For Assessing Projects such as Quality Assurance, Quality Improvement, Program Evaluation, or Public Health Practice

Determining whether a project constitutes human subjects research rather than quality improvement or program evaluation involves multiple factors. The federal definition of research is “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." In contrast, quality improvement projects or program evaluation projects systematically collect data for administrative, clinical, or reporting purposes, but are not designed to contribute to, or to advance generalizable knowledge. Instead, they are designed to develop or contribute to knowledge relevant to the organization.  

The IRB Office is often requested to provide a determination as to whether a project is research under the Federal regulations or whether the activity is program evaluation or quality improvement. Formal IRB determinations are requested in anticipation of such documentation being required for journals, conferences, funding sources and others.  The following IRB self-determination tool guides whether the project is quality improvement versus research requiring IRB review. Documentation can be printed at the completion of the checklist. Please note that this is not an ethical review of the project as that responsibility falls to the individual or institution that is conducting the quality improvement project.

If you have questions about this determination form, then please contact your IRB Research Analyst (opens in a new window) for assistance.

See table for a summary of the differences between research and not research


Overview of Differences Between Research Under Regulations and Quality Improvement or Program Evaluation
  Research Quality Improvement Program Evaluation

Intent/Purpose

Intent of project is to develop or contribute to generalizable knowledge (e.g., testing hypotheses) Intent of project is to improve a practice or process within a particular institution or ensure it confirms with expected norms Intent of project is to improve or assess a specific program

Deviation from Standard Practice

May involve significant deviation from standard practice Unlikely to involve significant deviation from standard practice  

Design

May involve randomization of individuals to different treatments, regimens or educational practices Generally does not involve randomization to different treatments, or practices Does not involve randomization of individuals, but may involve comparison of variations in programs

Effect on Program or Practice Evaluated

Findings of the study are not expected to directly affect institutional or programmatic practice Findings of the study are expected to directly affect institutional practice and identify corrective action(s) needed Findings of the evaluation are expected to directly affect the conduct of the program and identify improvements

Population

Usually involves a sample of the target population- universal participation of an entire clinic, program, or department is not expected; statistical justification for sample size is used to ensure endpoints can be met Information is collected on all or most of the target population Information on all or most participants in the program

Risks/Burdens

May put participants at risk Does not increase risk to participants, with exception of possible privacy or confidentiality concerns No risks to participants expected

Dissemination of Results

Intent to publish or present generally presumed If the results are publicized, they are described as “quality improvement” in public presentations, academic curriculum vitae, publications, etc.

Intent to disseminate the information to program stakeholders and participants is assumed

This may be publicly posted (e.g., website) to ensure transparency of results



Complete the Requiring IRB Review Self-Determination Tool