Record review studies also involve “human subjects” unless…

In research, the regulatory definition of a “human subject” encompasses more than just living, breathing, actual humans. In fact, a research study that involves accessing identifiable medical records involves human subjects, even if the investigators will have no direct contact with the study participants.

Federal regulations governing research define human subjects as living individuals about whom an investigator conducting research obtains either a) data through intervention or interaction with the individual, or b) identifiable private information. Medical information collected from an identifiable medical record is identifiable private information. This definition means a research study that is done solely by collecting data from identifiable medical records involves human subjects.

“Identifiable” is a key qualifier here. Data that don’t include anything allowing reidentification of individual subjects, such as medical record numbers or names, are not considered human subject data. Luckily, the UAMS Translational Research Institute can connect investigators with the Arkansas Clinical Data Repository, which, per TRI’s webpage, “provides a single and secure source of data for use in clinical and translational research.” You can query this database to get information about your population of interest, and, depending how you structure your query, you can get data that does not include identifiers.* You can also use the database to estimate how many patients at UAMS meet the inclusion criteria for your proposed study. Click on the TRI link highlighted above for more information.

*If the data you access doesn’t include anything that allows reidentification of individuals, your study may not involve human subjects. You can complete a human subject determination form through CLARA to get an “official” determination of whether your project needs IRB review.