Here. The paper work, and their approval had not been obtained. These lawyers are enemies to clinical care. They must be stopped. I would support patient direct action groups expressing their frustrations to these horrible people, at the OHRP. Fire the lot, to start. No one may do research without their permission. These lawyer rent seekers threaten the safety of patients, and do not protect it.
The process of IRB approval is itself unauthorized, unproven human experimentation. It violates the Nuremberg Principles. A central underlying tenet of that list is whether the experimenter would be a subject of his own experiment. These enemies of clinical care are saying, if they were in intensive care, they would not want staff to wash their hands, use barrier precautions, wash with long lasting antiseptic soap, avoid their femoral artery site, and remove unnecessary catheters. They would want their staff to spend days getting IRB approval and shuffling papers.