalism endorsed by American bioethicists like Tom Beauchamp and Ruth Macklin will not play on (...) an international stage. Deploying techniques of postmodern scholarship, I argue that principlist fundamentalism justifies neither the condemnation of the Nazi doctors at Nuremberg, nor, as the Report of the Advisory Committee on the Human Radiation Experiments (ACHRE) demonstrates, condemnation of Cold War radiation researchers. Principlist fundamentalism thus appears to be philosophically bankrupt. In this issue of the Journal, Beauchamp and Macklin reject this claim, arguing that I have misread the ACHRE report and misunderstood Nazism. They also argue that the form of post-postmodern negotiated human rights theory that I proffer is adequate only insofar as it is itself really fundamentalist; insofar as I take postmodernism seriously, however, I mire international bioethics in relativism. In this response, I reaffirm my anti-fundamentalism, provide further evidence in support of my reading of the ACHRE report, and defend my post-postmodern version of rights theory. I also develop criteria for a minimally adequate theoretical framework for international bioethics.Universal Morality Reconsidered 1Paradoxically, the need for content-full universal moral principles tends to be most deeply felt and most adamantly asserted in the face of striking evidence of their absence. People are inspired to claim that Nazis must accept the universal principle that doing harm is wrong because they are appalled by the horror of the Holocaust. Yet the event itself provides palpable evidence that the Nazis saw no wrong in doing harm. One has the suspicion that claims of universalism [End Page 423] confound philosophical aspirations with empirical observations. This distinction makes a significant difference because empirical claims can be disconfirmed by data, whereas philosophical claims can only be challenged on the level of theory.I am, like Tom Beauchamp and James Childress, a common morality theorist. Thus, I believe, as they do, that ethics “relies heavily on ordinary shared moral beliefs for its content, rather than relying on pure reason, natural law, a special moral sense, and the like” (Beauchamp and Childress 1994, p. 100). For most of human history sexism and slavery were considered moral. They certainly were the norm. Thus, if one looks to common morality as the source of moral content, empirical claims of moral universalism appear suspect. Insofar as one would condemn sexism and slavery, one needs to find some theoretical justification for condemnation that goes beyond a consensus on moral content (hence my embrace of the structural analogue of human rights theory).Beauchamp, however, takes a very different view. He asserts in his critique of my position, that: “it is an institutional fact about the substance of morality (not merely [as Baker claims] the formal features of the concept of morality and not merely my view of it) that it contains fundamental and shared precepts. It is by appeal to this shared moral substance that persons are enabled to make justifiable cross-temporal and cross-cultural judgments” (Beauchamp 1998, p. 395). Beauchamp is thus claiming that it is both an empirical and a conceptual truth there is common core underlying the morality of all societies. He fleshes this claim out in another passage.[T]he term morality refers to norms about right and wrong human conduct that are so widely shared that they form a stable... communal consensus.... These standards sometimes vary from society to society, but embedded in the beliefs of all moral societies are the core dimensions of morality: Persons must keep their promises, must respect the rights of others, must not kill or cause harm to innocent persons, must not abuse children, and the like. All morally committed persons are comfortable with these norms and do not doubt their relevance and importance.(Beauchamp 1998, p. 394)Insofar as Beauchamp is making an empirical claim in this passage, the examples cited are problematic. “Promise keeping,” for example, cannot be a cultural universal because the practice is... (shrink)

During the last two decades, national bioethics committees have been established in many countries all over the world. They vary with respect to their structure, composition, and working methods, but the main functions are similar. They are supposed to facilitate public debate on controversial bioethical issues and produce opinions and recommendations that can help inform the public and policy‐makers. The dialogue among national bioethics committees is also increasingly important in the globalized world, where biomedical technologies raise ethical dilemmas (...) that traverse national borders. It is not surprising, therefore, that the committees are established and active in the technologically advanced countries. There have also been a few international capacity‐building initiatives in bioethics that have had a dual task: networking among existing national bioethics committees and helping establish such committees in those countries that still lack them. The problem is that, due to a lack of information, it is not clear what problems and challenges committees face in the transitioning societies often characterized as low‐ and middle‐income countries. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:A Theory of International Bioethics: Multiculturalism, Postmodernism, and the Bankruptcy of Fundamentalism 1Robert Baker (bio)AbstractThis first of two articles analyzing the justifiability of international bioethical codes and of cross-cultural moral judgments reviews “moral fundamentalism,” the theory that cross-cultural moral judgments and international bioethical codes are justified by certain “basic” or “fundamental” moral principles that are universally accepted in all cultures and eras. Initially propounded by (...) the judges at the 1947 Nuremberg Tribunal, moral fundamentalism has become the received justification of international bioethics, and of cross-temporal and cross-cultural moral judgments. Yet today we are said to live in a multicultural and postmodern world. This article assesses the challenges that multiculturalism and postmodernism pose to fundamentalism and concludes that these challenges render the position philosophically untenable, thereby undermining the received conception of the foundations of international bioethics. The second article, which follows, offers an alternative model—a model of negotiated moral order—as a viable justification for international bioethics and for transcultural and transtemporal moral judgments.Man in the Twentieth Century can not be circumscribed by the standards of any single culture.American Anthropological Association (1948) in a statement officially denouncing the 1948 United Nation’s Declaration of Human Rights.Recently... so-called “liberal” medicine has revived the old rights of a clinic understood in terms of a special contract, a tacit pact made between one man and another. This patient gaze has even been attributed the power of assuming [a role in clinical decision making].Miracles are not so easy to come by....Michel Foucault (1975, p. 5) [End Page 201]An Overview of the AnalysisInternational bioethics originated in the trauma of the Holocaust, specifically, in the 1946–1947 Nuremberg “Doctors Trial” when a tribunal of three American judges convicted Nazi medical researchers of “crimes against humanity.” In justifying their judgment, the Nuremberg Tribunal cited 10 principles for morally permissible research, which, they claimed, were based on “fundamental” principles that civilized societies “all agree” upon and accept as the foundations of their “moral, ethical, and legal” norms. Foremost among the principles was one stating that morally permissible human experiments require the informed voluntary consent of the subject. The Nuremberg judgment soon became associated with the ideal of human rights declared in the 1948 United Nations Charter. These two ideas—fundamental principles of morality and human rights—have been linked in all major formulations of international bioethics promulgated in the past 50 years, including the Council of Europe’s 1997 Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Biomedicine (Council of Europe 1997; Dommel and Alexander 1997). In this paper, I explore the received justification for international bioethics—the idea that it is grounded in fundamental principles accepted in all societies—tracing it from its initial, almost off-hand, promulgation by the Nuremberg Tribunal, through its more thoughtful development by such bioethicists as Ruth Macklin, to its more complex use by the President’s Advisory Committee on Human Radiation Experiments.After a brief review of the evolution of the received justification, I discuss the viability of this justification in the face of the critique implicit in two important intellectual movements: multiculturalism and postmodernism. In the international context, multiculturalism asserts the claim that there are no common moral principles shared by all cultures. Postmodernism asserts a similar claim against all universal standards, moral and nonmoral. In the 1990s, bioethicists have attempted to respond to these claims in various ways. These responses are documented, analyzed, and then shown to be “bankrupt,” in the sense that they undercut the most important objective of moral fundamentalism: the justification of transcultural moral judgments, such as the condemnation of the Nazi doctors.A second article, which follows the present one in the same issue of the Kennedy Institute of Ethics Journal, revisits the contractarian tradition [End Page 202] of Hobbes and Locke, as it has been reinterpreted by David Gauthier (1986), John Rawls (1971, 1993), and Robert Nozick (1974), to develop the idea of negotiated moral order as the basis of international bioethics. When conceptualized as a negotiated moral order, international bioethics can accept the genuine insights... (shrink)

Bioethical and bio‐political questions are increasingly tackled by committees, councils, and other advisory boards that work on different and often interrelated levels. Research ethics committees work on an institutional or clinical level; local advisory boards deal with biomedical topics on the level of particular political regions; national and international political advisory boards try to answer questions about morally problematic political decisions in medical research and practice. In accordance with the increasing number and importance of committees, the quality of their (...) work and their functional status are being subjected to more and more scrutiny. Besides overall criticism regarding the quality of their work, particular committees giving political advice are often suspected of being incompatible with democratic values, such as respect for affected parties, representation of diverse values and transparency in the decision‐making processes. Based on the example of the German National Ethics Council, whose inauguration caused a still ongoing debate on the aims and scopes of committees in general, this paper discusses: (1) the requirements of modern democratic societies in dealing with complex scientific‐technical problems; (2) the composition and organisation of committees working as political advisory boards; and (3) the appointment procedures and roles of laymen and experts, and here in particular of ethicists, who may legitimately be taken on by a committee. I will argue that bioethics committees do not necessarily endanger democratic values, but can considerably improve their realisation in democratic decision‐making procedures – if, and only if, they do not act as substitutes for parliamentarian processes, but help prepare parliamentarian processes to be organised as rationally as possible. (shrink)

Human Biological Materials are an invaluable resource in biomedical research. Objective To determine if researchers and a Research Ethics Committee at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Study Design Ethically approved retrospective cross-sectional descriptive audit. Results Of the 1305 protocols audited, 151 fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors were from the USA . The principle investigators in all 151 protocols informed the (...) REC of their intent to store HBMs. Only 132 protocols informed research participants . In 148 protocols informed consent was obtained from research participants, 116 protocols solicited broad consent compared to specific consent [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC than the research participants that HBMs would be exported . Export permits and Material Transfer Agreements were not available in 109 and 143 protocols, respectively. Conclusions Researchers and the REC did not adequately address the inter-related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)

Human Biological Materials (HBMs) are an invaluable resource in biomedical research.ObjectiveTo determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries.Study DesignEthically approved retrospective cross‐sectional descriptive audit.ResultsOf the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols informed (...) the REC of their intent to store HBMs. Only 132 protocols informed research participants (P < 0.0001). In 148 protocols informed consent (IC) was obtained from research participants, 116 protocols (76.8%) solicited broad consent compared to specific consent (32; 21.2%) [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC (90) than the research participants (67) that HBMs would be exported (p = 0.011). Export permits (EPs) and Material Transfer Agreements (MTAs) were not available in 109 and 143 protocols, respectively.ConclusionsResearchers and the REC did not adequately address the inter‐related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)

This book, based on the Round Table on Bioethics and Women held at UNESCO during the Fourth Session of the International Bioethics Committee (IBC), presents the ...

The following article analyzes the process of conception, elaboration, and adoption of the Universal Declaration of Bioethics and Human Rights, and reflects on the lessons it might hold for public bioethics on the international level. The author was involved in the process at a variety of levels: he provided advice to the IBC on behalf of the President's Council of Bioethics; he served as the U.S. representative to UNESCO's Intergovernmental Bioethics Committee; and led the (...) U.S. Delegation in the multilateral negotiation of Government experts that culminated in the adoption of the declaration in its final form. The author is currently serving a 4-year term as a member of UNESCO's International Bioethics Committee. (shrink)

The Universal Declaration on Bioethics and Human Rights adopted by the United Nations Educational, Scientific, and Cultural Organisation on 19 October 2005 is an important step in the search for global minimum standards in biomedical research and clinical practice. As a member of UNESCO International Bioethics Committee, I participated in the drafting of this document. Drawing on this experience, the principal features of the Declaration are outlined, before responding to two general charges that have been levelled (...) at UNESCO’s bioethical activities and at this particular document, are outlined. One criticism is to the effect that UNESCO is exceeding its mandate by drafting such bioethical instruments—in particular, the charge is that it is trespassing on a topic that lies in the responsibility of the World Health Organization. The second criticism is that UNESCO’s reliance on international human rights norms is inappropriate. (shrink)

Implementation of existing ethical guidelines for international collaborative medical and health research is still largely controversial in sub-Saharan Africa for two major reasons: One, they are seen as foreign and allegedly inconsistent with what has been described as an ‘African worldview’, hence, demand for their strict implementations reeks of ‘bioethical imperialism’. Two, they have other discernible inadequacies – lack of sufficient detail, apparent as well as real ambiguities, vagueness and contradictions. Similar charges exist(ed) in other non-Western societies. Consequently, these (...) guidelines have been correctly judged as an inadequate response to the complex and ever shifting dilemmas met by researchers and research regulators in the field. This paper proposes a framework for effective implementation of existing guidelines without much worry about bioethical imperialism and other inadequacies. This framework is proposed using an analogy of Legal Realism, specifically its key assertions on how, in reality, judicial systems operate using general legal rules to settle specific cases. Legal realists assert that in judicial decision-making, general legal rules do not totally dictate court decisions in specific cases. This analogy is used to coin a new term, ‘Bioethical Realism.’ The framework suggests that local Research Ethics Committees ought to be construed as analogues of judicial courts with the resulting implications. Consequently, just like legal rules are general rules that do not always dictate court decisions, similarly international bioethical guidelines are general ethical rules that should not always dictate local RECs’ decisions and such decisions (ought to) enjoy considerable immunity from outsiders. (shrink)

With the advance of biomedicine, certain individuals and groups are vulnerable because of their incapacities to defend themselves. The International Bioethics Committee as a UNESCO working group has for the last several years dedicated to deepen this principle of human vulnerability and personal integrity. This book serves to supplement this effort with a religious perspective given a great number of the world's population is affiliated with some religious traditions. While there is diversity within each of these traditions, (...) all of them carry in them the mission to protect the weak, the underprivileged, and the poor. Thus, here presented is a collection of papers written by bioethics experts from six major world religions-Buddhism, Christianity, Confucianism, Hinduism, Islam, and Judaism-who were gathered to discuss the meaning and implications of the principle of vulnerability in their respective traditions. (shrink)

Historically, the preconditions for the emergence of bioethics in China. were political reforms and their applications. The Hanzhong Euthanasia Case and the publication of Qiu Ren-zong's academic work Bioethics played a significant role in the development of bioethics in China. Other contributory factors include the establishment of the Chinese Society of Medical Ethics/Chinese Medical Association (C.M.A), the publication of the Journal of Chinese Medical Ethics, and the teaching and education of bioethics in China. Major achievements of (...) bioethics in China include the establishment of ethics committee and ethics review system, active international communication and cooperation among the academic circles, and the successful management of the 8th World Congress of Bioethics in Beijing in 2006. Chinese bioethics focus on native Chinese realities and conditions, absorb the international research achievements in relevant fields, and combine international ideas with traditional Chinese doctrines. Admittedly, there are still some aspects to be improved, yet bioethics has attracted a lot of attention from the core leadership in China and has gained sound financial support, which augers well for its further development. This article also briefly introduces the development of bioethics in Hong Kong and Taiwan, China. (shrink)

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

A central question of this chapter is how we can relate the unique ethos of Japan to the ways that influences of international bioethics, civil rights and legal reforms have shifted medical research in Japan from the legacy of the structured paternalism and impunity that allowed abuses to be committed by medical researchers in the World War II era, including in Unit 731 and in medical schools in Japan, to contemporary research agendas and policies. Throughout the twentieth century, (...) Japan has been a centre of research and innovation. The pro-technology attitudes still exist in current Japan, with the evolution of bioethics. Although we can trace the origins of bioethics in Japan back through millennia, with the Ainu indigenous practices and relationships to nature, the sophisticated hierarchical relationships expressed in the seventh century A.D. book the Kojiki, the conversion of forest to rice paddies, emergence of an integrated religious system including Shintoism and Buddhism, and the sophisticated class system supported by linguistics and social relationships, this chapter would argue that one of the most influential influence for this question is the Samurai tradition. This tradition values both autonomy and informed choice, while also allowing the legacy of tolerance of the elite classes to make decisions that may sacrifice some persons for the greater good. While principles of solidarity and social justice are a solid basis for universal health insurance they also allow sacrifices when necessary. Informed consent is now widely accepted, and bioethics is part of a transition which is transforming Japanese society from a paternalistic society to an individualistic one. Among the issues that will be used to illustrate the situation, are the functioning of research ethics committees, large gene bank and epidemiological projects, organ transplantation, truth telling, euthanasia and the public health measures such as mask wearing in the current COIVD-19 pandemic. (shrink)

Today local, national and international ethics committees have become an effective means of social regulation in many European countries. Science itself is an important precondition for the development of bioethical knowledge and ethics expertise. Cultural, social, historical and religious preconditions can facilitate different forms and methods of ethics expertise in each country. Ukrainian ethics expertise has some methodological problems connected with its socio-cultural, historical, science and philosophy development particularities. In this context, clarification of some common legitimacies or methodological approaches (...) to ethics committee (EC) phenomena such as globalization, scientization and the prioritization of an ethics paradigm are very important. On the other hand, elaborate study and critical analysis of international experience by Ukraine and other Eastern European countries will provide the integration of their local and national ethics expertises into a world bioethics ethos. (shrink)

ABSTRACT Objective: To identify perceived barriers to capacity building for local research ethics oversight in El Salvador, and to set an agenda for international collaborative capacity building. Methods: Focus groups were formed in El Salvador which included 17 local clinical investigators and members of newly formed research ethics committees. Information about the proposed research was presented to participants during an international bioethics colloquium sponsored and organized by the St. Jude Children's Research Hospital in collaboration with the National (...) Ethics Committee of El Salvador and the University of El Salvador. Interviews with the focus group participants were qualitatively analyzed. Results: Participants expressed the need to tailor the informed consent process and documentation to the local culture; for example, allowing family members to participate in decision‐making, and employing shorter consent forms. Participants indicated that economic barriers often impede efforts in local capacity building. Participants valued international collaboration for mutual capacity building in research ethics oversight. Conclusions: Research ethics committees in El Salvador possess a basic knowledge of locally relevant ethical principles, though they need more training to optimize the application of bioethical principles and models to their particular contexts. Challenges increase the value of collaborative exchanges with ethics committee members in the United States. Further research on facilitating communication between host country and sponsor country ethics committees can maximize local research ethics expertise, and thus raise the standard of protecting human participants involved in international research. (shrink)

This paper problematises the ethics of genetic modification (GM) in sport by outlining the perspectives of four organisations which have recently spent time considering the subject: the International Olympic Committee, the World Anti-Doping Agency, the United States President’s Council on Bioethics, and the Australian Law Reforms Commission. The paper outlines scientific developments in genetic research, which might make realisable the genetic engineering of athletes. Subsequently, an overview of the varied perspectives of the four organisations is given, by (...) articulating the moral discourses which is present through each. Various arguments are recognised as having importance in reaching a conclusion about whether GM in sport should be legal or not. In particular, these arguments comprise concerns about safety, fairness, and moral character. It is suggested that reflective bioethical investigations can assist the development of a coherent ethical policy about genetics in sport, by informing sports ethics with a rich basis of literature dealing with such central concepts as personhood, autonomy, and humanness. In conclusion, it is argued that sport ought not approach GM in a comparable manner to how it has approached doping, as GM entails a much wider breadth of ethical implications, often unrelated to sport. (shrink)

Background Clinical Ethics Committees are well established at healthcare institutions in resource-rich countries. However, there is limited information on established CECs in resource poor countries, especially in Africa. This study aimed to establish baseline data regarding existing formal CECs in Africa to raise awareness of and to encourage the establishment of CECs or Clinical Ethics Consultation Services on the continent. Methods A descriptive study was undertaken using an online questionnaire via SunSurveys to survey healthcare professionals and bioethicists in Africa. Data (...) were subjected to descriptive analysis and Fischer's exact test was applied to determine associations. Texts from the open-ended questions were thematically analysed. Results In total 109 participants from 37 African countries completed the survey in December 2019. A significant association was found between participants’ bioethics qualification or training and involvement in clinical ethics. All participants were familiar with Research Ethics Committees, and initially conflated RECs with CECs. When CECs were explained in detail, approximately 85.3% reported that they had no formal CECs in their institutions. The constraints to developing CECs included lack of training, limited resources, and lack of awareness of CECs. However, the majority of participants were interested in establishing CECs. Participants listed assistance required in establishing CECs including funding, resources, capacity building and collaboration with other known CECs. The results do not reflect CECs established since the onset of COVID-19 in Africa. Conclusions This study provides a first look into CECs in Africa and found very few formal CECs on the continent indicating an urgent need for the establishment of CECs or CESs in Africa. While the majority of healthcare professionals and bioethicists are aware of ethical dilemmas in healthcare, the concept of formal CECs is foreign. This study served to raise awareness of CECs. Research ethics and RECs overshadow CECs in Africa because international funders from the global north support capacity development in research ethics and establish RECs to approve the research they fund in Africa. Raising awareness via educational opportunities, research and conferences about CECs and their role in improving the quality of health care in Africa is sorely needed. (shrink)

The involvement of developing countries in international clinical trials is necessary for the development of appropriate medicines for local populations. However, the absence of appropriate structures for ethical review represents a barrier for certain countries. Currently there is very little information available on existing structures dedicated to ethics in western and central Africa. This article briefly describes historical milestones in the development of networks dedicated to capacity building in ethical review in these regions and outlines the major conclusions of (...) two workshops on this issue, which were held in September and October 2002 in Libreville, Gabon, and Paris, France. The workshops were the culmination of collaboration between the African Malaria Network Trust (AMANET) and the Pan African Bioethics Initiative (PABIN). They produced an update on ethics organizations with regard to mission, function, activities, members, and contact people, in eight countries within the regions discussed. As a result of the commitment of mandated delegates, a further prominent outcome followed these workshops: the creation of national structures, where none existed before, dedicated to the ethical review of clinical trials. (shrink)

Abstract Gender and Ethics Committees: Where’s the Different Voice? -/- Prominent international and national ethics commissions such as the UNESCO Bioethics Commission rarely achieve anything remotely resembling gender equality, although local research and clinical ethics committees are somewhat more egalitarian. Under-representation of women is particularly troubling when the subject matter of modern bioethics so disproportionately concerns women’s bodies, and when such committees claim to derive ‘universal’ standards. Are women missing from many ethics committees because of relatively straightforward, (...) if discriminatory, demographic factors? Or are the methods of analysis and styles of ethics to which these bodies are committed somehow ‘anti-female’? It has been argued, for example, that there is a ‘different voice’ in ethical reasoning, not confined to women but more representative of female experience. Similarly, some feminist writers, such as Evelyn Fox Keller and Donna Haraway, have asked difficult epistemological questions about the dominant ‘masculine paradigm’ in science. Perhaps the dominant paradigm in ethics committee deliberation is similarly gendered? This article provides a preliminary survey of women’s representation on ethics committees in Eastern and Western Europe, a critical analysis of the supposed ‘masculinism’ of the principlist approach, and a case example in which a ‘different voice’ did indeed make a difference. (shrink)

The coming of bioethics to Singapore / W. Calvin Ho and Sylvia S.N. Lim -- The impact of the bioethics advisory committee on the research community in Singapore / Charmaine K.M. Chan and Edison T. Liu -- Engaging the public : the role of the media / Chang Ai-Lien and Judith Tan -- Confucian trust and the biomedical regulatory framework in Singapore / Anh Tuan Nuyen -- The clinician-researcher : a servant of two masters? / Alastair V. (...) Campbell, Jacqueline Chin, and Teck Chuan Voo -- The US model for oversight of human stem cell research / Lindsay Parham and Bernard Lo -- Genetics and stem cell research : models of international policy-making / Bartha Maria Knoppers, Emily Kirby and Rosario Isasi -- Public engagement and bioethics commissions / Thomas H. Murray and Ross S. White -- Norm-making on human-animal chimeras and hybrids in Singapore, the United Kingdom and the international domain / W. Calvin Ho and Martin Bobrow -- How will future bioethical issues engage Singapore? / John Elliott. (shrink)

International transfers of human biological material (biospecimens) and data are increasing, and commentators are starting to raise concerns about how donor wishes are protected in such circumstances. These exchanges are generally made under contractual material transfer agreements (MTAs). This paper asks what role, if any, should research ethics committees (RECs) play in ensuring legal and ethical conduct in such exchanges. It is recommended that RECs should play a more active role in the future development of best practice MTAs involving (...) exchange of biospecimens and data and in monitoring compliance. (shrink)

The Handbook of Bioethical Decisions Volume II addresses and analyzes the most important ethical concerns and moral quandaries related to scientific integrity and institutional ethics. It counts on two parts, Part One: Research Ethics, which addresses issues related to Scientific Integrity, Research Misconduct and Conducting Ethical Research, and Part Two: Institutional Ethics and Bioethics Committees, which explores Institutional Ethics issues, Ethics and Bioethics Committees’ roles and scopes, and Bioethical Issues in Institutional Ethics. Consequently, the Handbook, Vol. II, offers (...) a remarkable collection of works by outstanding international experts on institutional and research ethics, in order for bioethics practitioners to obtain better elements to address key issues related to integrity in research as well as to decision-making processes. In this fashion, this volume is a valuable resource for professionals working on different bioethical and biomedical fields, such as, ethics and bioethics committees, health care institutions, biomedical and pharmacological companies, and academic settings, among others. Chapter 26 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com. (shrink)

Guidelines for Institutional Review Boards (IRBs) or research ethics committees exist at national and international levels. These guidelines are based on ethical principles and establish an internationally acceptable standard for the review and conduct of medical research. Having attained a multinational consensus about what these fundamental guidelines should be, IRBs are left to interpret the guidelines and devise their own means of implementing them. Individual and community values bear on the interpretation of the guidelines so different IRBs attain different (...) levels of effectiveness. In the Caribbean and Pan American regions there are few IRBs. Obstacles to the establishment and function of IRBs are exacerbated in developing regions like these by differences in language, literacy, and local value systems; education, administrative expertise, facilities, and access to information are also limited. A regional IRB network might facilitate more uniform ethical review in developing countries, and simplify IRB procedures. (shrink)

The purpose of this article is to provide a short overview of the condition of clinical ethics committees (CECs) and other forms of the so-called "ethics support" infrastructure. This includes but is not limited to CECs because some countries also have ethics consultation services that function independently from the CECs. It seems that properly structured CECs and other types of ethics support have a potential to act as facilitators of ethically sensitive healthcare decision-making. This goal can be achieved if the (...) ethics support infrastructure becomes an integral part of the healthcare institution where the majority of ethical dilemmas and the need for ethical debate arise. At the same time, CECs can become a useful tool for implementing bioethical standards developed at both national and international levels, including those established by the Council of Europe instruments. This is the main reason why the issue of developing clinical ethics support services might be very important for the Steering Committee on Bioethics (CDBI) of the Council of Europe. More specifically, the question is what special role ethics support services can play in the context of the follow up to the Council of Europe Symposium in the decision-making process regarding medical treatment in end-of-life situations (Strasbourg, 30 November-1 December). Very often, cases to be considered by the CECs and ethics consultants deal with the difficult end-of-life treatment choices. (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)

In lieu of an abstract, here is a brief excerpt of the content:Another Bioethics Commission?Renie Schapiro (bio)Ever Since the Ill-Fated Biomedical Ethics Advisory Committee (BEAC) ended almost before it began a few years ago, bioethicists and the members of Congress who take an interest in them have wondered whether a governmental commission is still a feasible way to address bioethics issues.The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the 1970s, and (...) the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research in the early 1980s, have generally received high marks for their work. But since the expiration of the President's Commission in 1983, no federal body has been able to sustain the momentum.Tempers around the abortion issue couldn't be tamed enough even to elect a board chairman for the BEAC, or for the body to begin studying the issues. From its inception, abortion politics threatened to dog its work.Both the National Commission and the President's Commission studied issues touching on the abortion question. The President's Commission reported on genetic screening. The National Commission looked at fetal research. Both were able to produce respected reports that largely steered clear of the abortion acrimony.But that was then. The question facing policy makers inside the Beltway is how we can learn from the past experiences to make some new body work now. The question extends far beyond the abortion issue, of course.When certain people in Washington start asking questions, the answer usually comes by way of a study. Sometimes, as in this case, more than one study.In the March 1992 issue, this Journal reported on an Institute of Medicine study on ethics commissions. That study is still underway. It is scheduled to be completed in January 1994.More recently, the Office of Technology Assessment (OTA), an arm of Congress, also took on the issue. The OTA project is intended to be a quicker, more confined study. It began last fall and a final report is expected later this month.The primary force behind the OTA study is Senator Mark Hatfield. In a September 8, 1992 letter, co-signed by Senators Edward Kennedy and Dennis DeConcini, he asked OTA to prepare a background report to assist Congress in [End Page 77] "determining what is the best approach to explaining policy problems with biomedical and ethical dimensions."The letter noted: "As the 21st Century approaches, Congress will face policy dilemmas for which an informed decision can only be made through understanding not just the legal or economic dimensions of the questions, but the ethical considerations as well."Hatfield's interest in bioethics issues over the past few years has centered largely on biotechnology, and particularly patent rights. He had planned to introduce legislation to put a moratorium on patenting of genetically altered organisms, which according to Hatfield staffer Douglas Pahl caused a "firestorm" in the biotechnology community.As a result, Kennedy and DeConcini said they would hold hearings on the issue if Hatfield would withdraw the amendment. The three agreed to request a short-term OTA report on possible governmental structures for dealing with bioethics issues and a longer report looking at patenting issues.In their letter, the three senators asked OTA to prepare a history of bioethics in public policy. Referring specifically to the past commissions, they asked, "What lessons can we learn from each of these—or similar—entities? What worked, or did not work, and why?" The request also asked OTA to examine international institutions.In response to the request, OTA held a workshop entitled "Biomedical Ethics in U.S. Public Policy" on December 4, 1992. It brought together 15 people who had participated in commissions—from local to international—as well as observers of these bodies and health professionals who used their products.1According to project director Robyn Nishimi, the workshop was meant to be a free-wheeling discussion. Although there was no total consensus, the focus of the discussion tended to be on how to make a commission function effectively, rather than on whether there should be one. That workshop will be part of a report of about 40-60 pages OTA hopes to... (shrink)

Governments have used several mechanisms to deal with intractable policy conflicts about issues in bioethics. One mechanism is the installment of an ethics committee and another one is the organization of public debates. Often, ethics committees have an implicit or explicit role in the stimulation of such public debate. However, this role is not self-evident and we therefore analyse the relation between committees and public debate. What should the function of biotechnology ethics committees be, how does this relate (...) to their composition, and to what extent are these functions met in practice? To this end, we have examined the three national committees of the Netherlands, Switzerland, and Australia in the field of animal and plant biotechnology. We argue that there is often a mismatchbetween the goals one wants to reach by stimulating public debate and the way this has been given shape, partly through ethics committees. In fact, installing (biotechnology) ethics committees is to a certain extent a premature move that contains rather than stimulates public debate. (shrink)

BackgroundThis study aims to quantitatively and qualitatively evaluate the activities of a Bioethics Unit (BU) 5 years since its implementation (2016–2020). The BU is a research unit providing empirical research on ethical issues related to clinical practice, clinical ethics consultation, and ethical education for health care professionals (HPS).MethodsWe performed an explanatory, sequential, mixed-method, observational study, using the subsequent qualitative data to explain the initial quantitative findings. Quantitative data were collected from an internal database and analyzed by descriptive analysis. Qualitative (...) evaluation was performed by semi-structured interviews with 18 HPs who were differently involved in the BU’s activities and analyzed by framework analysis.ResultsQuantitative results showed an extensive increment of the number of BU research projects over the years and the number of work collaborations with other units and wards. Qualitative findings revealed four main themes, concerning: 1. the reasons for contacting the BU and the type of collaboration; 2. the role of the bioethicist; 3. the impact of BU activities on HPs, in terms of developing deeper and more mature thinking; 4. the need to extend ethics support to other settings. Overall, our results showed that performing both empirical bioethics research and more traditional clinical ethics activities at the same unit would produce an impetus to increase collaboration and spread an 'ethical culture' among local HPs.ConclusionsOur findings contribute to a growing body of literature on the models of clinical ethics support services and the role of empirical research in bioethics internationally. They also prepare the ground for the implementation of a multidisciplinary Clinical Ethics Committee (CEC) that aims to support the BU’s ethics consultation service within the local context. (shrink)

Background: As actors with the key responsibility for the protection of human research participants, Research Ethics Committees (RECs) need to be competent and well-resourced in order to fulfil their roles. Despite recent programs designed to strengthen RECs in Africa, much more needs to be accomplished before these committees can function optimally.Objective: To assess training needs for biomedical research ethics evaluation among targeted countries.Methods: Members of RECs operating in three targeted African countries were surveyed between August and November 2007. Before implementing (...) the survey, ethical approvals were obtained from RECs in Switzerland, Cameroon, Mali and Tanzania. Data were collected using a semi-structured questionnaire in English and in French.Results: A total of 74 respondents participated in the study. The participation rate was 68%. Seventy one percent of respondents reported having received some training in research ethics evaluation. This training was given by national institutions (31%) and international institutions (69%). Researchers and REC members were ranked as the top target audiences to be trained. Of 32 topics, the top five training priorities were: basic ethical principles, coverage of applicable laws and regulations, how to conduct ethics review, evaluating informed consent processes and the role of the REC.Conclusion: Although the majority of REC members in the targeted African countries had received training in ethics, they expressed a need for additional training. The results of this survey have been used to design a training program in research ethics evaluation that meets this need. (shrink)

Records the papers and commentaries, with an edited discussion, presented at an international consultation convened by the Council for International Organizations of Medical Sciences (CIOMS) to guide revision of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The Guidelines, first issued in 1982 and then revised in 1993, are being updated and expanded to address a number of new and especially challenging ethical issues. These include issues raised by international collaborative trials of drugs (...) in developing countries, especially expensive drugs, and the use of placebo controls in randomized clinical trials. Others arise from the complexity of research in human genetics, including stem-cell research, and in reproductive biology. Throughout, particular attention is given to the difficult questions that arose during the heated debate over trials in developing countries, of short-duration zidovudine (AZT) therapy to reduce perinatal transmission of HIV. The International Ethical Guidelines for Biomedical Research Involving Human Subjects set out a code of research ethics that is widely used by ethical review committees and other bodies responsible for reviewing and overseeing the ethical design of studies and conduct of research. The revision of the Guidelines is being coordinated by CIOMS, in collaboration with WHO. The consultation centered on seven specially commissioned papers, authored by international experts that explore some of the more difficult issues in depth. Each is followed by an invited commentary, often expressing opposing views, and a summary of the issues or conclusions that emerged during the subsequent debate. The first paper, on justice in international research, deals with the question of whether proposals for research to be conducted in a developing country should make provision for future access of the population involved to the interventions under investigation. Also considered are questions that arise when research uses populations in developing countries to investigate interventions that will be of exclusive benefit to the industrialized world. Case studies of recent drug trials and their research protocols are discussed to illustrate circumstances in which use of populations in developing countries is justified or constitutes exploitation. Ethical challenges of the randomized controlled trial are considered in the second paper, which includes a discussion on the equitable distribution of benefits and risks, the use of placebo for controls, and the obligation to ensure that the participation of controls does not compromise their medical care or endanger their health. A paper on informed consent in international health research considers how cultural factors influence communication and language in the informed-consent process and respect for privacy and confidentiality in the research. Subsequent papers address issues in genetics research and reproductive biology, including the moral status of fetuses and the use of embryos in research, and examine the contribution which international human rights instruments can make in the application of the general principles of ethics to research involving human subjects. The final paper gives an overview of capacity building and the role of communities in international biomedical research. (shrink)

In response to a mandate conferred on the International Bioethics Committee (IBC) of UNESCO in November 1993, the IBC has drafted a "universal declaration on the human genome and human rights," which will be considered by the General Conference of UNESCO in November 1997. This article discusses the development of the document and provides the text of the "revised preliminary draft" of the declaration.

Nearly fifteen years after the Council of Europe first called for a pan‐European convention on issues in bioethics to harmonize disparate national regulations, in November 1996 the council's Committee of Ministers approved the Convention on Human Rights and Biomedicine for formal adoption. The draft convention, released in July 1994, provoked strong public, professional, and governmental debate among European nations, particularly regarding provisions for biomedical research with subjects unable to give informed consent. If ratified, the “bioethics convention” will (...) become the first such document to have binding force internationally. (shrink)

Contemporary bioethics is usually notable for its focus on the uses and abuses of biomedical technology, on personal liberty and the on the formulation of ethical problems as dilemmas to be solved by utilitarian calculus within the frameworks of committees and institutional guidelines. It is argued that these developments actually reflect a technologization of medical ethics itself, which more often relies non-personal algorithms of utility.This is explained, from a historical point of view, by the impact of technology on the (...) concepts of nature and naturalism and by the triumphs of modern science, which obscures non-scientific modes of discourse. The article acknowledges some benefits of the technologization of ethics such as the democratization of decision-making but the discussion concentrates on five arguments against the dominance of utilitarianism in medical ethics. The common denominator of these arguments is that utilitarianism fails its own standards by undermining trust in the public domain. The loss of trust is brought about by the displacement of the phenomenological self and from fostering adversarialism in ethical discourse. (shrink)

Bioethics emerged as a discipline in the 70s of the last century. One of its main objectives has been to analyze clinical cases that pose moral problems. This analysis is generally carried out by a multidisciplinary group, the Health Care Ethics Committee, which is comprised of ethical experts or healthcare providers assisted by a facilitator, depending on the context. Different methodologies are used in these situations. The deliberative method, in its various configurations, is the most widely used in (...) many Committees. Identify whether the deliberative method is included in regulated undergraduate and postgraduate teaching; analyze whether a single model can be identified or whether there is heterogeneity in the proposals. A bibliographic review was carried out, following the scoping review method. With respect to the first objective, there is no evidence on the teaching and use of the deliberative method in the Faculties and Schools of Medicine and Nursing, the emphasis is placed on training oriented to the resolution of clinical cases and a certain deliberative proposal is developed from them, more pragmatic than ethical-philosophical. In relation to the second objective, differences are observed between the two most prevalent schools (D. Gracia and B. Molewijk), with the model proposed by Gracia being used more in the Spanish-speaking world, and Molewijk's model in the English-speaking world. It can be seen that D. Gracia's proposal is more philosophical and Molewijk's more pragmatic. Finally, it is considered pertinent to further disseminate the deliberative method and its advantages, as well as its potential for bioethics education. (shrink)

The Article focuses on the concept of social solidarity, as it is used in the Report of the International Bioethics Committee On Social Responsibility and Health. It is argued that solidarity plays a major role in supporting the whole framework of social responsibility, as presented by the IBC. Moreover, solidarity is not limited to members of particular groups, but potentially extended to all human beings on the basis of their inherent dignity; this sense of human solidarity is (...) a necessary presupposition for a genuinely universalistic morality of justice and human rights. (shrink)

Health research has increased during the last decade, which has enhanced the importance of research ethics. However, little is known regarding the knowledge, awareness, attitudes, and practices of investigators in Myanmar. To assess awareness, knowledge, and attitudes of post-graduates regarding research ethics and research ethics committees (RECs) and their informed consent practices and to determine the association between their responses and certain independent factors. We conducted a cross-sectional study using a questionnaire that was distributed to a convenience sample of post-graduates (...) at the Defence Services Medical Academy in Myanmar. We used descriptive, t test, and chi-square statistics to analyze the data. Significance was set at p < 0.05. We obtained surveys from 204 participants, which included 177 MSc and 27 PhDs of whom 63.6% had performed research and 86.5% had prior ethics training. Regarding awareness, 92.2% were aware of an REC at their academy, but only 47.1% were “fully aware” of the functions of an REC and only 52.9% stated they were familiar with ethical principles that govern human subject research. More than 90% thought that research involving human subjects should be submitted to an REC and that post-graduates should have training on research ethics. However, several of their attitudes were sub-optimal; for example, 20.2% said that informed consent is only necessary from the community leader of a village rather than from the individual, 32.8% agreed it is acceptable to fabricate research data, and 33.0% believed that ethical review of research should be restricted to international collaborative research. Calculated mean total attitude scores were statistically significantly higher in post-graduates with PhDs compared with those with MSc and higher in those with knowledge of research ethics principles compared with those lacking such knowledge. Significant gaps exist among post-graduates regarding their knowledge, awareness, and attitudes regarding research ethics and RECs. We recommend that post-graduates receive further training in research ethics to ensure the ethical conduct of research. Further studies should be performed to determine the generalizability of our findings to other institutions in Myanmar. (shrink)

The 2005 Report on Social Responsibility and Health of the UNESCO International Bioethics Committee (Ibc) proposes a new approach to implementing the right to healthcare and suggests a number of Courses of Action to be followed in various fields. Based on the latest available data, we intend to present an overview of the current state of European health systems in two of those fields—decision-making procedures and quality assurance in health care—and to attempt a comparison of the situation (...) with the Report’s provisions, in order to pave the way for the identification of what still has to be done to bridge international recommendations and the reality of policy and practice in Europe’s health care. (shrink)

The contributions collected in this section deal with some of the most crucial issues addressed in the Report on “Social Responsibility and Health” of the International Bioethics Committee: the importance of ‘social responsibility’ in the promotion of health, i.e. far beyond the context of the ethics of management and private companies where the term was introduced at first; the role of solidarity as a necessary presupposition for a genuinely universalistic morality of justice; the content of the right (...) to health care, especially when we consider it as a ‘legal’ right; the quest for efficiency in health care policies, which is indispensable if we want to effectively extend the enjoyment of progressively higher standard of health; the sense of responsibility in the context of professional activities; the decision making procedures that are to be implemented in order to achieve a fair and just allocation of resources. (shrink)

Benefiting from a widely recognised experience of the field of bioethics, the Council of Europe which represents all the democratic countries of Europe, has embarked on the ambitious task of drafting a European Convention on bioethics. The purpose of this text is to set out fundamental values, such as respect for human dignity, free informed consent and non-commercialisation of the human body. In addition to this task, protocols will provide specific standards for the different fields concerned with the (...) application of biomedical sciences. The convention and the first two protocols (human experiments and organ transplants) are due to be ready for signature by mid 1994. (shrink)