"First, I presume your studies have more substantiative work, such that the ratio of IRB overhead is lower. A large part of his problem stemmed from basically j

"First, I presume your studies have more substantiative work, such that the ratio of IRB overhead is lower. A large part of his problem stemmed from basically just trying to formalize things that were already being done anyway. This certainly doesn't mean he should be exempt from any additional overhead, but it does set the priors for the "smell test" when the answers to various questions are rejected outright rather than iteratively clarified." There's a huge difference between research and routine practice, as well there should be. Note that things that are actually done for quality improvement and routine care are exempt from IRB regulations. Even at the most onerous institution I was at, that was a one page form. At the most lenient, it was a online "Choose your Own Adventure" flow chart. He'd know that if he had paid attention at the training past "Don't be a Nazi". Because IRB training is pretty much universally run by CITI, and I've done that training more times than I care to think about. "There does seem to be a few points where ethics do directly conflict with his desires (eg getting explicit consent to be "part of a study" versus priming the patient), but reasonable stakeholders should be able to mutually work out their real concerns, rather than go off the rails with arbitrary bureaucracy - say, ask the question first for the clinical purpose, and then obtain consent to incorporate that data in the study itself." One of the things that he ignores is you have to justify these things, rather than just going "I want to do it". I've been part of studies that do not even ask for informed consent due to the study design, but that's a point of negotiation and discussion with the IRB. And I absolutely think their default stance should be "No". "You're really referencing the signatures being in pencil?! I don't see how this could possibly be construed as a strict ethical requirement. Please do enlighten." I am. Pencil is really, really easy to alter. Having a requirement like the form must be signed in ink is a reasonable compromise between something like pencil and, as you allude to, notarized and witnessed, etc. And his excuse, that his patients can stab themselves with pens, seems untrue for a subset of pens (felt tips) and still true for pencils. Basically, he cast himself in the best, most put upon light as possible. I am already pre-disposed to muttering about the IRB, because it does add time to things, and sometimes is silly. That I came off reading that going "Noooope!" is a really bad sign.