NEW DIRECTIONS IN AFRICAN BIOETHICS: WAYS OF INCLUDING PUBLIC HEALTH CONCERNS IN THE BIOETHICS AGENDA

Research ethics is the most developed aspect of bioethics in Africa. Most African countries have set up Institutional Review Boards (IRBs) to provide guidelines for research and to comply with international norms. However, bioethics has not been responsive to local needs and values in the rest of the continent. A new direction is needed in African bioethics. This new direction promotes the development of a locally‐grounded bioethics, shaped by a dynamic understanding of local cultures and informed by structural and institutional problems that impact the public's health, as well as cognisant of the salient contribution of social sciences and social epidemiology which can bring a lasting impact on African local communities. In today's post‐Structural Adjustment Africa, where healthcare has been liberalized and its cost increased, a bioethics agenda that focuses essentially on disease management and clinical work remains blind in the face of a structural marginalization of the masses of poor. Instead, the multidimensional public health crisis, with which most African countries are confronted, calls for a bioethics agenda that focuses primarily, but not exclusively, on health promotion and advocacy. Such an approach to bioethics reckons with the macro‐determinants of health and well‐being and places clinical and research ethics in the broader context of population's health. The same approach underscores the need to become political, not only by addressing health policymaking processes and procedures, but also by becoming an advocacy forum that includes other constituencies equipped with the potentialities to impact the population's health.     

TRAINING NEEDS ASSESSMENT IN RESEARCH ETHICS EVALUATION AMONG RESEARCH ETHICS COMMITTEE MEMBERS IN THREE AFRICAN COUNTRIES: CAMEROON,MALI AND TANZANIA

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.     

Bioethics and Its Gatekeepers: Does Institutional Racism Exist in Leading Bioethics Journals?

Who are the gatekeepers in bioethics? Does editorial bias or institutional racism exist in leading bioethics journals? We analyzed the composition of the editorial boards of 14 leading bioethics journals by country. Categorizing these countries according to their Human Development Index (HDI), we discovered that approximately 95 percent of editorial board members are based in (very) high-HDI countries, less than 4 percent are from medium-HDI countries, and fewer than 1.5 percent are from low-HDI countries. Eight out of 14 leading bioethics journals have no editorial board members from a medium- or low-HDI country. Eleven bioethics journals have no board members from low-HDI countries. This severe underrepresentation of bioethics scholars from developing countries on editorial boards suggests that bioethics may be affected by institutional racism, raising significant questions about the ethics of bioethics in a global context.     

Enriching Our Views on Clinical Ethics: Results of a Qualitative Study of the Moral Psychology of Healthcare Ethics Committee Members

The contribution of healthcare ethics committee (HEC) members to HECs is fundamental. However, little is known about how HEC members view clinical ethics. We report results from a qualitative study of the moral psychology of HEC members. We found that contrary to the existing Kohlberg-based studies, HEC members hold a pragmatic non-expert view of clinical ethics based mainly on respect for persons and a commitment to the patient’s good. In general, HEC members hold deflationary views regarding moral theory. Ethical principles are not abstract foundations but the expression of moral commitments to patients that pre-exist awareness of moral theory. Emotions and proximity to patient sufferance fundamentally shape the views of HEC members on clinical ethics. Further work at the intersection of clinical ethics and qualitative research could bring to the foreground lay perspectives on moral problems that may differ from bioethics expert views.     

Beyond the Sterility of a Distinct African Bioethics: Addressing the Conceptual Bioethics Lag in Africa

In the current debate on the future of bioethics in Africa, several authors have argued for a distinct communitarian African bioethics that can counter the dominancy of Western atomistic principlism in contemporary bioethics. In this article I examine this rather contentious argument and evaluate its validity and viability. Firstly, I trace the contextual origins of contemporary bioethics and highlight the rise and dominance of principlism. I particularly note that principlism was premised on a content‐thin notion of the common morality that is in need of enrichment. I also contend that bioethics is essentially two‐dimensional, being both conceptual and empirical, and indicate the lag in Africa with regard to conceptual bioethics. I then appeal for authentic engagement by 1) African health care professionals, 2) African health care training institutions, 3) Africa's bioethics development partners, and 4) African bioethicists and philosophers, towards addressing this critical lag. I underline the need to maintain the essential universality of bioethics as a discipline. I particularly argue against the pursuit of a distinct African bioethics, as it appears to be rooted in sterile African ethno‐philosophy. Rather, African bioethicists and philosophers would do well to elucidate the universalisability of insights from traditional African thought, for the benefit of bioethics as a whole. Thus we must engage beyond the sterility of a distinct African bioethics ‐ authentically reflecting on the essentially universal contemporary bioethical concerns ‐ to effectively articulate a viable trajectory for bioethics in Africa.     

African Bioethics vs. Healthcare Ethics in Africa: A Critique of Godfrey Tangwa

It is nearly two decades now since the publication of Godfrey Tangwa's article, ‘Bioethics: African Perspective’, without a critical review. His article is important because sequel to its publication in Bioethics, the idea of ‘African bioethics’ started gaining some attention in the international bioethics literature. This paper breaks this relative silence by critically examining Tangwa's claim on the existence of African bioethics. Employing conceptual and critical methods, this paper argues that Tangwa's account of African bioethics has some conceptual, methodic and substantive difficulties, which altogether do not justify the idea of African bioethics, at least for now. Contra Tangwa, this article establishes that while African bioethics remains a future possibility, it is more cogent that current efforts in the name of ‘African bioethics’ be primarily re‐intensified towards ‘Healthcare ethics in Africa’.     

Challenges faced by research ethics committees in El Salvador: results from a focus group study

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.     

When Listening to the People: Lessons from Complementary and Alternative Medicine (CAM) for Bioethics

Complementary and alternative medicines (CAM) have become increasingly popular over recent decades. Within bioethics CAM has so far mostly stimulated discussions around their level of scientific evidence, or along the standard concerns of bioethics. To gain an understanding as to why CAM is so successful and what the CAM success means for health care ethics, this paper explores empirical research studies on users of CAM and the reasons for their choice. It emerges that there is a close connection to fundamental principles of medical ethics. The studies also highlight that CAM’s holistic ontology of health and illness has an empowering effect on people in caring for their health, and on an even deeper level, safeguards against biomedicine’s reducing image of oneself as biological body-machine. The question is raised what lessons bioethics should draw from this emancipatory social movement for its own relationship with biomedicine.     

The genesis of public health ethics

As bioethics emerged in the 1960s and 1970s and began to have enormous impacts on the practice of medicine and research – fuelled, by broad socio‐political changes that gave rise to the struggle of women, African Americans, gay men and lesbians, and the antiauthoritarian impulse that characterised the New Left in democratic capitalist societies – little attention was given to the question of the ethics of public health. This was all the more striking since the core values and practices of public health, often entailing the subordination of the individual for the common good, seemed opposed to the ideological impulses of bioethics. Of what relevance is autonomy‐focused bioethics for public health, with its mix of justifications including those that are either implicitly or explicitly paternalistic or that seek to impose strictures on individuals and communities in the name of collective welfare? To examine the deep divide between the central commitments of bioethics and the values that animate the practice of public health, we focus on a series of controversies implicating the concepts of privacy, liberty, and paternalism. Recognising the role of moral values in decision‐making was a signal contribution of bioethics in its formative period. Over the past three decades a broad array of perspectives emerged under the rubric of bioethics but individualism remains central. As we commence the process of shaping an ethics of public health, it is clear that bioethics is the wrong place to start when thinking about the balances required in defence of the public's health.     

International research ethics: progress, but not perfection

To the uninitiated researcher, bioethics can be a confusing and sometimes bureaucratic process. The recent debates in international research ethics have both increased understanding of contentious issues while extending confusion to the international arena. Here, we attempt to demystify bioethics, or more specifically international research ethics, by defining ethics in the context of morality, reviewing core Western ethical principles, and highlighting challenges in international research ethics.     

Composition and capacity of Institutional Review Boards,and challenges experienced by members in ethics review processes in Addis Ababa,Ethiopia: An exploratory qualitative study

Few studies in sub-Saharan Africa evaluate Institutional Review Boards (IRBs) capacity. The study aims to explore the composition of IRBs, training, and challenges experienced in the ethics review processes by members of research institutions and universities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs members were trained on research ethics and good clinical practice. However, majority perceived the trainings as basic. IRB members faced several challenges including: investigators wanting rapid review; time pressure; investigators not following checklists; limited expertise in reviewing clinical trials, studies on genetics, and traditional medicine; lack of IRB offices for administrative work; competing tasks; limited staffing and the lack of a standardized review system. There is need for advanced training on research ethics to meet the evolving research needs. In addition, investments in IRBs are needed in terms of funding, and physical and human resources in Addis Ababa and Ethiopia in general.     

Relational autonomy,care, and Jehovah's Witnesses in Germany

Drawing from an ethics of care, relational approaches to autonomy have recently emerged in bioethics. Unlike individual autonomy with its emphasis on patients’ rights, choice, and self‐determination which has been the hallmark of bioethics consistent with the ideology of individualism in neoliberal democracies in Western countries, relational autonomy highlights the relatedness, interdependency, and social embeddedness of patients. By examining the mediating role that male Hospital Liaison Committee members in Germany play in facilitating care that supports Jehovah's Witnesses’ refusal of blood transfusions, this article moves beyond ‘dyadic relations’ and contexts of caregiving. It also contributes to a deeper understanding of care and relational conceptualizations of Witness patients’ autonomy globally.     

VIEWS OF THE PROCESS AND CONTENT OF ETHICAL REVIEWS OF HIV VACCINE TRIALS AMONG MEMBERS OF US INSTITUTIONAL REVIEW BOARDS AND SOUTH AFRICAN RESEARCH ETHICS COMMITTEES

Given the ethical controversies concerning HIV vaccine trials (HVTs), we aimed to understand through an exploratory study how members of institutional review boards (IRBs) in the United States (US) and research ethics committees (RECs) in South Africa (SA) view issues concerning the process and content of reviews of these studies. We mailed packets of 20 questionnaires to 12 US IRB chairs and administrators and seven REC chairs to distribute to their members. We received 113 questionnaires (76 from the US and 37 from SA). In both countries, members tended to be white males with advanced academic degrees. Compared to the US, SA members called for ‘major changes’ in HVT protocols more frequently (p = 0.004), and were less likely to think that HVT participants understood risks and benefits (p = 0.033) or informed consent forms (p = 0.000). In both countries, members were divided on several critical issues (e.g. the minimum standard for treatment for HVT participants who became infected during the HVT), but agreed that they needed more training. Of the SA respondents, 40% reported that they were ‘self‐taught’ in ethics. This study, the first we know of to offer quantitative data comparing US vs. non‐US IRBs/RECs, thus suggests key similarities and differences (e.g. compared to SA respondents, US respondents appeared to overestimate participants' understanding of informed consent), along with needs for education. These initial exploratory data in this area have important implications for IRBs, RECs, policy‐makers and scholars concerning future practice, training, policy, and investigations in research ethics, and prevention and treatment of HIV and other diseases in the developing world and elsewhere.     

Enhancing Research Ethics Review Systems in Egypt: The Focus of an International Training Program Informed by an Ecological Developmental Approach to Enhancing Research Ethics Capacity

Recently, training programs in research ethics have been established to enhance individual and institutional capacity in research ethics in the developing world. However, commentators have expressed concern that the efforts of these training programs have placed ‘too great an emphasis on guidelines and research ethics review’, which will have limited effect on ensuring ethical conduct in research. What is needed instead is a culture of ethical conduct supported by national and institutional commitment to ethical practices that are reinforced by upstream enabling conditions (strong civil society, public accountability, and trust in basic transactional processes), which are in turn influenced by developmental conditions (basic freedoms of political freedoms, economic facilities, social opportunities, transparency guarantees, and protective security). Examining this more inclusive understanding of the determinants of ethical conduct enhances at once both an appreciation of the limitations of current efforts of training programs in research ethics and an understanding of what additional training elements are needed to enable trainees to facilitate national and institutional policy changes that enhance research practices. We apply this developmental model to a training program focused in Egypt to describe examples of such additional training activities.     

什么是生命伦理学？——从历史发展的视角

生命伦理学是20世纪60年代兴起于美国的一门新兴学科,旨在应对生命科学和生物技术的发展或医疗保健的演变使人类面临的种种伦理难题。生命伦理学的兴起有着特殊的社会历史背景。它在发展过程中出现的一些里程碑式的案例,对生命伦理学的发展产生了深远的影响。从其发展特征上看,生命伦理学和医学伦理学紧密联系,有着更为广泛的研究内容和独特的专业特性。生命伦理学要有效回应现代医学和生命科学的发展给人类带来的伦理难题,既要准确地界定伦理问题,又要以适当的方式将伦理学基础理论应用到具体问题当中。对生命伦理学的基本理论进行概述。     

Improving the Quality of Host Country Ethical Oversight of International Research: The Use of a Collaborative ‘Pre‐Review’ Mechanism for a Study of Fexinidazole for Human African Trypanosomiasis

Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to these concerns, the Drugs for Neglected Diseases Initiative (DNDi), an independent nonprofit organization founded by a coalition of public sector and international organizations, developed a mechanism to facilitate more effective and efficient host country ethics review for a study of the use of fexinidazole for the treatment of late stage African Trypanosomiasis (HAT). The project involved the implementation of a novel ‘pre‐review’ process of ethical oversight, conducted by an ad hoc committee of ethics committee representatives from African and European countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative process.     

THE VIRTUE ETHICS APPROACH TO BIOETHICS

This paper discusses the viability of a virtue‐based approach to bioethics. Virtue ethics is clearly appropriate to addressing issues of professional character and conduct. But another major remit of bioethics is to evaluate the ethics of biomedical procedures in order to recommend regulatory policy. How appropriate is the virtue ethics approach to fulfilling this remit? The first part of this paper characterizes the methodology problem in bioethics in terms of diversity, and shows that virtue ethics does not simply restate this problem in its own terms. However, fatal objections to the way the virtue ethics approach is typically taken in bioethics literature are presented in the second section of the paper. In the third part, a virtue‐based approach to bioethics that avoids the shortcomings of the typical one is introduced and shown to be prima facie plausible. The upshot is an inviting new direction for research into bioethics' methodology.     

A Framework to Link International Clinical Research to the Promotion of Justice in Global Health

How international research might contribute to justice in global health has not been substantively addressed by bioethics. Theories of justice from political philosophy establish obligations for parties from high‐income countries owed to parties from low and middle‐income countries. We have developed a new framework that is based on Jennifer Ruger's health capability paradigm to strengthen the link between international clinical research and justice in global health. The ‘research for health justice’ framework provides direction on three aspects of international clinical research: the research target, research capacity strengthening, and post‐trial benefits. It identifies the obligations of justice owed by national governments, research funders, research sponsors, and investigators to trial participants and host communities. These obligations vary from those currently articulated in international research ethics guidelines. Ethical requirements of a different kind are needed if international clinical research is to advance global health equity.     

Biothics in Brazil

In this article the authors briefly sketch the nature of Brazilian bioethics. Bioethics emerged in Brazil later than in other Western countries and the 1990's were the most important period for the spread of the discipline in the country. It is in this period that some structural elements of bioethics were established, such as research groups, regulation of Local Research Ethics Committees (Comitês Locais de Ética em Pesquisa – CEP), the creation of the National Commission of Ethics in Research with Human Beings (Comissão Nacional de Ética em Pesquisa com Seres Humanos – CONEP) and the Brazilian Bioethics Society (Sociedade Brasileira de Bioética – SBB). With regard to theoretical work, Brazilian bioethics is clearly an importer of theories from countries central to the studies of bioethics, or, in another words, countries where bioethics first emerged and was established. The most commonly used theory among Brazilian researchers is principlism