Browsing by Author "Moloi, Gaotswake Patience"

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    Informed consent : communication and miscommunication in clinical trials
    (Stellenbosch : Stellenbosch University, 2012-03) Moloi, Gaotswake Patience; Khondowe, Oswell; Damons, Anneleen; Stellenbosch University. Faculty of Health Sciences. Dept. of Interdisciplinary Health Sciences. Nursing Science.
    ENGLISH ABSTRACT: Background Informed Consent (IC) has been proposed as the optimal method for ensuring the ethical entry of patients into clinical trials. IC is a vital part of the research process and as such entails more than obtaining a signature on a form. The IC must be given freely, without coercion, and must be based on a clear understanding of what participation involves. Aim The overall aim of this study was to attain an understanding of participants' knowledge regarding informed consent when participating in a research project. Methods The study was conducted at two public hospitals in a city in the Eastern Cape Province of South Africa. The quantitative study used descriptive survey design. A self administered questionnaire was used as a tool for data collection. Results The sample size consisted of 170 women with an average of 25.9 years. The majority had completed secondary level education. More than half of the participants did not have knowledge of the purpose of the original study. The majority of participants did not have knowledge of their responsibilities. Forty-two percent gave uninformative responses and 26% indicated they did not know their responsibilities. None of the participants understood the concept of randomization. The majority (85.9%) of participants indicated that information provided on the IC forms was sufficient for them to decide to participate. Conclusion Despite extensive efforts to ensure that participants understood their participation in the original studies, this study found poor recall of vital information for IC. A signed informed consent does not guarantee that participants understand information given. Recommendations The existing methods of communicating and obtaining of an informed consent seem to be insufficient for participants to make an informed decision. A new approach with more interactive features such as combination of audio-visual techniques might increase the possibilities of the understanding.