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QI V Research Worksheet.pdf (180.8 KB)
SUMMARY
Purpose of the Worksheet
This checklist helps determine whether a project qualifies as Quality Improvement (QI) or Research under Trinity Health West Region IRB guidelines. This distinction is crucial for deciding whether IRB submission is required.
Key Comparison Criteria
| Category | Quality Improvement / Program Evaluation | Research |
|---|---|---|
| Purpose | Improve local processes/practices (e.g., care quality, cost, efficiency). Avoids research-related language. | Test a hypothesis to contribute to generalizable knowledge. |
| Methods | Flexible, iterative, may lack randomization or control groups. | Systematic, protocol-driven, may include randomization or control groups. |
| Benefit | Direct benefit to patients, staff, or institution. | Benefit to scientific community; participant benefit uncertain. |
| Risks | Minimal, similar to usual care. Privacy concerns addressed via Notice of Privacy Practices. | May include physical, psychological, social, or financial risks. Informed consent may be required. |
| Results | Intended for internal use. May be published to share models, not generalizable knowledge. | Intended for external dissemination and contribution to literature. |
Determination Guidance
- If all boxes are checked on the QI side, IRB submission is not required. You may self-declare and file the document with project records.
- If any box is checked on the Research side, IRB submission is required via IRB Manager before starting any research activities.
Signatures Required
- Project Leader: Name, signature, institution/department, date
- Faculty/Supervisor (if applicable): Name, signature, institution/department, date