Babies and consent: yet another NHS scandal

But it should lead to improvements in research governance within the NHS

News p 1291

The chief medical officer of England has a slide that he often shows of a long list of scandals within the NHS. He must now add to his list the failures in the paediatric department in North Staffordshire Hospital (p 1291). A review of what happened in the hospital shows that the case is complex, but the story will probably play out in the media and in public consciousness as babies being entered into a dubious trial of a new treatment without their parents' consent.1 The worst single accusation is that consent forms were forged, and the police and the General Medical Council are investigating that possibility. At best, the North Staffordshire episode will lead to an overdue improvement in research practice throughout the NHS. At worst, it will further undermine public confidence in the NHS and doctors and lead to a proliferation in bureaucracy that will increase the difficulties of doing research.

The North Staffordshire review started out by examining complaints about consent for a trial of continuous negative extrathoracic pressure (CNEP) in premature babies, but the panel found that it had to consider other issues. These included other research, the …