Health Research Authority (Establishment and Constitution) Order 2011
(12 years, 7 months ago)
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Lord Turnberg
That the Grand Committee do consider the Health Research Authority (Establishment and Constitution) Order 2011 (SI 2011/2323).
Lord Turnberg
My Lords, this instrument is to set up the Health Research Authority as a special health authority. The main reason given for taking this step rather than the primary legislation route is because there is some urgency in finding a home for the national research ethics committees that will soon find themselves homeless when the strategic health authorities and the National Patient Safety Agency go out of business.
I can, of course, understand why it is necessary to go down this rapid secondary legislation route because even if the Health Research Authority were to find a place in the current Health and Social Care Bill, it would still be a couple of years before it would be fully enacted and we need something sooner. However, there remains the question of why it cannot be put into the Bill as well so that there can be a smooth transition from this temporary solution to a more permanent one. No doubt, we will be exploring that when we come to debate it later in the Bill.
The anxiety remains that we will have to wait a considerable amount of time before we see another round of primary legislation to set up a permanent agency. In our debates on the Bill yesterday, we heard about the doubts being expressed about when we will see further legislation. Can the Minister enlarge on the hint he gave in the debate last week that we might see something relevant to this in 2012?
It might be helpful if I said a few words about why the establishment of a health research authority or agency is so important. It comes directly from the recommendations in the Academy of Medical Sciences’s report A New Pathway for the Regulation and Governance of Health Research which the Government commissioned last year and which, to their credit, they have endorsed enthusiastically. The report described in great detail the current regulatory burden faced by clinical researchers and proposed a number of solutions, the most important of which was setting up this agency. It pointed out how the UK research effort is being undermined by an overly complex regulatory and governance environment and how this has caused a fall in the UK’s global share of patients in clinical trials of all types, as well as a marked increase in the time needed to navigate a very complex research approval process. Regulation has grown as new regulatory bodies have been set up, often in response to some scandal or other, and often with seemingly good reason, but without any consideration of the overall impact of yet another new hurdle and without any evidence whatever that they have improved the safety of patients or the public.
The problem is confounded by the delays and duplication in the governance arrangements within individual NHS trusts. They are now thought to be the single greatest barrier to health research, especially where several trusts are involved in multicentre trials, for example. There is a definite need for a regulatory pathway that allows us to cut through all this unnecessary and complex bureaucracy while at the same time ensuring the safety and interests of patients.
Now we have a research regulatory authority as an important government response, and we have to see how it is going to achieve all that is expected of it. First, the National Research Ethics Service, with its 80 or so local ethics committees, has done a marvellous job in the past few years in streamlining the ethics approval process. It has, for example, made it much easier for those engaged in multicentre research proposals to gain approval. Preserving its function has been vital, but unfortunately moving it by itself from one body to another will do no more than preserve the status quo. It simply moves it from one home to another, yet the research regulatory agency was expected to do so much more.
My questions for the noble Earl are: will the authority have any more responsibilities? For example, will it have any of the responsibilities currently undertaken by the ethics and confidentiality committee of the National Information Governance Board? That committee advises the Secretary of State on whether permission should be given to researchers wanting to use data about patients where it is not possible to gain consent. It is a very important safeguard for patients, but it means that researchers have to have two sets of ethical permission to do the research, one from a normal ethics committee and another from this committee, and that causes all sorts of delays. Can we expect some streamlining here? I see in the Explanatory Memorandum to this order that that might be on the horizon. If so, can the Minister give any further information on that and on when it might happen?
Then there is the problem posed by the delays caused by the local R&D committees in each of the NHS trusts. They can hold up research for months, especially if more than one trust is involved in multicentre research proposals. For example, Cancer Research UK said that the average time for a multicentre research grant to be approved was over 600 days. Can the noble Earl say whether the new authority will have any role in easing that problem, perhaps by ensuring that limits are set on the times that trusts can take in considering proposals? Will it, for example, be able to vet research proposals in such a way that it can save local R&D committees from each having to repeat much of the straightforward common areas of a proposal, leaving them to check on aspects of specific local importance? That would certainly help to speed up the process.
The excellent report from the academy outlines a whole range of other regulatory bodies and functions that could and should be rolled up into the new authority. I shall not go into them, save to recommend that noble Lords who have not read the report might find it of some interest.
A research regulatory authority or agency has enormous potential for good if we can get it right. If we do, all will benefit—the researchers, certainly, but most importantly the patients, who will access new treatments sooner and more efficiently. We will gain economically too, because we will regain something that we are already losing: the investment from the pharmaceutical industry, which is watching our debates with interest.
We owe a debt of gratitude to the Government for setting up this authority and removing the uncertainty surrounding the ethics committee, but much more needs doing. I look forward with interest to the response of the noble Earl, Lord Howe.
Lord Willis of Knaresborough
My Lords, first, I apologise to the noble Lord, Lord Turnberg, for arriving one minute into his speech; I did not realise that the earlier business would have been dispatched so summarily this afternoon. I am grateful to him for introducing the debate and giving us an opportunity to address the issues he raised ahead of discussions during the passage of the Health and Social Care Bill, to which there are clear amendments on some of these issues. Like him, I say to the Minister without hesitation that I welcome the establishment of this special health authority. He promised it in answer to questions some time after I had arrived in the House and saw the need to move on the academy’s report as quickly as possible, and I compliment him and the Government for moving so speedily; there is no issue about that.
The need to find a home for the National Research Ethics Service was important. There was haemorrhaging of staff and good will and, in terms of any research project, it is important that you have a stable, effective and well respected ethics service. We probably have the best research ethics service in the world. We welcome the appointment of Janet Wisely, the current chairman of NRES, as the new chief officer for the Health Research Authority; she is well respected and that level of continuity will serve us well.
Lord Willis of Knaresborough
My Lords, I am delighted to continue. It is a punishment for coming a minute late that we have a Division half way through. While welcoming the special health authority, it is important to look at the order that has been referred to the Grand Committee. What we see, particularly under the heading “Functions of the Authority”, is the wonderful phrase in Article 3(1)(b),
“such other functions; as the Secretary of State may direct”.
What concerns me is that, while this organisation is set up as temporary, it could in fact simply continue indefinitely. There is no time limit on it.
As the noble Lord, Lord Owen, said in the debate yesterday, we have a real issue over the Government’s promises that there will be legislation. In reality, what we have been promised is a draft Bill in the next Session of Parliament, which will deal with research, education and training and any other such matters. As the noble Lord said yesterday, the Government will not be terribly enthusiastic about introducing another Bill. It will probably take us to 2013—or even beyond that—before a draft Bill is fully considered. That takes us right up to the end of this Parliament; perhaps to the final year or final Session of this fixed-term Parliament. Are we really saying that we are going to have a Bill of such importance and magnitude coming before Parliament at that stage? Quite frankly, I have my doubts despite the best intentions of the noble Earl, Lord Howe. If that is the case, we will see this temporary authority simply running on beyond the next election. Unless the Minister can give us a clear indication today of how long this organisation is going to stay in place, whether it has an end date and whether we will have actual, not draft, legislation, then I for one will continue to press the point.
Why do I say this is important? It is because it is not just the research ethics service that is in limbo. Several other organisations are in limbo as well. We have had the Public Bodies Bill. We have two organisations, the Human Tissue Authority and the Human Fertilisation and Embryology Authority, in limbo and running down their permanent staff. There is a real question about their future and significant elements of both may—I stress “may”—come into this new authority.
My first question is: when Article 3(1)(b) says,
“such other functions; as the Secretary of State may direct”,
is there a plan or an intention to take key elements out of the Human Tissue Authority and Human Fertilisation and Embryology Authority and move them into this organisation? The legislation is there for that to happen. It does not need any further primary legislation. Secondly, there is the issue of the Medicines and Healthcare Regulation Agency. What is going to happen to that? It is another organisation that is intricately involved with the research agenda and again there is an element of uncertainty about its future. Is there any intention to move parts of that into the new agency? Is that what we mean by “any other such functions”?
The other issue is the research and development permissions for each NHS trust. The noble Lord, Lord Turnberg, summed it up quite admirably. The main thrust of the Academy of Medical Sciences’s excellent report—which, to be fair, politicians on all sides of the House, including the Minister, have supported and agreed—is the key point that the noble Lord, Lord Turnberg, made. Recruiting people to trials can take over 600 days and while there is a commitment, quite rightly and importantly made last year by the Government, to go to a 70-day average period, how is that going to be driven? Paragraph 3(a)(i) refers to,
“the facilitation and promotion of research”.
Is that what this order actually means, and is it what the Minister means? When I asked him in a Question for Written Answer—I am sorry, but I do not have the reference; Hansard will find it—whether there was any requirement for legislation in order to ensure that NHS foundation trusts become actively involved as part of their duty to promote research and clinical trials, the clear response from the Minister was that there is no need for that because there is perfectly sufficient legislation at the moment for that to happen. I do not know how that is going to happen. If we are going to have an authority, other than the National Research Ethics Service, that simply treads water on every other aspect of research, we will be missing a trick because we could be two, three or four years away from having a permanent solution.
In conclusion, I ask the Minister what work the special health authority will do to prepare for new functions which may come down the line with the new Health Research Authority. What timescales does the Minister envisage for the establishment for the new Health Research Authority and for it becoming operational? Does he have a clear timeline that is not simply in terms of legislation? Indeed, what preliminary work will be done to pave the way for the new national research governance service, which was going to be swept into this organisation too? I think I can give the Minister eight out of 10 for making a commitment to the House. He has made a promise, and I thank him for that, but can we please now have some flesh on these bones as well so that we know what direction of travel we are heading in so that we can all get on the bus?
Baroness Finlay of Llandaff
My Lords, I would add my words of welcome to the principles of research which have been supported by the Government. I know that the Minister has done much personally to promote this. In welcoming the Health Research Authority as a special health authority, I also echo the words: “The problem is this: for how long and where will it lead to?”. The current regional ethics committees that are going will be covered in this, but they are only half the problem in relation to research. The other half is R&D committees in trusts. There is a separate committee for every trust and people who want to undertake multi-centre research have to take their research through them. If you are researching into rare diseases, you may have to go through every trust in the country in order to be able to recruit enough patients to enter into whatever study you are conducting. That could be 100 or so different committees. It means that researchers have to sign up at every trust. Each trust behaves quite differently. Some speed research through in about two weeks, but others become extremely fussy. Unfortunately, that fussiness often focuses on things like the patient information sheet. The committees will spend time requesting redrafts of that sheet, but the redraft may be rejected by another trust. Researchers end up going around in circles for months on end in what is in fact a pretty futile activity.
That is because the original research ethics committee which looked at the proposal will have to go through everything, including the consent form, the patient information sheet and so on. The committee also has to look at the protocol of the study itself and the science behind it. If the science is bad, that is really when the research programme should be stopped in its tracks. That is the role of the ethics committee, and if it does its job properly, it could centralise all these other factors and look at them.
Apart from the duplication taking time for researchers, it is duplication across the whole country with people doing exactly the same job and coming to slightly different, but often not very consequentially different, conclusions. There is duplication at many levels. One could say that if something is good enough for the research ethics committee, it really should be good enough across the board. If it is not, there is a question about the research ethics committee and the way it functions, and it needs to be looked at again because it is not up to scratch.
There are quite a few things that I hope can be centralised, and it will be helpful if the Minister will clarify what will and will not be centralised. For example, will checks on the principal investigator’s qualifications to undertake the research be centralised? Will the protocol of a study and the science behind it be scrutinised with patient information sheets and patient consent forms? Will there be a way of informing the trust that that has been done adequately and does not have to be done again? At a local level, of course the trust has to look to see whether it has the right research facilities and the right infrastructure. That is not usually about the nature of the research but more about whether it is in a position to participate. That is a feasibility check at a local level. That could be done very quickly, but it needs a different mindset. I am concerned that with the push to autonomy for all the different trusts, a trust can say, “No, we’re not going to play ball with this. We want to have our own processes and do our own research ethics rather than participate at a national level”, which might strengthen its R&D committee processes.
An issue not being addressed in this order is indemnity for research. Are there plans to establish an all-England research risk pool or some kind of centralised and co-ordinated indemnity so that we free research processes and stop risk-averse behaviour at local level? Sometimes, risk aversion, which is an inappropriate interpretation of risk, is making some of these committees particularly nitpicking in their processes. I recognise that that might need primary or secondary legislation, but I urge the Minister to take away the amendments that we have tabled to the Health and Social Care Bill and think very carefully about them because they would solve quite a large part of this problem. They would not solve it all, but this order is an interim measure, and it cannot last for years because the gaps will widen and we will then carry on losing research from our shores. We are all aware of the urgent need to turn that traffic around and to bring pharmaceutical and all other types of research back because it is a strength and an economic earner for this country if we can get it right. The infrastructure is critical.
Baroness Thornton
My Lords, I thank my noble friend Lord Turnberg for introducing the debate on this order. As noble Lords know, this order establishes the Health Research Authority to facilitate and promote research related to the health service through the research ethics committee that will check that research proposals meet ethical standards and will establish and appoint members to those committees. I think everybody would agree that the provenance of this initiative is the Academy of Medical Sciences’s review, which was published in January, and that the urgency arises from the abolition of the National Patient Safety Agency.
I will first ask a couple of questions about the National Patient Safety Agency because I would like to get some issues on the record. We are all aware of the reason that this order has been brought forward. The Minister has been completely clear with the House about the process. It needs to be there to scoop up the National Research Ethics Service. What is happening to the National Reporting and Learning Service and the National Clinical Assessment Service? The National Patient Safety Agency had three functions, and those were they. What is going to happen to the other two very important functions?
In addition the National Patient Safety Agency was responsible for commissioning and monitoring the National Confidential Enquiry into Patient Outcomes and Death, the Confidential Enquiry into Maternal and Child Health, and the National Confidential Inquiry into Suicide and Homicide by People with Mental Illness. I would like to know what will to happen to them. Where are they going to live when the National Patient Safety Agency no longer exists? Indeed, what will happen to the special programmes that the agency has conducted over the years, such as the programme into maternal and newborn babes? This is very important work, with accumulated knowledge and skilled staff, and I am concerned about that.
I agree with the noble Lord, Lord Willis, about the momentum that there is to establish an independent health research body. That was underlined by the discussions we had on the Public Bodies Bill over the future of the Human Tissue Authority and the HFEA. It would also benefit the Committee if we could be brought up to date as to where things are with them, and their future. But the outstanding question is: why can we not start now and include the new agency in the Bill, and get on with it? We will have that debate on the Floor of the House.
I have just a few more questions. How will the independence of this special health authority be guaranteed, because it is not the arm’s-length body that will ultimately be created? What costs are involved with this? Are there any extra costs for which funding will have to be found to set up this ethics committee? How will that be progressed? Finally, what will happen to the current board members of the National Patient Safety Agency led by Sir Liam Donaldson?
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)
My Lords, I thank the noble Lord, Lord Turnberg, for his positive comments on the creation of the HRA as a special health authority and welcome the opportunity of this debate to clarify the role of the authority on its establishment on 1 December. As I said last week when we discussed amendments to the Health and Social Care Bill, the Government have signalled their clear and strong support for research by increasing the research budget of the Department of Health in real terms over the current spending review period. I fully recognise the importance of ensuring that research is promoted within the health service. High quality health research is critical to the ability of the NHS to deliver world-class health outcomes, an end towards which we are all striving.
I think that noble Lords will agree that regulation of research is excessively complex. Both this and inconsistent local practices need to be addressed. As the Academy of Medical Sciences’s report set out, it is still far too difficult for researchers to navigate the complex national and local processes for research approvals. The Plan for Growth, which was published alongside the Budget 2011, announced the Government’s proposals. At the national level, we said that we would create a Health Research Authority to combine and streamline the approvals for health research, which are scattered across many organisations. At a local level, we said that we would transform the incentives for efficiency in research initiation and delivery. These two components are critical and we are already tackling the complex local processes for research approvals. Through the Health and Social Care Bill and the efforts of my department and the National Institute for Health Research, we are seeking to embed a positive and proactive research culture across the depth and breadth of the NHS. The noble Lord, Lord Turnberg, asked me what we are going to do about delays at trust level, and that question was echoed by the noble Baroness, Lady Finlay.
We have developed a co-ordinated system for gaining NHS permission for research that is supported by the National Institute for Health Research. It aims to standardise the checks that lead to trust approval, and centralise those that do not have to be carried out locally. In May we fulfilled our commitment to launch a framework of good practice and standard procedures to facilitate consistent local research management and greatly improve performance.
NHS trusts which adopt these standards will stop unnecessary duplication of checks, a local barrier to getting a research project off the ground that has frustrated researchers for many years. For clinical trials the National Institute for Health Research will publish outcomes against public benchmarks, including—and I address this particularly to my noble friend Lord Willis—an initial 70-day benchmark to recruit the first patient to a trial. Future NIHR funding will be conditional on meeting benchmarks.
I turn back to national-level commitments. The instruments not only fulfil our commitment to establish the Health Research Authority as a special health authority this year; alongside the directions we are giving it, they also ensure that the Health Research Authority will have substantive functions from the outset.
First, the HRA will unify the existing functions of the National Research Ethics Service from the National Patient Safety Agency and strategic health authorities. This will provide continuity and a stable platform for the National Research Ethics Service to build on the achievements it has already made. For example, a major obstacle to conducting research has been the completion of the numerous forms required to gain research approvals and permissions. The Health Research Authority will continue to run the integrated research application system developed by the National Research Ethics Service. It is an online one-stop shop that lets researchers apply for all the research approvals they need, not just to ethics committees but to NHS trusts and other health research approval bodies.
Secondly, in addition to ethical approvals, and from the outset, the HRA will have duties to co-operate with other bodies to improve the whole system: to create a unified research approval process and to promote consistent standards for compliance and inspection. This means it will promote alignment across the whole system, working closely with other bodies, such as other regulators. For example, it will work with the Medicines and Healthcare Products Regulatory Agency on operating a co-ordinated national approval process for research involving medicines or medical devices. It will also work with the National Institute for Health Research on promoting proportionate action to demonstrate compliance with standards that are consistent on both the regulatory and provider sides. Therefore, it will support the work of the National Institute for Health Research to promote improvements in local NHS approval processes.
Thirdly, and most importantly, from the outset the HRA’s role will be to protect and promote the interests of patients and the public. It is crucial that members of the public participating in research are—and feel—safe. The HRA will protect patients from unethical research, and enable patients to benefit from opportunities to participate in research by facilitating research which conforms to ethical standards and the law. Its role in combining and streamlining health research approvals, alongside the work of the National Institute for Health Research with NHS trusts, will improve the timeliness of decisions about research projects. This will increase opportunities for our patients to benefit from research.
The noble Lord, Lord Turnberg, asked about the ethics and confidentiality committee function within the National Information Governance Board for Health and Social Care. The NIGB is an independent statutory body established to improve and monitor information and governance in health and adult social care. It provides advice to the Secretary of State on the appropriate use, sharing and protection of patient and service user information. In particular, it has set up a committee—the ethics and confidentiality committee—for advice on the processing of patient information, including confidential patient information, under the Health Service (Control of Patient Information) Regulations 2002. Confidential patient information may be processed under those regulations only where the processing has been approved by the Secretary of State and, in the case of medical research, also by a research ethics committee. It is intended that the HRA will take on the Secretary of State’s role in approving the processing of such information for medical research as part of its role in combining and streamlining approvals for health research. The establishment of the HRA will help to ensure that the application and review processes are streamlined and, as I have said, follow consistent standards.
My noble friend Lord Willis asked me to summarise the functions of the HRA as a special health authority. I have already mentioned that it will assume the NRES functions from the NPSA as well as strategic health authorities’ functions as the appointing authorities for research ethics committees. In due course, it will perform the Secretary of State’s function of approving the processing of patient information for medical research. My noble friend mentioned the reference to directions in the order. Principally, those directions will relate to the need for the HRA to co-operate in the exercise of its functions with the regulatory bodies that I have referred to and with others.
My noble friend asked whether the Government have any intention to transfer HFEA or HDA functions into the special health authority. The answer is no, because we cannot. As a special health authority, the Health Research Authority is generally restricted to exercising the Secretary of State’s functions relating to the health service in England. Establishing it as an NDPB in due course will enable functions to be conferred on it which are not specific to the health service in England, including giving it functions which go beyond health, including functions relating to social care. The Academy of Medical Sciences’s report proposed that the research-related functions of the HFEA should reside with the Health Research Authority. We will be consulting on the future of the HFEA and on our preferred option that the research-related functions of the HFEA should pass to the HRA. Establishing the HRA as an NDPB will enable it in due course to take on functions relating to embryo research which are not health service functions in England.
The noble Baroness, Lady Finlay, asked me about indemnity for research and the possibility of an all-England risk pool. Trusts are members of the NHS clinical negligence scheme, which indemnifies them in respect of negligence for which they have assumed vicarious liability, whether the negligent activity was standard care or research.
The noble Baroness, Lady Thornton, asked about other functions of the NPSA and, in particular, the National Reporting and Learning Service and the National Clinical Assessment Service. I will write to her on that, but I can tell her that most of the NPSA’s functions are expected to transfer to the NHS Commissioning Board after Royal Assent. Patient safety will of course be at the heart of the new system. Responsibility for national confidential patient inquiries has already moved to the Healthcare Quality Improvement Partnership, which manages the national clinical audit programme.
The noble Baroness also asked me about the cost of the Health Research Authority. The funding will follow the functions. The Health Research Authority will continue the reform of the National Research Ethics Service releasing efficiency savings, we trust, for developing the authority’s other functions.
Looking forward, it is important to ensure that we maintain momentum and build on the advances that the Health Research Authority will be able to take forward as a special health authority. It is our intention to publish draft clauses on the Health Research Authority for pre-legislative scrutiny in the second Session. Future legislation will allow us to establish the Health Research Authority as a stable and independent non-departmental public body. The current regulatory framework for health research involves many overlapping acts and instruments, so there is much work to be done to ensure that we develop legislation that is fit for purpose.
Research has been a core function of the National Health Service since its foundation. It is key to the future of health and healthcare in the UK. The creation of the Health Research Authority as a special health authority is, I believe, an important step on the road to removing unnecessary bureaucracy that could stifle research in this country.
I am most grateful for the support of noble Lords. We will no doubt be returning to these issues when debating amendments tabled to the Health and Social Care Bill. In the mean time, I recognise the value of these exchanges and thank all who have contributed so fully to this debate.
Lord Turnberg
My Lords, the noble Earl said that in future the NIHR will require trusts to have a 70-day limit on the time in which it can consider requests. Does that also reflect on non-NIHR-funded research from other organisations or is it only NIHR research?
Baroness Finlay of Llandaff
Before the noble Earl concludes his response to that question, I should like to raise the matter of “any qualified provider”, how the all-England risk pool might relate to that, and whether there will be a research obligation and a research link in relation to the broad range of people who will provide services under the “any qualified provider” remit. It would be both their indemnity and how much they would be part of this process.
Earl Howe
My Lords, the precise arrangements for the CSND are being worked through at the moment. I will write to the noble Baroness on that. As I have described, the incentive relates directly to the NIHR funding but the benchmark is measured against other research and all studies that are going on. There is a wider dimension to this.
Lord Turnberg
I should apologise to the noble Earl for burdening his day off from the health Bill during several weeks of hard work. I thank him for his detailed response and will reflect carefully on what he has said. Today’s debate will be useful when we debate this issue in the health Bill proper on the Floor of the House. I hope that it will reduce the amount of time that we discuss the Bill, although I cannot promise that. We will wait and see.