When drafting your protocol, please pay close attention to how the subjects’ age range is described in the text. Different regulatory requirements apply to different ages, which is why the IRB may send contingencies asking you to be very, very specific when describing how old your participants are. For example, when we see an age range of birth to 18 in a chart-review study, we may ask you to clarify if that means birth through the last day of age 17, with people who have reached their 18ths birthday being ineligible, or if people who were 18 at the time the data of interest were collected are also eligible. The rationale for that clarification is that the IRB must make different risk-level determinations for adults and minors. Eighteen-year-olds are considered adults, so their inclusion means the IRB would have to make adult risk determinations. However, if subjects are only eligible through the last day that they’re 17 years old, the IRB would make only the risk determinations that pertain to minors, which, per the regulations, differ from those for adults.
You’ll also notice on the new submission form that age ranges are listed in the categories of in utero, birth to 6 years, 7 to 17 years, and 18+ years old. Again, a different set of regulatory requirements applies to each of these age categories, so we ask that you indicate all the age ranges that apply. Note that selecting an age range does not mean that the entire age range will be included. For example, if you are enrolling children ages 4 through 10, you would check both the birth to 6 years and 7 to 17 years categories, as your study population falls into both of those ranges.