In a recent survey of 100 top medical centers and 11 independent institutional review boards, researchers discovered that the authorization language used to satisfy the Privacy Rule has a median length of 744 words and is written at a median 12th-grade reading level (7). This wording is well above the eighth-grade reading level mandated by many institutional review boards (8) and the literacy level of most U.S. citizens (9). This complex language also seems inconsistent with the Privacy Rule's requirement that authorizations be written in "plain language." In another survey of investigators and institutional review board personnel, researchers found that the addition of extensive language to satisfy the Privacy Rule's authorization requirements often confuses research participants, burdens the informed consent process, and undermines recruitment (10).
Why, oh why do we insist on making the process so danged opaque? The KISS rule should be tattooed on the forehead of every person who is in charge of anything that comes into contact with the public or even general front-line users. Make things difficult to understand, and folks will just opt out.