Like many of the debates on this Bill in Committee, this has been a fascinating one. It has been really interesting to hear from experts who themselves have engaged in clinical research. I start by thanking my noble friends Lady McIntosh of Pickering and Lady Blackwood and the noble Lords, Lord Sharkey and Lord Kakkar, for bringing this debate before the Committee today. I also thank the noble Lord, Lord Howarth, for his points about the arts and social prescribing.
Before I turn to the amendments, perhaps I could make two personal reflections. One is from my early academic career as a postdoctoral research fellow. I saw the benefit of taking the results of my research directly into my teaching. It made the courses more dynamic—it was not just a repeat of last year’s slides for this year’s students—and it showed what progress we were making in that field of research.
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Secondly, during my appointment as the Minister for Technology, Innovation and Life Sciences, it has been really exciting to see the level of research and innovation across this country, not only in the golden triangle that people talk about—London, Oxford and Cambridge—but throughout the country. It is evidence-led, research-led and really interesting, positioning the UK as a leading place for research and a hub for life sciences. We have looked at where our strengths are. One example is clinical trials. A number of companies say to us, “What is really interesting about the UK is that, especially with social care joined up, we will have data on patients literally from cradle to grave throughout their life”. But there are also all the different pathways and some of the exciting stuff we are doing with Genomics England, which opens up whole new possibilities.
In our previous debate, we heard from the noble Lord, Lord Rennard, about type 1 diabetics and how the technology is improving quickly. When I speak to relatives and friends who are type 1 diabetics, they are excited by the advances being made, which gives them greater confidence that they can lead as near as possible a long and healthy life.
Let me start by addressing Amendment 78, on integrated care boards reviewing all innovations. Although I appreciate the intention behind the amendment, for reasons that I will explain it is unclear what additional benefit such a review would produce. The National Institute for Health and Care Excellence already plays an important role in ensuring that patients have access to promising new innovations by recommending whether health technologies represent a clinically and cost-effective use of NHS resources. Where NICE so recommends, NHS commissioners are under statutory obligations to fund the technology. I note the previous debate on NICE and the points made by the noble Lord, Lord Hunt, but we expect that this requirement will carry over to integrated care boards.
On appointing a dedicated innovation officer and developing and maintaining a system to keep up to date with innovations on boards, this is part of the overall debate on how much you mandate at the ICB level, and I am sure that a number of noble Lords will recognise how many requests there have been to mandate particular places on the ICBs. I suggest that we consider that in the round.
The Accelerated Access Collaborative, the umbrella organisation overseeing health innovation and its ecosystem, will work with NHS partners to look to embed research and innovation within the new statutory ICBs. For example, in their proposed job descriptions, there is a clear requirement for ICB chief executives and chairs to foster a culture of innovation. I have seen a lot of such innovation in many places.
We also have existing reporting tools to monitor the use of innovative medicines and medicinal products. This includes NHS Digital’s innovation scorecard and the AAC scorecard. The AAC is also scoping the development of an innovation metric to help to identify and address unwarranted variation.
On Amendment 79, I share the noble Lord’s intention that the NHS should be research active, that research participation is diverse and research needs are met. The existing research duty in the Bill requires each ICB to promote research on matters relevant to the health service and the use in the health service of evidence obtained from that research. The existing research duty in the Bill is broad and wide-ranging, encompassing actions including facilitating and enabling research, such as through their commissioning functions. I am concerned that the amendment may narrow the research duty to a small number of actions which would not necessarily capture the existing range of activity.
Proposed new paragraph (a) in the amendment would also apply to
“those eligible organisations for which the integrated care board is responsible”.
Although ICBs will be able to influence and affect organisations through their functions, they are not directly responsible for any organisation. Rather than directly funding or conducting research, ICBs will primarily facilitate and enable research. But where it is appropriate for an ICB itself to play a more direct role in research, it will have the power to commission and conduct research, just as CCGs do currently.
A requirement for ICBs to
“co-produce with place-based partnerships research aims to meet the needs of their local communities and ensure diversity of participation”,
risks replicating the requirement for integrated care partnerships to prepare an integrated care strategy setting out how the “assessed needs” of their areas, which can include research needs, are to be met by the functions of the ICBs and others.
The Government are committed to diverse patient participation in research. I am sure that many noble Lords are aware of data, particularly for example in the area of artificial intelligence—as we know, it is not really intelligence but analysing large datasets to look at patterns and help the decision-making of clinicians and others. There has been a lack of diversity in data; we have seen racial bias, for example, in recruitment and college admissions. It is important that we do not repeat that in this country, especially since we do have a diverse population, and that we ensure that we have a diverse a research set as possible. I know from speaking to my noble friend Lady Blackwood that Genomics England is concerned about this and is looking to make sure that its datasets are as diverse as possible, especially with the increased use of AI.
There are requirements for researchers on equality, diversity and inclusion. These have been strengthened in research funded by the Department of Health and Social Care through the NIHR. Researchers are now expected to demonstrate how they will ensure that recruitment is inclusive and representative of the population. The Bill also requires that the forward plan must set out how the ICB and others propose to exercise their functions and the annual report must report on how it has discharged these functions. This must include how ICBs will plan and promote research and deliver clinical research.
Amendment 81 would mandate ICBs to develop a research strategy for patient benefit each year, following engagement with the NIHR and all relevant regional and national health and care organisations. However, ICBs already have a duty to promote research, and the power to commission and conduct research, so they will already need to plan their research activity to be able to discharge these functions. Where they are aware of local research needs, this should be addressed when they plan their activity. As a result, we do not think that it would add value to require ICBs to develop a separate strategy.
On the requirement for ICBs to engage with all relevant regional and national health and care research organisations, we expect ICBs to collaborate with relevant bodies where necessary without requiring this through primary legislation. Integrated care partnerships—ICPs—as joint committees of ICBs, local authorities and others, also have a huge role to play here. They must prepare an integrated care strategy setting out how the “assessed needs” of an area are to be met by the functions of the ICBs and others. Local research need could fall under an “assessed need” as it is capable of being met by ICBs and could be affected by the actions of the responsible local authority, so would need to be addressed by the integrated care strategy without the need for a separate strategy relating only to research.
The Government, through the NIHR and UK Research and Innovation funding, provide support to organisations to undertake research and develop strategies. This includes providing funding directly to meet support costs so that the NHS can deliver non-commercial research, through the NIHR Clinical Research Network, for example.
I now turn to Amendment 96, which would create a duty for ICBs to consider requests to engage in clinical trials and would mandate that participation to any eligible patient within their area. I understand and share the desire of your Lordships’ House for ICBs to take research seriously. A research-active NHS culture brings benefits for patients, staff, the NHS and the wider economy. I am keen that we harness those benefits to build on the progress made by CCGs as well as the research that I have become aware of since becoming the Minister for Technology, Innovation and Life Sciences.
In wanting to give ICBs the flexibility to develop the processes and structures that work most effectively, we feel that a statutory duty for ICBs to consider requests would be overly prescriptive. Also, a duty only to consider requests is likely to have little effect in practice. We expect ICBs to consider requests put to them without needing this to be in primary legislation. While ICBs will play a role in enabling and facilitating research in the NHS, in many instances we would expect that it would be for trusts rather than ICBs to consider participation in individual clinical trials.
We believe that a more effective way to broaden participation in these trials is to ensure adequate funding and infrastructure to support research in all parts of the country. The Government do this through NIHR funding and infrastructure; 100% of NHS Trusts in England are research active. This is due to support such as the NIHR Clinical Research Network, which meets many costs, including of equipment.
I turn to some of the questions on diverse trial participation. As noble Lords have alluded to, the Government published in March last year the UK vision for clinical research delivery. This includes provisions on diversity. It supports diversity in child participants through such initiatives as INCLUDE, funded by the NIHR. Other examples include partnership with the centre for black and minority ethnic health. In Leicester, the NIHR is addressing low participation by black, Asian and minority ethnic communities in research, in particular Covid-19 studies. These are just a couple of examples.
I turn now to Amendment 135, which aims to ensure that the ICB’s annual report covers research activity. In this Bill, ICBs have a broad duty to promote research and the evidence obtained from research, and they will be able to fulfil this duty by exercising their power to commission and conduct research. But ICBs will also be uniquely positioned to facilitate and enable research in ways broader than direct activity, such as through the exercise of their commissioning function. For example, ICBs could promote research by commissioning services from providers that are research active or are proactive in facilitating research—a much broader range of research, as the noble Lord, Lord Howarth, said.
The Bill’s drafting on the ICB’s annual report is deliberately broad and permissive, and sets out that an ICB must prepare the annual report
“on how it has discharged its functions”.
This already includes research activity, as well as broader actions to promote research. The Bill provides that NHS England may give directions to ICBs as to the form and content of an annual report.
On a requirement for an ICB’s annual report to cover the progress of applications considered by the relevant research ethics committee, I reassure my noble friend that the Health Research Authority, which administers research ethics committees, already publishes performance data on its website regarding the time taken to approve such studies. The HRA’s transparency strategy also asks research sponsors to include a plain-language summary of their findings in their final report; these can be found on the HRA’s website.
The requirement that the Secretary of State’s annual report on the performance of the health service should cover the research activity that ICBs have included in their annual report is something that we consider unnecessary as it would duplicate the performance assessment regime already provided for in the Bill.
I end my remarks on this group with Amendment 196. I understand the intention behind this amendment: making sure that research is taken seriously by NHS trusts is something that I think all noble Lords would agree on. However, we consider that an amendment to require trusts and foundation trusts to conduct research is unnecessary, since 100% of acute NHS trusts and foundation trusts in England are already active. The amendment would impose a duty for trusts to promote the use in health and care of evidence obtained from research. In fact, there is already a range of legislative and non-legislative means by which providers are required to provide services that are informed by the evidence from research. The equivalent duty already applies to CCGs, and will do so for ICBs.
As regards the requirement for NHS trusts to
“co-produce with place-based partnerships research aims to meet the needs of their local communities and ensure diversity of participation”,
I have already referred to a number of the requirements for diversity. On the requirement for NHS trusts and foundation trusts to publish, via their annual report, the steps they have taken to deliver clinical research, the NHS Act 2006 already requires this, and trusts must send their reports to the Secretary of State. NHS foundation trusts can similarly already report their research activity through their annual reports, which they are required to make publicly available.
The Government do not therefore believe that it is necessary to require on the face of legislation that trusts set out their clinical research plans in their joint forward plans. This is because the existing requirements in the Bill are deliberately broad. Having said all this, I have heard from a number of clinical research experts. Although the Government believe this, some research experts in this Chamber believe that it should be in the Bill. It is obvious, therefore, that further discussion is needed before Report so that we can consider this in the round. In that spirit, I thank all noble Lords for this helpful debate, which has been very informative, and ask noble Lords not to press their amendments.
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