The Structure and Function of Research Ethics Committees in Africa:
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Date
2007
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PLoS medicine
Abstract
According to international guidelines [1,2] and several nations’ laws [3–5], research with humans requires independent ethics committee review. In the United States, committees are called institutional review boards (IRBs) [6]; elsewhere they generally are called research ethics committees (RECs). Committees are designed to: provide third party review, thereby minimizing confl icts of interest; protect the welfare of research participants through attention to risks, benefi ts, and informed consent; and avoid exploitation of vulnerable individuals and populations. Most literature examining RECs comes from wealthier countries. One US study found “serious concerns” with the quality of 14% of IRB reviews [7]. Another found that IRBs focused predominantly on consent documentation, spending less time examining voluntariness, selection of participants, and risk [8]. Many US [9–15] and international [16–18] studies have found that different research ethics committees reach different conclusions when reviewing the same study. Several scholars and advisory bodies have made recommendations to address challenges facing US IRBs [19–22]. However, there has been little research examining procedures, strengths, and challenges of RECs in developing countries. Two case reports describe disagreements between host and sponsoring country RECs [23,24], and an international survey reports differences in sponsoring and host country reviews [25]. Three articles describe RECs within one country (Turkey [26], Granada [27], and Sudan [28]), and fi ve within a larger region.
MethodsThe Johns Hopkins Bloomberg School of Public Health received a training grant from the Fogarty International Center in 2000 to train three African professionals in bioethics each year [33]. Several of these professionals explicitly seek to increase the scholarly and administrative capacity of their African RECs. In 2004, program faculty and trainees created a structured questionnaire to document the history, composition, functioning, fi nancing, strengths, and challenges of RECs with which the trainees were affi liated. Questionnaires were completed by e-mail. Follow up e-mails clarifi ed responses. Data were entered into Microsoft Excel and tabulated. Trainees and faculty met for two days in 2005 to refi ne concepts and work on the manuscrip
Results of Our Case Study
Eleven of the 12 trainees who attended the program in 2001–2004 collaborated. Nine had personal experience on one or more African REC. Another trainee secured information from her institution’s REC; one contributed no data. One trainee worked with two committees in his country; another worked with two committees from two countries. Twice, two trainees from the same country were affi liated with different RECs. Thus, twelve RECs were included in this case study from nine African countries: Democratic Republic of the Congo, Ghana (2), Kenya, Nigeria, South Africa (2), Sudan (2), Tanzania, Zambia, and Zimbabwe.Two RECsRivera described 20 RECs in Latin America, fi nding that only 45% had standard operating procedures and that members had limited training [29]. Coker examined RECs in Central and Eastern Europe [30]. Ten countries had national committees, most committees included non-medical members, and three provided training. The World Health Organization’s (WHO) Southeast Asian Regional Offi ce, fi nding that only some of the 16 respondents had national RECs, called for capacity development in the area of research ethics [31]. The WHO African Regional Offi ce found that 36% of member countries had no REC. In the countries that did have RECs, most RECs met monthly, fi ve met quarterly, and one never met [32]. Finally, Milford examined African RECs’ resource needs in the context of HIV vaccine trial preparedness, fi nding that 97% believed African RECs had inadequate training in ethics and HIV vaccine trials and 80% believed African RECs had inadequate training in health research ethics. Additional information on how African RECs function, including their staffi ng, operating procedures, strengths, and challenges would be useful for African and international researchers working within Africa, and for growing efforts to enhance ethics capacity on this vast continent. We therefore used a case study approach to shed light on the structure and functioning of RECs in Africa.
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Keywords
Research Ethics, Africa
Citation
Kass, N.E., Hyder, A.A., Ajuwon, A., Appiah-Poku, J., Barsdorf, N., Elsayed, D.E., Mokhachane, M., Mupenda, B., Ndebele, P., Ndossi, G. and Sikateyo, B., 2007. The structure and function of research ethics committees in Africa: a case study. PLoS medicine, 4(1).