18 July 2011

Legal Waivers Incomprehensible

You will be shocked to find that:

[C]onsent 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. . . . lead investigator, Nancy Kass, Sc.D., deputy director for public health at the Johns Hopkins Berman Institute of Bioethics [said], "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. . . . commonly misunderstood research concepts -- namely, randomization and placebos -- seemed 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. . . . institutional review boards recommend that consent documents be written at or below the eighth-grade level. But the majority of the forms that Kass reviewed required readers with at least a ninth-grader's comprehension. . . . Almost half of Americans read at or below the eighth-grade level[.]

Yet, John Hopkins scientists say this is true (underlying source: Nancy E. Kass, Lelia Chaisson, Holly A. Taylor, Jennifer Lohse. Length and Complexity of US and International HIV Consent Forms from Federal HIV Network Trials. Journal of General Internal Medicine, 2011; DOI: 10.1007/s11606-011-1778-6).

We wait with baited breath for the stunning revelation that legal documents other than informed consent forms which ordinary people are expected to sign have been "extremely long and used wording that may have been complex enough to hinder full understanding."

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