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重新思考健康研究中的获益:伦理委员会的反思

Rethinking Benefits in Health Research, Reflections of an Ethics Committee.

机构信息

Comité de Ética en Investigación, Instituto Nacional de Psiquiatría Ramón de la Fuente Muñíz, Ciudad de México, México.

Dirección de Investigaciones Epidemiológicas y Psicosociales, Instituto Nacional de Psiquiatría Ramón de la Fuente Muñíz, Ciudad de México, México.

出版信息

Yale J Biol Med. 2022 Sep 30;95(3):389-398. eCollection 2022 Sep.

Abstract

The principle of beneficence in health research implies the effort of researchers to minimize risk to participants and maximize benefits to participants and society, which could be considered an abstract definition. Therefore, the benefits are not easily conceived by researchers who fail to achieve their goal, which is to privilege the well-being of participants. The purpose of this work was to describe and discuss the theoretical elements that support the principle of beneficence so that their knowledge allows designing and granting adequate benefits to participants. The present document defines the principle of beneficence. It also analyzes the maximization of benefits, the distinctions between different classifications of benefits, and the differentiation from compensations or incentives. With all this information, researchers must do a critical deliberation to select adequate benefits for participants of their studies, considering the type of study, potential participants, probability of risk, among others. These benefits should not be understood as a charity that researchers grant to the participant; they should be conceived as any form of action in favor of the well-being of participants. Participants must always be considered as moral agents, responsible for deciding whether the benefits would outweigh the possible negative unintended consequences of a particular study. Finally, no risk should be taken if it is not commensurate or proportional to the benefit of the research study.

摘要

健康研究中的行善原则意味着研究人员努力将参与者的风险最小化,将参与者和社会的利益最大化,这可以被认为是一个抽象的定义。因此,对于未能实现将参与者的福祉置于优先地位这一目标的研究人员来说,利益并不容易被理解。这项工作的目的是描述和讨论支持行善原则的理论要素,以便他们的知识能够设计并给予参与者适当的利益。本文档定义了行善原则。它还分析了利益最大化、不同利益分类之间的区别,以及与补偿或激励的区别。有了这些信息,研究人员必须进行批判性思考,为研究参与者选择适当的利益,考虑研究的类型、潜在参与者、风险概率等。这些利益不应被理解为研究人员给予参与者的慈善行为;它们应该被视为任何有利于参与者福祉的行动形式。参与者必须始终被视为道德代理人,负责决定利益是否超过特定研究可能产生的负面意外后果。最后,如果风险与研究的利益不成比例或不成比例,则不应承担风险。

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