“…Daly and colleagues call for external review of new non-validated treatments, since they believe that it is not right to leave decisions about novel interventions entirely up to individual doctors and consenting patients [ 6 ], a view supported by others [ 1 , 2 , 5 , 18 , 19 ]. But if it is not right that research-ethical review boards have the final say on whether or not to initiate novel treatment in individual cases either, then who should?…”