Symposium Recap: Consent Comprehension

I would not have read the form, because I did not read any of the forms, because the forms are for lawyers, not for parents. I had not slept in days. I was scared out of my mind. I had the mental capacity of a drunk being chased by bears. What kind of form can protect a parent in a situation like that?

-Kelley Benham, Tampa Bay Times.  October 18, 2013.

Dr. Carl D’Angio likes to share this passage because, well, the image of a drunk being chased by bears is so evocative.


Dr. Carl D’Angio

But he also shares it because the excerpt, written by a newspaper reporter whose daughter was born after just 23 weeks of gestation – barely halfway through pregnancy – highlights the often-colossal challenge faced by doctors and researchers looking to provide patients with an informed consent form that they will actually comprehend.

D’Angio, the host and first local presenter at the 2014 CTSI Symposium, shared a selection of research on the topic of informed consent.  A neonatologist at UR Medicine’s Golisano Children’s Hospital, D’Angio included some of his own research, and showed that when it comes to providing truly informed consent, there are rarely any easy answers.

Contrasting findings

Prior to discussing his own findings, D’Angio touched on several seemingly conflicting studies that had been done in the past.

A commonly used approach to informed consent is to decrease the reading level of the forms as much as possible in the hopes of increasing understanding.  But some studies have shown that decreasing the reading level isn’t always helpful, said D’Angio.

Lots of white space is good — consent forms should have about a third of the page be white space, said D’Angio.  But an attractive form has its limits, as visual aids are sometimes helpful in increasing understanding, but not always.

Shorter consent forms have also been tested, including a study from the Journal of Pediatrics in 1998, which compared two consent forms.  There was the traditional form, which was opt-in, and a shorter, modified consent form, which was opt-out; the modified form scored better when it came to understanding level.  But a study published in 2007 in the same journal surveyed a group of parents of oncology patients about the informed consent process, and showed that a shorter form wasn’t always what they wanted.

“They wanted clearer information,” said D’Angio.  “But many parents wanted more information rather than less.  We know shorter forms may not always be practical, but they also may not always be preferred.”

D’Angio’s own studies have also generated inconclusive results when attempting to measure the benefits of a shorter form.  In a randomized single-blind controlled study, his team tested the effectiveness of adding a simplified cover sheet to an informed consent form.  The idea was to offer a short, easy-to-read summary of the study up front, while continuing to allow patients to read the entire form in more depth, if they wanted to learn more.  But use of a cover sheet did not impact patients’ understanding.

Human interaction

Though many studies have led to inconclusive results, one of the only consistent findings across nearly every study that D’Angio mentioned was that human interaction increased understanding levels.

“Human interaction in the consent process is invaluable,” said D’Angio.  “That came out over and over and over again.”

In a study that measured a consent form from the United Kingdom with one from the United States, both consent forms were understood more clearly when a verbal explanation was offered alongside.

And while his team’s study was inconclusive in terms of the addition of a cover sheet, D’Angio said that volunteers cited interaction, as well, as vital to their level of understanding.

“When asked about what was the most helpful part of the consent process, they said the interactions with faculty and staff were valued most highly,” he said.


The 2014 CTSI Symposium, which took place on March 13, was titled “Ethics in Research: Consent Quandaries,” and was hosted by Dr. Carl T. D’Angio, Professor of Pediatrics and Medical Humanities & Bioethics at the School of Medicine and Dentistry.  To view the Symposium in its entirety, click here.

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