Quality Improvement and Program Evaluation

Quality Improvement (QI) and Program Evaluation (PE) projects are not considered human subjects research and do not require approval by COMIRB. If you intend to conduct a QI or PE project, utilize COMIRB’s QI/PE decision tool to confirm that your project is not in fact a research study.

The most crucial consideration in making this determination is the intent of the project: If you are simply evaluating the effectiveness of a specific program in meeting its intended goals, or if you are measuring a planned improvement to a specific clinic or business practice, you are not conducting human subjects research and do not need to submit to COMIRB for approval. On the other hand, if the purpose of the project is to generalize your findings so that they can be applied to other institutions or practices, the project would be considered a human subjects research study and would require COMIRB approval.

If you would like to discuss your project, contact COMIRB or attend COMIRB office hours.