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研究伦理的演变:从纽伦堡到赫尔辛基。

The research ethics evolution: from Nuremberg to Helsinki.

出版信息

S Afr Med J. 2014 Mar;104(3):178-80. doi: 10.7196/samj.7864.

Abstract

Health research sets out to acquire not only theoretical knowledge but also benefits for many people and often society as a whole, and is therefore justified. The quandary, though, is how such an important, shared purpose can be pursued with full protection of individuals and communities, in particular those with vulnerabilities. Abuses in the field surfaced in the early 1800s, and by the 1890s, anti-vivisectionists were calling for laws to protect children because of the increasing numbers of institutionalised children being subjected to unethical research. When read together, the Nuremberg Code and the Universal Declaration of Human Rights can be interpreted as establishing a basis for underpinning the principles of free and informed consent and avoiding harms and exploitation in scientific experiments involving human participants. The Declaration of Helsinki has been recognised as one of the most authoritative statements on ethical standards for human research in the world.

摘要

健康研究不仅旨在获取理论知识,还旨在为许多人乃至整个社会带来益处,因此是合理的。然而,问题在于如何在充分保护个人和社区、特别是弱势群体的情况下实现这一重要的共同目标。19 世纪初,该领域就出现了滥用现象,到 19 世纪 90 年代,反活体解剖主义者呼吁制定法律来保护儿童,因为越来越多的机构化儿童被置于不道德的研究之下。纽伦堡法典和世界人权宣言可以被解读为确立了支撑自由和知情同意原则以及避免涉及人类参与者的科学实验中的伤害和剥削的基础。《赫尔辛基宣言》被公认为世界上最具权威性的人类研究伦理标准声明之一。

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