Exploring informed consent in HIV clinical trials: A case study in Uganda.

Agnes Ssali,Fiona Poland,Janet Seeley

doi:10.1016/j.heliyon.2016.e00196

Abstract

IntroductionIn settings with low literacy levels ensuring that participants are fully-informed before they consent to participate in clinical trials is a challenge. We explored the experiences and concerns of key actors in the informed consent process in two HIV clinical trials.MethodSemi-structured interviews were conducted with 46 respondents including trial participants, research study team and research ethics committee members about their experiences during the informed consent process. Three focus group discussions were conducted with 14 Community Advisory Board (CAB) members and 17 trial participants. Data were analysed to identify key themes.FindingsThe consent process was highlighted as an important procedure by all the key actors however each group had a particular area of emphasis. Signing a consent form was given importance by research team and ethics committee members, because it provided documented evidence of a participant’s willingness to join a clinical trial. Participants did not welcome the presence of a witness for a non-literate participant because understanding study information was not closely related to an ability to read and write.ConclusionThis study’s findings indicated that obtaining a volunteer’s signature or thumbprint on a consent form did not necessarily mean that the participant was fully-informed about the information relevant to their taking part nor that they understood all the information shared with them. Informed consent requires sufficient time in the research process to have staff trained well enough before research begins. Ensuring and gaining informed consent should be understood and treated as a relation-centred, dynamic supportive process throughout the duration of a research study.

Highlights

In settings with low literacy levels ensuring that participants are fully-informed before they consent to participate in clinical trials is a challenge
This paper focuses on the perceptions of the different actors in the informed consent process on their experience of managing the procedure of signing a consent form in two HIV clinical trials in the Uganda context
The results presented cover responses from the different categories of actors in the informed consent process: the trial participants, the research team, the Regulatory Ethics committee (REC) and the Community Advisory Board (CAB)

Summary

Introduction

In settings with low literacy levels ensuring that participants are fully-informed before they consent to participate in clinical trials is a challenge. Method: Semi-structured interviews were conducted with 46 respondents including trial participants, research study team and research ethics committee members about their experiences during the informed consent process. This paper focuses on the perceptions of the different actors in the informed consent process on their experience of managing the procedure of signing a consent form in two HIV clinical trials in the Uganda context. The actors in the informed consent process examined here include: the research team, the trial participants, the Regulatory Ethics committee (REC) and the Community Advisory Board members (CAB). The term ‘informed consent' will be used to refer to researchers giving full information about what is involved in conducting an HIV clinical trial and ensuring that the person receiving the information has the capacity to make a decision and is voluntarily consenting to take part when he/she is satisfied that they have understood the information [3], [7], [8]. In this paper, as well as receiving information on the study and signing the consent form, the ‘informed consent process’ includes, all the interactions that occur during a research process which inform a participant about the study

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Discussion

Conclusion