Lindegger G, Richter L M
School of Psychology, University of Natal, Private Bag X01, Scottsville, Pietermaritzburg, 3209 South Africa.
S Afr J Sci. 2000 Jun;96:313-7.
Informed consent (IC), a fundamental principle of ethics in medical research, is recognized as a vital component of HIV vaccine trials. There are different notions of IC, some legally based and others based on ethics. It is argued that, though legal indemnity is necessary, vaccine trials should be founded on fully ethical considerations. Various contentious aspects of IC are examined, especially the problem of social desirability and of adequate comprehension. The need for sensitivity to cultural norms in implementing IC procedures is critically reviewed, and some of the potential conflict between ethos and ethics is considered. The transmission of information is examined as a particular aspect of IC in HIV vaccine trials.
知情同意是医学研究伦理的一项基本原则，被视为艾滋病毒疫苗试验的重要组成部分。对于知情同意存在不同的概念，有些基于法律，有些基于伦理。有人认为，虽然法律赔偿是必要的，但疫苗试验应基于充分的伦理考量。本文探讨了知情同意的各个争议方面，特别是社会期望和充分理解的问题。批判性地审视了在实施知情同意程序时对文化规范保持敏感的必要性，并考虑了道德观念与伦理之间的一些潜在冲突。作为艾滋病毒疫苗试验中知情同意的一个特定方面，本文对信息传播进行了研究。
