What can be done about the unwieldy consent form?
First step: Revise sponsors’ documents
Ask most critics of the modern informed consent document what the biggest problem is, and they’ll say investigators rely too heavily on the sponsor’s cumbersome informed consent form.
"When informed consent comes from the sponsor, it isn’t all that readable," says Steve Joffe, MD, an attending physician at the Dana-Farber Cancer Institute and the Children’s Hospital, both located in Boston.
Then the IRB is put into the position of negotiating how phrases will be changed, he says.
"The consent form is the IRB’s document, but the sponsor may say, If you’re not willing to include this language, this disclaimer, then we won’t open the trial at your institution,’" Joffe explains. "Then the IRB can think of creative ways to put it in there without distracting from the message they want to convey in the consent form."
Since drug and device companies want to avoid lawsuits, they take the easy route of lifting language from the Federal Register and putting it into the consent form, says Mark Hochhauser, PhD, a readability consultant and a member of the IRB at North Memorial Healthcare in Robbinsdale, MN.
"They want to be compliant even if it means no one can understand what they are writing," he explains. "Everyone wants to protect themselves from being sued, and they don’t really care whether someone understood them or not, and yet when they are sued it’s often because the language is ambiguous, and people didn’t understand what they meant."
At most academic health science centers, the investigator takes the sponsor’s model consent document and converts it into a format that the IRB has adopted, says Ernest Prentice, PhD, associate vice chancellor for academic affairs at the University of Nebraska Medical Center in Omaha. He also is the chair of the Secretary’s Advisory Committee on Human Research Protection for the U.S. Department of Health and Human Services.
It’s important to make certain the IRB’s format is as clear and readable as possible, Prentice and the other experts say.
Here are some of their tips on improving the informed consent document:
• The key is to simplify the language and design the format. This is not as easy a process as running the consent document through a software program that is scaled for a particular reading level, Hochhauser says.
"People assume that if you write something at a statistical eighth-grade level that anyone with an eighth-grade education will be able to understand it," he says. "People who assume this don’t understand readability and reading skills and how they develop."
Studies have shown that when a document written at college level is rewritten to a lower grade level, there is some improvement in comprehension, but it’s only a small improvement, Hochhauser notes.
"It’s maybe a 10%-15% improvement in understanding," he says. "So it’s not a panacea to get it down to an eighth-grade reading level."
One strategy IRBs might employ is having a junior high school English teacher on the committee that writes the consent document, Hochhauser suggests.
"I’d like to see a private accrediting agency give awards for a particularly good consent form," he adds. "I’d like to see the whole simplified consent form on-line so people could see what it looks like."
Equally important is the consent form’s design. It should be designed with the same sort of eye-catching features used in marketing materials, Hochhauser suggests.
Documents could use bold-faced words and italics, along with different font styles and sizes to emphasize key points, he says.
Consent forms also could feature a glossary and graphics, and they could include blank space for subjects to write notes or questions.
"There is no reason why a consent form couldn’t look more like a newsletter," Hochhauser says. "There are all kinds of document design features that could make the consent form a much more appealing form that someone might actually want to read."
• Create a template for use by investigators. IRBs could create a template that uses standardized subheadings that identify the consent elements and are placed in a standard sequence, Prentice suggests.
"For example, don’t talk about benefits before discussing risks; don’t allow first-person narrative, don’t allow a mixture of elements, and don’t throw in procedures with the risks," he explains.
Sponsor-written consent documents have boilerplate language on confidentiality and compensation for injury, so the investigator’s job is to take this unwieldy consent form and revise it to fit the IRB’s template, Prentice says.
"Don’t use the sponsor’s language," he adds. "Sponsors occasionally will discuss with us the inclusion of certain language, and sometimes we agree, and sometimes we don’t agree."
A well-written consent form can make a difference in how well subjects understand the research process, Joffe says.
The National Cancer Institute (NCI) recently updated its booklet on consent documents. It addressed clarity, readability, and the use of standard language. (See table)
"What happened was our hospital was going along using the old consent form with its one- or two-word titles, dense paragraphs, and then the NCI recommendations came out, and we flipped over to using a new template with all new consent forms," Joffe recalls. "We had studies with the older consent forms and studies with newer consent forms, and we compared those subjects."
Evidence showed that subjects who were given the new consent forms demonstrated better understanding of the clinical trials, he says.1
• Give subjects time to think about the study and consent process. "It makes a difference to delay the consent decision and to give people time to think about the decisions they’re making, particularly for more complicated studies," Joffe says. "If you ask them right then to make a decision, they won’t understand as well as if you told them to go home and return to talk about it in a few days."
This extra time to consider and think is crucial to a person’s comprehension, he says.
"In our study, we asked people, Did you sign the consent form right then, or did it take a day or two to think about it?’" Joffe says. "One quarter of the people signed right then and there, and those who signed in the moment didn’t understand as well as those who took time to think about it."
1. Joffe S, Cook EF, Cleary PD, et al. Quality of informed consent in cancer clinical trials: A cross-sectional survey. Lancet 2001; 358:1,772-1,777.