Consent Forms Deemed Too Dense to Inform

Study finds them hard for people to understand what they're signing

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By
HealthDay Reporter

WEDNESDAY, Feb. 19, 2003 (HealthDayNews) -- "The research physicians treat all subjects under a specific protocol to obtain generalizable knowledge and on the premise that you may or may not benefit from your participation in the study."

Is that perfectly clear?

No? Then, how about this?

"There is no benefit to you from being in the study. Your taking part may help patients in the future."

The first example is an excerpt from a U.S university's informed-consent form, the document research subjects have to sign to acknowledge that they understand their risks, their rights and the procedures that are going to be done. The second example contains the same information simplified.

A new study takes aim at these confusing consent forms, charging that many are written in such a complicated way that most people have no idea what they are getting themselves into.

"It's unethical to have people participate in things that they don't understand," says Dr. Michael Paasche-Orlow, the lead author of the study and a research fellow in the department of general internal medicine and the Phoebe R. Berman Bioethics Institute at Johns Hopkins University.

The use of such forms is mandated by federal law, which requires that universities, companies and other research institutions obtain consent anytime they conduct experiments on people.

For the study, which appears in the Feb. 19 issue of the New England Journal of Medicine, Paasche-Orlow and his colleagues conducted "readability" tests on informed-consent forms obtained from 114 universities. They used two measures of "readability," the Flesch-Kincaid scale and the Fry score.

The Flesch-Kincaid scale, which is included with Microsoft Word, determines readability by measuring the average number of syllables per word and the average number of words per sentence. The Fry score determines readability by measuring the average number of syllables for three, 100-word blocks and the average number of sentences per three, 100-word blocks.

Researchers described the readability score as the grade level a person would have to attain in order to understand it.

Using the Flesch-Kincaid scale, researchers found the average grade level for the consent forms was 10.6. But that number underestimates the true degree of confusion because Flesch-Kincaid only measures up to grade 12.

When researchers analyzed a subset of 21 consent forms using the Fry score, they found the average went up to 13, or college level. Some forms had scores as high as grade 16 or 17.

This is a problem considering almost half of American adults read at or below the 8th grade level, Paasche-Orlow says. About 21 percent are functionally illiterate, he adds.

He recommends universities and other research institutions rewrite their informed consent forms to a 4th-grade level.

There are not only ethical reasons for this, but practical ones as well.

People who don't quite understand what they're supposed to do might not follow directions correctly -- taking a pill at certain times, for example -- and thereby compromise the results of the experiment.

Furthermore, research institutions rely on informed consent to protect themselves from liability. But there have been court cases in which people have claimed they didn't understand the consent form they signed, and the judge has sided with them.

The onus is on the research institution to make sure people understand what they are signing, not the other way around, Paasche-Orlow says.

"The institutions are hoping these forms will protect them from liability, but the approach has been a bit cynical," he says. "If the forms are confusing, it won't necessarily protect them."

"It's better to be plain and clear and straightforward," he adds.

Paasche-Orlow would not reveal which universities flunked the readability tests. Universities that did well include State University of New York Downstate Medical School, which has a 6th-grade reading level for informed-consent forms. The University of Washington and the University of Minnesota set and met their own goal of an 8th-grade reading level for consent forms.

His own university, Johns Hopkins, is in the process of revamping its informed-consent forms using not only the readability tests, but also focus groups for input from patients.

"In the long run ,it's going to be better to take a more direct approach," he says. "The primary relationship should be between the patients and their health care provider. The legalese is evidence that other interests have been getting in-between the doctors and their patients."

More information

To read more about the ethics of informed consent, visit the University of Washington School of Medicine. Or check out these tips on writing clear, informed consent forms from the Social Psychology Network.

SOURCES: Michael Paasche-Orlow, M.D., research fellow, department of general internal medicine and Phoebe R. Berman Bioethics Institute, Johns Hopkins University, Baltimore; Feb. 19, 2003, New England Journal of Medicine

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