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Confronting the language issues in obtaining informed consent for health-related research.

Abstract

The large number of studies on the readability and understandability of informed consent forms used in health research testifies to their problematic nature and to their authors' inability to simplify them. With the attendant risk to the lives of study participants, concern with health research consent forms extends to every individual and not only to those with low levels of education. Using readability theory, this study solicited the responses of eight final-year university students of reading with a view to acquainting them with readability issues in health research. The students volunteered to assess their comprehension of an informed consent (1C) form which targeted HIV/AIDS patients by responding to a cloze test and a comprehension quiz. As in other studies, findings confirmed that the form was difficult to read and that failure to understand the health research jargon hampered the good intentions of obtaining participants' valid informed consent. It is recommended that informed consent forms be prepared as rigorously possible so as to make them readable and understandable to participants unfamiliar with health research jargon. There is potential for graduate teachers working as resource persons for drafting and/or interpreting 1C forms.

Key words: human subjects, readability, consent, health research, health literacy

Introduction

The ever-growing number of studies on the readability of informed consent forms used in health research (Nielsen-Bahlman, Panzer & Kindig 2004, p. 187) testifies to their problematic nature and to their authors' inability to simplify them. With the attendant risk to participants' lives, concern with health research consent forms extends to every user and not only to those with low levels of education. Using readability theory, this study involved eight final-year education students specialising in the teaching of reading. After surveying the structure and contents of a small number of informed consent forms, the students volunteered to assess their comprehension of one form which targeted HIV/AIDS. Using readability theory, this study discusses the responses of these eight students, all unfamiliar with the language of health research in order to explore the issues surrounding the process of obtaining informed consent in health research.

One major challenge of obtaining such consent in a country such as Botswana arises from the country's multilingual situation. While Kachru (1989) would classify Botswana as an ESL country belonging to 'the outer circle', English is not a language widely used; an estimated 70 per cent of the population speaks Setswana, whereas the other 30% of the population speaks about 28 other languages (Maruatona & Cervero, 2004), spread out in the vastness of the country (Bagwasi 2004, Nyati-Ramahobo 2000). Under these circumstances, participants in health research face many challenges in reading and understanding English informed consent forms, as they have to overcome the problems embedded in the text of the IC form besides their unfamiliarity with health research jargon. Additionally, the informed consent form may not meet participants' differences in age, cultural background, literacy level, and educational level. The participant may have no recourse to assistance due to either the confidentiality involved or the mutual helplessness of those around.

The Informed Consent Form

The doctrine of informed consent demands that researchers inform participants of the risks, benefits, and the right to, or not to participate. However, the label 'informed consent form' can be misleading, because the document is not formatted as a 'form' for the research participants to fill. In fact, there is nothing participants write except their signature to show that they have read and understood it. This places a high premium on the form's readability and comprehensibility. Despite this, signing the IC form is now acknowledged as a critical ethical step in health research. By signing or thumb printing the IC form, participants give tangible evidence of their consent and it is assumed that this is done after understanding fully the study's procedures, risks, and benefits.

Participant consenting has its origins in World War II following the inhuman medical experiments conducted on camp prisoners without their consent. As a result, the 1949 Nuremberg Code was published in 1949 (Bulger, 2002) and continues to provide guidance to researchers internationally today. Another international convention, known as the Helsinki Declaration, was published in 1964 in response to the numerous ethical debates surrounding human subject research; and has had many subsequent amendments in 1975, 1983, 1989, 1996, 2000, 2002, 2004, and 2008 as new ethical insights emerged. In 1993 the International Ethical Guidelines for Biomedical Research Involving Human Subjects was issued by the Council for International Organizations of Medical Sciences (CIOMS). All these guidelines and others published by individual governments to meet specific country needs assist researchers in obtaining participant consent. However, the highly technical language of ethics, research, and medicine unfamiliar to the majority of participants, makes 1C readability and comprehension major challenges.

There have been several studies that have examined the readability and understandability of 1C forms, for example Ancker (2004), who examined whether they are readable at all. One challenge is the participant's ability to overcome the text-embedded problems such as the overall length of the form or the sentences in it; the unfamiliarity with the topic, etc. Also texts may not meet participants' vast differences in cultural background (see Lindegger & Richter, 2000), age, as well as literacy and educational levels. Studies reviewed by Nielsen-Bahlman et al. (2004) reported that 'the consent form is often at a scientific level that contributes to information overload, poor understanding, and misinformed consent'. The participant may have no recourse to assistance either due to the confidentiality involved or the helplessness of those around. The mother tongue may not be relied upon to alleviate the difficulties encountered partly because of the specialised language of the consent form, but also because such problems are best investigated case by case.

Kithinji and Kass (2010) explored whether a translated version was preferred by bilingual speakers of English and Swahili and reported a preference for the English version. LoVerde, Prochazka & Byyny (1989) noted that IC forms are long and written at reading levels that are beyond the capacity of most potential subjects. Sudore et al. (2006) reported that research subjects often do not understand fundamental concepts required for participation. Raich et al. (2001) noted the failure of IC forms to respond to the needs of vulnerable populations from whom it is difficult to obtain informed consent. Flory and Emmanuel (2008) investigated specifically participants' understanding of a study's procedures, risks, and benefits and reported misconceptions regarding the benefits accruing to subjects as a result of their participation in clinical trials. Lidz, Applebaum & Renaud (2002) say that such misconceptions may be attributable to socialisation to ordinary medical care and the role of doctors, which distorts the way research subjects understand the benefits, risks, and procedures. Consent form studies focusing on the readability of translated versions of IC forms are emerging (see Kithinji & Kass, 2010). All these studies point to a close link between readability (which is text-based) and understandability (which is reader-based). Taking an interactive view of reading, the current study adds a factor that is missing - the author.

Most health research operates in environments dominated by the English language. Yet more and more health research is conducted outside native English-speaking contexts. In such contexts, a person's basic difficulties with English result in barriers to understanding the IC form.

Theoretical Framework

Obtaining valid consent from would-be study participants is increasingly becoming the subject of study by a cross-section of people. Linguists, for example, may use Critical Discourse Analysis (Van Dijk, 2001; Fairclough, 1995; 2001; Wodak & Meyer, 2001) to analyse the IC form in terms of power imbalances such as between the researcher and the participant. To the linguist using CDA, the text of the IC form is not neutral and the meaning of the form is not just from the words-on-the-page, but also from how those words are used in a particular social context (Fairclough, 1995; 2001). In this study however, we opted to use readability analysis, which presupposes a non-critical reader responding to what confronts a typical reader in trying to read and understand a text in an uncritical manner. Readability analysis, unlike CDA on the other hand, restricts analysis to the text itself, and presupposes that the text has good intentions for the reader, but that these good intentions may be lost due to the difficulty with which that reader reads and understands the text. The rationale for using readability analysis is that research in HIV/ AIDS targets a large number of people, the majority of whom may be illiterate and living in remote hard-to-reach, poverty-stricken areas. If such participants were not assisted in understanding the good intentions of the consent form, their consent would not be said to be informed and therefore valid.

Reading is increasingly being theorised as an interactive process. In this view of reading, the author as the originator of the interaction plays a central role. When we accept that authors are responsible for much of the meaning in the text, then we can predict the success of the interaction between the author, reader, and that text. Studies grounded in the interactive view of reading (Greene, 2001; Prins & Ulijn, 1998; Dean et al .2006; Cutting & Scarborough, 2006; Bensoussan, 1998; Singhal, 1998) also indicate that reader-based factors (such as the readers' linguistic proficiency) exist. In the case of IC forms, the researchers' strong knowledge of the topic may make it difficult for them to see textual difficulties from the participants' viewpoint resulting in loss of comprehension. But, in order to make meaning during the act of reading - however simple the text is readers engage in a very complex cognitive and linguistic process involving accuracy and efficiency in decoding phonological and syntactic information, resourcing vocabulary and background knowledge, remembering what has been read, and focusing on the purpose for reading (see Cain, Oakhill, & Bryant, 2000; Gottardo, Stanovich & Siegel, 1996; RAND Reading Study Group, 2002; Seigneuric, Ehrlich, Oakhill, &Yuill, 2000; Sweet & Snow, 2003).

Like most research, health research operates in environments dominated by the English language (Maher, 1986), including countries where only a few people use English as a Second Language (ESL) such as Botswana where estimates, according to Bagwasi (2003) are that people in the country who have knowledge of English range from 35 to 40%; and that this estimate includes those speakers who are completely fluent and those who just have a basic knowledge of English (p.212). Secondly, health research is global in nature due to endemics such as HIV/AIDS. Consequently, more and more health research is conducted outside native English-speaking contexts. In such contexts, a person's basic difficulties with English result in barriers to understanding vitally important information so as to give valid consent. Kithinji & Kass (2010) showed that the language in which the text is written affects the success with which it is read. Kintsch's (1994,1998) discourse-processing theory also emphasises the role of language in text comprehension, because knowledge of word meanings, grammar, and cohesion at the intersentential level, paragraph level, and at text structure level, facilitate understanding. Informed consent readability and comprehension can therefore be schematised diagrammatically as follows:

This interaction with regard to the IC form comprises three key elements which are: the provision of adequate information by the researcher so that participants will make an informed choice; the capacity of the individual participant to understand what they are told and to make a reasonable choice based on that information; and the voluntariness with which that choice is made (Macklin, 1999). When this information is conveyed in writing, the ease with which the written text can be read is fundamental to understanding. Many factors such as syntax, textual length and organisation, legibility of print, vocabulary, and conceptual content may facilitate or curtail the success of the interactive process between researcher (author), the text of the IC form, and participant (reader).

The Study

The study combined the use of editing, the cloze test, and the comprehension quiz so as to allow a cognitive assessment of the readers, their application of interactive text processing, and their knowledge of English sentence structure in order to read and understand an IC form they were encountering for the first time. Readability assessment attempts to predict if a reader can read the words of that text. However, because readability, as noted by Kithinji and Kass (2010, p.10), is closely linked to understandability, it was not enough to predict if readers can read the form without also predicting whether it made sense for those readers. So we proceeded to test the comprehension as well.

The IC form: The Research Unit of the Ministry of Health granted permission to us to use one old form, 19 pages long, submitted for review for a study conducted in 2009 where consent from people with HIV and tuberculosis was being obtained. For ethical reasons we removed all information pertaining to the identities of the investigators, the institutions where the study originated, and where it was conducted.

The participants: Eight Bachelor of Education students specialising in Language Education and taking a 4th year course in the teaching of reading volunteered to participate in this study. They were all ESL learners and their general reading and literacy levels, though not pre-assessed, were assumed to be advanced. This study considers a hypothetical situation where would-be participants are all university graduates. Since English and Setswana are taught at school, a university level of education is a safe indicator of the literacy levels of these graduates in both languages. It can therefore be assumed that, for these would-be participants, an IC form written in English would not create a barrier to obtaining valid consent from them.

The three steps below were followed in the sequence they are presented:

STEP 1: The cloze test. A continuous section of the consent form uninterrupted by subtitles or lists was selected for use on the participants in this study. It was retyped to make sure the length of the blank spaces were uniform. After retaining the first sentence, every fifth word thereafter was deleted until we had deleted a total of 50 blanks. Students had to fill in the blanks with only the author(s)' original word. Its synonym would be wrong. The blanks that were correctly filled indicated the form's readability level for that individual student. A high rate of correct responses would mean the form was readable for this target group.

STEP 2: The comprehension quiz: After the cloze test, students were given the following five open-ended comprehension questions to answer: (i) State the purpose of the study (ii) List the study benefits to participants (iii) State the risks to participants mentioned in the 1C form (iv) State the number of participants' visits to hospital (v) State the confidentiality measures the study undertakes.

STEP 3: Text editing: This was the final activity on the consent form and took 30 minutes. The eight students were paired and asked to underline all text-embedded readability problems they found, including: (a) spelling, omissions, repetition, sentence structure (fragmented, run-on), subject-verb-agreement, pronoun reference agreement, and (b) any other readability issues, e.g. logical flow of ideas, text organisation, print style and size, page layout, and linguistic appropriateness or adaptations. The editing process involved spotting problem areas including typo and grammar errors (if any). In this step of the study, the students would be assessing the form's readability in view of the reading abilities of members of the general public in Botswana for whom it was intended.

Findings and Discussion

Analyses of performance on the cloze test, the comprehension quiz, as well as students' observations from the editing activity were made and the findings are reported below.

(i) Findings from the cloze test

Data from the cloze test do not require complex computation. The total number of correct responses was totaled and computed as a percentage. As stated earlier, a correct response was the exact word in the text of the 1C form; its synonym was not accepted. In this way, a judgment could be made about the student's ability to predict as they read the author's word choice; a skill efficient readers use.

Although in the literature there are various score ranges for interpreting performance on cloze tests (see DuBay, 2004), the preferred score ranges for this current study were those used by Kithinji & Kass (2010) in a readability study of IC forms in Kenya. They are as follows:

* Above 66% means the form is very easy to read

* Between 38 and 65% means the form is readable

* Below 38% means the form is unreadable

Table 1 below shows the results of the students' performance on the cloze test in this current study.

Table 1: Students' performance on the cloze test

Student   A    B    C    D    E    F    G    H

Score %   69   33   45   40   42   45   40   64


Out of eight students, only one student (with a score of 69%) found the form very easy to read, six found it readable, and one (with a score of 33%) found it unreadable. This was expected, given these students' level of education.

(ii) Findings from the comprehension quiz

Below are the five questions - which are boldfaced - followed by the pattern of responses generated by the students.

* State the purpose of the study:

There were four correct responses [to find out which drug works besf\. Curiously, the incorrect responses all said the purpose of the study was 'to collect data for the government'. This response may be attributed to the high expectations people have regarding the government's role in combating HIV/AIDS.

* State the required number of participants' visits to the hospital:

Five students were correct [11 visits for 1 year]. However, two said 'Don't know', and one said 'seven times'. In the real world, failure to understand the required number of visits results in non-compliance with study procedures, which can have serious repercussions for the participant and this can also negatively affect study results.

* List the benefits:

Two students skipped this question. Another said 'not mentioned clearly'. Each one of the other five students could only identify one single benefit, verbatim: (1) getting free treatment as a participant (2) get the right treatment as test would have shown which treatment to take between the two mentioned (3) knowledge of treatment (4) they will be tested and given medication (5) have treatment of TB. The general vagueness in students' responses may be attributed to the unfamiliarity of this ethical issue; and the expectation that hospitals provide 'benefit' to patients.

* State the risks to participants:

Five students skipped this question. One was non-committal, saying 'benefits and shortcomings of the study be given'. Two other attempts at this question were equally unclear, saying, verbatim: (1) to know what would happen if death occurs due to the sereness [seriousness] of study side effects - who will be accountable? (2) What will happen to a person who dies during the study in one group? These responses indicate that the concept of 'risk to the participant' was difficult for the students to understand.

* State the confidentiality measure the study undertakes:

This question was avoided by all eight students. It is unclear why this was the case. One explanation could be that the issue of confidentiality appeared at the very end of the form and by this time, many students had stopped reading.

In conclusion, performance on the comprehension quiz was poor due to the several abstentions from answering specific questions, and the unclear answers from some of those who attempted answering.

(iii) Findings from the editing activity

Students spotted occasional spelling errors (examples were: tuubeculosis, natiuonal, sputim, etc.); spacing errors (are infected); words omitted (you will continue receive)', words inserted (asked to how); and one incident of comma use instead of a full stop. Though not serious enough to cause a breakdown in communication, careful editing should have eliminated these errors in mechanics. They also complained of information clutter on the title page resulting in difficulty in recognising the title, leading one student to complain that 7 was unable to predict what the paper was' (verbatim). Others complained about acronym overuse. They were also unhappy about the twenty-two (22) section subtitles followed by paragraphs providing minimal detail. Specific grammar criticism went to two sentences, namely: 'These reactions, if they happen to you ...' students restructured this to read: 'If these reactions happen to you'. They also disliked the 'frequent use of long medicine names' which they 'could not pronounce'. Osborne (2005, p. 16) shows preference for developers of such texts as consent forms to assess readability by hand rather than computer-based formulas, because authors are able to 'add a dose of common sense' as they work.

Discussion

The eight students in this study were all ESL speakers. Their English reading proficiency levels, though not ascertained prior to the study, were assumed to be adequate given their level of university education. They also spoke Setswana, which for some, was the mother tongue. However, the form only expected proficiency in English. Because the form we used appeared not to have been initially adequately edited, readability and comprehension were compromised. Such a situation compromises the validity of the consent participants would give. Additionally, due to reader-based problems, it is doubtful whether a Setswana-translated version of the form would have helped, given the fact that in actual research situations, participants range from healthy volunteers to those rendered vulnerable by a combination of various debilitating circumstances. For example, in Botswana, of the HIV/AIDS patients which this IC form targeted, there are participants who are debilitated by age, such as under-age children and the elderly; by gender, where estimates for literacy show 47% male and 53% female; by unemployment, which was estimated at 19.3% in 2001; and poverty, with an estimated 37.4% of the population living below the national poverty line (Republic of Botswana, 2003). All the above factors impact heavily on the ability to read and understand the information provided in the informed consent forms. Ascertaining that valid informed consent was obtained requires a complex process of minimising such factors.

Another readability challenge is the difficulty of adequately conveying basic research concepts in settings where functional literacy (Osborne 2005, p. 132), let alone scientific study, is not widely known. Schema theory informs us that readers understand written texts through a process of referring to background experiences in the reader's past. Research on reading comprehension (see Klingneretal., 2007, p.15) reports that effective readers connect a new text with past experiences, interpret, evaluate, synthesise and consider alternative interpretations of what they have read; and are able to monitor their understanding and use of all available information while attempting to make sense of the text; and that a reader's response to the text is quite personal and is affected by interest, background knowledge, purpose for reading, and textual characteristics. Concepts that are basic to obtaining valid informed consent such as confidentiality, risk, and benefit, can be extremely challenging for participants whose pasts are devoid of such concepts, as the students' responses indicated in this study. Evidence from the eight students showed that because readers have no schema for these concepts, let alone L1 equivalents for them, comprehension was lost. The problem may also be attributed to the low health literacy levels these students possess. Shaibu and Phaladze (2010) showed that low levels of health literacy prevail even for people whose general reading abilities may be appropriate, such as these university students. Nielsen-Bohlman, Panzer and Kinding (2004, p.32) observed that because of the impact of culture, language and the characteristics of health-related settings, health literacy may be unrelated to years of education. For the students in this brief study, low health literacy levels must be the result of having been socialised to regard hospitals as places of care and cure. Therefore the sentence 'We want to see you when you are sick so that we can take care of you' drew heated objection from many students, arguing that it did not reflect patients' hope of healing expected from a health facility. One asked: 'As teachers, can we tell students that we want you to fail the exam so we can help you pass?' Such responses clearly indicate a strong cultural view that health care is the sole responsibility of hospitals and not a shared responsibility between physician and patient.

Conclusion

Using readability theory, this study solicited the responses of eight final-year university students of reading, all unfamiliar with the language of health research, in order to explore the issues surrounding the process of obtaining informed consent in health research. These students are in a similar situation as many actual participants in health research studies who find themselves being required to indicate their voluntarism by signing informed consent forms. Findings from the cloze test and from the comprehension quiz show that the students found the consent form difficult to read and understand; and were rightly unhappy with the editorial work that had been performed on the form by the authors; and with the health research jargon that obscured the form's good intentions.

It is recommended that if valid consent is to be realised, the consent forms should be made as readable and as understandable as possible to participants, a large majority of whom are unlikely to be familiar with health research jargon. Since our capacity to understand increases if our schema is up to the task, enriching health-related settings with appropriate health information is beneficial. Alternatively, face-to-face sessions between researcher and participant, though time-consuming, would greatly minimise the problems identified.

Finally, the study underscores the potential for teachers (such as those in this study) working as informed consent form resource persons for drafting, interpreting, translating, editing, or serving in an advisory capacity, particularly in areas where literacy levels are low. In view of the many challenges, the findings in this paper point to the possibility of enlisting teachers as resource persons in facilitating corrective action in the process of obtaining informed consent from participants. Figures for 2011 show that teachers represent a highly trained resource in Botswana: of the total primary school teaching force alone, 65% hold diplomas while 12% hold either a bachelor's or a master's degree in education and are distributed across the country's 810 primary schools (CSO 2011).

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D. Kasule, University of Botswana

Dr Daniel Kasule is a Senior Lecturer in Language Education at the University of Botswana. He teaches literacy, language teaching methodology, as well as language acquisition. He has published several papers in academic journals on various aspects of applied linguistics.
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