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IRB Consent Form Readability Tips

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Tips to Writing a Readable Form

According to the general requirements for informed consent under 45 CFR 46.116, "The information that is given to the subject or the representative shall be in language understandable to the subject or the representative."

While most Institutional Review Boards require a reabability between the 6th-8th grades, Marywood University's IRB understands that readability may be skewed by such factors as the use of formal names, providing definitions, or even the analysis program itself. As a result, our IRB requires a readability between the 8th-10th grade reading levels for the general public. However, readability may need to be increased or decreased depending on the particular population under study. For children or the mentally challenged, assent or consent forms should be developmentally appropriate.

Below is a list of tips to make your consent form more reader friendly:

  • Avoid use of acronyms or abbreviations.
  • Use familiar words instead of jargon. Define terminology if it absolutely must be used.
  • Be consistent throughout the document with any words or terminology.
  • Change passive voice sentences to active voice (i.e. subject is doer of act).
  • Use words with no more than 3 syllables.
  • Make sentences short, simple and direct.
  • Break all compound sentences (and, but, because) into two short sentences.
  • Create short pargraphs. Support one idea per paragraph.
  • Limit line length to 30-50 characters and spaces.
  • List procedures in chronological order.
  • Use an easy to read font and type size, making sure it is suitable for the participants involved. For instance, 12 point Times New Roman is widely accepted for the general public.
  • Restrict procedural descriptions to those the participant will experience and understand (i.e. tell them you will give a test or survey rather than naming the actual tool, or in clinical studies, that you are testing blood for a particular reason rather than naming the test).

Examples:

Instead of stating, "A questionnaire will be administered", you should state, "We will give you a questionnaire."

Instead of stating that "You will need to consume additional fluids while in this study in order to maintain hydration", you should state, "The drug can cause you to become dehydrated. It will be important for you to drink plenty of water while you are in this study."

Please also see the federal Document Checklist for Plain Language.


How to Check Readability

In Microsoft Word 2003:

If readability does not currently show when you run a spell check, you must first set it.

  1. On the top menu, click Tools, Options, and then select the Spelling & Grammar tab.
  2. Select the Check grammar with spelling check box.
  3. Select the Show readability statistics check box, and then click OK.
  4. On the Standard toolbar, click Spelling and Grammar Button image (Icon of ABC with a checkmark).


When Microsoft Word finishes checking spelling and grammar, it displays the Flesch Reading Ease and Flesch-Kinkaid grade level readability statistics.

In Microsoft Word 2007:

If readability does not currently show when you run a spell check, you must first set it.

  1. Right click on the Microsoft icon in upper left corner (circle graphic).
  2. Click Word Options button at the bottom of the popup menu.
  3. Click on Proofing on left menu.
  4. Under the Grammar and Spelling section, check the Show Readability Statistics box. Click OK.
  5. Click the Review ribbon at the top menu. Click Spelling and Grammar (icon of ABC with a checkmark) on the left to initiate the check.


When Microsoft Word finishes checking spelling and grammar, it displays the Flesch Reading Ease and Flesch-Kinkaid grade level readability statistics.

 

Readability tips were adapted from NCI's Checklist for Easy-to-Read Informed Consent and OHSU's Consent Form Readability Tips.

 


Please direct comments to IRB staff here: irb@maryu.marywood.edu

 


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