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在线调查知情同意的横断面审计:特征及对现行指南的遵循情况

A cross-sectional audit of informed consent of online survey: Characteristics and adherence to prevalent guidelines.

作者信息

Mondal Himel, Mondal Shaikat, Soni Sachin

机构信息

Department of Physiology, AIIMS, Deoghar, Jharkhand, India.

Department of Physiology, Raiganj Government Medical College and Hospital, Raiganj, West Bengal, India.

出版信息

Perspect Clin Res. 2023 Jul-Sep;14(3):123-129. doi: 10.4103/picr.picr_175_22. Epub 2023 Apr 17.

Abstract

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 [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.

摘要

背景

涉及人类参与者的研究需要获得主管伦理委员会的正式批准。在招募研究参与者的过程中,获得知情同意是一个先决条件。许多研究人员采用在线调查方法,因为它可以在短时间内从不同人群中收集数据。

目的

本研究旨在观察与在线调查相结合的知情同意的特征以及对现行指南(由印度医学研究理事会制定)的遵循情况。

方法

我们从同事网络获取的在线调查链接中收集知情同意文本,这些同事收到了参与调查的请求。数据收集时间为2020年7月至2022年6月。文本经过匿名处理以进行进一步分析。计算单词数、句子数和弗莱什易读性得分。由两位作者分别检查对印度医学研究理事会指南的遵循情况,并达成共识以得出最终结果。

结果

共审核了44份英文在线调查,其中10份没有知情同意书。34份调查中的知情同意书的句子中位数为6句,单词数为84个。易读性得分中位数为45.7(大学水平)。大多数同意书陈述了研究目的(91.18%)、参与的自愿性质(85.29%),并提到这是一项研究(64.71%)。然而,大多数调查同意书忽略了其他部分。

结论

在线调查的知情同意书缺乏对印度医学研究理事会建议的组成部分 的遵循。因此,研究人员应谨慎制定这些表格,以便在在线调查中保持知情同意的效力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3332/10405532/a3068d6ea3ae/PCR-14-123-g001.jpg

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