Yeah, more or less. A risk assessment for the study is done and submitted and there's many more layers of beurocracy (both the good human-protective kind and the less-good regulatory capture kind). Providing things like information on effects and generalized consent forms and whatnot are included so the patient is given prior understandings of what the effects might be, from animal studies or previous human studies in some cases if you're testing for a novel effect in an existing treatment, for example, have determined might occur. You then, ideally, do a double blind study on the group of participants.