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.
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.
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
Organize information in sections with clear
Print all headings in bold
Use spacing to emphasize important concepts
Avoid contractions such as don’t
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 . . .”
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.
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.
version number and/or date on each version of a consent document.