| HIV vaccine research--South Africa's ethical-legal framework and its ability to promote the welfare of trial participants. | |
| | |
MedLine Citation:
|
PMID: 16201004 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
An effective ethical-legal framework for the conduct of research is critical. We describe five essential components of such a system, review the extent to which these components have been realised in South Africa, present brief implications for the ethical conduct of clinical trials of HIV vaccines in South Africa and make recommendations. The components of an effective ethical-legal system that we propose are the existence of scientific ethical and policy-making structures that regulate research; research ethics committees (RECs) that ethically review research; national ethical guidelines and standards; laws protecting research participants; and mechanisms to enforce and monitor legal rights and ethical standards. We conclude that the ethical-legal framework has, for the most part, the necessary institutions, and certain necessary guidelines but does not have many of the laws needed to protect and promote the rights of persons participating in research, including HIV vaccine trials. Recommendations made include advocacy measures to finalise and implement legislation, development of regulations, analysis and comparison of ethical guidelines, and the development of measures to monitor ethical-legal rights at trial sites. |
| | |
Authors:
|
Ann Strode; Catherine Slack; Muriel Mushariwa |
Related Documents
:
|
19936964 - The use of human tissue in epidemiological research; ethical and legal considerations i... 82854 - Controlled clinical trials and medical ethics. 18035844 - Legal pragmatism and the pre-birth continuum: an absence of unifying principle. 12184614 - Ethical considerations in syria regarding reproduction techniques. 12172524 - Clinical ethics in rehabilitation medicine: core objectives and algorithm for resident ... 20806524 - Healthcare reform in the usa, 2010: the rocky road ahead? |
Publication Detail:
|
Type: Comparative Study; Journal Article; Research Support, Non-U.S. Gov't; Review |
Journal Detail:
|
Title: South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde Volume: 95 ISSN: 0256-9574 ISO Abbreviation: S. Afr. Med. J. Publication Date: 2005 Aug |
Date Detail:
|
Created Date: 2005-10-04 Completed Date: 2005-10-31 Revised Date: 2007-11-15 |
Medline Journal Info:
|
Nlm Unique ID: 0404520 Medline TA: S Afr Med J Country: South Africa |
Other Details:
|
Languages: eng Pagination: 598-601 Citation Subset: IM |
Affiliation:
|
Faculty of Law, Pietermaritzburg centre, University of KwaZulu-Natal. strodea@ukzn.ac.za |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
AIDS Vaccines
/
administration & dosage*,
economics* Clinical Trials, Phase I as Topic Developing Countries Ethics, Research Female HIV Infections / economics, epidemiology, prevention & control* Humans Male Patient Selection / ethics Risk Assessment Social Welfare / economics* Socioeconomic Factors South Africa |
| Chemical | |
Reg. No./Substance:
|
0/AIDS Vaccines |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Research ethics review--protecting participants in research.
Next Document: Clinical features and outcome in children admitted to a TB hospital in the Western Cape--the influen...