Duke University's checklist for QI activities
Research vs. QI checklist
Duke University's IRB in Durham, NC, uses a checklist, adapted with approval from a similar checklist developed by the Yale University IRB, to help students, faculty, and others determine whether their project meets the criteria for human subjects research or is a quality improvement (QI) project. Its nine questions must be answered with a "yes" for the project to be a QI activity and not require an IRB review.
Here are the nine questions:
- Purpose: Is the activity intended to improve the process/delivery of care while decreasing inefficiencies within a specific healthcare setting?
- Scope: Is the activity intended to evaluate current practice and/or attempt to improve it based upon existing knowledge?
- Evidence: Is there sufficient existing evidence to support implementing this activity to create practice change?
- Clinicians/Staff: Is the activity conducted by clinicians and staff who provide care or are responsible for the practice change in the institutions where the activity will take place?
- Methods: Are the methods for the activity flexible and include approaches to evaluate rapid and incremental changes?
- Sample/Population: Will the activity involve a sample of the population (patients/participants) ordinarily seen in the institution where the activity will take place?
- Consent: Will the planned activity only require consent that is already obtained in clinical practice, and could the activity be considered part of the usual care?
- Benefits: Will future patients/participants at the institution where the planned activity will be implemented potentially benefit from the project?
- Risk: Is the risk to patients/participants no greater than what is involved in the care they are already receiving, OR can participating in the activity be considered acceptable or ordinarily expected when practice changes are implemented within a healthcare environment?