There are many activities that use research type techniques (interviews, for example) that are not defined as research by regulation. Evaluators may do both research and quality assessment but only one may need IRB review.
Activity not defined as research by regulation may be quite valuable, usable, publishable and honorable but it does not meet the definition of research that puts it into the regulated arena.
“Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
Each of these concepts are constantly debated in IRB circles. Research is NOT defined in terms of risk or intent to publish; however, if an activity that was not research results in something interesting, it can be published as a case study or with an IRB supported determination that it is not research with human subjects. This determination can be retroactive but if it is denied and the research is already done, it is too late. The activity cannot be retroactively approved.
FDA defines a “clinical investigation.” This definition is very different and involves use of an investigational product. A clinical investigation can be minimal risk as can be the case with in vitro diagnostic devices.
CONTINUE if you are doing “Research” and may have human subjects