- IRB approval for quality improvement projects or activities is not required if the investigator has no intention to contribute to generalizable knowledge (publish) and data is meant solely for internal use.
- If the investigator, some time after the quality improvement activities have been completed, decides they want to publish the results from number 1 above they would need to seek IRB approval to conduct a secondary data analysis on data collected originally not for research purposes.
- If the investigator at the outset of the quality improvement activity is already thinking about publishing what they might discover, IRB approval must be sought before beginning the data collection. The investigator cannot receive retrospective IRB approval for data that was collected for both quality improvement and research purposes.