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Taking social relationships seriously: Lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast

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  • Gikonyo, Caroline
  • Bejon, Philip
  • Marsh, Vicki
  • Molyneux, Sassy

Abstract

Individual informed consent is a key ethical obligation for clinical studies, but empirical studies show that key requirements are often not met. Common recommendations to strengthen consent in low income settings include seeking permission from community members through existing structures before approaching individuals, considering informed consent as a process rather than a single event, and assessing participant understanding using questionnaires. In this paper, we report on a qualitative study exploring community understanding and perceptions of a malaria vaccine trial (MVT) conducted in a rural setting on the Kenyan Coast. The MVT incorporated all of the above recommendations into its information-giving processes. The findings support the importance of community level information-giving and of giving information on several different occasions before seeking final individual consent. However, an emerging issue was that inter-personal interactions and relationships between researchers and community members, and within the community, play a critical role in participants' perceptions of a study, their decisions to consent or withdraw, and their advice to researchers on study practicalities and information to feedback at the end of the trial. These relationships are based on and continually tested by information-giving processes, and by context specific concerns and interests that can be difficult to predict and are well beyond the timescale and reach of single research activities. On the basis of these findings, we suggest that the current move towards increasingly ambitious and stringent formal standards for information-giving to individuals be counter-balanced with greater attention to the diverse social relationships that are essential to the successful application of these procedures. This may be assisted by emphasising respecting communities as well as persons, and by recognising that current guidelines and regulations may be an inadequate response to the complex, often unpredictable and ever shifting ethical dilemmas facing research teams working 'in the field'.

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  • Gikonyo, Caroline & Bejon, Philip & Marsh, Vicki & Molyneux, Sassy, 2008. "Taking social relationships seriously: Lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast," Social Science & Medicine, Elsevier, vol. 67(5), pages 708-720, September.
    • Handle: RePEc:eee:socmed:v:67:y:2008:i:5:p:708-720
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    References listed on IDEAS

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    1. Molyneux, C.S. & Peshu, N. & Marsh, K., 2005. "Trust and informed consent: insights from community members on the Kenyan coast," Social Science & Medicine, Elsevier, vol. 61(7), pages 1463-1473, October.
    2. Marsh, Vicki & Kamuya, Dorcas & Rowa, Yvonne & Gikonyo, Caroline & Molyneux, Sassy, 2008. "Beginning community engagement at a busy biomedical research programme: Experiences from the KEMRI CGMRC-Wellcome Trust Research Programme, Kilifi, Kenya," Social Science & Medicine, Elsevier, vol. 67(5), pages 721-733, September.
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    8. Molyneux, C. S. & Peshu, N. & Marsh, K., 2004. "Understanding of informed consent in a low-income setting: three case studies from the Kenyan coast," Social Science & Medicine, Elsevier, vol. 59(12), pages 2547-2559, December.
    9. Edwards, Sarah J. L. & Lilford, Richard J. & Thornton, Jim & Hewison, Jenny, 1998. "Informed consent for clinical trials: in search of the "best" method," Social Science & Medicine, Elsevier, vol. 47(11), pages 1825-1840, December.
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    3. Katwa, Joseph Kigen & Joyce Lugulu, 2022. "Understanding Informed Consent: An in Depth Analysis," International Journal of Research and Innovation in Social Science, International Journal of Research and Innovation in Social Science (IJRISS), vol. 6(5), pages 762-769, May.
    4. Molyneux, Sassy & Geissler, P. Wenzel, 2008. "Ethics and the ethnography of medical research in Africa," Social Science & Medicine, Elsevier, vol. 67(5), pages 685-695, September.
    5. shuster, stef m., 2019. "Performing informed consent in transgender medicine," Social Science & Medicine, Elsevier, vol. 226(C), pages 190-197.
    6. Gouda, H.N. & Kelly-Hanku, A. & Wilson, L. & Maraga, S. & Riley, I.D., 2016. "“Whenever they cry, I cry with them”: Reciprocal relationships and the role of ethics in a verbal autopsy study in Papua New Guinea," Social Science & Medicine, Elsevier, vol. 163(C), pages 1-9.
    7. Kelly, Ann H. & Ameh, David & Majambere, Silas & Lindsay, Steve & Pinder, Margaret, 2010. "'Like sugar and honey': The embedded ethics of a larval control project in The Gambia," Social Science & Medicine, Elsevier, vol. 70(12), pages 1912-1919, June.
    8. Sariola, Salla & Simpson, Bob, 2011. "Theorising the 'human subject' in biomedical research: International clinical trials and bioethics discourses in contemporary Sri Lanka," Social Science & Medicine, Elsevier, vol. 73(4), pages 515-521, August.
    9. Marsh, Vicki & Kamuya, Dorcas & Rowa, Yvonne & Gikonyo, Caroline & Molyneux, Sassy, 2008. "Beginning community engagement at a busy biomedical research programme: Experiences from the KEMRI CGMRC-Wellcome Trust Research Programme, Kilifi, Kenya," Social Science & Medicine, Elsevier, vol. 67(5), pages 721-733, September.
    10. Maureen Njue & Francis Kombe & Salim Mwalukore & Sassy Molyneux & Vicki Marsh, 2014. "What Are Fair Study Benefits in International Health Research? Consulting Community Members in Kenya," PLOS ONE, Public Library of Science, vol. 9(12), pages 1-21, December.
    11. Reynolds, Lindsey & Cousins, Thomas & Newell, Marie-Louise & Imrie, John, 2013. "The social dynamics of consent and refusal in HIV surveillance in rural South Africa," Social Science & Medicine, Elsevier, vol. 77(C), pages 118-125.

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