Informed-Consent Forms Should Be Shortened and Simplified

The forms spanned on the average more than 20 pages each, providing study volunteers with information regarding study procedures, risks, and benefits. The researchers found that whereas confidentiality sections had a median length of about two pages, commonly misunderstood research concepts, such as randomization and placebos seemed to be explained with far less attention.

Since randomization is one of science's most trusted tools for minimizing biases in studies, the minimal attention put on the randomization process itself may result in participants not realizing that half of them will get a different medicine from the one tested, or perhaps no medicine at all. The researchers also found the majority of the forms were not as readable as they should be. Institutional review boards recommend that consent documents be written at or below the eighth-grade level; however, the majority of the forms reviewed required readers with at least a ninth-grader's comprehension. Such findings demonstrate lower readability than consent form studies from decades past, while at the same time failing to meet commonly agreed-upon standards.

The authors cite data on literacy rates in the United States and abroad in light of the rise in research in developing countries, where half or more of the populations are illiterate. For instance, literacy rates in India, Bangladesh, and Senegal are 63%, 55%, and 42%, respectively, and almost half of Americans read at or below the eighth-grade level. But as long as these template forms, which come from research funders, remain lengthy, the investigators and review boards in the field will assume they must use those forms, concluded the authors. The study was published in the August 2011 issue of the Journal of General Internal Medicine.

“The forms that researchers were given by their funders as models, what we call 'template' forms were themselves very, very long,” said lead author Nancy Kass, ScD, deputy director for public health at the JHU Institute of Bioethics. “I imagine many researchers wish they could use methods that were not only shorter, but maybe that used strategies other than written communication altogether.”

Informed consent is a legal procedure to ensure that a patient or client knows all of the risks and costs involved in a treatment. The elements of informed consents include informing the patient of the nature of the treatment, possible alternative treatments, and the potential risks and benefits of the treatment. For informed consent to be considered valid, the patient must be competent and the consent should be given voluntarily.

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