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临床研究中的伦理原则违背。对拉丁美洲的影响及可能的解决方案。

Violation of ethical principles in clinical research. Influences and possible solutions for Latin America.

机构信息

Research Coordinator Medical Associate, Planning and Institutional Liaison Coordination, Healthcare Services Management, The Mexican Institute of Social Security, Hidalgo Delegation, Delegación Hidalgo, Pachuca de Soto, CP, Mexico.

出版信息

BMC Med Ethics. 2012 Dec 16;13:35. doi: 10.1186/1472-6939-13-35.

Abstract

BACKGROUND

Even though we are now well into the 21st century and notwithstanding all the abuse to individuals involved in clinical studies that has been documented throughout History, fundamental ethical principles continue to be violated in one way or another.

DISCUSSION

Here are some of the main factors that contribute to the abuse of subjects participating in clinical trials: paternalism, improper use of informed consent, lack of strict ethical supervision, pressure exerted by health institutions to increase the production of scientific material, and the absence of legislation regarding ethics in terms of health care and research. Are researchers ready to respect fundamental ethical principles in light of the ample window of information provided by individual genomes, while defending the rights of the subjects participating in clinical studies as a major priority?

SUMMARY

As one of the possible solutions to this problem, education regarding fundamental ethical principles is suggested for participants in research studies as an initial method of cognitive training in ethics, together with the promotion of ethical behavior in order to encourage the adoption of reasonable policies in the field of values, attitudes and behavior.

摘要

背景

尽管我们现在已经进入 21 世纪,尽管历史上有记录表明,对参与临床研究的个人的所有虐待行为,但基本伦理原则仍以这样或那样的方式被违反。

讨论

以下是导致参与临床试验的受试者受到虐待的一些主要因素:家长式作风、知情同意书的不当使用、缺乏严格的伦理监督、医疗机构施加的增加科学材料产量的压力,以及缺乏关于医疗保健和研究伦理的立法。鉴于个体基因组提供的广泛信息窗口,研究人员是否准备好尊重基本伦理原则,同时将保护参与临床研究的受试者的权利作为首要任务?

总结

作为解决此问题的方法之一,建议对研究参与者进行基本伦理原则教育,作为伦理认知培训的初始方法,并促进伦理行为,以鼓励在价值观、态度和行为领域采取合理政策。

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