TIPS FOR INCREASING COMPREHENSION OF

 INFORMED CONSENT DOCUMENTS

 

 

 

These guidelines were developed for investigators at Columbia University Medical Center in an effort to increase comprehension of informed consent documents.

 

 

  1. All informed consent documents not created in RASCAL should be written on CUMC letterhead or include information identifying the institution and research team or center.  One inch margins are to be used on either side and on the bottom with 1.5 inches at the top.  The type size to be used should be 12 point.  Number all pages and use a header beginning with the second page of the document.

 

  1. The document should be written at the eighth grade reading level.  Suggestions for meeting an eighth grade reading level include:

 

·         Use one or two syllable words whenever possible

·         Write short sentences and paragraphs

·         Define all medical or technical terms in lay language

·         Organize information in sections with clear headings

·         Print all headings in bold

·         Use spacing to emphasize important concepts

·         Avoid contractions such as don’t

 

  1. Address the consent document to the reader by using the active voice and the word “you” throughout, i.e. “You are being asked to take part in a research study . . .”

 

  1. Detailed information on do’s and don’ts, complex drug dosing, and concomitant medications should not be included in a consent form.  This information could be in a separate information sheet for subjects.

 

  1. Providing information in a question and answer format is one method of increasing comprehension.  This format is particularly useful when the consent document includes difficult information to understand and the target subject population has a below average education or reading level.

 

  1. Include version number and/or date on each version of a consent document.