The Benefits of Ethical Review in African Research

In 2013, Creative Consulting & Development Works was appointed by an international donor to evaluate the achievements and impact of ethics activities employed in 75 ethics programmes across sub-Saharan Africa. The evaluation led to a deeper look at the impact of clinical trials in developing countries and the ethics behind such medical trials and their implementation.

In recent years, large-scale multinational research in developing countries has become the order of the day. In African countries where sociological, epidemiological and developmental contexts are of interest to various disciplines - and where there is a greater prevalence of diseases with a global impact, such as HIV, tuberculosis (TB) and malaria - research activities are carried out at an amplified scale.

This intensified research activity, competition in research and the attractive research environment, may sometimes result in dishonest and fraudulent practice. In particular, research in Africa generates intricate ethical issues such as possible exploitation, the use of incentives, informed consent, involving vulnerable populations and benefit sharing for local participants (Van Niekerk 2013, pers. comm., 26 June 2013)1.

(South) Africa was indeed for many years regarded as a ‘researcher’s paradise’ by Western researchers who worked in Africa and were seemingly exempt from the stringent regulations for ethical research applicable in their home countries (Van Niekerk and Benatar, 2011: 144). In the midst of the current increase in multinational research, it is important to consistently hold practitioners to the highest ethical standard, monitor implementation of research studies and ensure the well-being of participants.

Research ethics become predominantly challenging when there is an economic gap between researchers and subjects. For instance, in the case of HIV and AIDS in Africa, the burden is so great that subjects are often eager to participate, regardless of the infringements of their rights, in the hope of getting treatment. This involvement of vulnerable populations, especially when HIV and AIDS patients may not have access to other forms of treatment, requires great care to conduct ethically. It is therefore important for researchers to acknowledge that the processes involved in ethical research may be compromised in African countries where wide social disparities and weak social welfare systems exist along with therapeutic misconceptions and illiteracy (Mamotte et al., 2010).

Further to the research conduct itself, major concerns over the practices and capacity of ethical review committees’ operations also remain2. Most African research ethics committees do not have the adequate resources, expertise and capacity of institutional and national research committees, required to conduct ethical reviews and subsequent monitoring of health research. Due to this lack of resources, expertise and capacity at the institutional level, ethics review committees are at risk of accepting even ethically challenged research, considering the financial benefit the organisation and community may get from the research.

Throughout the evaluation conducted by Creative Consulting & Development Works, the team strived to address challenges faced in this sector and identify clinical trials and ethics review committees best practice.

The organisation evaluated was established in 2003, to address the global health crisis caused by HIV and AIDS, TB and malaria. In all sub-Saharan African countries where the organisation is facilitating clinical trials, funding is also provided for the establishing, development and support of ethics review capacity. The 75 ethics programmes reviewed in the 2013 evaluation were involved in the parent organisation’s intervention to build capacity for ethical review and increase the relevance of clinical trials for indigenous populations, cultural sensitivity and quality of life.

Strengthening ethics committees with capacity, knowledge, infrastructure and effective review and monitoring tools provides countries with the ability to independently lend oversight of national and multi-site international research in Africa. Knowledge dissemination is in turn encouraged through the organisation, and the facilitation of ethical issues workshops for researchers, policy formulators, clinicians, municipality representatives, research regulators, academics, civil society and opinion leaders in the field of human subjects research.

Our team confirmed that building the capacity of ethical review boards has contributed to a number of improvements in the sector. Best practices are identified, research studies are conducted by qualified investigators and there is a fair selection of research participants into studies.

Fair selection and use of qualified researchers leads to a higher quality of research to be approved by the National Ethics Committees (NECs) and Institutional Review Boards (IRBs), and to the development of relevant conclusions and recommendations derived from study results on HIV, TB and Malaria. NECs are in turn better able to ensure that international research conducted in their respective countries benefits the local population, emphasising benefit sharing in the developing world.

Creation of clinical trial databases and registries by IRBs, provides the general population and other researchers with information on studies taking place in the country. Research subjects are able to ensure the study has received ethics approval, while investigators can follow research results in order to promote best practices in ethical research conduct and prevent the duplication of studies. This, coupled with increased reporting of serious and adverse events during research procedures, raises the general public’s level of trust towards the research community.

Promoting collaborative research partnerships between communities and investigators facilitates community rights and community ownership, both fundamental benchmarks for the conduct of ethical research in developing countries. In addition, trained community members play a critical role when Community Advisory Boards (CAB) are established as a voice for study participants and the community. The CAB ensures community concerns are considered during clinical research studies, while advising investigators on target community demographics, culture and how to efficiently obtain informed consent.

There are potentially countless innovations ready to be developed to address global challenges in both the social and physical sciences. As the research ethics field continues to grow, we need to ask how we as development researchers can remove barriers to ethical participatory research while ensuring that the research produced in Africa is scientifically and contextually relevant. This evaluation suggested that investing in comprehensive ethical review enhances the development of academia, society (specifically in developing countries), and human rights in general.

Creative Consulting and Development Works, The Benefits of Ethical Review in African Research

[1] Prof. Anton van Niekerk, Centre for Applied Ethics, Stellenbosch University. Training on 26 June 2013: Research Ethics Committees in Africa: background, constitution and assessment.
[2] Department of Health. 2006. Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa. Pretoria.

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