The SRA Symposium - College of Medicine

Informed Consent: Writing? Readability? Understanding? Deciding?
Mark Hochhauser, Ph.D.
Readability Consultant
3344 Scott Avenue North
Golden Valley, MN 55422
Phone: 763-521-4672
Fax: 763-521-5069
E-mail: MarkH38514@aol.com
Papers
Abstract:
This article analyzes the consent form both from the writer’s perspective (Writing and Readability)
and the subject’s interpretation (Understanding and Deciding). The Writer (Part I) suggests consent
form improvements via 1) a plain English Summary and 2) document design recommendations.
Because regulators and IRBs assume that consent form “readability” affects understanding,
Part II (Readability) explains 1) consent form readability, 2) why reading and understanding are
not the same, and 3) the difficulty of writing consent forms at a 6th-8th grade reading level. The
Subject (Part III) 1) summarizes consent form comprehension studies showing that consent forms
written at lower grade levels improve comprehension only slightly, 2) identify flaws in consent
form comprehension research, and 3) describe how to reduce therapeutic misconceptions by contrasting
research and treatment. Part IV (Deciding) points out how brain anatomy affects consent
form understanding, 2) why logic and emotion influence consent decisions, 3) the relationship
between working memory and information overload, 4) how prospective subjects use “heuristics”
to make decisions under uncertainty and 5) how “cognitive illusions” can affect consent form understanding
and the decision making process.
Introduction
The Writer: Federal regulations (45 CFR 46) state that:
“The information that is given to the subject or the representative shall be in
language understandable to the subject or the representative.”
The Nuremburg Code states that:
“The person involved…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.”
The World Medical Association Declaration of Helsinki states that:
“In any research on human beings, each potential subject must be adequately
informed of the aims, methods, anticipated benefits and potential hazards of the
study and the discomfort it may entail.”
But implementing those broad recommendations into the consent form process has proved difficult,
if not impossible. Unfortunately, these three documents do not suggest how consent form
writers can produce consent forms in “understandable language” so potential subjects can “be
adequately informed” in order to make “an understanding and enlightened decision.” This writing
problem is compounded by the requirement that consent forms include the FDA’s eight “basic
elements” of informed consent, six “when appropriate” elements of consent, plus as many as six
to eleven HIPAA privacy topics. Such requirements lead to average (oncology) consent forms of
2,700 words in eleven pages (Sharp, 2004).
But HIPAA adds even more words and topics to the consent form. Whether HIPAA information
is included as part of the consent form or as an addendum to the consent form, it still contributes
to the prospective subject’s cognitive load. Researchers must consider the all 20-25 topics in the
consent process/consent form, because the topic count gives an idea of the information overload
2005 Symposium Proceedings Book 105