6.4: References

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Boutron, I., Moher, D., Altman, D. G., Schulz, K. F., Ravaud, P., and CONSORT Group.

2008. Extending the CONSORT statement to randomized trials of nonpharmacologic treat-

ment: explanation and elaboration. Annals of Internal Medicine, 148, 295–309.
Council for International Organizations of Medical Sciences (CIOMS). 2009. International

ethical guidelines for epidemiological studies [Online]. Geneva: CIOMS. Available at: <http://

www.ufrgs.br/bioetica/cioms2008.pdf>.
D’Arcy Hart, P., Sutherland, I., and Thomas, J. 1967. The immunity conferred by effective

BCG and vole bacillus vaccines, in relation to individual variations in induced tuberculin

sensitivity and to technical variations in the vaccines. Tubercle, 48, 201–10.
Edwards, S. J., Braunholtz, D. A., Lilford, R. J., and Stevens, A. J. 1999. Ethical issues in the

design and conduct of cluster randomised controlled trials. BMJ, 318, 1407–9.
Groves, A. K., Maman, S., Msomi, S., Makhanya, N., and Moodley, D. 2010. The complexity of consent: women’s experiences testing for HIV at an antenatal clinic in Durban, South Africa.

AIDS Care, 22, 538–44.
International Conference On Harmonisation. 1996. Technical requirements for registration of

pharmaceuticals for human use: guideline for good clinical practice E6(R1) [Online]. Available at: <http://www.ich.org/fileadmin/Public_...s/Efficacy/E6/ E6_R1_Guideline.pdf>.

Lema, V. M., Mbondo, M., and Kamau, E. M. 2009. Informed consent for clinical trials: a re- view. East African Medical Journal, 86, 133–42.

Molineaux, L. and Gramiccia, G. 1980. The Garki Project: research on the epidemiology and con- trol of malaria in the Sudan Savanna of West Africa [Online]. Geneva: World Health Organi- zation. Available at: <http://garkiproject.nd.edu/static/do...rkiproject.pdf>.

Nuffield Council On Bioethics. 2002. The ethics of research related to healthcare in developing countries [Online]. London: Nuffield Council on Bioethics. Available at: <http:// nuffieldbioethics.org/wp-content/uploads/2014/07/Ethics-of-research-related-to- healthcare-in-developing-countries-I.pdf>.

Nuffield Council On Bioethics. 2005. The ethics of research related to healthcare in developing countries: a follow-up discussion paper [Online]. London: Nuffield Council on Bioethics. Available at: <nuffieldbioethics.org/wp-cont.../HRRDC_Follow- up_Discussion_Paper.pdf>.

Rid, A., Saxena, A., Baqui, A. H., et al. 2014. Placebo use in vaccine trials: recommendations of a WHO expert panel. Vaccine, 32, 4708–12.

Schulz, K. F., Altman, D. G., and Moher, D. 2010. CONSORT 2010 statement: updated guide- lines for reporting parallel group randomised trials. PLoS Med, 7, e1000251. Available at: <http://www.plosmedicine.org/article/...l.pmed.1000251>.

World Medical Association. 2008. Declaration of Helsinki: ethical principles for medical research involving human subjects [Online]. World Medical Association. Available at: <www. wma.net/en/30publications/10policies/b3/17c.pdf>.