Understanding the informed consent process in HIV clinical trials in Uganda: a case study

The regulatory guidelines on obtaining informed consent require that all protocols be reviewed by an ethics review committee; in addition study information must be presented to volunteers by the research teams in simple and understandable language, to ensure they are able to give informed consent for their participation. Despite the innovative methods that have been developed over the years to improve informed consent, the informed consent process is still a difficult subject and not fully understood particularly in developing countries. Objective: In this study I sought to understand and evaluate the informed consent process as perceived by the different actors in two HIV clinical trials and how their understandings and interpretation of the process are reflected in standardized informed consent guidelines. Methodology: The actors included: members of the ethics review committee, senior researchers, the field research teams, the community advisory board members and the research volunteers. Data were collected using semi-structured interview guides and focus group discussion guides and unstructured observation and document review. Results: A total of sixty three respondents took part in this study. I found that although the informed consent process is emphasised in research ethics guidelines and clinical research protocols which are approved by the ethics research committees before they are implemented, how the process is perceived and interpreted by the actors is very varied. The different actors’ beliefs, values, gender, trust, power differentials and decision making all contribute to the negotiations that take place during the informed consent process. The standardised informed consent guidelines are a useful tool to manage the bureaucracy of conducting research in order to protect research volunteers from any form of harm and allow for individual autonomy; it is however the relationships and interactions of the different actors which are built over time during the research process that in practice lead to a meaningful informed consent process as each actor interprets and understands the process within their own context and experience.

Name dc:type.qualificationname

phd

Level dc:type.qualificationlevel

doctoral

Grantor dc:publisher.institution

University of East Anglia

Year dc:date.issued

2014

Author dc:creator

• Ssali, Agnes

Language dc:language

en