评估临床研究的风险：直接比较分析
Evaluating the risks of clinical research: direct comparative analysis.
作者信息
Rid Annette, Abdoler Emily, Roberson-Nay Roxann, Pine Daniel S, Wendler David
机构信息
1 Department of Social Science, Health & Medicine, King's College London , United Kingdom .
出版信息
J Child Adolesc Psychopharmacol. 2014 Sep;24(7):390-8. doi: 10.1089/cap.2014.0039.
OBJECTIVES
Many guidelines and regulations allow children and adolescents to be enrolled in research without the prospect of clinical benefit when it poses minimal risk. However, few systematic methods exist to determine when research risks are minimal. This situation has led to significant variation in minimal risk judgments, raising concern that some children are not being adequately protected. To address this concern, we describe a new method for implementing the widely endorsed "risks of daily life" standard for minimal risk. This standard defines research risks as minimal when they do not exceed the risks posed by daily life activities or routine examinations.
METHODS
This study employed a conceptual and normative analysis, and use of an illustrative example.
RESULTS
Different risks are composed of the same basic elements: Type, likelihood, and magnitude of harm. Hence, one can compare the risks of research and the risks of daily life by comparing the respective basic elements with each other. We use this insight to develop a systematic method, direct comparative analysis, for implementing the "risks of daily life" standard for minimal risk. The method offers a way of evaluating research procedures that pose the same types of risk as daily life activities, such as the risk of experiencing anxiety, stress, or other psychological harm. We thus illustrate how direct comparative analysis can be applied in practice by using it to evaluate whether the anxiety induced by a respiratory CO2 challenge poses minimal or greater than minimal risks in children and adolescents.
CONCLUSIONS
Direct comparative analysis is a systematic method for applying the "risks of daily life" standard for minimal risk to research procedures that pose the same types of risk as daily life activities. It thereby offers a method to protect children and adolescents in research, while ensuring that important studies are not blocked because of unwarranted concerns about research risks.
目的
许多指南和法规允许儿童和青少年参与不具有临床获益前景但风险极小的研究。然而，几乎没有系统的方法来确定研究风险何时极小。这种情况导致在极小风险判断上存在显著差异，引发了对一些儿童未得到充分保护的担忧。为解决这一担忧，我们描述了一种新方法，用于实施广泛认可的“日常生活风险”极小风险标准。该标准将研究风险定义为极小，当这些风险不超过日常生活活动或常规检查所带来的风险时。
方法
本研究采用了概念性和规范性分析，并使用了一个示例。
结果
不同的风险由相同的基本要素组成：伤害的类型、可能性和严重程度。因此，可以通过相互比较各自的基本要素来比较研究风险和日常生活风险。我们利用这一见解开发了一种系统方法，即直接比较分析，用于实施“日常生活风险”极小风险标准。该方法提供了一种评估与日常生活活动具有相同类型风险的研究程序的方式，例如经历焦虑、压力或其他心理伤害的风险。我们通过使用直接比较分析来评估呼吸二氧化碳激发试验在儿童和青少年中诱发的焦虑是否构成极小或大于极小风险，从而说明其在实践中的应用方式。
结论
直接比较分析是一种系统方法，用于将“日常生活风险”极小风险标准应用于与日常生活活动具有相同类型风险的研究程序。因此，它提供了一种在研究中保护儿童和青少年的方法，同时确保重要研究不会因对研究风险的无端担忧而受阻。
Zotero 插件