Strode Ann, Slack Catherine, Mushariwa Muriel
Faculty of Law, Pietermaritzburg centre, University of KwaZulu-Natal.
S Afr Med J. 2005 Aug;95(8):598-601.
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.
建立一个有效的研究行为伦理 - 法律框架至关重要。我们描述了这样一个体系的五个基本组成部分，审视了这些组成部分在南非的实现程度，阐述了对南非HIV疫苗临床试验伦理行为的简要影响并提出了建议。我们提议的有效伦理 - 法律体系的组成部分包括：存在规范研究的科学伦理和决策结构；对研究进行伦理审查的研究伦理委员会（RECs）；国家伦理指南和标准；保护研究参与者的法律；以及执行和监督法律权利与伦理标准的机制。我们得出的结论是，伦理 - 法律框架在很大程度上具备必要的机构和某些必要的指南，但缺乏许多保护和促进参与研究（包括HIV疫苗试验）人员权利所需的法律。提出的建议包括采取宣传措施以最终确定并实施立法、制定法规、分析和比较伦理指南，以及制定在试验地点监测伦理 - 法律权利的措施。
