Listing the resources available to protect human subjects in record review studies
The CLARA new submission form’s Risks section starts with a question asking you to list the resources available to protect human subjects in the research setting. If you are doing a record review study, please go ahead and include an answer in this box, even though you won’t be interacting directly with living individuals. The people whose records you will access do meet the regulatory definition of human subjects, and you no doubt have protection measures in place such as ensuring that all research staff have appropriate training and all data will be stored securely.
We know that there is a bit of help text indicating you can write “n/a” in response to this query if you’re not interacting directly with subjects. Please disregard that help text and provide an answer to the query. We’re working on getting that unhelpful help text removed, but that might take some time.