Simpson J S
Med J Aust. 1981 Feb 21;1(4):169-71. doi: 10.5694/j.1326-5377.1981.tb135436.x.
Clinical trials now have an established place in the evaluation of new cancer treatments. It is vital that there should be no conflict between the scientific aspects of clinical trials and the interests of patients with cancer. This conflict can be avoided if trial designs meet accepted standards, and if patients are able to make "informed" decisions abut participation. This process of obtaining informed consent is the subject of much debate. How the debate can be resolved by an individual clinician depends on his perception of a number of fundamental ethical principles. There is growing agreement, however, that regardless of the details of the process of obtaining informed consent, certain basic requirements must be met. The patient must be told that he is participating in a research procedure, that entry is optional, that withdrawal at any time is his right, and he must understand the nature of the trial and the likely effects of treatment, both good and bad.
临床试验如今在新癌症治疗方法的评估中占据了既定地位。至关重要的是，临床试验的科学层面与癌症患者的利益之间不应存在冲突。如果试验设计符合公认标准，并且患者能够就参与事宜做出“知情”决定，那么这种冲突是可以避免的。获取知情同意的这一过程是诸多辩论的主题。个体临床医生如何解决这场辩论取决于他对一些基本伦理原则的理解。然而，越来越多的人达成共识，即无论获取知情同意过程的细节如何，某些基本要求必须得到满足。患者必须被告知他正在参与一项研究程序，参与是可选择的，随时退出是他的权利，并且他必须了解试验的性质以及治疗可能产生的效果，包括好的和坏的。
