Just a friendly note from your local IRB reminding research team to try to make informed consent materials read at somewhere in the grades 4 through 8 range. We know that sounds like a low reading level, but in most cases, it’s doable. It’s also appropriate for most studies. Health literacy can be low in the general population, and people considering joining some research studies may not be in the best frame of mind to digest the information in a long consent form (e.g. they may have just learned of a tough diagnosis).
One thing we’ve noticed recently is that some draft consent forms we get include language that is cut and pasted verbatim from the protocol. Because protocols are written for people with a scientific background, protocol language will hardly ever be appropriate for potential subjects, who are generally not scientists. So no matter how great the temptation to pick up language straight from the protocol and drop it into the consent form, please try to resist.
A last hint — the Center for Health Literacy worked with the IRB and others to create a plain language informed consent template. This template uses word choice, sentence structure, and formatting to create a simple, relatively easy-to-understand consent document. It can be customized to your individual study. Please take a look at the template and consider using it for your research.