Godfrey B. Tangwa

Does the FDA have the authority to trump the Declaration of Helsinki

A new rule seems to be more about imperialism than harmonisation

Capacity building of ethics review committees across Africa based on the results of a comprehensive needs assessment survey.

A needs assessment survey of ethics review committees (ERCs) across Africa was conducted in order to establish their major needs and areas of weaknesses in terms of ethical review capacity. The response rate was 84% (31 of 37 targeted committees), and committees surveyed were located in 18 African countries. The majority of the responding committees (61%) have been in existence between 5 and 10 years; approximately 74% of the respondents were institutional committees, with the remainder being either national (6/31) or regional (2/31). In terms of the ethical review process, nine of the 31 committees that responded did not have standard operating procedures (SOPs), and seven of the 22 that did have SOPs had never revised them after their initial development (an average period of three years). Of the 31 committees, 10 operated without any ethical guidelines. Many of the committees (13/30) met once per month, and the number of proposals reviewed annually varied, ranging from five to over 100. All respondents relied on paper-based data management and archiving systems. Overall, the survey identified the major constraints on ERCs as lack of office equipment, outdated or lack of SOPs, lack of electronic data management systems, inadequate resources, lack of or insufficient expertise on the committees, and poor recognition of the importance of the role of the committees. Consequently, the authors are addressing the identified needs and weaknesses through the Bill and Melinda Gates Foundation-funded capacity building project. The impact of the intervention project will be assessed during and at the end of the four-year longitudinal project.

Addressing ethical issues in H3Africa research – the views of research ethics committee members

In June 2014, the H3Africa Working Group on Ethics organised a workshop with members of over 40 research ethics committees from across Africa to discuss the ethical challenges raised in H3Africa research, and to receive input on the proposed H3Africa governance framework. Prominent amongst a myriad of ethical issues raised by meeting participants were concerns over consent for future use of samples and data, the role of community engagement in large international collaborative projects, and particular features of the governance of sample sharing. This report describes these concerns in detail and will be informative to researchers wishing to conduct genomic research on diseases pertinent to the African research context.

Ethical principles in health research and review process.

In this paper I want to reflect on the fundamental ethical principles and their application in different particular contexts, especially in health research and the ethics review process. Four fundamental ethical principles have been identified and widely discussed in bioethical literature. These principles namely are: autonomy or respect for others, beneficence, non-maleficence and justice. These principles have cross-cultural validity, relevance and applicability. Every real-life situation and every concrete particular case in which ethical decision-making is called-for is unique and different from all others; but the same fundamental ethical principles are relevant and used in addressing all such cases and situations. Very often ethical problems will present themselves in the form of dilemmas and it is then necessary to use the same fundamental principles to analyze the situations, to argue persuasively and cogently with competence for the best options or choices in such situations. The issues I will be dealing with in this paper are necessarily more abstract and theoretical, but we will be discussing them from a very practical viewpoint and impulse, with a view to application in concrete real-life situations. The paper ends with some sample practical examples of cases that the reader can use to test his/her grasp of the principles, how to apply them, how to balance them in differing situations and contexts and how to adjudicate between them when they seem to be in conflict.

Research with vulnerable human beings.

Some categories of human beings are particularly vulnerable vis-à-vis medical research. Vulnerability could be considered as the liability to be harmed, exploited, deceived, cheated, wronged, or otherwise unfairly treated, in roughly that descending order of importance. Vulnerable human beings obviously include the incompetent (minors and mentally handicapped adults), the desperately poor, ill or ignorant, prisoners, refugees, pregnant women, subordinates in highly authoritarian systems, etc. Vulnerability in itself does not imply that no research whatsoever should be carried out with such categories of humans but only that it should be carried out only under very special conditions. In this paper I treat of vulnerability in research of particularly developing world populations; of the types of research which exploit such vulnerability, and of why and how research subjects should be protected. The aim in this paper is to stimulate practical reflection on the possible vulnerabilities of potential research subjects that researchers or investigators need to avoid exploiting rather than on an adequate theoretical treatment of the issue.

Moral agency moral worth and the question of double standards in medical research in developing countries.

International regulations governing medical research, healthcare and medical practice, are, obviously, meant to be guidelines and not detailed procedural rules of thumb that can be applied unreflectively without any danger of doing moral wrong. Moreover, such regulations are meant to apply internationally, and no set of straight-jacketed rules of thumb can conceivably apply to all societies and communities of the world, extremely diverse and differently situated as they are. The mark of a good international guideline or regulation, in my view, is that it should provide a clear principle of action that applies equally to all global communities and societies without seeking to foist the particular or momentary moral dilemmas, quandaries, obsessions and preoccupations of some on all. In this paper, I propose to argue that, because moral obligations are obligations only from the point of view of a particular moral agent, we should avoid making the peculiar problems of any particular moral agent(s) the obsessive concern of all moral agents, and that we need, in particular, to make appropriate distinctions between the ethics of developed world research in the developing world, collaborative or cooperative research between the developed and developing worlds, developed world research in the developed world and developing world research in the developing world. A consequence of looking at things this way is that, while it should be clear that there are ethical concerns, imperatives and obligations at all levels, different standards may and, in fact, cannot but be applied in different contexts at different levels, without resorting to the use of double standards, which can never be morally justified. Finally, I venture to propose a formula for a solemn pledge of moral integrity and noble intent, from the perspective of the agent, that is to say, the investigator, sponsor and funder of any research, to complement and balance the widely accepted informed consent requirement, from the perspective of the patient, the subject of any biomedical research.

Ethics in occupational health: deliberations of an international workgroup addressing challenges in an African context

BackgroundInternational codes of ethics play an important role in guiding professional practice in developing countries. In the occupational health setting, codes developed by international agencies have substantial import on protecting working populations from harm. This is particularly so under globalisation which has transformed processes of production in fundamental ways across the globe. As part of the process of revising the Ethical Code of the International Commission on Occupational Health, an Africa Working Group addressed key challenges for the relevance and cogency of an ethical code in occupational health for an African context through an iterative consultative process.DiscussionFirstly, even in the absence of strong legal systems of enforcement, and notwithstanding the value of legal institutionalisation of ethical codes, guidelines alone may offer advantageous routes to enhancing ethical practice in occupational health. Secondly, globalisation has particularly impacted on health and safety at workplaces in Africa, challenging occupational health professionals to be sensitive to, and actively redress imbalance of power. Thirdly, the different ways in which vulnerability is exemplified in the workplace in Africa often places the occupational health professional in invidious positions of Dual Loyalty. Fourth, the particular cultural emphasis in traditional African societies on collective responsibilities within the community impacts directly on how consent should be sought in occupational health practice, and how stigma should be dealt with, balancing individual autonomy with ideas of personhood that are more collective as in the African philosophy of ubuntu. To address stigma, practitioners need to be additionally sensitive to how power imbalances at the workplace intersect with traditional cultural norms related to solidarity. Lastly, particularly in the African context, the inseparability of workplace and community means that efforts to address workplace hazards demand that actions for occupational health extend beyond just the workplace.SummaryA stronger articulation of occupational health practice with advocacy for prevention should be an ethical norm. Ethical codes should ideally harmonize and balance individual and community needs so as to provide stronger moral authority guidelines. There is a need to consider an African Charter on Bioethics as complementary and strengthening of existing codes for the region.

Giving voice to African thought in medical research ethics

In this article, I consider the virtual absence of an African voice and perspective in global discourses of medical research ethics against the backdrop of the high burden of diseases and epidemics on the continent and the fact that the continent is actually the scene of numerous and sundry medical research studies. I consider some reasons for this state of affairs as well as how the situation might be redressed. Using examples from the HIV/AIDS and Ebola epidemics, I attempt to show that the marginalization of Africa in medical research and medical research ethics is deliberate rather than accidental. It is causally related, in general terms, to a Eurocentric hegemony derived from colonialism and colonial indoctrination cum proselytization. I end by proposing seven theses for the critical reflection and appraisal of the reader.

Ebola Vaccine Trials

The Ebola epidemic that broke out in West Africa towards the end of 2013 had been brought under reasonable control by 2015. The epidemic had severely affected three countries. This case study is about a phase I/II clinical trial (testing for safety and immunogenicity) of a candidate Ebola virus vaccine in 2015 in a sub-Saharan African country which had not registered any cases of the Ebola virus disease. The study was designed as a randomized double-blinded trial. It was sponsored and funded by one of the biggest Northern multinational pharmaceutical companies. The protocol received ethics clearance from the relevant national ethics committee. The study was coordinated and managed at the local branch of a big Northern diagnostic laboratory and a laboratory of a local regional hospital. The overall study was a multi-country, multi-site trial aimed at recruiting a total of 3,000 research participants across four or five sub-Saharan African countries. For this country, the recruitment sites were two big cities, each aiming to recruit 200 participants: adults at the first site and children at the second. The target sample size was almost achieved at the first site but, before the study commenced at the second site, some members of (the public) raised the alarm that the government was carelessly risking the health, safety and lives of citizens in the cause of an unproven vaccine that could precipitate a public health disaster. The trial was immediately suspended. A commentary on this case, and on the importance of trust, is provided by Katharine Browne and Doris Schroeder at the end of this chapter. It highlights differences between this case and a phase I Ebola vaccine trial in Canada in 2014.

Morality and Culture: Are Ethics Culture-Dependent?

Culture is basically a way of life of a group of people, underpinned by adaptation to a common environment, similar ways of thinking and acting and doing, similar attitudes and expectations, similar ideas, beliefs and practices, etc. There is a remarkable diversity and variety in the human cultures of the world and in the ecological niches in which cultures flourish. This diversity, an observable fact, is analogous to the equally remarkable diversity of the biological world, of the different biological species that populate the earth. Cultures and sub-cultures are like concentric circles (Tangwa 1992, pp. 142–143) and there is no human being who does not fall within at least more than one such circle, as the nuclear family or, more ideally, the extended family in its African conception, could, in fact, be considered as delimiting the smallest of such cultural circles. Like biological diversity, cultural diversity is thus a datum of our existence with which we may tinker in the hope or with the aim of giving it a particular shape, colour or direction. Such tinkering is as liable to achieve satisfactory beneficial results as unbeneficial or harmful ones. For this reason, cultures, like living things, may, over time, flourish or atrophy. But to attempt introducing biological or cultural changes that are too sudden or too drastic is to run the risk of achieving more disastrous than beneficial results. Unlike culture, morality is grounded on human rationality and common biological nature, and on human basic needs which, being common to all, irrespective of culture, may be considered as defining what it is to be human. For this reason, divergence of moral opinion, both within and across cultures, is a descriptive fact which is a short-falling from the prescriptive ideal. Moral imperatives are necessarily universal. But moral thinking and practices may differ from culture to culture and even from person to person within the same culture, because of human limitations, including the impossibility of perceiving from more than a single point of view, the impossibility of being an experiential participant of all human existential situations, coupled with human ego-centrism and human fallibility.