Is my project Research or Quality Improvement/Program Evaluation?

Quality improvement (QI) activities and/or Service Program Evaluation are important components of maintaining a clinical or public service program. Because these activities are data-driven and involve human participants there can be significant overlap with research methodologies common to human subjects research whether the data is intended for publication or not.  The simplest difference lies in the intended use of the data.  Will the data gathered be used for current program improvement, accreditation or benchmarking, or will it be analyzed in a manner that could contribute to generalizable knowledge?  Where overlap exists between evaluation and research methodologies, the federal regulations that protect human research participants will apply and IRB approval must be obtained.

Whether the evaluation activity is human subjects research or not, it is vital that it be executed in a manner that is ethical and respects the rights and welfare of the human participants.

Last updated: 2/21/2023