Who is being studied? How retrospective chart reviews can obscure "about whom" researchers obtain information
Friday, September 20, 2024
10:15 AM – 11:15 AM CT
Location: Midway 6 (First Floor)
Abstract: When researchers submit retrospective chart review protocols for IRB approval, they commonly identify the patients whose charts are to be reviewed as the human subjects. However, a nontrivial percentage of these studies are conducted at least in part to draw conclusions about provider behavior. In these cases, providers are human subjects. This is often obscured by the way the studies are described throughout the research cycle. Consider, for instance, a recent article in a peer-reviewed cardiology journal that discusses "use of” a specific medicine in patients with heart failure. On examination, the reader learns more about prescribing behavior of providers than about adherence behavior of patients. In our experience reviewing protocols for IRBs, we have never encountered a retrospective chart review that lists providers as among the human subjects even when the primary aim is about provider behavior such as prescribing or ordering tests. Here we describe this practice of obscuring who is being studied. We share examples and preliminary findings from a study of retrospective review articles indexed in PubMed in 2022. We explore how these practices violate expectations for human subjects protections, and offer suggestions for improved practices.
Learning Objectives:
After participating in this conference, attendees should be able to:
Describe how some retrospective chart review protocols misrepresent who is actually being studied as human subjects
Propose ways for IRBs to improve human subjects protections when evaluating retrospective chart reviews
Julia Harzheim, MA, cand. med. – University of Tubingen; Joanne Doucette – Massachusetts College of Pharmacy and Health Sciences
