Who determines if a study is “research” or “quality improvement”?
Regional Researchers determine if a study qualifies as research or quality improvement (QI) and Health Area Principal Investigators (PI) approve this decision (see Figure 2 in REB Toolkit Chapter 1). Research studies must comply with specific policies and regulations designed to protect human subjects and privacy rights, as outlined in the PSI Research Ethics Board policies and procedures manual. QI studies are not subject to research policies and regulations. In some cases it may be difficult for the Regional Researchers and Health Area PIs to determine if a study is research or QI. Since this determination may have a significant impact on the study design, procedures, and regulatory compliance, Regional Researchers and Health Area PIs are urged to seek guidance from the REB by contacting the PSI REB Coordinator (REBcoordinator@psi.org) when a study’s category is unclear.
