The question of what constitutes research may be especially relevant in relation to activities designed to gather data to evaluate a specific program. If there is also an intent to contribute to generalizable knowledge, the activity would also be considered research, and require IRB review. In general, OHRP gives guidance that if the activity will be used to draw conclusions related to a larger entity then the activity is considered research. Therefore, the following considerations should be made:

QA/QI, program evaluation, surveillance, etc. activities would be considered research if any of the following are true:

• there is also an intent to use the data to contribute to generalizable knowledge
• experimental or non-standard interventions will be involved
• there is a random assignment of participants to compare outcomes
• the activities are not normally done as part of standard operating procedures
• results will be used to apply knowledge to other programs
• project is subject to peer review (designed to be used outside of the institution).