Informed consent process: A step further towards making it meaningful!
Informed consent process: A step further towards making it meaningful!
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DOI：
10.4103/picr.picr_147_16
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发表时间：
2017-07
影响因子：
--
通讯作者：
Kadam RA
中科院分区：
文献类型：
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作者：
Kadam RA
知情同意程序是临床研究伦理的基石。从参与临床研究的患者那里获得知情同意是临床试验研究人员的重要法律和伦理要求。虽然知情同意在临床研究中是一个重要的过程，但其有效性和有效性一直是一个令人担忧的问题。与临床试验参与者的理解、理解、能力和自愿有关的问题可能会对知情同意过程产生不利影响。对于临床研究人员来说，向文化水平有限、社会文化背景多样、自主性减弱和疾病衰弱的参与者传达高度技术性、复杂性和专业性的临床试验信息是一项艰巨的任务。因此，有必要研究和采用创新的沟通策略，以提高参与者对临床试验信息的理解。这篇综述文章探讨了影响知情同意过程的挑战，并探索了加强同意过程的各种创新战略。
Informed consent process is the cornerstone of ethics in clinical research. Obtaining informed consent from patients participating in clinical research is an important legal and ethical imperative for clinical trial researchers. Although informed consent is an important process in clinical research, its effectiveness and validity are always a concern. Issues related to understanding, comprehension, competence, and voluntariness of clinical trial participants may adversely affect the informed consent process. Communication of highly technical, complex, and specialized clinical trial information to participants with limited literacy, diverse sociocultural background, diminished autonomy, and debilitating diseases is a difficult task for clinical researchers. It is therefore essential to investigate and adopt innovative communication strategies to enhance understanding of clinical trial information among participants. This review article visits the challenges that affect the informed consent process and explores various innovative strategies to enhance the consent process.