When completing the new submission form for a chart review study you expect to qualify for exempt status review, a careful response to one particular question will save you some unnecessary hassle. In the form’s “Subjects” section, you’ll get a question asking you to “Select all of the vulnerable populations that will be, or potentially could be, included in the study.” Unless your study is specifically targeting prisoners, please check the “unknown (for chart review studies only)” response option. Checking anything else will lead you to additional CLARA questions that aren’t applicable to exempt status research.
We do ask that you check the “prisoners” box if you are targeting that population, because such studies involving prisoners may not qualify for exempt status review.
