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Role of E-Learning in Teaching Health Research Ethics and Good Clinical Practice in Africa and Beyond

  • R. CHILENGI, A. NYIKA, G. B. TANGWA, R. A. NOOR, S. W. RAMADHANI, S. BOSOMPRAH and W. L. KILAMA...

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1. Declaration of Helsinki. World Medical Association. Ethical Principles for Medical Research Involving Human Subjects. Edinburgh: World Medical Association; 2008.

2. Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: Council for International Organizations of Medical Sciences; 2002.

3. International Conference on Harmonization (ICH). Good Clinical Practice (GCP) ICH Harmonized Tripartite Guideline on Good Clinical Practice. Geneva: World Health Organization; 1996, ICH/GCP, E6. (R1).

4. Levine, RJ.Institutional review boards: A crisis in confidence. Annals of Internal Medicine 2001;132(2):161–3.

5. Sugar, AM.The crisis in local institutional review boards. Annals 2002;136:410–7.

6. Burman, WL, Reves, RR, Cohn, DL, Schooley, RT.Breaking the camel’s back: Multicenter clinical trials and local institutional review boards. Annals of Internal Medicine 2001;134:152–7.

7. Siegfried, N, Clarke, M, Volmink, J.Randomised controlled trials in Africa of HIV and AIDS: Descriptive study and spatial distribution. British Medical Journal 2005;331:742–7.

8. Hyder, AA, Wali, SA, Khana, AN, Teoh, NB, Kass, NE, Dawson, L.Ethical review of health research: A perspective from developing country researchers. Journal of Medical Ethics 2004;30:6872.

9. See note 8, Hyder et al. 2004.

10. Kirigia, JM, Wambebe, C, Baba-Moussa, A.Status of national research bioethics committees in the WHO African region. Journal of Medical Ethics 2005;6:1016.

11. Kass, NE, Hyder, AA, Ajuwon, A, Appiah-Poku, J, Barsdorf, N, Eldin Elsayed, D, et al. The structure and function of research ethics committees in Africa: A case study. PLoS Medicine 2007;4:e3. doi:10.1371/journal.pmed.0040003.

12. Nyika, A, Kilama, WL, Chilengi, R, Tangwa, GB, Tindana, P, Ndebele, P, et al. . Composition, training needs and independence of ethics review committees across Africa: Are the gate-keepers rising to the emerging challenges? Journal of Medical Ethics 2009;35:189–93. doi:10.1136/jme.2008.025189.

13. Kilama, WL.Ethical perspective on malaria research for Africa. Acta Tropica 2005;95:276–84.

14. See note 12, Nyika et al. 2009.

15. See note 12, Nyika et al. 2009.

16. Ezekiel, JE, Wendler, D, Grady, C.What makes clinical research ethical? JAMA 2000;283(20):2701–11.

17. See note 16, Ezekiel et al. 2000.

We acknowledge various contributions made by the following individuals: Paulina Tindana, Rosemary Kingamkono, and Joyce Ikingura; Djuaka Rousseau; Rosemary Msesengwa; Paul Ndebele; Joseph Mathew Mfutso-bengo; Edfonse Nfuka; and evaluation workshop participants. The AMANET e-learning project was initially funded by the European Developing Countries Clinical Trials Partnership (EDCTP).

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Role of E-Learning in Teaching Health Research Ethics and Good Clinical Practice in Africa and Beyond

  • R. CHILENGI, A. NYIKA, G. B. TANGWA, R. A. NOOR, S. W. RAMADHANI, S. BOSOMPRAH and W. L. KILAMA...

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