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Soc Sci Med. 2004 Dec;59(12):2547-59.

Understanding of informed consent in a low-income setting: three case studies from the Kenyan Coast.

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1
Kenya Medical Research Institute, PO Box 230, Kilifi, Kenya. smolyneux@kilifi.mimcom.net

Abstract

In our research unit on the Kenyan Coast, parents sign consent for over 4000 children to be involved in research activities every year. Children are recruited into studies ranging from purely observational research to the testing of new procedures and drugs. Thousands more community members consent verbally or in writing to the interviews and sometimes invasive procedures required in community-based research. Although every study and consent form is reviewed in advance by independent national and international committees, the views and understanding of the 'subjects' of these activities had not been documented before this study. In this paper, we focus on participant understanding of one field-based and two hospital-based studies, all of which involve blood sampling. The findings highlight a range of inter-related issues for consideration in the study setting and beyond, including conceptual and linguistic barriers to communicating effectively about research, the critical and complex role of communicators (fieldworkers and nurses) in consent procedures, features of research unit-community relations which impact on these processes, and the special sensitivity of certain issues such as blood sampling. These themes and emerging recommendations are expected to be relevant to, and would benefit from, experiences and insights of researchers working elsewhere.

PMID:
15474208
DOI:
10.1016/j.socscimed.2004.03.037
[Indexed for MEDLINE]
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