新冠肺炎大流行时代的临床试验伦理

Muhammet Arslan, Nüket Örnek Büken
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引用次数: 1

摘要

世界一直在遭受冠状病毒的致命影响,而且似乎还将持续相当长的时间。人类目睹了多种疾病的爆发,这些疾病地方性地或流行病地影响了人口。迫切需要治疗COVID-19是必要和必不可少的。本文分析了临床试验伦理的基础、目前的出版物和声明,以克服流行病的困难,并进一步关注土耳其。研究医师、志愿患者、行业、机构和国家/国际伦理法律团体在临床研究中发挥着重要作用。正如希波克拉底誓言中所述,医生的职责是“首先不造成伤害”。许多国际文件也指出,维护人的尊严和基本权利是最基本的态度。临床试验遵循立法机构规定的一套原则。医学伦理学试图为所有研究建立一个共同的基础,以满足国际上可接受的标准的需要。道德标准不是服务于资格的利益,而是维护质量价值。可以说,医学伦理学是一门为科学和道德发展服务的学科。
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Clinical Trial Ethics in the Era of COVID-19 Pandemic
The world has been suffering from the deadly effects of coronavirus and seemingly will continue to suffer for quite more time. Humanity has witnessed many kinds of outbreaks that have affected the population endemically or epidemically. Urgent need for treatment of COVID-19 is necessary and essential. In this article the cornerstones of clinical trial ethics, current publications and statements are analyzed to overcome the difficulties of pandemics with an additional focus on Turkey. The researching physician, volunteering patients, industry, institutions, and national/international ethico-legal bodies are playing important role in clinical research. As stated in the Hippocratic Oath, it is a physician’s duty to “first do no harm”. Many international documents also state the fact that preserving the dignity of people and basic rights is the most essential attitude. Clinical trials follow a certain set of principles regulated by legislative bodies. Medical ethics try to establish a common base for all research to fulfill the need for an internationally acceptable standard. Rather than serving the benefit of qualifications, ethical standards preserve qualitative values. It can be said that medical ethics is an appropriate discipline to serve the improvement of both science and morals.
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