IDEAS home Printed from https://ideas.repec.org/a/eee/socmed/v48y1999i2p139-148.html
   My bibliography  Save this article

An evaluation of the informed consent procedure used during a trial of a Haemophilus influenzae type B conjugate vaccine undertaken in The Gambia, West Africa

Author

Listed:
  • Leach, A.
  • Hilton, S.
  • Greenwood, B. M.
  • Manneh, E.
  • Dibba, B.
  • Wilkins, A.
  • Mulholland, E. K.

Abstract

It has recently been debated whether it is possible or desirable to have one internationally recognised standard of "informed consent" or whether research ethics should be adapted to the culture and educational level of the study population. This study examined the attitudes of the Gambian people to consent to medical research, and evaluated the informed consent process used in a major efficacy trial of a Haemophilus influenzae vaccine. Consent was requested after parents had received a verbal explanation and an information sheet which described the vaccine trial in a local language. A semi-structured interview was conducted with 137 acceptors and 52 refusers. Certain points of knowledge were recalled well by the acceptors; 90% knew the purpose of the vaccine was to prevent disease, but the placebo control design was understood by only 10%. The prime motive for consenting was to receive the HIB vaccine (93%) and that for refusing was that the vaccine was experimental (35%) and might have unknown side effects (29%). Although parents took advice from researchers (50%), health workers (24%), friends (16%) and family (12%), in all cases the decision was made by one of the child's parents. Only 1% of parents sought the opinion of traditional or religious leaders. The principles of informed consent, that it should be free, autonomous and informed were affirmed by this community. Therefore, in The Gambia, the international code of informed consent is appropriate.

Suggested Citation

  • Leach, A. & Hilton, S. & Greenwood, B. M. & Manneh, E. & Dibba, B. & Wilkins, A. & Mulholland, E. K., 1999. "An evaluation of the informed consent procedure used during a trial of a Haemophilus influenzae type B conjugate vaccine undertaken in The Gambia, West Africa," Social Science & Medicine, Elsevier, vol. 48(2), pages 139-148, January.
    • Handle: RePEc:eee:socmed:v:48:y:1999:i:2:p:139-148
    as

    Download full text from publisher

    File URL: http://www.sciencedirect.com/science/article/pii/S0277-9536(98)00317-7
    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.

    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. Lawrence, David S. & Ssali, Agnes & Moshashane, Neo & Nabaggala, Georgina & Maphane, Lebogang & Harrison, Thomas S. & Meya, David B. & Jarvis, Joseph N. & Seeley, Janet, 2022. "Decision making in a clinical trial for a life-threatening illness: Therapeutic expectation, not misconception," Social Science & Medicine, Elsevier, vol. 305(C).
    4. Tengbeh, Angus Fayia & Enria, Luisa & Smout, Elizabeth & Mooney, Thomas & Callaghan, Mike & Ishola, David & Leigh, Bailah & Watson-Jones, Deborah & Greenwood, Brian & Larson, Heidi & Lees, Shelley, 2018. "“We are the heroes because we are ready to die for this country”: Participants' decision-making and grounded ethics in an Ebola vaccine clinical trial," Social Science & Medicine, Elsevier, vol. 203(C), pages 35-42.
    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. Barata, Paula C. & Gucciardi, Enza & Ahmad, Farah & Stewart, Donna E., 2006. "Cross-cultural perspectives on research participation and informed consent," Social Science & Medicine, Elsevier, vol. 62(2), pages 479-490, January.

    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:48:y:1999:i:2:p:139-148. 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.

    We have no bibliographic references for this item. You can help adding them by using 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.