Research study consent forms too complex, analysis reveals

Research study consent forms are too long and use overly complex vocabulary that hinder full understanding by participants, according to analysis.
Written by Andrew Nusca, Contributor

Consent forms provided to volunteers for HIV/AIDS research in the United States and abroad detailing study procedures, risks and benefits are too long and use overly complex wording that hinder full understanding, according to a new study.

Bioethicists at Johns Hopkins University analyzed 124 informed-consent documents for U.S. government-sponsored, multinational HIV/AIDS research conducted in 2006.

Their findings: at more than 20 pages long and chock full of uncommon vocabulary used without explanation, participants may enter the study without a full understanding of what's actually going to happen.

"We were honestly surprised to see that the median length was 22 pages, and the median length for adult forms was a full 27 pages," lead investigator Nancy Kass said in a statement.

The problem is that, despite all those pages, terms such as "randomization" or "placebos" are barely explained. That means participants might not realize that they may or may not get a different medicine than what's really being tested -- or none at all.

The researchers say regulations are partly to blame, as they don't require an explanation for these scientific concepts.

Another problem? Jargon. Consent documents are supposed to be written at or below the eighth-grade level, but the majority of the forms reviewed required at least a ninth-grader's comprehension.

That might not seem like much of a difference, but it's a major factor in how well a participant understands the study at hand -- especially when these forms are used in developing countries where half or more of the population is illiterate. (And the problem is hardly isolated to those countries. Here's a sobering statistic: more than half of Americans can't read beyond the eighth-grade level.)

The researchers recommend that the study funders -- who tend to supply template consent forms that researchers must use -- shorten and simplify the documents. But since "recommendation" and "regulation" don't mean the same thing, it remains unclear whether this data is enough to spark reform.

Their research was published in the August issue of the Journal of General Internal Medicine.

This post was originally published on Smartplanet.com

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