Consent for participating in clinical trials - Is it really informed?
Consent for participating in clinical trials - Is it really informed?
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DOI：
10.1111/dewb.12199
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发表时间：
2018-09-01
影响因子：
2.2
通讯作者：
Ioan, Beatrice Gabriela
中科院分区：
文献类型：
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作者：
Alexa-Stratulat, Teodora;Neagu, Marius;Ioan, Beatrice Gabriela
本文探讨了确保自愿和知情同意，这是从潜在的研究对象在罗马尼亚东北部的挑战。本研究报告是罗马尼亚最早的这类实证性论文之一。该研究采用了定量调查设计，采用了改编的知情同意质量（QuIC）问卷。目标人群包括100名自愿参加临床试验的成年人。知情同意书必须包含有关潜在风险和获益、临床试验目的、研究设计、保密性、保险和联系方式（如有其他问题）的详细信息。我们的研究证实，尽管ICF中包含了所有要求的信息，但很少有临床试验参与者真正理解它。我们还发现，对临床试验进行良好的主观和客观理解的最重要预测因素是教育水平。我们的研究表明，研究人员应该考虑投入更多的努力，以帮助临床试验参与者实现更好地理解知情同意。这样，它们将确保参与者的决策是有意义的，他们的利益得到保护。
The article explores the challenges of ensuring voluntary and informed consent which is obtained from potential research subjects in the north-eastern part of Romania. This study is one of the first empirical papers of this nature in Romania. The study used a quantitative survey design using the adapted Quality of Informed Consent (QuIC) questionnaire. The target population consisted of 100 adult persons who voluntarily enrolled in clinical trials. The informed consent form must contain details regarding the potential risks and benefits, the aim of the clinical trial, study design, confidentiality, insurance and contact details in case of additional questions. Our study confirmed that although all required information was included in the ICF, few clinical trial participants truly understood it. We also found that the most important predictive factor for a good subjective and objective understanding of the clinical trial was the level of education. Our study suggests that researchers should consider putting more effort in order to help clinical trials participants achieve a better understanding of the informed consent. In this way they will ensure that participants' decision-making is meaningful and that their interests are protected.