Readability & Consent Form Development

What is readability, and why should the research community be concerned about it? Readability refers to the ease of reading and understanding written information. At this time and for the foreseeable future, written informed consent is the standard for participation in biomedical research and a significant proportion of social-behavioral research. The use of language that is understandable to research participants is central to the concept of informed consent.

The US Department of Health and Human Services (DHHS) defines health literacy in terms of an individual’s ability to understand basic health information and use it to make appropriate decisions. In the 2003 National Assessment of Adult Literacy, about 37% of adults surveyed had only “basic” or “below basic” health literacy. Approximately half of the US population cannot read at the 8th grade level that is typically recommended as the maximum for a consent form. Even individuals who normally read well may present to the research clinic in challenging situations that undermine their ability to comprehend information. They may also be hesitant to ask questions that would reveal their lack of understanding. Writing for readability can help prospective participants at all literacy levels make better decisions about research participation, and may also enhance their ability to comply with the protocol if they do enroll.

Producing a readable consent form that satisfies all of the regulatory, institutional and sponsor requirements may seem like a daunting challenge, but it is possible. Help is available online from sources such as the National Cancer Institute and the University of Michigan Medical School. Reading grade level can be assessed using formulas such as SMOG (the “Simple Measure of Gobbledygook”) or Flesch-Kincaid, which is built into Microsoft Word. Both have limitations that can be overcome by using the two approaches together and keeping in mind that reliance on a formula is not enough to ensure the final product will be understandable. The most important tips for improving the readability of participant materials come from English Composition 101:

  • Write for the intended audience.
  • Present information in a logical order and format.
  • Limit the use of abbreviations and technical terms.
  • Use correct grammar and spelling.
  • Address readers in the first person and use active voice.
  • Eliminate redundant or irrelevant details.
  • Break up long sentences and paragraphs – when possible, use tables or bulleted lists.
  • Incorporate visual aids, such as diagrams or photos.

Another approach that is gaining in popularity is to supplement the standard written consent form with learning aids such as podcasts, videos, slideshows or workbooks. Some research teams are using quizzes to confirm understanding and identify areas that may need further discussion before a participant signs the consent form. These techniques can be useful at the time of initial enrollment and throughout the lifecycle of a trial, especially in situations where research participation may continue for many months or even years.

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