Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda
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Date
2015
Authors
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Journal ISSN
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Publisher
BMC medical ethics
Abstract
Informed consent as stipulated in regulatory human research guidelines requires that a volunteer is
well-informed about what will happen to them in a trial. However researchers are faced with a challenge of how to
ensure that a volunteer agreeing to take part in a clinical trial is truly informed. We conducted a qualitative study
among volunteers taking part in two HIV clinical trials in Uganda to find out how they defined informed consent
and their perceptions of the trial procedures, study information and interactions with the research team.
Methods: Between January and December 2012, 23 volunteers who had been in the two trials for over 6 months,
consented to be interviewed about their experience in the trial three times over a period of nine months. They also
took part in focus group discussions. Themes informed by study research questions and emerging findings were
used for content analysis.
Results: Volunteers defined the informed consent process in terms of their individual welfare. Only two of the
volunteers reported having referred during the trial to the participant information sheets given at the start of the
trial. Volunteers remembered the information they had been given at the start of the trial on procedures that
involved drawing blood and urine samples but not information about study design and randomisation. Volunteers
said that they had understood the purpose of the trial. They said that signing a consent form showed that they
had consented to take part in the trial but they also described it as being done to protect the researcher in case a
volunteer later experienced side effects.
Description
Keywords
Informed consent, Clinical trials, Research volunteers
Citation
Ssali, A., Poland, F., & Seeley, J. (2015). Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda. BMC medical ethics, 16(1), 1-14.DOI 10.1186/s12910-015-0073-1