在线调查知情同意书的横断面审计:特点和对流行指南的遵守情况。

Q2 Medicine Perspectives in Clinical Research Pub Date : 2023-07-01 Epub Date: 2023-04-17 DOI:10.4103/picr.picr_175_22
Himel Mondal, Shaikat Mondal, Sachin Soni
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引用次数: 0

摘要

背景:对人类参与者的研究需要得到主管伦理委员会的正式批准。在招募研究参与者期间,获得知情同意是一个先决条件。许多研究人员使用在线调查方法,因为它可以在短时间内从不同人群中收集数据。目的:本研究旨在观察知情同意书与在线调查的特点和对流行指南(由印度医学研究委员会制定)的遵守情况。方法:我们从收到参与调查请求的同事网络中获得的在线调查链接中收集知情同意书文本。数据收集时间为2020年7月至2022年6月。为了进一步分析,对文本进行了匿名处理。计算单词数、句子和Flesch阅读轻松度得分。两位作者分别对ICMR指南的遵守情况进行了检查,并达成共识以准备最终结果。结果:共审计了44项英文在线调查,其中10项没有知情同意书。在34项调查中,知情同意书的中位数为6句话和84个单词。中位阅读能力得分为45.7(大学水平)。大多数同意书陈述了研究的目的(91.18%)、参与的自愿性质(85.29%),并提到这是研究(64.71%)。然而,大多数调查同意书忽略了其余部分。结论:在线调查的知情同意书缺乏对ICMR建议的组成部分的遵守。因此,研究人员应该仔细制作表格,以便在在线调查中保持知情同意的活力。
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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A cross-sectional audit of informed consent of online survey: Characteristics and adherence to prevalent guidelines.

Background: Research on human participants requires formal approval from a competent ethics committee. During the recruitment of the research participants, obtaining informed consent is a prerequisite. The online survey method is used by many researchers as it can collect the data from a diverse population in a short time.

Aim: This study aimed to observe the characteristics and adherence to prevalent guidelines (set by the Indian Council of Medical Research [ICMR]) of informed consent coupled with online surveys.

Methods: We collected the informed consent text from online survey links obtained from a network of colleagues who got a request to participate in a survey. Data were collected from July 2020 to June 2022. The text was anonymized for further analysis. The word count, sentences, and Flesch reading ease score were calculated. The adherence to ICMR guidelines where checked by two authors individually and a consensus was reached to prepare the final result.

Results: A total of 44 online surveys in English were audited and among them, 10 did not have informed consent. The informed consent in 34 surveys had a median of 6 sentences and 84 words. The median reading ease score was 45.7 (college level). The majority of the consent states the purpose of the research (91.18%), the voluntary nature of the participation (85.29%), and mentioned that it is research (64.71%). However, the rest of the components are ignored by the majority of the survey consent form.

Conclusion: Informed consent form with online surveys lacks adherence to the components suggested by ICMR. Hence, the forms should be made carefully by the researchers so that the vigor of informed consent is maintained in the online surveys.

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来源期刊
Perspectives in Clinical Research
Perspectives in Clinical Research Medicine-Medicine (all)
CiteScore
2.90
自引率
0.00%
发文量
41
审稿时长
36 weeks
期刊介绍: This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.
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