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the informed consent form: document development and evaluation

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In<strong>form</strong>ed Consent Forms 1313<br />

<strong>and</strong> second year of college—about five to <strong>form</strong>. While <strong>the</strong>re are literally hundreds of<br />

six grade levels higher than <strong>the</strong> NCI recom- type faces, <strong>the</strong> most important distinction is<br />

mendation. between serif <strong>and</strong> sans serif type.<br />

Serif fonts are generally believed to be<br />

“Avoid ...Wordscontaining more than three syl- more readable (2), because <strong>the</strong>y have both<br />

lables.” thick <strong>and</strong> thin strokes, <strong>and</strong> serifs, <strong>the</strong> small<br />

strokes at <strong>the</strong> end of a letter. The serifs do<br />

Such long words can be hard to read <strong>and</strong> not get in <strong>the</strong> way of reading (3). On <strong>the</strong><br />

underst<strong>and</strong> because <strong>the</strong>y are long (hard to o<strong>the</strong>r h<strong>and</strong>, sans serif strokes are usually of<br />

pronounce), <strong>and</strong> because <strong>the</strong>y are often unfa- a single thickness, <strong>and</strong> do not have <strong>the</strong> small<br />

miliar to most readers. Unfamiliar words, es- strokes at <strong>the</strong> end of a letter. Sans serif fonts<br />

pecially if <strong>the</strong>y are not explained in <strong>the</strong> text, are harder to read over many pages of singlecan<br />

slow down <strong>the</strong> reading process. If <strong>the</strong>re spaced text. These fonts lack <strong>the</strong> small<br />

are too many long words, <strong>the</strong> reader may just strokes on <strong>the</strong> ascending <strong>and</strong> descending letgive<br />

up, perhaps refusing to participate in <strong>the</strong> ters (such as b, d, f, g, h, j, k, l, p, q, <strong>and</strong> t),<br />

study, or perhaps signing <strong>the</strong> <strong>consent</strong> <strong>form</strong> so <strong>the</strong> eye cannot follow <strong>the</strong> text as easily.<br />

without really underst<strong>and</strong>ing <strong>the</strong> nature of<br />

<strong>the</strong> study.<br />

For example:<br />

Serif: Before participating in this research study,<br />

Some Additional Factors<br />

it is important that you read <strong>and</strong> underst<strong>and</strong> this<br />

statement which describes <strong>the</strong> purpose, proce-<br />

Although not identified by <strong>the</strong> NCI, <strong>the</strong>re are dures, benefits, risks, discomforts, <strong>and</strong> precautwo<br />

additional factors that make <strong>consent</strong> <strong>form</strong>s tions of <strong>the</strong> study. Signing <strong>the</strong> <strong>consent</strong> <strong>form</strong> will<br />

easier <strong>and</strong> more enjoyable to read. One is <strong>the</strong> indicate that you have been <strong>in<strong>form</strong>ed</strong> <strong>and</strong> that you<br />

use of personal pronouns (eg, Flesch Human<br />

Interest Score). Readers are more likely to be<br />

interested in a <strong>consent</strong> <strong>form</strong> that refers to “you”<br />

instead of “<strong>the</strong> subject.” The 12 <strong>consent</strong> <strong>form</strong>s<br />

were all at a “very interesting” level.<br />

Overall writing style combines basic text<br />

elements into a broader measure. The progive<br />

your <strong>consent</strong>.<br />

Sans Serif: Before participating in this research<br />

study, it is important that you read <strong>and</strong><br />

underst<strong>and</strong> this statement which describes<br />

<strong>the</strong> purpose, procedures, benefits, risks, dis-<br />

comforts, <strong>and</strong> precautions of <strong>the</strong> study. Signing<br />

<strong>the</strong> <strong>consent</strong> <strong>form</strong> will indicate that you<br />

have been <strong>in<strong>form</strong>ed</strong> <strong>and</strong> that you give your<br />

gram WStyle calculates “overall writing<br />

style” based on:<br />

<strong>consent</strong>.<br />

Of <strong>the</strong> 12 <strong>in<strong>form</strong>ed</strong> <strong>consent</strong> <strong>form</strong>s evalu-<br />

1. Use of <strong>the</strong> active voice—35 points,<br />

2. Word economy—25 points,<br />

3. Readability—20 points, <strong>and</strong><br />

ated, 10 were written in a serif typeface, <strong>and</strong><br />

2 in a sans serif typeface.<br />

4. Word choice—20 points. “Left margins are justified. Right margins are<br />

Only one of <strong>the</strong> 12 <strong>in<strong>form</strong>ed</strong> <strong>consent</strong> <strong>form</strong>s<br />

ragged.”<br />

scored as high as “satisfactory—<strong>the</strong> o<strong>the</strong>r 11<br />

were all written in a “weak” or “poor” writing<br />

style, with an overall average rating of “poor.”<br />

Justification means that both margins are<br />

straight. Even so, <strong>the</strong>re are two types of justi-<br />

fied text. Ragged right justification means<br />

that <strong>the</strong> right margin is uneven. There are<br />

DOCUMENT DESIGN ISSUES two kinds of even right justification: one<br />

where <strong>the</strong> spaces between <strong>the</strong> words are even<br />

“Style of print is easy to read.” (preferred) <strong>and</strong> one where <strong>the</strong> spaces between<br />

<strong>the</strong> words are uneven (not recom-<br />

Typeface is <strong>the</strong> type (or font) that <strong>the</strong> mended). When spaces between <strong>the</strong> words<br />

writer chooses for <strong>the</strong> <strong>in<strong>form</strong>ed</strong> <strong>consent</strong> are not even, <strong>the</strong> overall design leads to “riv-

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