This is the total number of people that will sign a consent form or agree to participate in the research. This should not be a range.
“Enrolled” means that these subjects have consented to participation in the study. These subjects count towards your total enrollment number even if they screen fail, withdraw, or are dropped from the study. The PI may submit a project revision form to increase the total enrollment number after IRB approval is obtained.
If total enrollment is exceeded prior to IRB approval, the data on those subjects cannot be represented as having been gathered with IRB approval. This creates a problem for the use of that data in publications, dissertations, theses, and the like. If there is a screening process, it is suggested that the enrollment number be increased to account for screen fails. This should be explained in the Target Enrollment section of the HRPP Application and Protocol Form. This FAQ is only relevant to greater than minimal risk or FDA-regulated research.