An in-depth review of consent forms provided to volunteers for HIV/AIDS research in the United States and abroad about study procedures, risks and benefits has found that the forms were extremely long and used wording that may have been complex enough to hinder full understanding, according to bioethicists at The Johns Hopkins University.
A systematic analysis of 124 informed-consent documents for U.S. government-sponsored, multinational HIV/AIDS research conducted in 2006 revealed that the forms spanned more than 20 pages, says the study's lead investigator, Nancy Kass, Sc.D., deputy director for public health at the Johns Hopkins Berman Institute of Bioethics.
"While we were familiar with many fairly long consent forms for several different types of studies," Kass says, "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."
Their study, described in the August issue of the Journal of General Internal Medicine, and funded by the National Institute of Allergy and Infectious Diseases, also found that commonly misunderstood research conceptsnamely, randomization and placebosseemed to be explained with far less attention. For instance, whereas confidentiality sections had a median length of about two pages, randomization was treated to just 53 words.
Randomization is one of science's most trusted tools for minimizing biases in studies. But when studies spend so much time explaining why they are testing a new medicine or approach, and so little on randomization itself, participants may be left not realizing that half of them will get a different medicine, or perhaps no medicine at all, Kass points out.
Kass says this "unfortunate" trend may be because research regulations don't require that forms explain such concepts. Indeed, her study shows that researchers spend considerable time on the key concepts regulations require them to cover, s
|Contact: Michael Pena|
Johns Hopkins Medical Institutions