information.” Assessing whether quality improvement research is actually “research” may be a problem because the definition states that investigations must contribute to generalizable knowledge, Cohen said. Communication is necessary between IRBs and quality improvement researchers to discuss this issue. The second question is determining whether quality improvement research is human subject research. The definition uses the term “about whom,” which begs the question of who subjects are in quality improvement research. In many instances it could be argued that the subjects are institutions and systems, while others target individual patients. Quality improvement researchers should clearly identify subjects in discussions with IRBs to determine whether IRB approval is necessary. A better framework explaining what quality improvement research is and what the research model is should also be clearly communicated to IRBs. Cohen agreed with Tierney’s point that quality improvement researchers should become members of IRBs to help facilitate this dialogue.

IRBs have the flexibility to efficiently and effectively review nonbiomedical research. Some believe the regulations do not match social science research, but Cohen does not believe regulations to be problematic for social science or quality improvement research.

Having separate IRBs focus on just quality improvement is a highly contested issue as well as a problem in social and behavioral research. Although there is some merit to separating ethics review for biomedical research and other types of research, the amount of overlap in protocols makes it difficult to separate the research. Another barrier to separating into different IRBs is expertise because there is often not enough expertise to fill multiple IRBs.

IRBs must have sufficient knowledge and expertise in order to rule on quality improvement research. Although this creates a burden for IRBs, there is also a burden on quality improvement researchers to develop clear research frameworks and ethical standards as well as to educate IRBs, Cohen said.


Evidence-based medicine and evidence-based management need to work together to sustain improvement in quality of care, said Steve Shortell of the University of California, Berkeley. Evidence-based medicine can be defined as using the best available evidence in making treatment decisions, interventions, and technologies to improve care for patients. Evidence-based management draws on the social and behavioral sciences, human factors engineering, and

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