Do I need IRB approval for collecting and using aggregated caseload data?

You can collect and review data for clinical or quality improvement purposes without IRB approval. Quality improvement activities are those in which leaders of a project intend to change local care for purposes of benefit to the patients in their clinic or organization, as opposed to to applying data beyond that health care setting. If there is a plan to publish or present the data outside of your organization, then you should obtain IRB approval.


Nerenz, David R., Patricia K. Stoltz, and Jack Jordan. “Quality improvement and the need for IRB review.” Quality Management in Healthcare 12.3 (2003): 159-170.

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