Community engagement has been recognised as an important aspect of the ethical conduct of biomedical research, especially when research is focused on ethnically or culturally distinct populations. While this is a generally accepted tenet of biomedical research, it is unclear what components are necessary for effective community engagement, particularly in the context of genomic research in Africa.

To participate in health research, there is a need for well-administered informed consent. Understanding of informed consent, especially in international health research, is influenced by the participants' understanding of information and the meaning attached to the information communicated to them regarding the purpose and procedure of the research. Incorrect information and the power differential between researcher and participants may lead to participants becoming victims of harmful research procedures. Meningitis epidemics in Kano in early 1996 led to a response from drug (...) companies, especially Pfizer, as well as humanitarian workers from Médecins Sans Frontiers, which resulted in an unethical trial. Pfizer's drug trial during the epidemics has left a lasting controversy, which has yet to be resolved. This paper examines the key issues surrounding the controversy, discusses the context of informed decision-making, the ethical issues and implications of the incident, and concludes with some recommendations. Relevant texts, journals, Internet materials, newspaper articles and documentary materials on the conduct of the Pfizer's Trovan trial have been consulted. Four types of action (act intuitively, act rationally, act ignorantly, and act contextually – based on information provided) are identified as possible options for decision making. Participants most likely acted in ignorance due to poor understanding of the information contained in the verbal informed consent administered, thereby raising ethical issues. It is concluded that health research ethics committees have an important role to play nationally and locally in overseeing research, and in avoiding future occurrences. (shrink)

In this paper I have attempted to open a window on an African approach to Bioethics — that of the Nso' of the Bamenda Highlands of Kamerun — from the vantage position of someone who has familiarity with both African and Western cultures. Because of its scientific-cum-technological sophistication and its proselytising character, Western culture, as well as Western systems of thought and practice, have greatly affected and influenced other cultures, particularly African culture. But Western culture, systems of thought and practice, (...) have been highly impervious and immune to influences from other cultures, philosophies, systems of thought and practice, even where these might have been salutary and enriching to Western culture and systems. What I have here termed Nso' eco-bio-cummunitarianism clearly indicates a viable alternative world-view within which some of the bioethical perplexities and controversies of today might be more satisfactorily resolved than within a Western framework. I have further attempted to show, by way of example, how within such a world-view, abortion and suicide, for instance, would be disapproved of while euthanasia, in its etymological purity, is approved of. (shrink)

Western moral philosophy is driven by the attempt to sharply distinguish persons from the rest of the cosmos, and then to identify the ways in which persons must be treated. The traditional African approach is different on both counts.

The importance of communities in strengthening the ethics of international collaborative research is increasingly highlighted, but there has been much debate about the meaning of the term ‘community’ and its specific normative contribution. We argue that ‘community’ is a contingent concept that plays an important normative role in research through the existence of morally significant interplay between notions of community and individuality. We draw on experience of community engagement in rural Kenya to illustrate two aspects of this interplay: (i) that (...) taking individual informed consent seriously involves understanding and addressing the influence of communities in which individuals’ lives are embedded; (ii) that individual participation can generate risks and benefits for communities as part of the wider implications of research. We further argue that the contingent nature of a community means that defining boundaries is generally a normative process itself, with ethical implications. Community engagement supports the enactment of normative roles; building mutual understanding and trust between researchers and community members have been important goals in Kilifi, requiring a broad range of approaches. Ethical dilemmas are continuously generated as part of these engagement activities, including the risks of perverse outcomes related to existing social relations in communities and conditions of ‘half knowing’ intrinsic to processes of developing new understandings. (shrink)

BackgroundThe potential contribution of community engagement to addressing ethical challenges for international biomedical research is well described, but there is relatively little documented experience of community engagement to inform its development in practice. This paper draws on experiences around community engagement and informed consent during a genetic cohort study in Kenya to contribute to understanding the strengths and challenges of community engagement in supporting ethical research practice, focusing on issues of communication, the role of field workers in 'doing ethics' on (...) the ground and the challenges of community consultation.MethodsThe findings are based on action research methods, including analysis of community engagement documentation and the observations of the authors closely involved in their development and implementation. Qualitative and quantitative content analysis has been used for documentation of staff meetings and trainings, a meeting with 24 community leaders, and 40 large public and 70 small community group meetings. Meeting minutes from a purposive sample of six community representative groups have been analysed using a thematic framework approach.ResultsField workers described challenges around misunderstandings about research, perceived pressure for recruitment and challenges in explaining the study. During consultation, leaders expressed support for the study and screening for sickle cell disease. In community meetings, there was a common interpretation of research as medical care. Concerns centred on unfamiliar procedures. After explanations of study procedures to leaders and community members, few questions were asked about export of samples or the archiving of samples for future research.ConclusionsCommunity engagement enabled researchers to take account of staff and community opinions and issues during the study and adapt messages and methods to address emerging ethical challenges. Field workers conducting informed consent faced complex issues and their understanding, attitudes and communication skills were key influences on ethical practice. Community consultation was a challenging concept to put into practice, illustrating the complexity of assessing information needs and levels of deliberation that are appropriate to a given study. (shrink)

Bioethics has now become a burgeoning interdisciplinary field of scholarly investigation which has in the past decades migrated from bedside consultations to public policy debates and wider cultural and social consultations that privilege all discourse about everyday life issues. It has made exponential progress in addressing moral issues in science, technology and medicine in the world. In spite of this progress, core bioethics issues, approaches and values are still exclusively Western dominated and largely foreign to most African societies. Although medical (...) ethics has existed since the time of Hippocrates, in Africa, there is a noted sluggish growth and low prestige of ethics education as bioethics is not taught in most higher educational systems of learning, low understanding of its processes as researchers manifest a general lack of appreciation for bioethics and general ignorance characterize those involved in research about ethical practices. This is unfortunate, considering that various research that aim at finding solutions to the multiple problems affecting African societies and the need to address and assess these problems in ethical terms are of crucial importance to Africans. In this work, I argue that Africa lacks human, institutional, infrastructural capacities and a real African authenticity in bioethics. Additionally, African views on bioethics are neither sufficiently developed nor heard. Africans need to confront these current challenges of bioethics to their lives and communities and to develop African conceptions to incorporate African specificities and approaches. (shrink)