Ethical Considerations in Clinical Research: A Comprehensive Review

V. Kandi, Sabitha Vadakedath
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引用次数: 1

Abstract

Clinical studies involve research that is carried out in human beings and has direct implications on the health of people who participate in it as study subjects. Moreover, clinical trials are performed on healthy and diseased human subjects, wherein the safety and efficacy of a novel drug/device are tested. Therefore, the study design and the subject recruitment assumes increased significance. In this review we attempt to comprehensively discuss the importance of ethics in clinical research and specific ethical considerations concerning the evaluation of medical products, epidemiological studies, human genetics, and genomic research, transplantation studies, reproductive procedures/interventions, research among geriatric and pediatric populations and research involving the development of vaccines and diagnostic devices.
临床研究中的伦理考虑:综述
临床研究涉及在人体中进行的研究,对作为研究对象参加研究的人的健康有直接影响。此外,在健康和患病的人类受试者上进行临床试验,其中测试了新药物/设备的安全性和有效性。因此,研究设计和受试者招募具有越来越重要的意义。在这篇综述中,我们试图全面讨论伦理在临床研究中的重要性,以及在医疗产品评估、流行病学研究、人类遗传学和基因组研究、移植研究、生殖程序/干预、老年和儿科人群研究以及涉及疫苗和诊断设备开发的研究方面的具体伦理考虑。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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