Compensation for research-related injury in South Africa: A critique of the good clinical practice (GCP) guidelines

Abstract

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 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.