My comment is not related to medical studies performed by pharmaceutical companies - which are indeed probably very well covered by legal experts - but by stude

My comment is not related to medical studies performed by pharmaceutical companies - which are indeed probably very well covered by legal experts - but by students/professionals working in university hospitals. Think PhD students. The ethics committees of these hospitals have far less access to trained legal professionals. Especially if you factor in the amount of studies that re submitted. The combination of "little time" + "lots of studies submitted" + "no real expertise", leads to very shallow analysis of each individual study protocol. They basically run some kind of checklist that all studies have to pass before being validated. And because there is no time to review each study in depth, the tendency is to say "regardless of what the law says, we'll just cover the hospital potential liability by refusing any study that does not include strong privacy protection". No one has the time or expertise to say "I believe it's ont of those case where the law does not apply, and I am willing to undersign that study protocol". In the hospital where my wife works, getting your study refused by the ethics committee leads to at least 3 month of delay in the study, since the commitee gathers once per quarter. PhD grants are given on a year-by-year basis, so getting 3 month of delay on your first target can sometimes be a death sentence.