These questions are designed to tell whether your study is research-based (requiring IRB approval) or a Program Evaluation/Quality Improvement.

Does the analytical or evaluative component of the activity change the way that the clinical care will be delivered in such a way that risks may be higher for those who participate (e.g., will those who participate be randomized to different interventions to permit statistical comparison of outcomes)?
Is there funding from an external organization based on support of a “research paradigm” to carry out the proposed activity?
Is there funding from an external organization with a commercial interest in the results or will the results of the study or project be used for commercial purposes?
Is the primary intent of the project or study to contribute to generalizable knowledge (transfer of knowledge across multiple situations)?
Has the study been designed so that results will be generalizable (e.g. randomization of subjects, comparison of cases vs controls)?
Does the project seek to test interventions that are beyond current the educational practices, science and experience, such as new treatments, drugs, biologics or devices?
Does the project involve care practices, interventions, or treatments that are not standard of care or have not been established in other settings?

NOTE:  After the Project Evaluation (PE) project is complete, the investigators may observe patterns and trends that might contribute to generalizable knowledge.  If it is decided at this point to expand the scope of this project by, for example, generating testable hypotheses, then the new project would be research.  The investigators could still analyze their PE data as described in the original PE protocol and submit for publication, but any new or additional analyses, with research goals as described in the questions above would be considered research.  The investigators would then need to submit an IRB protocol to conduct a research study.

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