Recent concerted efforts to address the Grand Challenges in Global Health^{1 2} and the 10/90 gap³ and to achieve the United Nations Millennium Development Goals (http://www.un.org/millenniumgoals/) have contributed to an unprecedented increase in health research involving humans in Africa. In the wake of such an increase in health research on mostly poverty-stricken and poorly educated populations, given Africa’s weak civic protection systems, it is imperative that attention be paid to the ethical review capacity of African health institutions. Review of research protocols before implementation is now regarded as one of the cornerstones of ethical research involving human participants, and some countries have made it a legal requirement.⁴ Various international and national guidelines also stipulate that ethical approval be a prerequisite for the commencement of research involving humans.

The main purpose of reviewing research protocols is to ensure that the research meets internationally acceptable scientific and ethical standards. It would be unethical for poorly designed research involving human beings to be approved, since data generated from such research would not contribute to the improvement of disease prevention or management. A holistic approach to reviewing research is critical, since issues that relate to ethical principles of autonomy, beneficence, non-maleficence and justice are equally important. One approach that has been proposed looks at seven requirements that should be considered when reviewing protocols, namely, the value of the research in terms of potential to improve health and/or knowledge, scientific validity in terms of experimental design, fair selection of participants in light of the scientific objectives of the research, favourable risk:benefit ratio with potential benefits outweighing potential risks, independent ethical review of the research before implementation, informed consent that emphasises voluntary participation, and respect for the participants recruited.⁵ In addition, community engagement has recently been recognised as a critical activity that helps to create an amicable relationship between researchers and the communities from which participants are drawn and demonstrates respect for communities as partners in research.^{6 7} It is imperative that ethical review committees (ERCs) that review the protocols are adequately knowledgeable about all these requirements; otherwise the welfare of people is compromised by approval of unethical research or wrongful rejection of scientifically and ethically sound research.

Although the requirements could be assessed during the review process, implementation of approved research protocols in the field, especially in developing countries, is bound to encounter practical challenges that are attributable to socio-economic factors.^8–13 Thus, ethical approval alone does not necessarily ensure protection of the safety and welfare of research participants throughout the research; hence the need for approved research to be monitored by ERCs. Ethical review and subsequent monitoring of health research require adequate resources and trained ERCs, which are limited in various ways in most African committees.

Thus, although the majority of countries in Africa are reported to now have at least some form of ethical review process in place,^14–16 the operations of these processes are generally hindered by a combination of challenges, including scarcity of resources, inadequate training of members and poor staffing levels.^{14 16 17} For instance, a study on health research ethics review and needs of institutional ERCs in Tanzania showed that 49% of 45 respondents had not had any training in health research ethics review.¹⁸ Milford and colleagues also reported on the extent to which limited resources available to ethics committees in Africa could affect preparations for HIV vaccine trials.¹⁷ Another example is a case study of 12 African ERCs that showed inadequate training of committee members and shortage of resources to be some of the major challenges faced by the committees.¹⁹

In light of the relatively weak ethical review capacity in Africa, it is encouraging to note that a number of not-for-profit African organisations are involved in capacity-building programmes. The South African Research Ethics Training Initiative (SARETI) (http://shsph.up.ac.za/sareti/sareti.htm), which is based at the universities of KwaZulu-Natal and Pretoria in South Africa, provides training in ethics to African researchers and ERC members through short-term fellowships and long-term educational programmes. Another programme based in South Africa is the International Research Ethics Network for Southern Africa (IRENSA) (http://www.irensa.org), based at the University of Cape Town, which runs short-term training programmes for mid-career African academics, scientists, clinicians and members of ERCs who generally cannot enrol for long-term, full-time programmes. An additional organisation involved in providing educational programmes in Africa is the Training and Resources in Research Ethics Evaluation (TRREE) (http://www.trree.org/site/en_home.phtml) for Africa, which focuses on development of research ethics educational programmes for e-learning and provision of e-resources.

The African Malaria Network Trust (AMANET) (http://www.amanet-trust.org) is also a not-for-profit organisation that was formed in 2002, succeeding the then African Malaria Vaccine Testing Network, founded in 1995 to promote malaria vaccine trials in Africa. Although the broad objective of AMANET is still the same as that of its predecessor, the roles and activities of AMANET have been expanded to include (1) trial site development for malaria vaccine trials, which entails infrastructural development and training of research personnel in various scientific fields, (2) strengthening of ethical review capacity in Africa and (3) sponsorship of malaria vaccine clinical trials.

The current study by AMANET was aimed at finding specific gaps in the ethical review process in Africa with a view to effectively implementing a capacity-building programme tailor-made for the identified needs. Having such empirical data would go a long way towards ensuring that any interventions would complement efforts by others in this field rather than duplicate their activities, although a certain amount of overlap is both inevitable and harmless. The paucity of resources for ethical review process in Africa and the need to strengthen the process through various training programmes make it critical for the organisations working in this field to streamline their activities and programmes and promote synergistic collaborative efforts. Indeed, the efforts of the organisations are beginning to bear fruit. For instance, two ethicists working in the AMANET programmes are products of the SARETI training programmes, and an additional ethicist working with AMANET also actively takes part in both IRENSA and SARETI programmes.

In order to fill the gaps identified by the needs assessment survey, AMANET targeted ERCs as entities rather than individual members of the committees, an aspect being addressed by other organisations. Collaboration with the Pan African Bioethics Initiative started at the design stage of the current project and has continued to the implementation stage, where the two organisations jointly conduct some training workshops on health research ethics. This paper reports on the findings of the needs assessment survey and gives an overview of a longitudinal capacity-building project by AMANET.