Boston College
Office for Research Protections
Guidance for Creating Consent Documents that Match the Comprehension Level of Participants
Consent cannot truly be called “informed” unless the participants understand the information to which they are
being asked to agree. The Nuremburg Code states that people being asked to participate in research projects
“…should have sufficient knowledge and comprehension of the elements of the subject matter involved as to
enable him to make an understanding and enlightened decision.” It is, therefore, the researcher’s responsibility
to ensure that the consent documents used in his/her project are comprehensible to the participants.
In each protocol submitted to the Boston College IRB (BCIRB), the Principal Investigator (PI) must use one of three
tools to check the comprehension/readability level of the consent form wording and indicate that level in the
protocol application form.
The BCIRB recognizes that sometimes it is challenging to reduce the comprehension level in a consent form. There
are certain steps that researchers can take, however, to significantly reduce the readability level.
1. Minimize the use of colons, semicolons, and punctuation other than standard periods and question
marks.
2. Use short, concise sentences. Long, complex sentences can often be divided into multiple shorter ones
that will significantly reduce the readability level..
3. Keep a thesaurus handy. It is the easiest way to find synonyms that are more comprehensible to the
participants.
4. People who volunteer for research projects are often unfamiliar with common terms used in academic
fields. To the extent possible, the researcher should explain what he/she is studying in common, lay terms
and avoid academic jargon.
5. The researcher should write the consent document as if he/she is sitting at a table and speaking directly
with a person. More often than not, in such situations, one will use simpler language than when writing a
document.
Sometimes, this process can be a bit frustrating. Try to remember, however, that reducing the readability level is
not a burden, rather it is at the core of fully informing research participants about their rights as well as what they
will experience. In other words, informed consent is a vital element in conducting ethical research.