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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
arts and humanities
Taking social relationships seriously: Lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast
Social Science and Medicine, Volume 67, No. 5, Year 2008
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Description
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'. © 2008 Elsevier Ltd. All rights reserved.
Authors & Co-Authors
Gikonyo, Caroline
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Bejon, Philip A.
United Kingdom, Oxford
University of Oxford
Marsh, Vicki M.
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Molyneux, Sassy C.
Kenya, Nairobi
Wellcome Trust Research Laboratories Nairobi
Statistics
Citations: 154
Authors: 4
Affiliations: 2
Identifiers
Doi:
10.1016/j.socscimed.2008.02.003
ISSN:
02779536
Research Areas
Infectious Diseases
Study Approach
Qualitative