Title page for ETD etd-11192008-093435


Document Type Doctoral Thesis
Author Nienaber, Annelize Gertruida
URN etd-11192008-093435
Document Title Ethics and human rights in HIV-related clinical research in Africa with specific reference to informed consent in preventive HIV vaccine efficacy trials in South Africa
Degree LLD
Department Legal History, Comparative Law and Legal Philosophy
Supervisor
Advisor Name Title
Prof F J Viljoen Committee Chair
Prof P A Carstens Committee Co-Chair
Keywords
  • human rights law
  • South Africa
  • vaccine
  • HIV- related clinical trials
Date 1997-09-05
Availability unrestricted
Abstract
This thesis examines the regulation of HIV-related clinical research in Africa, with special emphasis on preventive HIV vaccine efficacy trails in South Africa. The discussion centres on aspects of the South African economic, social and political context, which increase not only certain communities' vulnerability to HIV infection, thereby accelerating the spread of the disease but also those communities' vulnerability to exploitation and abuse during clinical research.

Human rights law is suggested as a viable alternate model to bioethical regulation to protect participants in HIV-related clinical trials. It is demonstrated that, in certain instances human rights law has important advantages over bioethics, not only because it has the force of law, but also because it positions the research participant within a specific social context It is proposed that a normative model derived from human rights' principles adds value to the bioethical debate in the context of clinical research in South Africa and the rest of the world.

The thesis concludes that in order to make clinical research more responsive to circumstance, bioethics should be inspired by a broader social, economic and political perspective, such as is provided by a human rights-based analysis.

The thesis recommends that bioethics and human rights law, rather than being seen as different systems, should be unified into a single system of protection under the constitution and the Bill of Rights. In order to do this, legislation that integrates ethical guidelines and human rights law needs to be drafted to give effect to the constitutional guarantee in section 12(2)(c). At the international level, the adoption of a convention which integrates human rights law and ethical guidelines is proposed.

AFRIKAANS : Die proefskrif ondersoek die regulering van MlV-verwante kliniese navorsing in Afrika met spesifieke verwysing na kliniese proefnemings in Suid-Afrika om die doeltreffendheid van voorkomende MlV-entstowwe te bepaal. Die bespreking gee aspekte van die Suid-Afrikaanse ekonomiese sosiale en politisie konteks weer, wat nie net sekere gemeenskappe se kwesbaarheid vir MlV-infeksie bevorder nie, en dus die verspreiding van die siekte aanhelp nie maar wat ook daardie gemeenskappe meer kwesbaar maak om uitgebuit en misbruik te word gedurende kliniese navorsing.

Menseregte word voorgestel as 'n lewensvatbare alternatiewe model teenoor bio-etiese regulering om die belange van deelnemers aan MlV-verwante kliniese proefnemings te beskerm. Die proefskrif wys daarop dat, onder sekere omstandighede, mensereqte belangrike voordele bo die bio-etiek het, nie net omdat dit regskrag het nie, maar ook omdat dit die deelnemer aan navorsing posisioneer binne 'n spesifieke sosiale konteks. Daar word aan die hand gedoen dat ln normatiewe model, afgelei vanaf menseregte-beginseis, waarde sal toevoeg tot die bio-etiek-debat in die konteks van kliniese navorsing in Suid-Afrika en die res van die wźreld.

Die proefskrif bevind dat, om navorsing meer responsief tot omstandighede te maak, die bio-etiek geļnspireer moet word deur 'n breėr sosiale, ekonomiese and politiese perspektief, soos wat voorsien word deur 'n menseregte-gebaseerde analise.

Die proefskrif maak die aanbeveling dat die bio-etiek en menseregte, eerder as om as twee verskillende stelsels gesien te word, saamgevoeg moet word in 'n enkele stelsel van beskerming ondergeskik aan die Grondwet en die Menseregtehandves. Ten einde hierdie doel te bereik, moet wetgewing aangeneem word wat effek gee aan die grondwetlike waarborg in artikel 12(2)(c) en sodoende etiese riglyne en menseregte integreer Op die internasionale vlak word aan die hand gedoen dat 'n internasionaie konvensie aangeneem moet word wat menseregte en etiese riglyne integreer.

Copyright © 2007, University of Pretoria. All rights reserved. The copyright in this work vests in the University of Pretoria. No part of this work may be reproduced or transmitted in any form or by any means, without the prior written permission of the University of Pretoria

Please cite as follows:

Nienaber, AG 2007, Ethics and human rights in HIV-related clinical trials in South Africa with specific reference to informed consent in preventive HIV vaccine efficacy trials in South Africa, LLD thesis, University of Pretoria, Pretoria, viewed yymmdd < http://upetd.up.ac.za/thesis/available/etd-11192008-093435/ >

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