Health Research Authority (Establishment and Constitution) Order 2011

Lord Turnberg Excerpts

Tuesday 15th November 2011 Grand Committee

Moved By

[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.

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[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?

[Earl Howe]

The NIHR has an obvious lever available to it, which is the funding that it provides. Clearly, if research is going on that is not NIHR-funded, that lever does not present itself.

[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.

Motion agreed.