Ethics and informed consent: is "informed" always best?

I am in the US, visiting some of the leading research groups studying human factors, patient safety and interactive technologies. This feels like "coming home": not in the sense that I feel more at home in the US than the UK (I don't), but in that these groups care about the same things that we do – namely, the design, deployment and use of interactive medical devices. Talking about this feels like a constant uphill struggle in the UK, where mundane devices such as infusion pumps are effectively "invisible".

One of the issues that has exercised me today is the question of whether it is always ethical to obtain informed consent from the patients who are receiving drugs via infusion devices. The group I'm working with here in Boston have IRB (Institutional Review Board, aka Ethics Board) clearance to just obtain informed consent from the lead nurse on the ward where they are studying the use of devices. Not even from all the nurses, never mind the patients. In one of our studies, we were only allowed to observe a nurse programming a device in the middle of the night if we had obtained permission to observe from the patient before they had fallen asleep (which could have been several hours earlier). Even though we were not gathering any patient data or disturbing the patient in any way. In fact, we were probably disturbing the patient more by obtaining informed consent from them than we would have been just observing the programming of the pump without their explicit knowledge.

We recently discussed the design of a planned study of possible errors with infusion devices with patient representatives. Feedback we got from one of them was: "patients and relatives need to have complete confidence in the staff and equipment, almost blind faith in many instances." There are times when ensuring that patients are fully informed is less important than giving them reassurance. The same is true for all of us when we have no control over the situation.

On the flight on the way here, there was an area of turbulence where we all had to fasten our seatbelts. That's fine. What was less fine what the announcement from the pilot that we shouldn't be unduly worried about this (the implication being that we should be a little bit worried): as a passenger in seat 27F, what use was it for me to worry? No idea! It made the flight less comfortable for me, to no obvious benefit (to me or anyone else).

Similarly with patients: if we accept that studying the use of medical devices has potential long-term benefits, we also need to review how we engage patients in the study. Does obtaining informed consent give them benefits or whatever-is-the-opposite? Maybe there are times where the principle of "blind faith" should dominate.