Academic journal article IRB: Ethics & Human Research

Assessing the Readability of Non-English-Language Consent Forms: The Case of Kiswahili for Research Conducted in Kenya

Academic journal article IRB: Ethics & Human Research

Assessing the Readability of Non-English-Language Consent Forms: The Case of Kiswahili for Research Conducted in Kenya

Article excerpt

One of the fundamental ethical requirements for research with humans is that individuals provide valid informed consent to participate in research studies. (1) A key issue regarding the validity of informed consent is whether individuals understand the information presented in the consent form. How easy or challenging it is for individuals to understand a consent form depends on their knowledge and ability to comprehend and on the text itself. Factors affecting the reader's ability to comprehend include her socioeconomic status and how many years of education she has. For instance, several studies assessing comprehension of consent forms have shown that research participants with more years of education had significantly higher comprehension levels than those with fewer years of education. (2) In another study, participants who had difficulty reading and those who were illiterate benefited more from a simplified consent form than their more educated counterparts did. (3) Text factors related to readability include a form's overall length, legibility of print, illustration, color, vocabulary, conceptual difficulty, syntax, and organization. (4)

The Kenya Medical Research Institute (KEMRI) is the national body responsible for carrying out health research in Kenya. The KEMRI national ethical review committee (KEMRI/NERC) has a general requirement that consent forms be of a readability level suitable for the research participants, although what this means is not specified. To assess acceptable readability, the KEMRI/NERC examines English-language consent forms; however, it never determines whether the forms translated into Kiswahili--which, with English, is one of the two official languages of Kenya--are comparable in readability to the English-language forms. Rather, the KEMRI/NERC assumes that a lower level of readability for the English-language consent form results in an equal level of readability for the Kiswahili-language form. Bearing in mind that the literacy rate in Kenya is 61%, it is important that the translated forms are at the lowest readability level possible.

To date, there has not been a single empirical study to document the readability of Kiswahili forms or to determine whether readability formulas previously developed for English text applies to Kiswahili text. Indeed, we are not aware of any studies that compare the readability of English-language forms to their translated forms in any language. To address this lacuna in knowledge, our study was designed to measure and compare the text difficulty of English-language consent forms to the version of those forms translated into Kiswahili. Knowing whether translated forms resemble the original English-language form in readability is important given that ethics review committees around the world generally make the assumption that a simplified English-language form will result in a simplified local language form. Without empirical data to determine whether this assumption is accurate, however, research ethics review committees may need other mechanisms to determine the readability of local language consent forms.

Assessing Readability

Readability, or reading ease, is a function of texts, while comprehension is a function of readers. Nonetheless, the concepts are inextricably linked. Readability formulas and methods, therefore, should not merely predict whether the reader can read the words, but whether the sentences have meaning to the reader. There currently are over 40 formulas that can be used to determine readability levels of English prose text. Although a smaller number of readability formulas exist for languages other than English, there are no readability formulas for Kiswahili. (5)

One method designed to measure readability of documents written in any language is called the cloze procedure. Briefly, it requires that the tester delete words from the passage of interest at regular intervals--for example, every fifth word. …

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