Abstract

VAN LOON, Katherine  and  LINDEGGER, Graham. Informed consent in clinical trials: Perceptions and experiences of a sample of South African researchers. Health SA Gesondheid (Online) [online]. 2009, vol.14, n.1, pp.81-87. ISSN 2071-9736.

The implementation of informed consent (IC) in clinical trials presents many challenges, especially in developing countries. This study explored the experiences and reported practices regarding the implementation of IC in clinical trials in South Africa. Data were gathered through semi-structured interviews with a range of stakeholders in clinical trials in two provinces. The interviews were analysed to identify themes and issues relating to IC. The findings show that IC practices involve attention being paid to both formal requirements and informal practices to attain IC. Research assistants or trial counsellors were found to play a critical role in facilitating the IC process. It is recommended that more recognition be given to the important role of trial counsellors in clinical trials, and that they be given more formal training, support and supervision.

Keywords : informed consent; clinical trials; perceptions; South Africa; ethics.

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