Published November 1, 2023
A key step for researchers developing a human subjects research study is submission of a protocol to the Internal Review Board (IRB). However, quality assurance/quality improvement (QA/QI) projects do not require IRB submission. To help determine whether a study qualifies as a QA/QI project, the University at Buffalo Clinical Research Office (CRO) has developed a new, easy-to-use tool.
The QA/QI self-assessment tool found on the UB Human Research web page and hosted in REDCap has been designed to assist researchers in determining whether IRB submission is necessary. At the completion of the survey portion of the tool, notification of QA/QI determination will be provided on the survey and via email. If the project does not meet the criteria for QA/QI, the tool and follow-up email will guide the study team to appropriate next steps.
“The QA/QI education and self-assessment tool was developed with input from the UB CRO, UB Office of Research Compliance, and individuals from Erie County Medical Center (ECMC) and Kaleida Health,” says UB Clinical and Translational Science Institute (CTSI) Clinical Research Facilitator Alexis O’Brien. “It is a tool that can be used by those who are planning QI projects at UB, ECMC, or Kaleida Health.”
UB CTSI Associate Director Sanjay Sethi, MD, Professor and Chief, Pulmonary, Critical Care and Sleep Medicine, and Assistant Vice President for Health Sciences, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, and Director of UB’s CRO, says it is essential for investigators to “clearly understand the difference between research and QA/QI. That is crucial because the former needs IRB approval and oversight, and QA/QI does not.”
Included in the first section of the “University at Buffalo Guidance on Quality Assurance and Quality Improvement Projects” guidance document is a breakdown of the differences between QA/QI and research, along with a “Research vs. QA/QI decision tree.” To learn more about the new tool, researchers are encouraged to attend the CTSI Open Research Office Zoom session at 10 a.m. on Wednesday, November 15. CTSI Clinical Research Facilitators O’Brien and Marchelle Brooks, MPH, will explore the tool and outline how it will assist researchers; register here to watch the Zoom live.
“The tool itself helps to make the distinction [between research and QA/QI], so that the self-determination only succeeds if the planned project meets all the key points that make it QA/QI project and not a research project,” Sethi explains. “Of course, beyond that, [project leads] need to know how to conduct a good quality QA/QI project.”
One of the reasons behind the creation of the self-assessment tool was the importance of IRB approval — when needed.
“Conducting a research project involving human subjects, materials, or data without prior IRB approval is to be avoided at all costs,” Sethi says. “As long as the researcher inputs the information asked for accurately, this tool can provide them with the assurance that their project is indeed QA/QI, not research. In case of doubt, it can steer them towards finding help and/or submitting the project to the IRB for review.”
A quicker, simpler process
The self-assessment tool also expedites project preparation and initiation.
“Our prior process involved submitting all projects for determination by the IRB as to whether they were QA/QI or research,” Sethi says. “This led to delays in the initiation of the project, as well as taking the IRB away from reviewing research projects. With this tool, the delay related to IRB submission and review of a QA/QI project will be avoided.”
Sethi explains that many QA/QI projects are done by trainees “who often have limited time during their clinical training to do these projects, so this time saving can be even more significant for them. Information about the project still needs to be entered in the tool, but that should be much easier and quicker than completing full IRB protocol submission.”
Investigators who are having difficulty determining whether an activity is research or QA/QI, who are interested in using the QA/QI self-assessment tool, and/or have questions, are encouraged to reach out to UB’s Clinical Research Facilitators at email@example.com or 716-829-4357.