Background

 

Fogarty International Center
National Institutes of Health
Grant Number 5 R25 TW001599-17

 

Extended Background and Rationale

SARETI is an Africa-based, multi-disciplinary consortium focussing on ethics and human rights in health research. SARETI staff between them have expertise in Public Health, Medicine, Psychology, Sociology, Basic Medical Sciences, Dentistry, Law, Human Rights, Philosophy, Ethics and Bioethics, and provide high quality education and research in health research ethics. SARETI has close links with a major US collaborator (the Johns Hopkins University, Bioethics Institute) and has representation from several other African countries, the European Union and the USA to ensure a global perspective. SARETI has built on existing modules and courses to create comprehensive, flexible, and innovative education and training programmes in health research ethics. SARETI training enables students from Africa and further afield to specialise in health research ethics and to become leaders in this field. Finally, some of the modules used for advanced training are offered as individual short courses aimed at increasing the capability of Research Ethics Committee members in dealing with the increasingly difficult issues facing African RECs as research decisions become more challenging and complex.

Why does Africa need training in Health Research Ethics?

High quality ethics review capacity is a key component of health research systems. Research that is unethical does not lead to useful interventions, and may ultimately do more harm as people become progressively more reluctant to participate in legitimate health research. Furthermore, when health research is conducted by researchers from developed countries in the developing world, and in Africa in particular, the social, cultural, and economic context of the research has a major bearing on ethical conduct of research.

Kirigia et al. (2005) found that 36% of World Health Organisation member states in Africa did not have formal research ethics committees (RECs), although many of these had ad hoc review systems in place. The need for undergraduate and postgraduate research ethics training is emphasised by these authors. Milford, Wassenaar et al. (2006) surveyed African countries with the capacity to conduct phase III HIV vaccine trials and found that only 40% of all REC members had any ethics training prior to serving on an REC and that only 52% overall had received any training after joining the REC.  Similar data emerged from a SARETI graduate study in Tanzania where only 51% of REC members surveyed reported receiving any research ethics training (Ikingura, Kruger, et al., 2007). A study by Kass et al. (2007) found that 16% of RECs surveyed had members with no ethics training; 50% had members with some Fogarty-funded ethics training, and the remainder had had some ad hoc workshops or GCP training. A SARETI graduate, Nyika et al. (2008) surveyed 31 African RECs and found that only 35% of RECs offered training to new members and only 54% offered training to members after joining, concluding that “inadequate training” (p. 5) of REC members was a major problem, given the growing volume and complexity of health research in Africa. A similar study in the East Mediterranean region (Abou-Zeid et al., 2009) found that only 21% of REC members had any formal training in research ethics, while 53% had no ethics training. Ateudjieu et al. (2010) surveyed three African countries and found that up to 71% of respondent members of RECs had received some ethics training, but the training was found to be rather short and superficial, largely delivered through short workshops. The above studies found that African RECs have an average of 11 member, suggesting that there are at least 1876 REC members in Africa, of whom at least 50% have received no substantive ethics training.

 

In addition to all the regular issues that arise in research ethics (e.g., Community Participation, Scientific Validity, Social Value, Fair Selection of Study Participants, Favorable Risk Benefit ratio, Valid Informed Consent, Independent Review, and Ongoing Respect for Participants; cf. Emanuel et al., 2008), recent papers argue clearly that RECs need to be more aware of promoting capacity development (IJsselmuiden et al., 2010) and ensuring that research aligns with local health policy and development agendas (Abdool Karim et al., 2010a; Sewankambo et al., 2008). Furthermore, some critics (Philpott et al., 2010) suggest that despite investment by foreign donors, ethics review of controversial studies (Abdool Karim et al., 2010b) in Africa remains inadequate. Research ethics training requires ongoing effort, even for those that have been trained (Rwabihama et al., 2010), as the research ethics agenda changes with regional development and health agendas, and the growing complexity of research and clinical trial designs (e.g., adaptive trial designs, (FDA, 2010; Hung et al., 2006); and globalized clinical trials (Annas, 2009; Glickman et al., 2009: Normile, 2008) in developing countries (Hyder et al., 2009; Lorenzo et al., 2010)).

 

 

Why should Health Research Ethics Training for Africa be based in Africa?

The relative lack of trained research ethicists and of advanced institutional research ethics training capacity in Africa means that African views on the ethics of health research are neither sufficiently developed nor heard. For example, in the controversy related to ‘standards of care’ in clinical trials in developing nations, both sides of the debate are represented almost exclusively by researchers and ethicists from the developed world, even though this is an ethical issue of crucial importance to the developing world. Furthermore, Africa is also generating its own ethical problems in health research. For example, alleged research on sexual reorientation therapy, the development of poisonous substances by medical practitioners for political ends, unauthorised trials in South Africa and Tanzania of an anti-AIDS preparation, and fraud in experimental treatments for breast cancer. Given the level of leadership needed to deal with complex and urgent ethical dilemmas in research, it is essential that Africa be able to mount its own training programmes in this field to deal with problems that affect Africa directly. To date, this need has only been marginally addressed.

Why is an African Health Research Ethics Training initiative best located in South Africa?

South Africa’s academic resources, faculty, and research enterprise are generally better funded and more numerous than elsewhere in Africa, placing South Africa in a prime position to provide high level research ethics education for African stake-holders. At the same time, its social and health problems are perhaps as great as in most countries in Africa, and the gap between wealth and poverty is stark. The enormity of its health problems, particularly the HIV epidemic, is staggering, with AIDS now the leading cause of death in adults. Experiences gained here will thus be relevant to professionals from across the continent, as well as to professionals from elsewhere in the developed world.

Given South Africa’s stable political institutions, its linkage to all countries on the continent through New Partnership for Africa’s Development (NEPAD), and its excellent transport, accommodation, communication and financial infrastructure, South Africa provides the right environment for an intense, engaged, relevant and productive study of health research ethics in Africa. South Africa is also sufficiently cosmopolitan to enable all Africa’s nations to have representation, and often formal collaboration.

The University of KwaZulu-Natal is one of South Africa’s leading research universities, based on available measures of research output (2005), provides world class education and facilities, and offers an academic home to many graduate students from elsewhere in Africa. Its location makes it a logical gateway to other countries in sub-Saharan Africa: the capitals of Mozambique, Zimbabwe, Botswana, Namibia, Swaziland and Zambia are closer to us than we are to our most southern city of Cape Town. Most are within comfortable driving distance to SARETI, which is based in Pietermaritzburg.

 


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