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国际组织与医学科学理事会(CIOMS)关于临床试验伦理的指南。

The Council for International Organizations and Medical Sciences (CIOMS) guidelines on ethics of clinical trials.

作者信息

Macrae Duncan J

机构信息

Pediatric Intensive Care Unit, Royal Brampton Hospital, London, UK.

出版信息

Proc Am Thorac Soc. 2007 May;4(2):176-8, discussion 178-9. doi: 10.1513/pats.200701-011GC.

Abstract

Numerous bodies from many countries, including governments, government regulatory departments, research organizations, medical professional bodies, and health care providers, have issued guidance or legislation on the ethical conduct of clinical trials. It is possible to trace the development of current guidelines back to the post-World War II Nuremburg war crimes trials, more specifically the "Doctors' Trial." From that trial emerged the Nuremburg Code, which set out basic principles to be observed when conducting research involving human subjects and which subsequently formed the basis for comprehensive international guidelines on medical research, such as the Declaration of Helsinki. Most recently, the Council for International Organizations and Medical Sciences (CIOMS) produced detailed guidelines (originally published in 1993 and updated in 2002) on the implementation of the principles outlined in the Declaration of Helsinki. The CIOMS guidelines set in an appropriate context the challenges of present-day clinical research, by addressing complex issues including HIV/AIDS research, availability of study treatments after a study ends, women as research subjects, safeguarding confidentiality, compensation for adverse events, as well guidelines on consent.

摘要

包括政府、政府监管部门、研究机构、医学专业团体和医疗服务提供者在内的许多国家的众多机构,都已发布了关于临床试验伦理行为的指导意见或法规。当前指南的发展可以追溯到第二次世界大战后的纽伦堡战争罪行审判,更具体地说是“医生审判”。从那次审判中产生了《纽伦堡法典》,它规定了进行涉及人类受试者的研究时应遵循的基本原则,随后成为诸如《赫尔辛基宣言》等医学研究全面国际指南的基础。最近,国际组织与医学科学理事会(CIOMS)针对《赫尔辛基宣言》中概述的原则的实施制定了详细指南(最初于1993年发布,并于2002年更新)。CIOMS指南通过解决包括艾滋病毒/艾滋病研究、研究结束后研究治疗的可及性、作为研究对象的女性、保密保护、不良事件补偿以及同意指南等复杂问题,在适当背景下阐述了当今临床研究的挑战。

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