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WVU PSYC 101 - The Structure and Function of Research Ethics

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PLoS Medicine | www.plosmedicine.org0026Policy FourmJanuary 2007 | Volume 4 | Issue 1 | e3According 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. Rivera 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.The Policy Forum allows health policy makers around the world to discuss challenges and opportunities for improving health care in their societies.The Structure and Function of Research Ethics Committees in Africa: A Case Study Nancy E. Kass*, Adnan Ali Hyder, Ademola Ajuwon, John Appiah-Poku, Nicola Barsdorf, Dya Eldin Elsayed, Mantoa Mokhachane, Bavon Mupenda, Paul Ndebele, Godwin Ndossi, Bornwell Sikateyo, Godfrey Tangwa, Paulina TindanaMost literature examining research ethics committees comes from wealthier countries.Funding: This project was funded, in part, by a grant from the Fogarty International Center, National Institutes of Health R25 TW01604.Competing Interests: The authors have declared that no competing interests exist.Citation: Kass NE, Hyder AA, Ajuwon A, Appiah-Poku J, Barsdorf N (2007) The structure and function of research ethics committees in Africa: A case study. PLoS Med 4(1): e3. doi:10.1371/journal.pmed.0040003Copyright: © 2007 Kass et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Abbreviations: FWA, Federal Wide Assurance; IRB, institutional review board; JHU, Johns Hopkins University; REC, research ethics committee; WHO, World Health OrganizationNancy E. Kass is the Phoebe R. Berman Professor of Bioethics and Public Health, and Adnan Ali Hyder is an Assistant Professor, Berman Institute of Bioethics, Johns Hopkins School of Public Health, Baltimore, Maryland, United States of America. Ademola Ajuwon is a Senior Lecturer, African Regional Health Education Centre, Department of Health Promotion and Education, College of Medicine, University of Ibadan, Ibadan, Nigeria. John Appiah-Poku is a Lecturer and institutional review board administrator, Komfo Anokye Teaching Hospital, Department of Behavioral Sciences, School of Medical Sciences, Kwame Nkrumah, University of Science and Technology, Kumasi, Ghana. Nicola Barsdorf is Project Coordinator for the Ethics, Law and Human Rights Working Group WHO/UNAIDS African AIDS Vaccine Programme, School of Psychology, University of KwaZulu-Natal, Pietermaritzburg, KwaZulu-Natal, South Africa. Dya Eldin Elsayed is an Assistant Professor, Department of Community Medicine, Faculty of Medicine, Alzaiem Alazhari University, Khartoum North, Sudan. Mantoa Mokhachane is Head of the Neonatal Unit, Chris Hani Baragwanath Hospital, Meyersdal, Gauteng, South Africa. Bavon Mupenda is Lecturer, Tropical Institute of Community Health and Development in Africa, Kisumu, Kenya. Paul Ndebele is Visiting Lecturer, University of Malawi Medical Research Council of Zimbabwe, Harare, Zimbabwe. Godwin Ndossi is Managing Director, Tanzania Food and Nutrition Centre, Dar es Salaam, Tanzania. Bornwell Sikateyo is a Research, Monitoring and Evaluation Specialist, Lusaka, Zambia. Godfrey Tangwa is Professor and Head of the Philosophy Department, University of Yaounde, Yaounde, Cameroon. Paulina Tindana is Research Offi cer/Bioethicist, Navrongo Health Research Centre, Ministry of Health, Navrongo U/E Region, Ghana.* To whom correspondence should be addressed. E-mail: [email protected] Medicine | www.plosmedicine.org0027MethodsThe Johns Hopkins Bloomberg School of Public Health received a training grant from the Fogarty International


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