It is recommended that forms for adult subjects be written at a 6th-grade reading level or lower, information should be accurate, precise, in sufficient detail, and organized in a way that facilitates an understanding of why one might, or might not, want to participate.
Moreover, the informed consent should not merely be a list of isolated facts. Many consent forms are not as good as they could be in terms of aiding decision-making. The goal is to help people process the complicated information they’re being given and make it easier for them to make a more informed decision. Ways to facilitate understanding:
- sentences and paragraphs are short,
- terms and concepts are simple,
- technical information is explained in non-technical ways, and
- subjects are directly addressed as “you;” investigators are referred to as “we.”
The consent form should be easy to look at, with:
- a clear layout,
- white-space borders, and
- easy to read fonts.
Exempt Research Informed Consent Example
Non-Exempt Research Informed Consent Example