Ensuring Readability
Readability of the consent document is an important component of
the process. Simply following the consent template is not enough to ensure readability,
as this is only a guide to acceptable content. The information in the consent
should be tailored to the potential participants and it should reflect a conversation
between the researcher and the subject. The consent document can be made readable
without compromising the content by applying some of the following recommendations
(more guidance / requirements available in the Informed
Consent Document GUIDANCE):
- Use lay terms, simple, straightforward sentences and remember that vocabulary
should not exceed the 8th grade level. Refer to our glossary for examples
of common lay terms.
- 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.
- If applicable, the risk section must address the frequency and severity
of each risk by using percentages, or the terms common or uncommon then provide
the likelihood, e.g. 1 in 10 or 1 in 100.
- 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 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. The following supplemental materials have been developed
by the IRB, and are already approved for general use: