de Vries M C, van Leeuwen E
Leids Universitair Medisch Centrum, sectie Ethiek & Recht van de Gezondheidszorg, Leiden.
Ned Tijdschr Geneeskd. 2008 Mar 22;152(12):679-83.
--Ethical approval of research involving human beings is based on two pillars: supervision of the scientific merit of the research and the risks and burdens for participants by an institutional review board (IRB) or the Dutch Central Committee on Research Involving Human Subjects (CCMO), and obtaining informed consent from the participant or his or her legal guardian. --Discussions on the ethical acceptability of a study generally focus on the first pillar, assessment by an IRB. The second pillar, obtaining informed consent, is often neglected. --Some ethical concepts play a role in obtaining informed consent, especially the concept of the 'therapeutic misconception', i.e. that participating in a study is the same as receiving individualised treatment from a physician. --Of importantance in this matter is the fundamental difference between the research relationship (between investigator and participant) and treatment relationship (between physician and patient). --Understanding the concept of therapeutic misconception is essential to explaining why it is often difficult to obtain valid informed consent from patients for medical research.
由机构审查委员会(IRB)或荷兰人类研究中央委员会(CCMO)对研究的科学价值以及参与者的风险和负担进行监督,以及获得参与者或其法定监护人的知情同意。关于一项研究伦理可接受性的讨论通常集中在第一个支柱,即由IRB进行评估。第二个支柱,获得知情同意,常常被忽视。一些伦理概念在获得知情同意中发挥作用,特别是“治疗性误解”的概念,即参与一项研究等同于接受医生的个体化治疗。在这件事情上重要的是研究关系(研究者与参与者之间)和治疗关系(医生与患者之间)的根本区别。理解治疗性误解的概念对于解释为什么往往难以从患者那里获得有效的医学研究知情同意至关重要。