I mentioned the Lords were discussing the government's plans for the Health Research Authority (HRA) on Tuesday afternoon. It was a short discussion but is a good summary of some of the main questions the scientific community have about the government's plans - what powers the HRA will have, which regulatory functions it will take on, when it will be established through primary legislation as a non-departmental public body - and the government's thinking. Plus a good basis for this to be discussed again in next few weeks during debate of the Health & Social Care Bill.
The government committed to establishing the Health Research Authority in their Plan for Growth published alongside the 2011 budget in March. This will eventually be established through primary legislation but initially will get up and running as a special health authority, housing the National Research Ethics Service. To do this, the government needs to introduce a statutory instrument.
This was not automatically going to be debated but peers brought a motion to consider so they could have more discussion of what the HRA is going to look like and how it will work.
They will have another opportunity to discuss this during the passage of the Health & Social Care Bill as they have tabled amendments to the bill which, if passed, would establish the HRA through that bill.
Earl Howe, the health minister, was joined by Lord Turnberg, Lord Willis, Baroness Finlay and Baroness Thornton. Issues touched on included
Exploring the responsibilities the Health Research Authority will take on
The statutory instrument establishes the HRA with the National Research Ethics Service at its core (this needs a new home because the National Patient Safety Agency where it currently sits is being closed). But the plan is for it to take on more responsibilities as it is developed. At the moment there is little detail of how the HRA will deliver the ambition the government outlined in the plan for growth for it to "streamline regulation and improve the cost effectiveness of clinical trials" and peers took this opportunity to push the government for more detail.
In particular they were keen to know what powers the HRA will have to speed up the process of getting multiple R&D permissions from different local NHS trusts before a project can get off the ground.
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.
At the moment this is where the big delays are coming from as different trusts look at each proposal separately introducing lots of duplication, differences of opinion and trusts working to different timeframes.
Peers asked whether aspects of this could be centralised to save on duplication, with the local checks focused on feasibility rather than reviewing all aspects of the application. And they wondered what powers the HRA may have to take measures to ensure Trusts do this in a sensible timeframe, whether the HRA could set limits on the time that trusts can take in considering proposals?
In the plan for growth the government did propose a 70-day benchmark for trusts to recruit the first patient to a trial, with NIHR funding contingent on achieving this. This is being implemented at the moment by the NIHR Research Support Services. But there are concerns that this is only a lever for NIHR-funded research although Earl Howe clarified on Tuesday that all research and studies conducted by the trust would be taken into account when benchmarking even if funding from other sources wouldn't be contingent on achieving the benchmarks. With the bill enabling any qualified provider to provide services, there were also questions about how and whether they would be involved in research and regulated by the HRA.
Earl Howe did confirm that the HRA once established by this statutory instrument as a special health authority will:
- bring together the functions of NRES into a single body and ensure continuity of its functions, including running the Integrated Research Application System.
- It will have duties to cooperate with other bodies to create a unified research approval process and to promote consistent standards for compliance and inspection. Earl Howe clarified that the clause in the statutory instrument enabling the HRA to take on "such other functions as the Secretary of State may direct" relates principally to enabling it to carry out these duties.
- That it will have a role to protect and promote the interests of patients and the public. Basically preventing unethical research and improving the timeliness of decisions about projects so people can have confidence in the system.
Taking over the research regulating functions of the Human Fertilisation and Embryology Authority (HFEA)
The Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) were both identified as arms length bodies to be abolished back in July 2010 and the HRA was proposed as the body to take over their research regulating functions. Peers probed the government's plans to do this.
Earl Howe confirmed that these powers could not be transferred until the HRA is established as a non-departmental government body (NDPB) through primary legislation. This is because the HFEA regulates the use of human embryos across the UK but a special health authority (which the HRA will be when established through this statutory instrument) only has power across England. He also confirmed that the government will consult on the best options for transferring the function of the HFEA. The government previously announced they would consult on the HFEA and HTA although Earl Howe did not mention a consultation on the HTA on Tuesday. The HTA are keen for all their functions to be kept together and transferred to the Care Quality Commission.
Regulating the use of patient data for research
The NHS keeps records of everyone registered with the health service. This patient data is a huge resource for medical research but we need a system that is safe and secure for both patients and the researchers to enable us to use this.
The National Information and Governance Board is an independent statutory body which governs the use of information in health and adult social care. It has a committee - the Ethics and Confidentiality Committee - which currently advises the Secretary of State on the appropriate use of patient information, including confidential patient information, for research. So if research projects want to use patient data, they have to go through this committee. Ultimately the Secretary of State has responsibility for approving the use of this information for research alongside the judgement of a research ethics committee.
Earl Howe confirmed that the government is planning for the HRA to eventually take over the Secretary of State's current responsibility to approve the use of this information for research.
How long will the HRA operate as a special health authority?
One of the big concerns peers have is that once the HRA is established as a special health authority, there may be a long time delay before primary legislation is introduced and it is made into a non-departmental public body (NDPB). And, as confirmed in this discussion, some of the regulatory functions it will ideally take over if it is going to effectively streamline and coordinate the regulation of health research cannot be transferred until it is properly established as an NDPB with power across the UK.
Lord Willis outlined peers's concerns that the political process will take a long time:
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.
There has been talk of a further health bill in the next session of parliament which would establish the HRA as an NDPB. But last week Earl Howe confirmed that the government were planning to publish their plans for the HRA for pre-legislative scrutiny in the next session, which means an actual bill is unlikely to be introduced until the following session at the earliest.
Responding to all these concerns, Earl Howe confirmed that the government are focused on keeping up the momentum with these changes and that they will publish draft clauses on the HRA for pre-legislative scrutiny in the next session of this parliament. On primary legislation to establish the HRA as an NDPB, he confirmed that this is planned for the future.
A new clause is tabled to the current Health & Social Care Bill which would establish the HRA as a NDPB through this bill. That is likely to come up for debate during committee stage of the bill in the next few weeks. This will be another opportunity for peers to probe government's plans in the light of today's discussion.