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the informed consent form: document development and evaluation

the informed consent form: document development and evaluation

1314 Mark Hochhauser

1314 Mark Hochhauser ers,” or open white spaces that flow down Of the 12 consent forms, all used a mix of the page (1). Although some typographers upper and lower case throughout the consent recommend ragged right justification, while form, although eight capitalized the major others recommend even right justification, headings (INTRODUCTION, PURPOSE research does not show that readers have a OF THE STUDY, etc.), while four used low- preference for either one. ercase. Text that is justified both left and right looks like a block, especially if the paragraph is fairly long. This kind of justification is “Line length is limited to 30–50 characters and spaces.” typical of formal documents, manuals, and A readable document should have about medical information, and while it may offer 8 to 12 words (40 to 70 characters) per line a pleasing appearance, readers often find it (1). Condensed text produces too many inaccessible because of its formal structure. words per line, expanded text too few—both Of the 12 consent forms, eight were ragged make reading more difficult. Words per line right justified and four were even right justi- and size of text are particularly important for fied. older readers, whose eyes may have a hard time reading small typefaces and too many “Upper and lower case letters are used.” words per line. Readers get tired when there are more than Capitalization should be used sparingly. Readers find it hard to read too much text that is in all caps. While consent form writers may use all caps to highlight a particularly important area, typographers recommend using lowercase type and bold or italics rather than all caps. When text is in all caps, there is no text above the line (ascenders) or below the line (descenders)—all the text is the same 70 characters per line. In addition, readers may have a hard time finding the next line, and may reread the same line over again, losing their place in the text (1). The 12 consent forms averaged 15.6 words per line, with a range of 14 to 18 words per line, suggesting the need for larger typefaces and wider margins. “Headers are simple and close to text.” height, making it difficult for the eye to recognize letters. Furthermore, all caps have a rectangular form, and must be read letter-byletter, instead of word by word (3): Leading refers to the amount of vertical space between lines of text (1). Too little spacing creates very dense text. The 12 con- sent forms averaged 5.6 lines per vertical ALL CAPS: I HAVE READ AND UNDER- STAND THE ABOVE INFORMATION, HAVE HAD MY QUESTIONS ANSWERED, AND I VOLUNTARILY CONSENT TO PARTICIPA- TION IN THIS RESEARCH STUDY. I UNDER- STAND THAT I MAY WITHDRAW FROM inch, ranging from four lines per inch (double-spaced text) to 6 lines per inch (singlespaced text.) Too much spacing makes it hard to associate headings and subheadings with the appropriate text. If a subheading is four spaces THIS STUDY AT ANY TIME WITHOUT IN- below a previous paragraph, and four spaces TERFERING WITH MY MEDICAL CARE. A above an upcoming paragraph, the subhead- COPY OF THIS CONSENT FORM HAS BEEN ing just seems to float in the white space. The GIVEN TO ME OR TO MY FAMILY/LEGAL GUARDIAN. Lowercase: I have read and understand the above information, have had my questions answered, and I voluntarily consent to participation in this research study. I understand that I may reader may not be able to readily associate it with the right paragraph. Of the 12 consent forms, five were spaced appropriately, but seven had too many spaces between the head- ing and the text. withdraw from this study at any time without interfering with my medical care. A copy of this PLAIN ENGLISH consent form has been given to me or to my fam- Writing in “plain English” has been sugily/legal guardian. gested as a good way to improve corporate

Informed Consent Forms 1315 and government communications with the 1. Readability Formulas (which often are public. Although the “plain English move- part of a word processing program). If ment” has been popular for many years in properly used, these formulas can give a the United Kingdom, Canada, and Australia, rough estimate of the grade level at which it seems to not have taken hold in the United the consent form is written. But equally States, even though there has been some em- important is an understanding of the literphasis on plain English in law (17) as well acy skills of the target population who will as in business (18). In June 1998, President be expected to read the consent form, Clinton signed a “Presidential Memorandum 2. The Readability and Processability For- on Plain Language,” which directed governmula (19). This is a series of 20 questions ment agencies to use plain language in all that can be used to assess consent forms, new documents by October 1, 1998, and to and rewrite older documents in plain language 3. A Suitability Assessment of Materials by January 1, 2002. (20). This 22-item questionnaire that as- A Medline search of “informed consent” sesses content, literacy demands, graphics, and “plain English” turned up only one cita- layout and typography, learning stimulation, Blenkinsop’s 1997 chapter (16) which tion/motivation, and cultural appropriate- bemoans the lack of plain English consent forms in the United Kingdom. While many ness. of the NCI recommendations are essentially While these three methods can give research- plain English recommendations, the phrase ers some insights into the strengths and “plain English” does not show up anywhere weaknesses of their consent form, these in the NCI document, including the refer- methods cannot assess reader comprehenences. Although the consent process has been sion. designed to protect the rights of human subjects who voluntarily choose to participate Testing the Reader or not to participate in a research study, the There is no substitute for direct testing of consent process has also been designed to readers, although this process certainly takes legally and financially protect the company more time and money than testing of the sponsoring the research. As a result, consent consent form itself. Reader testing can be form language (especially when dealing with “compensation”) is often full of “legalese.” done via: Rewriting consent forms into “plain English” 1. Informed Consent Interviews. Searight should help potential research subjects make and Miller (21) used an 11-item interview, more informed decisions about whether to asking questions such as “What can you participate in research or not. If they cannot tell me about the study that you were in- easily read or understand a consent form, volved in?” This study found fairly good they may rely almost exclusively on the rec- understanding of the consent process, but ommendation of the researcher—who may the results may be unique to the sample not always be looking out for the subject’s studied (14 white, 41 year-old participants best interest. averaging 14.4 years of education). These participants, however, did not clearly understand the difference between personal TESTING CONSENT FORMS AND medical care and research, TESTING READERS 2. The Deaconness Informed Consent Testing the Consent Form Comprehension Test (DICCT). This test (22) includes 14 open-ended questions There are several methods for testing the con- such as “What is the purpose of this sent form itself, including: study?” “What are the possible risks or

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