Hansson M O
Department of Public Health and Caring Sciences, Academic Hospital, Uppsala, Sweden.
J Med Ethics. 1998 Jun;24(3):182-7. doi: 10.1136/jme.24.3.182.
The rule that one must obtain informed consent is well established in medical ethics and an intrinsic part of clinical practice and of research in biomedicine. However, there is a tendency that the rule today is being applied too rigidly and with too little sensitivity to the values that are at stake in connection with different kinds of research protocols. It is here argued that the quality of consent needs to be balanced against variables such as degree of confidentiality and importance of values at stake, in order to be ethically acceptable. Appropriate information and consent procedures should be adjusted accordingly. Three levels are suggested, ranging from extensively informed consent with both written and oral information, through informed refusal with only a limited amount of information given to, at the other end of the scale, just making relevant information available.
必须获得知情同意这一规则在医学伦理中已确立，是临床实践和生物医学研究的固有组成部分。然而，如今存在一种趋势，即该规则的应用过于死板，对与不同类型研究方案相关的利害攸关的价值观缺乏敏感性。本文认为，为了在伦理上可接受，同意的质量需要与诸如保密程度和利害攸关的价值观的重要性等变量相平衡。相应地，应调整适当的信息和同意程序。建议分为三个级别，从提供书面和口头信息的广泛知情同意，到仅提供有限信息的知情拒绝，再到另一端仅提供相关信息。
