Chen Donna T, Miller Franklin G, Rosenstein Donald L
National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland 20892-1156, USA.
Med Care. 2002 Sep;40(9 Suppl):V20-9. doi: 10.1097/01.MLR.0000023952.15394.88.
Progress in diagnosing, treating, and preventing medical conditions that impair decision-making abilities depends on clinical research involving individuals who may be either unable to or have diminished ability to give informed consent. Such research, however, raises ethical concern and controversy about the potential exploitation of these vulnerable individuals. This article addresses a range of ethical and practical issues concerning the enrollment of adults who are decisionally impaired, and those at risk of becoming so, in clinical research. These include (1) the relationship of decision-making capacity to competence, and the framework for determining competence in adults receiving clinical care and making treatment decisions for those who lack competence; (2) the differences between clinical practice and clinical research that influence the criteria for permissible research involving incompetent adults and the applicability of the framework guiding treatment decisions to clinical research decisions; and (3) the regulatory framework developed to guide the ethical participation of children in research and its applicability to determining the scope and limits of research with incompetent adults.
在诊断、治疗和预防损害决策能力的医疗状况方面取得进展，依赖于涉及那些可能无法或给予知情同意的能力有所减弱的个体的临床研究。然而，这类研究引发了关于对这些弱势群体潜在剥削的伦理关注和争议。本文探讨了一系列与在临床研究中纳入决策受损的成年人以及有此风险的成年人相关的伦理和实际问题。这些问题包括：（1）决策能力与行为能力的关系，以及确定接受临床护理的成年人的行为能力的框架，和为缺乏行为能力者做出治疗决策的框架；（2）临床实践与临床研究之间的差异，这些差异影响涉及无行为能力成年人的可允许研究的标准，以及指导治疗决策的框架对临床研究决策的适用性；（3）为指导儿童伦理参与研究而制定的监管框架及其在确定无行为能力成年人研究的范围和限制方面的适用性。
