@ricci I think it's partly the scale that they're not equipped for, but really the systems thinking about downstream effects of that scale. When I did my last IRB training I was struck by the fact that the system assumes either individual interactions with researchers xor Internet surveys--- that any serious impact requires direct interaction or publication of private information.
No part of the system --- requirements or training for IRB members --- is tuned to consider impacts across millions of people (though this is the kind of obvious thing I'd expect submitters to identify clearly). This, that Minnesota kernel bug incident... I mean it's entirely possibly to fuck up traffic for millions bad enough that an ambulance doesn't get there in time, or accidents are made significantly more likely.