The CLARA new submission form includes a question asking “What is the lay summary of this study?” When we say “lay summary,” we mean “lay summary.” As the help text indicates, this response should be written in simple, non-technical vocabulary at a no-greater-than-high-school level.
Cutting and pasting text from the study summary in your informed consent form can be an appropriate way to answer this query, since the consent form is supposed to be written for laypeople. Cutting and pasting text from your protocol is pretty much never the right way to approach answering this question, as the protocol is written for scientists.
As you draft your response to this query, we ask that you keep in mind, say, a rather distant relative that you see only during family holiday celebrations and who has never worked in research, a.k.a. your Dear Aunt Sally. Think about the tone you’d use if Aunt Sally said to you, “Say, I hear you’ve been doing some research lately. What kind of stuff are you working on?” You wouldn’t respond using technical protocol language. It would be more along the lines of, “Well, we’re trying to see if this new drug can help people with a certain type of cancer. Some of the people in our study are getting the drug, and some are getting a placebo, and we’re trying to see if there’s a noticeable difference between the two groups.” That’s the same kind of language the IRB needs to see in the lay summary. Please note that we will have to return submissions to you for correction if the lay summary is not written in language readily understandable to a nonscientist.