All research involving human subjects requires IRB review, including data collection. Under the applicable regulations, data collection can fall into 1 of 4 categories of review depending on sreveral factors including:

• Type of data is being collected;
• If it is identifiable data;
• At what point the data is de-identified;
• If the data includes private health information

While some data collection is excluded from the definition of human subjects research, Investigators should still submit a protocol in Kuali to receieve a formal determination that their data collection project is Not Human Subjects Research.