CULTURE AND VOLUNTARY INFORMED CONSENT IN AFRICAN HEALTH CARE SYSTEMS

This paper discusses how to apply a collective decision model of the principle of voluntary informed consent in African communitarian culture, in a culturally sensitive way, in order to protect research candidates from potential exploitations and abuses. Dismissing cultural and ethical skepticism surrounding the global application of the principle of voluntary informed consent, the paper ultimately concludes that international collaboration on diagnostic and therapeutic medical research in Africa, especially HIV vaccine trials, is a moral imperative.     

An African theory of bioethics: reply to MacPherson and Macklin

In a prior issue of Developing World Bioethics, Cheryl Macpherson and Ruth Macklin critically engaged with an article of mine, where I articulated a moral theory grounded on indigenous values salient in the sub-Saharan region, and then applied it to four major issues in bioethics, comparing and contrasting its implications with those of the dominant Western moral theories, utilitarianism and Kantianism. In response to my essay, Macpherson and Macklin have posed questions about: whether philosophical justifications are something with which bioethicists ought to be concerned; why something counts as 'African'; how medicine is a moral enterprise; whether an individual right to informed consent is consistent with sub-Saharan values; and when thought experiments help to establish firm conclusions about moral status. These are important issues for the field, and I use this reply to take discussion of them a step or two farther, defending my initial article from Macpherson's and Macklin's critical questions and objections.     

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.     

The Challenges of Research Informed Consent in Socio‐Economically Vulnerable Populations: A Viewpoint From the Democratic Republic of Congo

In medical research, the ethical principle of respect for persons is operationalized into the process of informed consent. The consent tools should be contextualized and adapted to the different socio‐cultural environment, especially when research crosses the traditional boundaries and reaches poor communities. We look at the challenges experienced in the malaria Quinact trial, conducted in the Democratic Republic of Congo, and describe some lessons learned, related to the definition of acceptable representative, the role of independent witness and the impact of socio‐economic vulnerability. To ensure children's protection, consent is required by the parents or, in their absence, by a legally mandated representative. In our setting, children's responsibility is often entrusted permanently or temporarily to relatives or friends without a tribunal mandate. Hence, a notion of ‘culturally acceptable representative’ under supervision of the local Ethics Committee may be more suitable. To ensure protection of illiterate subjects, an independent witness is required to confirm that the consent was freely given. However, in low‐literacy contexts, potential witnesses often don't have any previous relationship with patient and there may be power‐unbalance in their relationship, rather than genuine dialogue. In poor communities, trial participation may be seen as an opportunity to secure access to healthcare. Poverty may also lead to ‘competition’ to access the research‐related benefits, with a risk of disturbance at societal or household level. Adjusting consent procedures to sociocultural and socioeconomic realities is essential for fulfilling the underlying ethical principles. This requires a collaborative dialogue between researchers, regulators and ethics committees.     

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.     

CULTURE AND GENETIC SCREENING IN AFRICA

Africa is a continent in transition amidst a revival of cultural practices. Over previous years the continent was robbed of the benefits of medical advances by unfounded cultural practices surrounding its cultural heritage. In a fast moving field like genetic screening, discussions of social and policy aspects frequently need to take place at an early stage to avoid the dilemma encountered by Western medicine. This paper, examines the potential challenges to genetic screening in Africa. It discusses how cultural practices may affect genetic screening. It views genomics science as a culture which is trying to diffuse into another one. It argues that understanding the existing culture will help the diffusion process. The paper emphasizes the importance of genetic screening for Africa, by assessing the current level of burden of diseases in the continent and shows its role in reducing disease prevalence. The paper identifies and discusses the cultural challenges that are likely to confront genetic screening on the continent, such as the worldview, rituals and taboos, polygyny, culture of son preference and so on. It also discusses cultural practices that may promote the science such as inheritance practices, spouse selection practices and naming patterns. Factors driving the cultural challenges are identified and discussed, such as socialization process, patriarchy, gender, belief system and so on. Finally, the paper discusses the way forward and highlights the ethical considerations of doing genetic screening on the continent. However, the paper also recognizes that African culture is not monolithic and therefore makes a case for exceptions.     

REFLECTION ON EUTHANASIA: WESTERN AND AFRICAN NTOMBA PERSPECTIVES ON THE DEATH OF A CHIEF

Largely, the concept of energy or vital force, as first analysed by Placide Tempels in Bantu Philosophy , permeates most African ontology systems, worldviews and life views. The Ntomba Chief is chosen because of his above average vital force. This puts him in the position of intermediary between the Supreme Being, the ancestors, and his subordinates. The waning of his energy is incompatible with his position because his energy is that of his tribe. When installed, he takes an oath that, when this happens, he has to accept mohilo , the 'hastening of death'. In the Chief's case, the hastening of death is not intended to relieve his pain, as it would be with other creatures. The Chief's dying a natural death would result in the loss of the entire community's vital force. Therefore, he has to be killed ritually to avoid that risk. That the Chief agrees to be killed – via a form of advanced directive – poses an ethical dilemma for a Western observer. From the Ntomba perspective, however, where the energy is being, and being is energy, it is the only way to preserve and protect the community's raison d'être .     

ACCESS TO TREATMENT IN HIV PREVENTION TRIALS: PERSPECTIVES FROM A SOUTH AFRICAN COMMUNITY

Access to treatment, in HIV vaccine trials (HVTs), remains ethically controversial. In most prevention trials, including in South Africa, participants who seroconvert are referred to publicly funded programmes for treatment. This strategy is problematic when there is inadequate and uneven access to public sector antiretroviral therapy (ART) and support resources. The responsibilities, if any, of researchers, sponsors and public health authorities involved in HVTs has been hotly debated among academics, scholars, representatives of international organizations and sponsors. However, there is little published on community perceptions. Recent guidance asserts that communities should make inputs into treatment and care decisions. This qualitative study explored a South African community's perceptions of who should provide what to HVT participants as well as how and why this should be done. Twenty‐nine adults working at or attending five primary health care clinics in two rural areas in KwaZulu‐Natal participated in in‐depth interviews. Respondents expressed that researchers should ‘help participants to access’ treatment and care ‘because they are in a position to do so’ and ‘are in a relationship with’ trial participants. Respondents suggested that researchers could help by ‘facilitating referral’ until such time that participants can access care and treatment on their own. We highlight a series of implications for researchers in HVTs, including their need to be aware of prospective participants' considerable trust in and respect for researchers, the responsibility that this places on them, and the need for clear communication with communities so as not to erode community trust.     

COERCION,AUTONOMY, AND THE PREFERENTIAL OPTION FOR THE POOR IN THE ETHICS OF ORGAN TRANSPLANTATION

The debate concerning whether to legalize and regulate the global market in human organs is hindered by a lack of adequate bioethical language. The author argues that the preferential option for the poor, a theological category, can provide the grounding for an inductive moral epistemology adequate for reforming the use of culturally Western bioethical language. He proposes that the traditional, Western concept of bioethical coercion ought to be modified and expanded because the conditions of the market system, as viewed from the perspective of organ vendors systemically deprived of access to sufficient resources, are sufficiently exploitative as to diminish the possibility of these vendors giving informed consent. Moreover, empirical studies conducted by professionals in medicine, sociology, psychiatry, economics, and medical anthropology continue to contribute support to the growing interdisciplinary consensus that functionally coercive structural factors exert the most significant influence upon a vendor's decision to sell an organ within any market, regardless of legality or degree of regulation. Therefore any proposal to legalize and regulate the organ market remains patently unethical because doing so would likely function to constrain further the agency of poor potential vendors.     

FAIRNESS AND EQUITY IN THE PROVISION OF ANTI‐RETROVIRAL THERAPY: SOME REFLECTIONS FROM LESOTHO

The number of people in immediate need of anti‐retroviral treatment (ART) in the southern African region continues to significantly exceed the capacity of health systems there to provide it. Approaches to this complex rationing dilemma have evolved in different directions. The ethical concepts of fairness and equity have been suggested as a basis to guide the development of approaches to select patients for ART. This article reports the results of a case study on patient selection at a rural ART clinic in Lesotho. The purpose of the study was to examine whether or not such concepts had relevance or operative value for a treatment team providing ART in rural Lesotho. The study found that while concepts of fairness and equity were relevant to the work of the treatment team, patient selection practices did not necessarily reflect what these concepts entail. The idea of fairness as a structured, formalized selection process did not figure in the approach to ART provision at the site. A less formal, ‘first‐come‐first‐served’ approach was adopted. While there was knowledge among some team members that social, economic or geographic conditions inhibit individuals and groups from gaining access to ART and that this was inequitable, it was felt that there was little they could do to try to mediate the impact of these conditions. The study's findings pose importance questions about the approach to ART programming in resource constrained settings. The findings also question the relevance of trying to achieve fairness and equity when the gap between need for care and capacity to provide it remains so large.     

LOCAL ATTITUDES, MORAL OBLIGATION, CUSTOMARY OBEDIENCE AND OTHER CULTURAL PRACTICES: THEIR INFLUENCE ON THE PROCESS OF GAINING INFORMED CONSENT FOR SURGERY IN A TERTIARY INSTITUTION IN A DEVELOPING COUNTRY

The process of obtaining informed consent in a teaching hospital in a developing country (e.g. Nigeria) is shaped by factors which, to the Western world, may be seen to be anti-autonomomous: autonomy being one of the pillars of an ideal informed consent. However, the mix of cultural bioethics and local moral obligation in the face of communal tradition ensures a mutually acceptable informed consent process. Paternalism is indeed encouraged by the patients who prefer to see the doctor as all-powerful and all-knowing, and this is buttressed by the cultural practice of customary obedience to those 'above you': either in age or social rank. The local moral obligation reassures the patients that those in authority will always look after others placed in their care without recourse to lengthy discussions or signed documentation, while the communal traditions ensure that the designated head of a family unit has the honor and sole responsibility of assenting and consenting to an operation to be carried out on a younger, or female, member of the family. Indeed it is to only a few educated patients that the informed consent process is deemed a shield against litigation by the doctors. This paper later addresses the need for physicians to update their knowledge on the process of informed consent through the attendance of biomedical ethics courses, which should highlight socio-cultural practices that may make this process different from the Western concept, but perfectly acceptable in this setting.