进行临床试验的伦理考虑

IF 0.3 Q4 MEDICINE, LEGAL
Shahriar Mousavinejad, S. Bazmi, M. Rezaei-Tavirani, Ehsan Shamsi-Gooshki, Seyed Ali Enjoo, M. Kiani
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引用次数: 0

摘要

背景:临床试验是人类参与医学研究的金钥匙。它们一直被这个领域的研究人员和科学家认为是有趣的话题。然而,这些样本是“人类参与者”,因此研究应该谨慎进行。方法:本研究对2010 - 2019年在谷歌Scholar、PubMed和Scopus上发表的关于开展临床试验的伦理挑战的文章进行评估。英文搜索关键词是“临床试验”,至少有一个短语是“伦理考虑”或“标准”。结果:在本文中,我们从研究设计与质疑、提案审核与批准、监督与实施、结果发表四个阶段考察了这些研究的伦理要求和考虑因素。我们利用2010年至2019年间发表的相关文章对它们进行了审查,并找出了重要和突出的问题或被忽视的问题。结论:在本次研究中,我们发现“研究设计和问题”阶段是讨论最多、最具挑战性的阶段,作者对此阶段的敏感性一直高于其他三个阶段。另一方面,“结果发表”阶段被认为不太敏感,因为文章中引用的文献数量最少。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Ethical Considerations in Conducting Clinical Trials
Background: Clinical trials are the golden key in medical science research with human participants. They have always been considered interesting topics by researchers and scientists working in this field. However, the samples are “human participants,” so the research should be carefully conducted. Methods: In the present study, the published articles on the ethical challenges of conducting clinical trials were evaluated between 2010 and 2019 in Google Scholar, PubMed, and Scopus. The English search keywords were “clinical trial,” with at least one of the phrases of “ethical consideration” or “standard”. Results: In this article, we examined the ethical requirements and considerations in these research studies in four stages: research design and question, proposal review and approval, supervision and implementation, and publication of the results. We have examined them using relevant articles published between 2010 and 2019 and identified important and prominent issues or neglected ones. Conclusion: During this study, it was found that the “research design and question” stage was the most discussed and challenging stage, and the authors’ sensitivity about it has been more than the other three stages. On the other hand, the “results publishing” stage has been considered less sensitive with the least number of references in articles.
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来源期刊
CiteScore
0.60
自引率
0.00%
发文量
50
审稿时长
12 weeks
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