Key information

A concise and focused presentation to open the Informed Consent (IC) process that is most likely to assist a prospective participant, Legally Authorized Representative (LAR), parent(s), or guardian in understanding the reasons why one might or might not want to participate in the research. The key information must be organized and presented in a way that facilitates comprehension. The Concise Summary section of UNC-Chapel Hill IRB’s Informed Consent Form (ICF) template includes guidance on what key information to include and examples of key information summaries. Common Rule, 2018 Requirements: 45 CFR 46.116(a)5(i)