The CLARA new submission form’s HIPAA section has been updated to make it easier to describe specific protected health information (PHI) elements to be accessed/recorded/used in research. Instead of asking you to describe “PHI data elements,” the first question now asks you to describe “specific health information that will be used/recorded for the research.” We hope this change makes it clearer that this response should list the health information the study will involve, and not the identifiers.
Speaking of identifiers, the response options to the “Select the identifiers that will be used/recorded for the research” question have been reorganized. You’ll notice that the first option lists all the identifiers that make a dataset PHI. The second response covers the identifiers that can be associated with a limited data set. There are also options for “no identifiers will be accessed or recorded,” and “other identifier,” just in case there’s some other identifier out there not already covered in the HIPAA identifiers.
Note that you should choose whichever response option applies whenever at least one of the identifiers in a response option will be accessed/used/recorded. This response will help reviewers determine which parts of the HIPAA regulations may apply, and what kind of authorization or agreements may be needed.
Our programmers tell us that since the response options have been changed, studies that are already open may need to be updated to re-answer these questions. We apologize for that inconvenience, but we hope the revised questions will simplify the response process.