Quality improvement (QI) versus research: The dilemma of distinguishing oversight

Background: Distinction between research studies for which federal regulation mandates IRB approval, and QI activities, for which IRB approval is not required, is often ambiguous. This confusion is reflected in inconsistent policies among institutions. We amended policies and procedures to provide a clear distinction between QI and research based on how criteria are chosen to distinguish between the two.

Methods: We reviewed KPSC IRB policies, federal guidelines and investigator inquiries (N=73) regarding QI versus research activities for oversight in 2007 to assess policy and researcher training needs.

Results: Existing policy lacked clarity of how to differentiate between QI versus research to comply with federal standards. The implementation of clearer policy and training indicated that although few investigators remained confused about what criteria to use to distinguish between QI and research, they increased seeking consultation from the IRB before engaging in QI activities to ensure compliance.

Conclusion: Establishing a policy consistent with the regulations to distinguish between QI and research depends on an oversight process that sets forth clear criteria based on the particulars of a protocol and to provide consultation to those who need further clarification. We believe we provide a useful distinguishing characteristic that will be equally useful to other institutions and that complies with the regulations enforced by the federal agencies that oversee research. Because regulation is continuously evolving, more discussion is needed among related professionals on participation in QI and research to promote better health delivery while improving respect for the rights of individuals.