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April 2003, Vol 93, No. 4 | American Journal of Public Health 582-584
© 2003 American Public Health Association


RESEARCH AND PRACTICE

Consent for Participation in the Bloemfontein Vitamin A Trial: How Informed and Voluntary?

Gina Joubert, MSc, Hannes Steinberg, DPH, MB, BCh, DTM&H, MFamMed, Dip Obst (SA), Elna van der Ryst, PhD, MB, ChB, MMed (Virol Path), DTM&H, and Perpetual Chikobvu, MMedStats

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).

Because this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.


    INTRODUCTION
 
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 . . . [Full Text]


    METHODS
 

    RESULTS
 

    DISCUSSION
 



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