Vulnerable populations in Chart Reviews
When completing a new submission form in CLARA, one question will ask you about the vulnerable populations that will be, or potentially could be, included in the study. This question is included because specific regulations come into play when vulnerable populations are included in research, and the IRB must make additional determinations when it approves research involving these groups.
In most chart review studies, the correct option to check on this page is “unknown (for chart review studies only),” because it can be difficult to predict if your chart review population of interest might include, say, an inmate or a cognitively impaired subject. If your chart review specifically targets one of the listed populations, e.g. you’re looking at something that relates to children, or prisoners, or people with dementia, then it’s appropriate to check the associated vulnerable population. However, if your research question applies to a general population that might incidentally include a member of a group deemed vulnerable, the “unknown (for chart review studies only)” box is the correct one to check.