Detailed answer for question 9 of the healthcare quality quiz.
A. Research is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
B. Quality Assessment (QA) is designed to determine if aspects of medical practice are being performed in line with established standards. It answers the questions “Is our practice up to established standards?” or “How does our practice compare to that reported by others?” Quality Improvement (QI) is initiated with the goal of improving the performance of medical practice in relation to an established standard. It answers the questions “How can our current practice be improved?” QA/QI usually refers to non-research activities and should be considered part of treatment and operations that contribute to knowledge for use within the institution. Research, QA/QI may use the scientific method to develop and test hypothesis and statistical methods to analyze data. In other words, they share the “systematic investigation” aspect of the definition of research. However, they do not share the goal or intent of the investigation, which is to “develop or contribute to generalizable knowledge.” It is this generalizability of research that distinguishes a research protocol from a QA/QI project.
C. QA/QI projects used to analyze and improve hospital operations do not qualify as research and do not need to be reviewed by the IRB. However, if a QA/QI project is undertaken with the intent of publishing the results or presenting the results at a forum open to others besides Rex Personnel, then it should be considered research and be reviewed by the IRB.
D. If a project began as a QA/QI project and did not have IRB review, the results may not be acceptable for publication. Many journals require documentation of IRB approval before research can be published and data obtained in unauthorized studies cannot be published. Federal Regulations do not provide for retroactive review by the IRB. Data collected after IRB approval may be published or presented outside of the institution.
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