W L Kilama argues that building capacity in ethical health research is the only way to safeguard the welfare of African participants in clinical trials.
The author is Managing Trustee of the African Malaria Network Trust (AMANET), based in Dar es Salaam, Tanzania.
With Africa shouldering most of the world’s disease burden — particularly HIV/AIDS, tuberculosis and malaria — health research is urgently needed on the continent. But this very need, exacerbated by poverty and a lack of relevant skills, leaves it vulnerable to exploitation by foreign research interests.
The good news is that there is growing interest in health research targeting Africa’s needs. But the motives are mixed. Some of the research is genuinely focused on finding ways to bridge the so-called 10/90 gap — namely the fact that 90 per cent of global research goes on diseases comprising only 10 per cent of the global burden of disease. But much of this research seems to be riding on expectations that biomedicine will produce new vaccines, drugs, devices, and diagnostics targeting the 'big diseases' — with backers poised to reap the associated commercial rewards.
Either way, there is no doubt that foreign researchers and research sponsors are already seizing on the unique opportunities inherent in Africa’s unfortunate health situation. High disease rates, for instance, mean that it is easy to attain large sample sizes. And an epidemiological transition to non-communicable conditions such as diabetes and heart disease presents research possibilities that were previously restricted to affluent societies in the North.
But the picture is clouded once one adds in low literacy rates, overwhelming levels of ignorance regarding scientific enquiry and innovation, and customs and beliefs that may conflict with 'standard' healthcare provision. Together these factors set the stage for the potential exploitation of African populations by biomedical researchers. It is therefore crucial that African researchers are able to participate fully in research initiated by foreign partners with a comprehensive knowledge of ethical considerations.
A role for local researchers
Yet surely “it is the wearer who knows where the shoe pinches”. Who can know better than a local researcher how best to address the health needs and priorities of his or her own population? And who knows better than a local researcher the cultural, social, ecological, epidemiological, political and economic values and needs of the prospective study communities?
A related issue is that many collaborative research projects are veiled in misinformation. The local researcher often lacks background information, but this is not taken into account; budget management may not be adequately explained, causing considerable mistrust; and the roles and responsibilities of the partners and how they will share any benefits may not be clearly spelt out (for example, whether the involvement of local researchers will be adequately acknowledged in subsequent publications).
Finally, guest researchers often depart immediately after a study is completed, leaving the national collaborator burdened both with the final stages of the projects, and with the responsibility of disseminating results to stakeholders such as study participants, local and national government representatives, and NGO-workers.
Training: a way forward
What this means in practice is that both African and guest researcher must identify the research problem together, and that they must involve all stakeholders in developing the proposal and in putting the study into action. Everyone’s roles, responsibilities and benefits should be agreed in advance, preferably in writing. Above all, there must be mutual trust, fairness and transparency.
Sadly, these ideals will not be easy to achieve as long as African governments continue to underfund their health research institutions. Nevertheless, hope is emerging in the form of the provision of training on the ethics of health research.
Leading the way in this field are the Tanzania-based African Malaria Network Trust (AMANET) and, to some degree, the US National Institutes of Health. Both are sponsoring a series of workshops on the subject, held at various African locations. AMANET workshops have already benefited some 200 individuals, including senior investigators, key members of ethics and scientific review committees, study monitors, members of monitoring and regulatory bodies, and editors of biomedical journals.
The prime aim of such training is to provide an overview of health research ethics in the international sphere, paying particular attention to African perspectives and concerns. At the same time, it attempts to ensure that international standards for designing, conducting and reporting studies will be met. This is achieved by covering a spectrum of ethical concerns, ranging from forming and running ethics review committees and developing standard operating procedures (SOPs) for ethics review and designing ethical studies, to issues raised by intellectual property rights, the use of archived specimens and human tissues, and the fair distribution of benefits and burdens.
AMANET, for example, envisions that workshop participants will help raise awareness of ethical concerns among their fellow health researchers. And on a practical level, it hopes they will directly use the knowledge and insights they have gained to carry out tasks such as formulating protocols, working on ethics review committees at institutional and national levels, establishing SOPs for ethics reviews, and developing ethically sound public health policies — as well as go on to provide basic training in health research ethics to others.
Jumping hurdles in the face of poverty
As heartening as these developments are, problems surrounding the conduct of clinical health research in African countries will undoubtedly persist as long as these nations experience rampant poverty. It is poverty, for example, that blinds research participants to take part in studies against their better judgement: they may be offered free treatment, the attention of medical doctors, the creation of local employment, or even access to the test product.
Poverty also blinds local researchers, who may seize the opportunity to supplement their meagre earnings, and who may be offered training abroad, exposure in prestigious publications and accelerated promotion. And poverty blinds leaders of research institutions, who badly need more funds to cover research and administrative costs.
Given all this, it is little wonder that foreign-sponsored research proposals with large budgets are likely to be given special treatment. Hopefully the continued efforts of bodies such as AMANET combined with genuine concern abroad will mean that training in health research ethics could soon be a major force in eliminating the potential misuse of Africa as a human laboratory.