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IRB Consent Form Readability Tips

Tips to Writing a Readable Form

According to the Common Rule's 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 reabability scores between grades six and eight, Marywood University's IRB understands that readability may be skewed by formal names, definitions, or even the analysis program itself. As a result, it should be at or below a tenth grade reading level for the general public. However, it may need to be decreased depending on the population under study. For children or those with impaired decision-making capacity, assent or consent forms also need to be developmentally appropriate.

To improve informed consent form readability:

Avoid use of acronyms or abbreviations.
Use familiar words instead of jargon.
If you must use terminology, briefly define it.
Be consistent with any words or terminology.
Change passive voice to active voice (i.e. sentence's subject is doer of act).
Make sentences short, simple and direct.
Use words with no more than 3 syllables.
Break all compound sentences (and, but, because) into two short sentences.
Create short paragraphs. Support one idea per paragraph.
Use bullets, tables or charts to make ideas clear.

Limit line length to 30-50 characters and spaces.
List procedures in chronological order.
Use an easy to read font and type size, suitable for subjects, such as 12 pt. Times New Roman or 10 pt. Arial.
Restrict procedures to those the subject will experience and understand (i.e. tell them you will give survey rather than naming an unfamiliar instrument, or that you are testing blood for a particular reason rather than providing the technical name).

Examples and Further Reference

Instead of stating, "An survey will be administered online", you should state, "You will take a survey online." Instead of stating that "You must consume additional fluids while in this study in order to maintain hydration", you should state, "The drug can cause you to become dehydrated. You must drink plenty of water while you are in this study."

Hemingway Editor - Use this to make your writing bold and clear, and highlight lengthy complex sentences and common errors.
Federal Plain Language Guidelines - Use this for guidance on how to make communication simple and clear.

How to Check Readability - Microsoft Word 2016, 2013 or 2010

If the below instructions do not work for you, check your word processing software's help menu with the term readability. It is often found where there's a question mark or lightbulb icon in the top menu. After you enable readability, you must run and complete a spell check for the readability statistics to appear.

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

At the top, click the File tab.
On the left panel, click Options.
On the left, click Proofing.
Under When correcting spelling and grammar in Word, make sure the check grammar with spelling check box is selected.
Select the box next to show readability statistics.
Click OK.

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