Department of Public Law, Stellenbosch University, Western Cape, South Africa.
S Afr Med J. 2012 Jul 6;102(9):746-8. doi: 10.7196/samj.5498.
Most differences, shortcomings and contradictions regarding voluntary informed consent for participation in clinical research relate to the South African-specific guidance documents, i.e. South African Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa (2006) and Ethics in Health Research: Principles, Structures and Processes (2004). These documents do not fulfil all the ethical and legal requirements for voluntary informed consent for clinical research participation in South Africa. International guidance documents reflect the minimum of the ethical requirements for the conduct of clinical research. Country-specific documents should be updated and aligned with relevant legislative and legal principles of that jurisdiction to ensure that research participants are adequately protected. The South African-specific guidance documents therefore require revision to address these deficiencies.
大多数关于参与临床研究的自愿知情同意的差异、缺陷和矛盾都与南非特有的指导文件有关，即《南非人体临床试验良好实践指南》（2006 年）和《卫生研究伦理：原则、结构和程序》（2004 年）。这些文件没有满足南非临床研究参与的自愿知情同意的所有伦理和法律要求。国际指导文件反映了进行临床研究的最低伦理要求。国家特定的文件应进行更新，并与该司法管辖区的相关立法和法律原则保持一致，以确保研究参与者得到充分保护。因此，南非特有的指导文件需要进行修订以解决这些缺陷。
