Readability of informed consent documents and its impact on consent refusal rate.

Q2 Medicine

Perspectives in Clinical Research Pub Date : 2025-01-01 Epub Date: 2024-08-30 DOI:10.4103/picr.picr_322_23

Yash V Kamath, Yashashri C Shetty, Ishita C Lanjewar, Ankita Kulkarni

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引用次数: 0

Abstract

Introduction: Informed consent documents (ICDs) are integral to a research project and must provide all required information to the participant. We undertook a 6-year retrospective cross-sectional analysis of ICDs to assess the same.

Methods: We accessed 300 ICDs from studies submitted to institutional ethics committee. Studies were selected using random proportional-to-size sampling across years and study types (thesis, pharma, government, investigator initiated [OA] studies). We used the Flesch-Kincaid Reading Ease Score (FRES), estimated reading time (ERT) and scored ICDs out of 13 points on the basis of the Indian Council of Medical Research (ICMR)-mandated headings (ICD Quality Score [IQS]). Information pertaining to the consent refusal rate (CRR) of each study was correlated with FRES, ERT, and other parameters. P <0.05 was considered statistically significant.

Results: Two hundred and ninety-three ICDs had complete information. Median FRES was 48.3 (interquartile range [IQR] = 7), median ERT was 4.5 min (IQR = 1.3), the median expected duration of participation was 35 min (IQR = 40); compensation was provided by 23 projects and median compensation was Rs. 2500 (IQR = Rs. 4750). Mean IQS improved from 11.95 to 12.60 in 6 years (Kruskal-Wallis test, P < 0.001). FRES was weakly negatively correlated to the CRR (r = -0.120, P = 0.039), while the expected duration of participation was weakly positively correlated (r = 0.144, P = 0.014).

Conclusion: Pharma studies performed better and ICDs have improved in their readability and ICMR guidelines compliance.

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知情同意文件的可读性及其对拒绝同意率的影响。

简介：知情同意文件（ICDs）是研究项目不可或缺的一部分，必须向参与者提供所有必要的信息。我们对icd进行了为期6年的回顾性横断面分析来评估这一点。方法：我们从提交给机构伦理委员会的研究中检索了300份icd。研究采用不同年份和研究类型（论文、制药、政府、研究者发起的[OA]研究）的随机比例抽样选择。我们使用Flesch-Kincaid阅读简易评分（FRES）、估计阅读时间（ERT），并根据印度医学研究委员会（ICMR）规定的标题（ICD质量评分[IQS]）对ICD进行评分，满分为13分。每项研究的同意拒绝率（CRR）相关信息与FRES、ERT和其他参数相关。结果：293份icd信息完整。FRES中位数为48.3（四分位间距[IQR] = 7）， ERT中位数为4.5 min (IQR = 1.3)，预期参与时间中位数为35 min (IQR = 40)；补偿由23个项目提供，补偿中位数为2500卢比（IQR = 4750卢比）。平均智商在6年内从11.95提高到12.60 （Kruskal-Wallis检验，P < 0.001）。FRES与CRR呈弱负相关（r = -0.120, P = 0.039），预期参与时长与CRR呈弱正相关（r = 0.144, P = 0.014）。结论：药物研究表现更好，icd的可读性和ICMR指南依从性有所提高。

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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来源期刊

Perspectives in Clinical Research Medicine-Medicine (all)

CiteScore

2.90

自引率

0.00%

发文量

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.