Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda

Ssali, Agnes, Poland, Fiona ORCID: https://orcid.org/0000-0003-0003-6911 and Seeley, Janet (2015) Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda. BMC Medical Ethics, 16. ISSN 1472-6939

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BACKGROUND: 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. CONCLUSION: Volunteers pay more attention during the consent process to procedures requiring biological tests than to study design issues. Trust built between volunteers and the research team could enhance the successful conduct of clinical trials by allowing for informal discussions to identify and review volunteers' perceptions. These results point to the need for researchers to view informed consent as a process rather than an event.

Item Type: Article
Uncontrolled Keywords: informed consent ,clinical trials ,research volunteers,sdg 3 - good health and well-being ,/dk/atira/pure/sustainabledevelopmentgoals/good_health_and_well_being
Faculty \ School: Faculty of Medicine and Health Sciences > School of Health Sciences
Faculty of Social Sciences > School of International Development
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Groups > Dementia & Complexity in Later Life
Depositing User: Pure Connector
Date Deposited: 21 Jan 2016 14:00
Last Modified: 22 Oct 2022 00:45
URI: https://ueaeprints.uea.ac.uk/id/eprint/56726
DOI: 10.1186/s12910-015-0073-1

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