Kato Renatha, Joseph Renatha, Haule Lazaro, Kafuye Mwanaidi
National Institute for Medical Research, 3 Barack Obama Drive, P.O. Box 9653, Dar es Salaam, 11101, Tanzania.
Department of Bioethics and Health Professionalism, School of Public Health and Social Sciences, Muhimbili University of Health and Allied Sciences, P.O. Box 65001, Dar es Salaam, Tanzania.
BMC Med Ethics. 2025 Apr 22;26(1):50. doi: 10.1186/s12910-025-01200-w.
Obtaining informed consent is the practice of respect for persons that gives the right to participants to make autonomous decisions about research participation. The difficult-to-read research informed consent forms (RICFs) hinder comprehension and can expose participants to harm. This study aims to assess the readability of health RICFs for studies approved by the National Health Research Ethics Committee (NatHREC) in Tanzania.
We used a retrospective cross-sectional study design. A total of 266 RICFs were sampled from the NatHREC database using stratified and systematic random sampling strategies. The readability of RICFs was assessed using the Flesch Reading Ease (FRE) and Flesch-Kincaid Readability Grade Level (FKRGL) formulas available in Microsoft Word Office and by manual check. Data were collected using the assessment checklist, analyzed, and presented with SPSS and MS Excel software.
Out of 266 RICFs assessed, 65.4% had the recommended page numbers, 81.6% had longer sentences, and 80.5% were difficult to read, necessitating a person to acquire a US grade 10 (Form Four educational level in Tanzania) to understand the presented information. Pearson's correlation coefficient with p-values of < 0.001 and 95% confidence level disclosed that sentence lengths in the RICFs had a statistical association with the difficult reading levels obtained.
Findings from this study showed that most of the RICFs were concise in terms of page numbers and word count but had long and difficult sentences. Researchers should assess the readability of RICFs before submitting them for ethical approval. Research Ethics Committees (RECs) should consider inclusion of RICFs readability measurements in the Ethics Guidelines for Health Research. The study recommends further studies to assess the Kiswahili versions of RICFs to determine if the results obtained in this study apply to Kiswahili texts.
Not applicable.
获得知情同意是尊重个人的做法，赋予参与者对参与研究做出自主决定的权利。难以阅读的研究知情同意书（RICF）会妨碍理解，并可能使参与者受到伤害。本研究旨在评估坦桑尼亚国家卫生研究伦理委员会（NatHREC）批准的健康研究RICF的可读性。
我们采用回顾性横断面研究设计。使用分层和系统随机抽样策略从NatHREC数据库中抽取了总共266份RICF。使用Microsoft Word Office中可用的弗莱什阅读简易度（FRE）和弗莱什-金凯德可读性等级水平（FKRGL）公式并通过人工检查来评估RICF的可读性。使用评估清单收集数据，进行分析，并使用SPSS和MS Excel软件呈现。
在评估的266份RICF中，65.4%有建议的页码，81.6%的句子较长，80.5%难以阅读，需要一个人达到美国10年级（坦桑尼亚的四年级教育水平）才能理解所呈现的信息。Pearson相关系数（p值<0.001，置信水平95%）表明，RICF中的句子长度与所获得的难读水平存在统计学关联。
本研究结果表明，大多数RICF在页码和字数方面较为简洁，但句子冗长且难懂。研究人员在提交RICF进行伦理批准之前应评估其可读性。研究伦理委员会（REC）应考虑将RICF可读性测量纳入健康研究伦理指南。该研究建议进一步开展研究，以评估RICF的斯瓦希里语版本，以确定本研究中获得的结果是否适用于斯瓦希里语文本。
不适用。
