AAMC Reporter: October 2007

Informed Consent Documents Group: Keep It Simple

Imagine that you are the parent of a child recently diagnosed with a serious brain malignancy. Your child's oncologist has asked if you would be interested in signing your child up for a clinical trial of an experimental treatment. As a means of explaining the trial and securing your consent, the doctor hands you a 30-page document rife with difficult-to-understand language and medical terminology.

All too often, this is the experience of patients and families considering participation in clinical research. But a group of experts in human subject protections has developed recommendations for overhauling the way in which these documents are created, in the hopes that patient confusion will decrease—and participation in clinical research trials will increase.

"Everybody agreed that there is a disconnect between the actual process that a patient is exposed to when they make a decision about participation in research, and the document that they have to sign," said Howard Dickler, M.D., the AAMC's director for clinical research and the organizer of the working group that formulated the recommendations.

"And everybody agreed that it would be very helpful if the documents were short, written in understandable language and contained everything they should, matching up with the oral process of informed consent that patients go through. So the question was— how do we get there?"

The working group convened by the AAMC included bioethicists, institutional review board (IRB) chairs, research deans, university counsels, and representatives of the National Institutes of Health, the Agency for Healthcare Research and Quality, and the Association for the Accreditation of Human Research Protection Programs.

Published studies have found that informed consent documents have lengthened over time, with a corresponding decrease in clarity. Nearly half the adult population cannot read at higher than an eighth grade level, yet studies have found that virtually no informed consent documents are written at less than a 10th grade level.

In order to change, researchers must first overcome the gravity of simple inertia, Dickler said.

"The easiest way to do an informed consent document, if you're a busy team, is to plagiarize the last one that was approved by the IRB, keeping the boilerplate language and substituting what is different about the trial you are now doing," Dickler said. "The problem with that is that documents inevitably get longer, not shorter."

The growing length of informed consent documents may also be attributable to a fear of litigation.When in doubt, investigators throw reams of extra information into a document, out of concern that an omission could come back to haunt them in a lawsuit.

"There's no reward to IRBs or investigators for making things shorter, and in fact, people feel they can avoid getting in trouble by throwing everything in there, whether or not the potential study participant actually understands it," said Daniel K. Nelson, director of the Office of Human Research Ethics at the University of North Carolina at Chapel Hill and a member of the Secretary's Advisory Committee on Human Research Protections for the Department of Health and Human Services.

The working group is creating a toolkit for researchers based on what it calls the "ABC model," which breaks consent documents down into three basic elements. Part A is the consent itself, consisting of brief and simply worded passages detailing the research question and the essential elements of consent, such as risks, benefits, and options.

"Ideally, for most studies, part A will be no longer than two pages," said Ross McKinney, Jr., M.D., professor of pediatrics and the director of the Trent Center for Bioethics, Humanities, and History of Medicine at Duke University School of Medicine. "The goal is to make sure patients really understand the questions we're trying to ask, and why they matter, without feeling coerced."

Part B would contain supplemental information such as detailed explanation of the standard treatment for the condition being studied, including side effects. Part C would be a verification section, in which the investigator certifies a potential participant's understanding of the informed consent process, through such devices as checklists and comprehension tests.

Even with the so-called "ABC system" as a starting point, one size or template will probably never fit all, according to working group members. At Duke, McKinney and an internal working group of colleagues have already begun creating their own templates based on the ABC model.

"We're researchers: the new informed consent process not only has to make sense, but we have to prove that it works and achieves better comprehension," he said.

"There is a whole world of people out there buying into the system we have now, so our goal is to first propose and then measure these new approaches."

Once the toolkit is created, Dickler said the AAMC will work to create a Web site that will be used to help keep the informed consent process consistent with society and research trends.

"We won't work for X period of time and then have everything we need, because research evolves, ethics evolve, and different issues arise. These documents will have to be kept fresh."

—By Gina Shaw, special to the Reporter

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