IDEAS home Printed from https://ideas.repec.org/a/eee/socmed/v67y2008i5p708-720.html
   My bibliography  Save this article

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

Author

Listed:
  • 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'.

Suggested Citation

  • 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
    as

    Download full text from publisher

    File URL: http://www.sciencedirect.com/science/article/pii/S0277-9536(08)00089-0
    Download Restriction: Full text for ScienceDirect subscribers only
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    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.
    3. MacQueen, K.M. & McLellan, E. & Metzger, D.S. & Kegeles, S. & Strauss, R.P. & Scotti, R. & Blanchard, L. & Trotter II, R.T., 2001. "What is community? An evidence-based definition for participatory public health," American Journal of Public Health, American Public Health Association, vol. 91(12), pages 1929-1938.
    4. Mitchell, Kirstin & Nakamanya, Sarah & Kamali, Anatoli & Whitworth, James A. G., 2002. "Balancing rigour and acceptability: the use of HIV incidence to evaluate a community-based randomised trial in rural Uganda," Social Science & Medicine, Elsevier, vol. 54(7), pages 1081-1091, April.
    5. Molyneux, C.S. & Wassenaar, D.R. & Peshu, N. & Marsh, K., 2005. "'Even if they ask you to stand by a tree all day, you will have to do it (laughter)...!': Community voices on the notion and practice of informed consent for biomedical research in developing countrie," Social Science & Medicine, Elsevier, vol. 61(2), pages 443-454, July.
    6. Benatar, S. R., 2002. "Reflections and recommendations on research ethics in developing countries," Social Science & Medicine, Elsevier, vol. 54(7), pages 1131-1141, April.
    7. Mechanic, David & Meyer, Sharon, 2000. "Concepts of trust among patients with serious illness," Social Science & Medicine, Elsevier, vol. 51(5), pages 657-668, September.
    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.
    10. Gilson, Lucy, 2003. "Trust and the development of health care as a social institution," Social Science & Medicine, Elsevier, vol. 56(7), pages 1453-1468, April.
    Full references (including those not matched with items on IDEAS)

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    1. Rosemann, Achim, 2014. "Standardization as situation-specific achievement: Regulatory diversity and the production of value in intercontinental collaborations in stem cell medicine," Social Science & Medicine, Elsevier, vol. 122(C), pages 72-80.
    2. 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.
    3. Gooding, Kate & Phiri, Mackwellings & Peterson, Ingrid & Parker, Michael & Desmond, Nicola, 2018. "Six dimensions of research trial acceptability: how much, what, when, in what circumstances, to whom and why?," Social Science & Medicine, Elsevier, vol. 213(C), pages 190-198.
    4. 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.
    5. 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.
    6. 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.
    7. 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.
    8. 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.
    9. shuster, stef m., 2019. "Performing informed consent in transgender medicine," Social Science & Medicine, Elsevier, vol. 226(C), pages 190-197.
    10. 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.
    11. 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.

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. 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.
    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.
    3. 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.
    4. Gooding, Kate & Phiri, Mackwellings & Peterson, Ingrid & Parker, Michael & Desmond, Nicola, 2018. "Six dimensions of research trial acceptability: how much, what, when, in what circumstances, to whom and why?," Social Science & Medicine, Elsevier, vol. 213(C), pages 190-198.
    5. Molyneux, C.S. & Wassenaar, D.R. & Peshu, N. & Marsh, K., 2005. "'Even if they ask you to stand by a tree all day, you will have to do it (laughter)...!': Community voices on the notion and practice of informed consent for biomedical research in developing countrie," Social Science & Medicine, Elsevier, vol. 61(2), pages 443-454, July.
    6. 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.
    7. Smirnova, Michelle & Owens, Jennifer Gatewood, 2017. "Medicalized addiction, self-medication, or nonmedical prescription drug use? How trust figures into incarcerated women's conceptualization of illicit prescription drug use," Social Science & Medicine, Elsevier, vol. 183(C), pages 106-115.
    8. Stasiulis, Elaine & Gibson, Barbara E. & Webster, Fiona & Boydell, Katherine M., 2020. "Resisting governance and the production of trust in early psychosis intervention," Social Science & Medicine, Elsevier, vol. 253(C).
    9. Arakelyan, Stella & Jailobaeva, Kanykey & Dakessian, Arek & Diaconu, Karin & Caperon, Lizzie & Strang, Alison & Bou-Orm, Ibrahim R. & Witter, Sophie & Ager, Alastair, 2021. "The role of trust in health-seeking for non-communicable disease services in fragile contexts: A cross-country comparative study," Social Science & Medicine, Elsevier, vol. 291(C).
    10. Kamat, Vinay R., 2014. "Fast, cheap, and out of control? Speculations and ethical concerns in the conduct of outsourced clinical trials in India," Social Science & Medicine, Elsevier, vol. 104(C), pages 48-55.
    11. Ozawa, Sachiko & Sripad, Pooja, 2013. "How do you measure trust in the health system? A systematic review of the literature," Social Science & Medicine, Elsevier, vol. 91(C), pages 10-14.
    12. Goudge, Jane & Gilson, Lucy, 2005. "How can trust be investigated? Drawing lessons from past experience," Social Science & Medicine, Elsevier, vol. 61(7), pages 1439-1451, October.
    13. Solbjør, Marit & Skolbekken, John-Arne & Sætnan, Ann Rudinow & Hagen, Anne Irene & Forsmo, Siri, 2012. "Mammography screening and trust: The case of interval breast cancer," Social Science & Medicine, Elsevier, vol. 75(10), pages 1746-1752.
    14. Russell, Steven, 2005. "Treatment-seeking behaviour in urban Sri Lanka: Trusting the state, trusting private providers," Social Science & Medicine, Elsevier, vol. 61(7), pages 1396-1407, October.
    15. Wilk, Adam S. & Platt, Jodyn E., 2016. "Measuring physicians' trust: A scoping review with implications for public policy," Social Science & Medicine, Elsevier, vol. 165(C), pages 75-81.
    16. Megan M McLaughlin & Louis Simonson & Xia Zou & Li Ling & Joseph D Tucker, 2015. "African Migrant Patients’ Trust in Chinese Physicians: A Social Ecological Approach to Understanding Patient-Physician Trust," PLOS ONE, Public Library of Science, vol. 10(5), pages 1-13, May.
    17. Asiyeh Salehi & Neil Harris & Elisabeth Coyne & Bernadette Sebar, 2015. "Trust and quality of life: A cross-sectional study of young women," International Journal of Social Psychiatry, , vol. 61(5), pages 506-514, August.
    18. Gilson, Lucy & Palmer, Natasha & Schneider, Helen, 2005. "Trust and health worker performance: exploring a conceptual framework using South African evidence," Social Science & Medicine, Elsevier, vol. 61(7), pages 1418-1429, October.
    19. Mohseni, Mohabbat & Lindstrom, Martin, 2007. "Social capital, trust in the health-care system and self-rated health: The role of access to health care in a population-based study," Social Science & Medicine, Elsevier, vol. 64(7), pages 1373-1383, April.
    20. Hampshire, Kate & Hamill, Heather & Mariwah, Simon & Mwanga, Joseph & Amoako-Sakyi, Daniel, 2017. "The application of Signalling Theory to health-related trust problems: The example of herbal clinics in Ghana and Tanzania," Social Science & Medicine, Elsevier, vol. 188(C), pages 109-118.

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:eee:socmed:v:67:y:2008:i:5:p:708-720. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Catherine Liu (email available below). General contact details of provider: http://www.elsevier.com/wps/find/journaldescription.cws_home/315/description#description .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.