Sample items from QI checklist
Is IRB review necessary?
The Partners Human Research Committee at Massachusetts General Hospital in Boston uses a clinical quality improvement checklist to help investigators determine whether their QI activity is a clinical quality improvement/measurement project that does not need IRB review, or a quality improvement research project that does require IRB review.
The two-page checklist first provides examples of QI projects that do not require IRB review, including an evaluation of characteristics of patients with catheter-associated UTIs on a particular service for the purpose of minimizing the problem.
And it refers to whether the intent is to publish results of the project. This alone does not determine whether it needs IRB review. However, if the project is funded by an external research grant, then it should be submitted for IRB review, according to the checklist.
There are 10 items on the checklist. If an investigator answers "yes" to all of these, then no IRB review is needed. If there are one or more "no" answers, then an IRB review is required. Here are some examples of items on the checklist:
• The specific aim is to improve performance on a specific service or program in the hospital and is part of usual care. All participants will receive standard of care.
• The project is not designed to answer a research question or test a hypothesis and is not intended to develop or contribute to generalizable knowledge.
• The project is conducted by staff where the project will take place, and involves staff who are working at, or patients who are seen at the partner institution.
• The clinical practice unit (hospital, clinic, division, or care group) agrees that this is a QI project that will be implemented to improve the process or delivery of care (i.e., not a personal research project that is dependent upon the voluntary participation of your colleagues, students and/or patients).
• If there is an intent to, or possibility of publishing your work, you and your Department/QI Oversight group are comfortable with the following statement in your methods section: "This project was undertaken as a Quality Improvement Initiative at X hospital or clinic, and as such was not formally supervised by the Institutional Review Board per their policies."