Quality Assurance/Quality Improvement activities are those designed to improve the quality of a process or assess its overall function. While such activities do not satisfy the definition of “research” under 45 CFR 46.102(d), which is “…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge…”, the determination of such can only be made by the IRB. If the IRB makes the determination that your QA/QI project qualifies for Exempt or Non Human Subjects Research, the HHS regulations for the protection of human subjects do not apply, and is not under the purview of the IRB (no review or approval necessary).
The clinical, practical, or administrative uses for such performance measurements and reporting could include, for example, helping the public make more informed choices regarding health care providers by communicating data regarding physician-specific surgical recovery data or infection rates. Other practical or administrative uses of such data might be to enable insurance companies or health maintenance organizations to make higher performing sites preferred providers, or to allow other third parties to create incentives rewarding better performance.
A majority of voting members (50% + 1) who must be present for a convened IRB meeting to proceed. Must be maintained and documented for all votes.
