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

BMC Medical Ethics

Janet Seeley³  Fiona Poland²  Agnes Ssali¹ 

[1] Medical Research Council/Uganda Virus Research Institute (MRC/UVRI) Uganda Research Unit on AIDS, Kampala, Uganda;University of East Anglia, Norwich, UK;London School of Hygiene and Tropical Medicine, London, UK

关键词: Research volunteers;    Clinical trials;    Informed consent;   

Others  :  1234639
DOI  :  10.1186/s12910-015-0073-1

 received in 2015-07-22, accepted in 2015-11-16,  发布年份 2015

【 摘 要 】

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.

【 授权许可】

   
2015 Ssali et al.

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