A big shake up of the ethics approval system is in the pipeline, Sir John Lilleyman, medical director of the UK’s National Patient Safety Agency has told delegates at the recent Institute for Clinical Research conference in Manchester.
The move follows consultation on the broad-reaching Warner Report, published last year, and is expected to reach its conclusion by the end of April. Amongst the proposals is the formation of a centralised team of research ethics advisers who will help screen out valid research applications, thus trimming decision timeframes, and an online application linked to all research bodies that permits one single data entry point. If approved, all the changes will be phased in over a two-year period from June 2006.
“The stimulus for the Warner Report was disquiet over excess bureaucracy and regulation, the perception that research ethics committees sometimes acted suspiciously and had a lack of common sense over the handling of small projects,” Sir John pointed out, adding: “The matter was brought to a head by the British Medical Journal in 2004, which published what effectively was a ‘collective whinge’ about ethics committees making research trials either difficult or impossible.”
In 2004, the UK had 195 ethics committees that assessed more than 10,000 applications every year, but the large majority of these (some 8,500) concerned studies that threatened little or no harm to humans.
The years following the World Medical Association’s Declaration of Helsinki – a statement of ethical principles underpinning clinical research that was first set in stone in 1964 – have seen an enormous escalation in the importance of research ethics. And, since 1991, the entire UK system has witnessed significant change in the shape of local and multicentre research ethics committees (LRECs and MRECs), followed by the formation of COREC (Central Office for Research Ethics Committees) in 2000 and its subsequent amalgamation into the NPSA, not to mention the European Union Clinical Trials Directive in 2004 and the establishment of a UK Ethics Committee.
But such a broad sweep of change meant the process became overly bureaucratic, Sir John noted, and, in June 2005, the Warner Report called for a restructuring in the country’s research ethics committees. It made nine recommendations, including the need for less research ethics committees, common national systems to increase local R&D approval, cutting inconsistencies through training and sharing of good practice, and placing scientific officers within COREC.
Responsibility for implementing these recommendations was placed at the door of the NSPA and, with its consultation period drawing to a close, it too has made a number of proposals that will be pulled into practice over the next two years if given the nod.
Firstly, there will be an online form for ethics applications that will be linked to all research bodies, including the Gene Therapy Advisory Committee, the Patient Information Advisory Group and the NHS Research Ethics Committee. There will also be a central allocation system for CTIMPs (clinical trials of investigational medicinal products) as well as a new function that sits across a number of roles in the REC system – the research ethics advisor – with the vision being to create a national research ethics service as a single employer across the country.
All changes will take local circumstances into account, but the aim of the research ethics advisor is to speed up the approvals process through a triage system that will weed out the wheat from the chaff, ie those applications that require full committee review from those that are inadequately presented, have no need for ethics review or offer little or no potential for harm. Student research will also be spotlighted for rapid review.
And Sir John believes the recent tragic events at Northwick Park will focus the Government’s attention on requirements for Phase I ethics review, with the NPSA also calling for specific expertise in these trials to be vested in designated committees.
“It will take a little while,” Sir John observes, “we are not going to get there overnight.” But the theory is already in place. MRECs and LRECs will in future be known just as research ethics committees and their numbers dramatically reduced down to a forecast 125 from the 195 in 2004 and 146 this year. “The strategic target is to cut the time to deliver provisional opinions (a decision reached by a REC on an application pending further information/clarification) by 25% in 2007 and a further 25% by 2009,” he noted. There is currently a 60-day review period in place.
So will this raft of changes to the ethics approval system help balance the ongoing dichotomy between clamours for faster access to medicines and improved drug safety? “We don’t want to clog the system up,” Sir John told PharmaTimesClinical.com, “but we are not in the business of cutting corners.”