The revised federal regulations on protecting human subjects in research (2018), known as the Common Rule, requires that:
“Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.” (45CFR46.116)
In this section, we provide you with guidance on how to optimize key information to facilitate understanding by providing simple tools and tips that anyone can apply. Specifically, we provide guidance on:
We additionally provide:
An example of key information that has utilized plain language and evidence based formatting
Sample language and references you could incorporate into an IRB application to explain why you have adopted these practices.