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  1. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects.World Medical Association - 2009 - Jahrbuch für Wissenschaft Und Ethik 14 (1):233-238.
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  • Composition, training needs and independence of ethics review committees across Africa: are the gate-keepers rising to the emerging challenges?A. Nyika, W. Kilama, R. Chilengi, G. Tangwa, P. Tindana, P. Ndebele & J. Ikingura - 2009 - Journal of Medical Ethics 35 (3):189-193.
    Background: The high disease burden of Africa, the emergence of new diseases and efforts to address the 10/90 gap have led to an unprecedented increase in health research activities in Africa. Consequently, there is an increase in the volume and complexity of protocols that ethics review committees in Africa have to review. Methods: With a grant from the Bill and Melinda Gates Foundation, the African Malaria Network Trust (AMANET) undertook a survey of 31 ethics review committees (ERCs) across sub-Saharan Africa (...)
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  • Status of national research bioethics committees in the WHO African region.Joses Kirigia, Charles Wambebe & Amido Baba-Moussa - 2005 - BMC Medical Ethics 6 (1):1-7.
    Background The Regional Committee for Africa of the World Health Organization (WHO) in 2001 expressed concern that some health-related studies undertaken in the Region were not subjected to any form of ethics review. In 2003, the study reported in this paper was conducted to determine which Member country did not have a national research ethics committee (REC) with a view to guiding the WHO Regional Office in developing practical strategies for supporting those countries. Methods This is a descriptive study. The (...)
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  • Ethics Committees in Western and Central Africa: Concrete Foundations.Pierre Effa, Achille Massougbodji, Francine Ntoumi, François Hirsch, Henri Debois, Marissa Vicari, Assetou Derme, Jacques Ndemanga-Kamoune, Joseph Nguembo, Benido Impouma, Jean-Paul Akué, Armand Ehouman, Alioune Dieye & Wen Kilama - 2007 - Developing World Bioethics 7 (3):136-142.
    The involvement of developing countries in international clinical trials is necessary for the development of appropriate medicines for local populations. However, the absence of appropriate structures for ethical review represents a barrier for certain countries. Currently there is very little information available on existing structures dedicated to ethics in western and central Africa. This article briefly describes historical milestones in the development of networks dedicated to capacity building in ethical review in these regions and outlines the major conclusions of two (...)
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  • How Independent Are IRBs?Ruth Macklin - 2008 - IRB: Ethics & Human Research 30 (3).
    What does it mean to say that ethics committees that provide prospective review of research involving human beings should be “independent”? In the United States, IRBs—which are typically located within and review research protocols at the institution for which most of their members work—cannot really be considered independent. Yet separating the IRB from the research institution may in turn mean less independence from a trial’s sponsors, as this kind of IRB is commercially motivated and paid directly by the sponsor. One (...)
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  • Continuing Ethics Review Practices by Canadian Research Ethics Boards.Karleen Norton & Donna Wilson - 2008 - IRB: Ethics & Human Research 30 (3).
    This study examined Canadian Research Ethics Board practices concerning continuing ethics review of approved studies. A mail-out questionnaire was used to elicit information from Canadian REB representatives about whether their board engaged in continuing ethics review, and, if so, what their methods were. The study found that a majority of REBs conduct continuing ethics review. REBs conduct continuing ethics review of clinical trial research significantly more often than of academic research. The study also found little difference in the frequency of (...)
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  • Conflicts of Interest in Research: How IRBs Address Their Own Conflicts.Leslie Wolf & Jolanta Zandecki - 2007 - IRB: Ethics & Human Research 29 (1).
    We conducted this study to determine whether medical schools address conflicts of interest among their IRB members and staff, and, if so, in what ways. We analyzed the conflict of interest policies for 121 U.S. medical schools whose research is funded by the National Institutes of Health. About three-quarters of the schools we studied have written policies that address IRB conflicts of interest, and almost 80% of them defined the term, although their definitions varied substantially. The majority of IRBs explicitly (...)
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