Please provide complete information on the HIPAA questions in new submissions
CLARA’s new submission form includes a section specific to HIPAA. If you indicate that you will be accessing existing PHI for your project, you will be asked to “Describe the PHI that will be accessed for the research.” The IRB asks that you briefly summarize the specific information to be accessed, e.g. diagnosis, treatment history, comorbidities. A general response of “medical records” is too vague for this question. Instead, the separate query asking “Where is your data source?” would be the appropriate place to list “medical records.” Providing complete, specific information to these questions may help you avoid a contingency that could slow approval.