Paediatricians at North Staffordshire Hospital who were accused by parents of forging their signatures on clinical trial consent forms will not face prosecution, Staffordshire police have decided.
Police have found no evidence to substantiate the allegations by six sets of parents, who claimed signatures on the forms consenting to their babies' participation in the trial were not theirs.
Their very premature babies took part in a trial of CNEP (continuous negative extrathoracic pressure) between 1989 and 1993. Babies were given respiratory support without intubation by placing them in breathing tanks.
The lead researchers, Professor David Southall and Dr Martin Samuels, were suspended by North Staffordshire Hospital NHS Trust—Professor Southall for 27 months and Dr Samuels 20 months—but were reinstated after a £750000 ($1.2m; €1.2m) inquiry found no evidence of wrongdoing.
The trial showed no significant differences in death or brain damage between babies treated with CNEP and those given standard ventilation, but the babies whose parents accused the doctors of forgery were brain damaged or died.
Staffordshire police said in a statement that its decision had been taken after “a long and careful process of high level legal consultation and advice with a senior specialist Queen's Counsel.”
The QC “has had the opportunity to review all the circumstances including other developments occurring throughout the period of those extended consultations,” the statement went on. “Having now received the final opinion of leading counsel, which has confirmed the force's long held opinion on this matter, Staffordshire police will not be taking any further action in relation to the complaints of forgery.”
Professor Southall's solicitor, Margaret Taylor, said: “The parents said there were so many doctors taking consent that you couldn't identify which doctors had signed. But the police found there was a contemporaneous book showing which doctors had taken consent from each patient.”
A spokesman for North Staffordshire Hospital NHS Trust said: “The police reached the same conclusion as we did in our investigation. Our inquiry found no evidence of forged consent forms.”
The allegations are still being investigated by the General Medical Council, which has been sent a copy of the police report.