J Empir Res Hum Res Ethics. 2013 Jul;8(3):75-6. doi: 10.1525/jer.2013.8.3.75.
This issue of JERHRE examines informed consent requirements as they arise in diverse countries and cultures, and in relation to level of risk of the research and vulnerability of the potential participants. It also examines issues of literacy as they affect informed consent. And it examines whether research participants want to be informed. Adequate informed consent is a statement that is meaningful and understandable by the particular research participant and that allows the participant free choice regarding participation. The way in which an adequate consent procedure is administered must, by definition, depend on the level of literacy of the potential research participants, and the nature and values of the culture of the potential participants. An implication of these requirements is that Western consent procedures are likely to violate ethical standards when employed in non-Western cultures. Educational activities presented below will enable readers to consolidate their knowledge and understanding of these issues. Written informed consent statements are not valid for use with research participants who lack literacy. The level of literacy required depends on the complexity of the research topic. In Clough et al., we find that cultural differences in self-concept, understanding of research methods, level of education, and deference to researchers challenge researchers to modify standard consent procedures to render them valid in some cultural contexts. In Abou Zeina et al., we find an even more complex problem of communicating patients' rights to illiterate patients in an Egyptian public hospital: not only can they not read, but they consider "patients' rights" as the least of their problems. In Iverson et al., we find still different issues concerning the scientific literacy of surrogate decision makers for critically ill patients. And in Ghandour et al., we find in Lebanon, within a very large sample of socioeconomically diverse students, a virtually total lack of interest in being informed before participating in a survey on a highly sensitive topic. For those of us who would unthinkingly impose standard Western consent procedures on everyone, these four articles may have much to teach us.
本期《欧洲健康研究伦理学杂志》探讨了在不同国家和文化中出现的知情同意要求，以及与研究风险水平和潜在参与者脆弱性的关系。它还研究了影响知情同意的识字问题。并且探讨了研究参与者是否希望得到信息告知。充分的知情同意是一份特定研究参与者能够理解且有意义的声明，它允许参与者就参与研究做出自由选择。根据定义，实施充分同意程序的方式必然取决于潜在研究参与者的识字水平，以及潜在参与者文化的性质和价值观。这些要求意味着，西方的同意程序在非西方文化中使用时可能会违反道德标准。下面介绍的教育活动将使读者巩固对这些问题的认识和理解。书面知情同意声明对缺乏识字能力的研究参与者无效。所需的识字水平取决于研究主题的复杂程度。在克拉夫等人的研究中，我们发现自我概念、对研究方法的理解、教育水平以及对研究人员的尊重等文化差异，促使研究人员修改标准同意程序，使其在某些文化背景下有效。在阿布·泽纳等人的研究中，我们发现了一个更复杂的问题，即在埃及一家公立医院向文盲患者传达患者权利：他们不仅不识字，而且认为“患者权利”是他们最不关心的问题。在艾弗森等人的研究中，我们发现了关于重症患者替代决策者科学素养的不同问题。而在甘杜尔等人的研究中，我们发现，在黎巴嫩，在社会经济背景多样的大量学生样本中，几乎完全缺乏在参与关于一个高度敏感话题的调查之前了解相关信息的兴趣。对于我们中那些不假思索地将标准西方同意程序强加于所有人的人来说，这四篇文章可能会给我们很多启示。
