© 2003 American Public Health Association
Gina Joubert and Perpetual Chikobvu are with the Department of Biostatistics, University of the Free State, Bloemfontein, South Africa. Hannes Steinberg is with the Department of Obstetrics and Gynecology, University of the Free State, Bloemfontein, South Africa. Elna van der Ryst is with the Department of Virology, University of the Free State, Bloemfontein, South Africa. Correspondence: Requests for reprints should be sent to Gina Joubert, MSc, Department of Biostatistics, University of the Free State, PO Box 339 (G31), Bloemfontein, 9300, South Africa (e-mail: gnbsgj@med.uovs.ac.za).
According to international regulatory authorities1 and local institutional guidelines,2 informed consent is a prerequisite for participation in every clinical trial. Consent implies that participation is voluntary. Furthermore, the participant must know the implications of participation.3 Even if a participant has signed an informed consent form, the participant does not necessarily understand what the participation will entail, and consent thus may not be informed.4 On the other hand, a study conducted in a South African hospital found that patient consent for HIV testing was informed but not truly voluntary.5
The aim of this study was to investigate whether the consent for
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