Abstract
BackgroundInformed 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.MethodsBetween 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.ResultsVolunteers 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.ConclusionVolunteers 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.
Highlights
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
In this paper we examine the process of obtaining informed consent reported by volunteers taking part in two HIV clinical trials in Uganda, considering volunteers’ views on the specific act of signing consent forms and the lessons these offer about the values, beliefs, gender differentials, power dynamics and decision-making patterns during the informed consent process
The study explored the implementation of the informed consent process in two different HIV clinical trials in relation to how the informed consent process was constructed and interpreted and what was meaningful to each group of actors, including the trial volunteers [55, 56]
Summary
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. As an ethical principle used in conducting research with human subjects, has two main underlying ethics theories; the deontology theory and consequentialist theory. The deontology theory of ethics is concerned with protecting a person’s dignity and ability to self-regulate [17]. According to this theory a researcher must never use a volunteer to meet his/her (researcher’s) own ends unless the volunteer benefits from participating. Our research, reported in this paper, incorporates more of the deontological theory,where the emphasis is volunteer participation in research where a person’s dignity is respected and he or she can make decisions during the course of the informed consent process
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