Ensuring Readability
Readability of the consent document is an important component of
the informed consent process. The information presented in the consent should
be tailored to the potential research population. The consent document can be
made readable without compromising the content by applying some of the following
recommendations.
- Use lay terms, simple, straightforward sentences and remember that vocabulary
should not exceed the 8th grade level.
- Avoid use of scientific jargon or technical language, and explain terms
that may not be easily understood.
- Spell out acronyms, at least the first time the term is used within the
text.
- The risk section must address the frequency and severity of each risk by
using percentages, or the terms common, uncommon, or rarely and provide the
likelihood, e.g. 1 in 10 or 1 in 100, etc.
- Use recognizable terms and measurement amounts, such as converting mL to
teaspoons (5mL = 1 teaspoon) or tablespoons (15mL = 1 Tablespoon) for blood
draw amounts.
- Use graphs and/or tables (i.e. study calendars/schedules showing study procedures
and participant responsibilities at different study visits or randomization
schemas).
- Use of supplemental materials is encouraged; however these require IRB
review and approval.