I recently ran across this article on Pharmalot, titled Informed Consent Forms Target 11th Grade Readers and as this topic is one about which I am extremely passionate, I wanted to comment further here.
Formal Informed Consent development for clinical trials is riddled with regulatory/legal requirements and interpretive language--and it is likely to stay that way.
I propose that this discussion is ultimately not just about the appropriate reading level to allow comprehension (historically set at an 8th grade level)-- but the race, culture, geography, experience, and numerous other factors that affect full comprehension at the individual level.
To obtain the desired results, those presenting informed consent need customizable resources that assist them in optimizing patient engagement, comprehension, and understanding. These tools can take various forms: DVDs, USBs, videos, power points, etc. that explain the meaning of the IC in the context of the individual patient. The materials should address issues related not only to general risk/benefit content, but other areas of specific concern that may vary by culture/ethnicity, language, age, geography, gender, and education. A collateral document that accurately interprets content on all of these levels should accompany the formal IC. Without such guidance we are failing the very patient volunteers we are trying to engage and retain in important studies.