The inquiry into a controversial ventilator trial at North Staffordshire Hospital trust, in which 28 premature babies died and 15 were left brain damaged, has found inadequacies at every level.
Junior health minister Lord Hunt accepted all the recommendations of the inquiry's report. He said a new research governance framework for the NHS was already being developed to ensure that valid consent was obtained before patients were enrolled in clinical trials.
Although the trial of the continuous negative extra thoracic pressure (CNEP) ventilator was broadly in line with Department o f Health guidance in the early 1990s, when it took place, the guidance itself was so lax it allowed poor practice to go 'undetected and uncorrected'.
The report concludes that neither the HA, the trust nor the local research and ethics committee acted to ensure it was being conducted properly. But consultant paediatrician Professor David Southall, the lead researcher, was responsible for the failings 'to a significant extent'.
Under the proposed framework regional offices will performance manage research governance. HAs take 'full responsibility' for their research ethics committees and 'actively support' trusts in their research. Trusts will be expected to give a senior staff member executive responsibility for research management.
North Staffordshire Hospital trust chief executive David Fillingham said it had already approved a system of 'rolling consent', so willingness to participate in trials could be 'checked and renewed' over time.
Report of a Review of the Research Framework in North Staffordshire Hospital trust . www.doh.uk/wmro/northstaffs.htm See comment, page 19.