Ethics and Human Rights in HIV-related Clinical Trials in Africa with Specific Reference to Informed Consent in Preventive HIV Vaccine Efficacy Trials in South Africa PDF Download
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Author: Annelize Nienaber
Publisher:
ISBN:
Category : AIDS vaccines
Languages : en
Pages : 1174
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Book Description
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.
Author: Annelize Nienaber
Publisher:
ISBN:
Category : AIDS vaccines
Languages : en
Pages : 1174
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Book Description
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.
Author: Annelize Gertruida Nienaber
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
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 wr̊eld. Die proefskrif bevind dat, om navorsing meer responsief tot omstandighede te maak, die bio-etiek gen︠s︡pireer moet word deur 'n brer︠ ︡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.
Author: Sana Loue
Publisher: Springer Science & Business Media
ISBN: 038771362X
Category : Medical
Languages : en
Pages : 347
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Book Description
This important work takes as its subject one of medicine’s most pressing arenas of ethical debate. There has been a consistent interest in ethical issues arising in the context of HIV research. Ongoing international and multi-site studies and the continuing search for an HIV vaccine continue to prompt examination of how this research is conducted. Also examined are how participants are engaged in the studies and the obligations of the researchers to individual participants and their communities during the course of and following the conclusion of the research. Each chapter of this book is authored primarily by one of the editors (secondarily by the other) and is accompanied by one to two case studies.
Author:
Publisher:
ISBN:
Category : AIDS vaccines
Languages : en
Pages : 56
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Book Description
This document highlights, from UNAID'S perspective, some of the critical elements that must be considered in HIV vaccine development activities.
Author: Emmanuelle E. Wollmann
Publisher: Springer Science & Business Media
ISBN: 030646800X
Category : Medical
Languages : en
Pages : 220
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Book Description
The motivation and inspiration for this book come directly from expe- ences with clients during the years that I practiced HIV-related law at the Legal Aid Society of San Diego, Inc. The issues discussed in this work reflect issues that arose on a recurring basis with clients participating in HIV research studies, with investigators calling for guidance on the legal implications of particular aspects of their proposed studies, and with research institutions and health care facilities struggling to make sense of legal maneuvers aimed at obtaining the records of their HIV-infected patients. It is impossible to thank each of these persons individually for their provocative questions and their insights. The discussion of ethical and legal issues relating to the design of clinical trials reflects questions raised during discussions with Donald J. Slymen, Ph.D. Don was one of the first researchers, in my realm of experience, to pay close attention to ethical concerns, and I am greatly appreciative of his contribution to both my professional growth and the development of various scenarios discussed in this text. The portions of this text dealing with confidentiality are the result of many hours of thoughtful discussion and analysis with Penn Lerblance, J.D., now deceased and still missed. Penn and I often participated together as presenters of in-service training programs for health prof- sionals. Penn addressed discrimination, and I focused on confidentiality.
Author: T. Kerns
Publisher: Springer
ISBN: 0230380018
Category : Social Science
Languages : en
Pages : 265
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Book Description
This book explores some of the complex ethical quandaries entailed by proposed phase III HIV preventive vaccine trials. The book argues that such trials must be initiated as soon as politically and ethically feasible on the one hand, and that no such trials should be undertaken until we can assure full compliance with the Nuremberg Code and the WHO/CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects on the other. The tension between these two positions is fully detailed and suggestions offered for how to think about possible resolutions.
Author:
Publisher:
ISBN:
Category : Clinical trials
Languages : en
Pages : 72
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Book Description
Author: A. A. Van Niekerk
Publisher: New Africa Books
ISBN: 9780864866738
Category : Health & Fitness
Languages : en
Pages : 254
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Book Description
Don: American Embassy 2 copies.
Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher: World Health Organization
ISBN: 9789290360889
Category : Bioethics
Languages : en
Pages : 0
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Book Description
"In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.
Author: Frans Viljoen
Publisher: PULP
ISBN: 0980265827
Category : AIDS (Disease)
Languages : en
Pages : 202
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Book Description
Don: Centre for Human Rights Pretoria 2 copies.
