Who Understands? A Survey of 25 Words or Phrases Commonly Used in Proposed Clinical Research Consent Forms

Abstract

We all write excellent consent forms to be presented to prospective participants in clinical research studies. That is, we think that they are excellent. But many times consent forms are written from our jaded perspective and contain terms of clinical research jargon, common to us, but foreign to a participant. These terms slip through unnoticed because of their familiarity in our everyday language. In a recent study 1 a computer analysis (Flesh-Fry scoring) 2-4 of 71 consent forms at a midwest university showed that a mean U.S. school grade for 70 percent comprehension was about 15. In simple terms this means that you would have had to complete your junior year in college to understand 70 percent of the language in the consent forms, which implies about 37 percent of the U.S. adult population could read them. Similar analyses were done with columns of Ann Landers, articles from Reader's Digest, and columns from the New Yorker. Analysis of Ann Landers columns showed readability by a median seventh grader and by 75 percent of the U.S. adult population. Reader's Digest articles yielded data showing a readability by a 10th grader or about 60 percent. Lastly, analysis of the New Yorker columns revealed they were readable by only about 43 percent of the U.S. population. In short, these three widely published columns and articles all were more easily read than the analyzed consent forms. It was the authors' opinion that in their case IRB review did little to improve readability. In the above study 64 of the 71 consent forms received final IRB approval. Eighty percent of the forms were revised according to the IRBs' wishes. No forms improved by more than a grade reading level and eight of the forms actually worsened. Prior studies have also shown that most consent forms are not readable by the general population. 5-9 In our IRB meetings we often question some of the terms that appear in the text. The clinical research jargon runs rampant in many cases and would appear to confuse the lay reader. In an effort to answer some of these questions we designed a questionnaire to quiz a cross-section of the population on their understanding of many of these terms. In the spring and summer of 1992 the survey was conducted in person by the interviewer on an individual basis. Many of the answers were predictable. Some were surprising! The questionnaire was on standard 81/2 x 11 plain bond with demographic information on top of the first page, such as gender, place of interview, occupation, and maximum educational level.

Informed Consent Readability: Subject Understanding of 15 Common Consent Form Phrases

“…Study participants scored much higher on this question than predicted by previous surveys. Waggoner and Mayo reported that only 75 percent could define the term, 17 but in this survey 81 percent gave a complete definition, and an additional 11 percent had some familiarity with the term placebo. Subjects 41 to 65 years old appeared to have better knowledge than both older and younger groups, with 93 percent writing complete definitions.…”

“…A previous study reported that only 33 percent of respondents to an interview survey knew the term. 17 There was no statistical difference found when knowledge was compared by group, age, or education.…”

“…Through their survey, Waggoner and Mayo identified often used consent form terminology that the general population does not appear to understand. 17 Dr. Waggoner's study is more relevant to subject understanding of consent forms than previous research, but the accuracy of the data is limited by the fact that the study population was not restricted to people who had participated in clinical research. This group may have a different knowledge level than the general public.…”

Therapeutic Misconceptions and Misestimations in Oncology: A Clinical Trial Nurse's Guide

“…Consent forms do not always use terms that are easily equatable with the experimental nature of the trial (Appelbaum & Lidz, 2008a); common clinical terminology such as efficacy, random, and double-blinded are not typically understood by the lay population, and "treatment" often is used to describe the trial itself (Instone, Mueller, & Gilbert, 2008;Waggoner & Mayo, 1995). Instone et al (2008) noted that therapeutic misconceptions and misestimations can occur within investigators and CTNs.…”

What the ANPRM Missed: Additional Needs for IRB Reform

“…There is no reason for the IRB committee to spend a lot of time discussing modification to consent forms, which ultimately might be better done by a well-trained specialist. 15 Equally important, we believe that the committee's focus on consent forms takes their attention away from other issues, especially the risks and benefits of the protocol, which are both more difficult to assess and ultimately more important. Leaving consent forms to an IRB staff member will create more time at full board meetings to discuss other difficult and important protocol issues.…”