oa South African Journal of Bioethics and Law - Compensation for research-related injury in South Africa : a critique of the good clinical practice (GCP) guidelines
|Article Title||Compensation for research-related injury in South Africa : a critique of the good clinical practice (GCP) guidelines|
|© Publisher:||Health and Medical Publishing Group (HMPG)|
|Journal||South African Journal of Bioethics and Law|
|Affiliations||1 University of KwaZulu-Natal, 2 University of KwaZulu-Natal, 3 University of KwaZulu-Natal and 4 University of KwaZulu-Natal|
|Publication Date||Dec 2012|
|Pages||91 - 94|
This article examines the current South African Department of Health Good Clinical Practice (2006) guideline recommendations regarding compensation for harm incurred in clinical trials. It applies the case of a phase IIb HIV vaccine trial in South Africa, for which enrolments and vaccinations were suspended early, based on data from an international companion study that indicated no evidence of efficacy and greater susceptibility to HIV infection in a subgroup of vaccinees. The case application indicates certain substantive and procedural limitations within the South African Department of Health Good Clinical Practice (2006) guideline recommendations on compensation for harm, which should be re-considered in order to improve protections for trial participants.
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