I come from a social science background and have recently moved into more of a public health role. Since I was doing experimental research, pretty much every study needed a review. As far as I can tell, only studies with publicly available data (i.e. secondary analysis) that is totally de-identified can skip review. Some of our studies meet that criteria but most don't. I think even at worst, better to submit and be told it is not necessary than the reverse.
Some team members are convinced that we do not need approval on primary data collection studies of qualitative interviews because they are not "about individuals", or even crazier, that it does not meet the definition of "research" based on the following: "According to federal regulations (45 CFR 46 102.d). Research means a systematic investigation (including research development, testing and evaluation) designed to develop or contribute to generalize knowledge."
Thankfully they are going to go through with it but there are still people who are unconvinced. Any time you gather data about perceptions, decision-making or personal opinions- anything outside of fact-based information about institutions (eg policies), I would argue it is "about individuals." I don't even know how to counter the argument that our work is not "research" or that we don't intend to generalize results, as this seems self-evident. I have tried to illustrate using language from existing documentation but it doesn't get far.
I think the real problem is that prospective study planning is a real weakness in this group, because from my perspective you should have everything you need to submit an IRB before you begin collecting data anyway. It should take an hour to prep an IRB application, not WEEKS like it takes these teams. I just don't see why they feel it appropriate to skip out on ethical oversight when we should already have everything we need to complete the application anyway before the study begins. But everything is so ad hoc that whenever they put together IRB materials, they have to change it later. I can't tell though if the arguments about lack of "human subjects" or "research" are a consequence of this or a separate issue, but I don't know how to address either by myself. I've spoken up on this many times but little progress is being made.
Anyone with similar experiences able to advise? Or am I just totally off base?