THURSDAY, July 21 (HealthDay News) -- The informed-consent documents that study volunteers must sign before joining HIV/AIDS research trials in countries around the world -- including the United States -- are too long and complicated, researchers say.
The consent forms added up to more than 20 pages, according to an analysis of 124 such documents used in multinational research projects funded by the United States at home and abroad, the new study found.
"While we were familiar with many fairly long consent forms for several different types of studies, 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," study lead investigator Nancy Kass, deputy director for public health at the Johns Hopkins Berman Institute of Bioethics, said in a news release from Johns Hopkins Medicine.
The forms gave very little information on research methods, such as explaining concepts like randomization and placebos, which means that study participants may not understand that they might get a different medication than other participants or no medicine at all, Kass said.
The researchers also found that most of the forms weren't easy enough to understand and often required higher-level reading skills, with most written for at least a ninth-grade reading comprehension level.
About half of the U.S. population reads at or below an eighth-grade reading level, the authors pointed out in the report published in the August issue of the Journal of General Internal Medicine.
The problems may begin with forms provided by funders. "In this study, the forms that researchers were given by their funders as models -- what we call 'template' forms -- were themselves very, very long," Kass said.
"I imagine many researchers wish they could use methods that were not only shorter, but maybe that used strategies other than written communication altogether," particularly in light of the rise of research trials in countries like India and Bangladesh, where much of the population cannot read, she added.
For more on clinical trials and informed consent, visit the U.S. National Library of Medicine.
-- Randy Dotinga
SOURCE: Johns Hopkins Medicine, news release, July 15, 2011
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