Conflict of interest statement: No conflicts declared
Feedback of Research Findings for Vaccine Trials: Experiences from Two Malaria Vaccine Trials Involving Healthy Children on the Kenyan Coast
Article first published online: 21 FEB 2013
© 2013 Blackwell Publishing Ltd
Developing World Bioethics
Special Issue: Field workers at the interface between research institutions and local communities
Volume 13, Issue 1, pages 48–56, April 2013
How to Cite
Gikonyo, C., Kamuya, D., Mbete, B., Njuguna, P., Olotu, A., Bejon, P., Marsh, V. and Molyneux, S. (2013), Feedback of Research Findings for Vaccine Trials: Experiences from Two Malaria Vaccine Trials Involving Healthy Children on the Kenyan Coast. Developing World Bioethics, 13: 48–56. doi: 10.1111/dewb.12010
- Issue published online: 22 MAR 2013
- Article first published online: 21 FEB 2013
- KEMRI-Wellcome Trust (Strategic Award and fellowship to SM)
- 1Efforts To Communicate Clinical Trial Results to Patients Face Uphill Climb. Journal of the National Cancer Institute 2007; 99: 11–13; CIOMS. 2002. International Ethical Guidelines for Biomedical Research involving Human Subjects. Council for International Organsiations of Medical Science; , et al. Communication of pharmacogenetic research results to HIV-infected treated patients: standpoints of professionals and patients. Eur J Hum Genet 2005; 13: 1055–1062;Nuffield Council on Bioethics. 2005. The ethics of research related to healthcare in developing countries. London: Nuffield Council on Bioethics. Available at: http://www.nuffieldbioethics.org/sites/default/files/HRRDC_Follow-up_Discussion_Paper.pdf [Accessed 2 Nov 2012]; World Medical Association (WMA). 2000. Ethical Principles for Medical Research Involving Human Subjects-Declaration of Helsinki. Ferney-Voltaire: WMA. Available at: http://www.wma.net/en/30publications/10policies/b3/17c.pdf [Accessed 2 Nov 2012]..
- 2See for example Receiving a summary of the results of a trial: qualitative study of participants’ views. Bmj 2006; 332: 206–210;Considerations and costs of disclosing study findings to research participants. Cmaj 2004; 170: 1417–1419;Informing Clinical Trial Participants About Study Results. JAMA: The Journal of the American Medical Association 2002; 288: 363–365;Communicating the Results of Clinical Research to Participants: Attitudes, Practices, and Future Directions. PLoS medicine 2008; 5: e91;Researchers Push for Sharing of Trial Results with Participants. Journal of the National Cancer Institute 2002; 94: 1049–1050., et al.
- 4See for example Offering Individual Genetic Research Results: Context Matters. Sci Transl Med 2010; 2: 38cm20;Ethical and practical guidelines for reporting genetic research results to study participants: updated guidelines from a National Heart, Lung, and Blood Institute working group. Circ Cardiovasc Genet 2010; 3: 574–580.& .
- 6.& . op. cit. note
- 7See Bejon et al., 2006 & 2008; Lusingu, et al., 2010 and Olutu, et al. 2011 for further reading on the FFM ME-TRAP & RTS,S/ASO1E vaccine trials.
- 8See Molyneux et al., 2006 & 2008; and Gikonyo et al., 2008 for further reading on the community engagement and informed consent processes and post vaccination quizzes and discussions with parents of children enrolled in the FFM ME-TRAP trial.
- 9Taking social relationships seriously: lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast. Soc Sci Med 2008; 67: 708–720;Incorporating a quiz into informed consent processes: Qualitative study of participants’ reactions. Malaria Journal 2007; 6: 145., et al.
- 10This suggestion is clearly problematic, and illustrates how on-going social relations influence participants’ hopes and expectations regarding findings, as discussed further later in the paper.