Human Subjects Committee

Consent-Writing Tips

The following tips are presented to assist investigators in effectively communicating with potential research subjects: 

1. Write simply
   1. Aim for 8th grade or lower reading level.  Microsoft’s Word readability tools can provide a general indication of the reading level.  The HSC recognizes that 8th grade level may be difficult to achieve in biomedical research; however, the suggestions below will lower the language level and improve comprehension. 
   2. Write short, simple, direct statements.
   3. Use active verbs.
   4. Keep paragraphs short and limited to one idea.  Avoid large blocks of printed text. 
   5. Use a conversational tone.  Some research indicates that comprehension is improved with a question-and-answer consent format. 
   6. Use lay language for medical terms.  For example, substitute “high blood pressure” for hypertension; substitute “adjust” for titrate; substitute “measure” for assess.

   Lists of simplified terms:

• The Center for Health Studies publishes the PRISM Readability Toolkit.  The toolkit gives helpful examples of consent language before and after simplification.
• Click here for the toolkit’s list of alternative wording suggestions for medical terms.  
• The federal Plain Language website has numerous resources and suggestions.  A glossary of terms is posted at: http://www.plainlanguage.gov/howto/wordsuggestions/simplewords.cfm.

2. Use reader-friendly layout and visual aids
   1. When applicable, investigators are encouraged to use the consent templates posted on the HSC website.
   2. If none of the templates seem appropriate for your study, please contact the HSC office.  Office staff can help in developing your consent document. 
   3. Refer to our consent form checklists
      1. Consent checklist for FDA-regulated research
      2. Consent checklist for non-FDA research

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