This is a nice first pass at the common sense problems with interpreting FDA regulations. I imagine that those who have been dealing with this for some time aren't as confused as the author suggests we should be. On the first pass, for example, are human subjects involved? Do you interact with humans? No, then probably not. There are many subtleties after that, but it's not so bad as the poster suggests. I remember a comment one investigator told me about animal research, where he illustrated the problem by saying you can go into a grocery store and buy a leg of lamb and do anything you want with it, but don't call it research!