Informed consent in clinical trials: Perceptions and experiences of a sample of South African researchers

Abstract

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.

Opsomming

Die implementering van ingeligte toestemming (IT) in kliniese proewe bied menige uitdagings, veral in ontwikkelende lande. Hierdie studie het die ervarings en vermelde praktyke betreffende die implementering van IT in kliniese proewe in Suid-Afrika ondersoek. Data is ingewin deur middel van semi-gestruktureerde onderhoude met 'n verskeidenheid van rolspelers in kliniese proewe in twee provinsies. Onderhoude is ontleed om herhalende temas rakende IT te identifiseer. Bevindings toon dat IT-benaderings die voldoening aan formele vereistes sowel as die gebruikmaking van informele metodes behels. Daar is bevind dat navorsingsassistente 'n kritieke rol in die fasilitering van die IT-proses speel. Daar word aanbeveel dat meer erkenning gegee word aan die rol van proefvoorligters in kliniese proewe, dat hulle meer formele opleiding ondergaan, dat hulle beter ondersteuning ontvang en dat daar beter oor hulle toesig gehou word.