ReSET, otherwise known as the Department of Health’s guidance on the attribution of NHS non-commercial Research costs, NHS Support Costs and Treatment Costs, was published two weeks ago. Very simply it sets out who – the NHS, Department of Health, or research funder – should pay for which component of running a research study such as a clinical trial.
It is a troubling document and one that is causing growing angst among medical research charities.
Medical research charities – indeed all charities – have a moral and legal duty to ensure that the donations they raise are spent on the purpose for which it is pledged. So, if you put £1 in a charity donation tin for research, you have every right to ask that charity to explain and demonstrate that they have spent your money on what it was raised for. It explains why charities are assiduous about their own costs and why they are hyper-sensitive about being expected to pay for things that are not in keeping with their charitable objectives. It explains why there is such concern over ReSET.
AMRC members do not disagree with the principle behind the guidance that each partner involved in making clinical research happen should pay for those elements that are rightly their responsibility. Nor do they question the need for the Department of Health to clarify previous guidance which was badly in need of review. But, if ReSET stays as it is now, they will see it as a re-writing of the rules resulting in potentially significant and unjustified additional costs for charities. Indeed, for some charities it could mean a reduction, or at worse an end, to their support for clinical research in the future. I suspect some may simply decide to walk away.
ReSET is an understandably long and complex document which I suspect you will want to read at your leisure over Easter! But the main focus of the concerns I have heard from AMRC members to date, is the degree to which activities that were once regarded as falling to the NHS to pay (such as research governance and sponsorship, regulatory preparation including gaining ethical approval, or the payment of NHS consultants for the time they are spending on research) have now become in part or in entirety the responsibility of the research funder. As one of my members very helpfully emailed me:
Our terms and conditions of grant state that payments cannot start until all licences and approvals necessary to allow the research to go ahead have been secured. Otherwise, we could be in a situation where we begin making payments on a grant – for example towards a researchers’ salary – then they fail to get ethics approval and the research project falls at the first hurdle. I have seen this happen elsewhere and it is, in my opinion, an unforgivable waste of donors’ money.
Another member charity said, looking ahead a their future research portfolio, that they expected the changes – simply on governance and sponsorship – to result in approximately £200,000 extra being spent on these overheads instead of research. One more estimated a 20% reduction in their clinical research portfolio. I am waiting for others to come back to me.
I suppose what is most baffling is that the guidance has – as far as I know – been produced with no attempt to cost or model the potential impact on different research partners. So, although the Department of Health stresses vehemently that it believes that extra costs to funders arising from the guidance will be balanced by savings made by some of the other changes, it has no evidence to support this claim. Nonetheless, it is happy to refute evidence to the contrary.
I think all our member charities who have had most to do with this subject to date share a deep frustration that so much more could have been done to engage and communicate with all research partners earlier and in a constructive manner. Still, ever the optimist, I believe we have time to put this right. The new guidance does not take effect until 1 September. There is a willingness to talk on the part of the Department. And there is now better engagement with funders through an implementation working group.
But nor do I underestimate the task ahead, after all this is complex stuff.
As I drove to the station this morning I was reflecting on a remark made by the latest AA man to rescue me and my car by the roadside. He had said, appropriately for this time of year: ‘We call these chocolate engine cars.’ I hope that ReSET will not go down as the chocolate engine of clinical research.