Talking about the Health Research Authority

Posted on February 1, 2013 by


Yesterday, our chief executive, Sharmila, discussed plans to establish the Health Research Authority (HRA) as a non-departmental public body with a group of peers and MPs.

This was part of the parliamentarians’ scrutiny of  the draft Care and Support Bill that includes a clause to establish the HRA as an independent body. They are looking at the whole bill and will publish some recommendations on how to improve it by 7 March 2013.

They picked up lots of issues including how the HRA will work with other bodies – including the NHS – to streamline regulation and whether the HRA can play a role in improving the publication of results and data of research (there was support at the evidence session for a duty to promote transparency to be included among the HRA’s responsibilities).


The draft Care and Support Bill was published in July for scrutiny. This is to allow the Department of Health to refine the proposals within it and look to publish a final Care and Support Bill, which will go through Parliament in the normal way in a future session.

We are particularly interested in it from a research perspective because it includes clauses to establish the Health Research Authority and Health Education England – both of which will have important roles on research in the NHS – as non-departmental public bodies (meaning they would be independent of the Department of Health).

The government held a public consultation on the draft Bill and a committee of peers and MPs are now looking at it in detail, making recommendations on how it can be improved. They are due to publish these by 7 March 2013.

To help them, they called for written comments on the plans in the draft bill – AMRC responded – and are now calling people in to ask them further questions.

Today’s evidence session

On the panel with Shar were:

  • Dr Janet Wisely, Chief Executive of the Health Research Authority
  • Sir John Tooke, President of the Academy of Medical Sciences
  • Nicola Perrin, Head of Policy at the Wellcome Trust

You can watch the whole session on parliament tv here

The HRA is already up and running as a Special Health Authority. It has been established to ensure research is safe and ethical so people taking part in it and benefiting from it can be confident that they are protected, and also to create a system that supports research taking place in the UK. One of the ways the HRA is doing this is by unifying the approvals process, which is currently quite complicated with researchers seeking permission from lots of different regulators. It is also working to promote proportionate and consistent research governance across the UK.

At today’s meeting, the parliamentarians wanted to know more about how the HRA is working now and its plans for the future so they could reflect on whether the clauses in the draft Care and Support Bill can be improved.

They picked up lots of issues including:

  • How the HRA will work with other bodies – including the NHS – to streamline regulation. The HRA recently launched a project to see if they could take on some of the NHS R&D permissions process centrally to save them being repeated at each local Trust. The draft bill includes a long list of bodies the HRA has a duty to cooperate with but concerns were raised that NHS Trusts are not among them.
  • Whether the HRA can play a role in improving the publication of results and data from research projects – Research Ethics Committees (which are coordinated by the HRA) ask for details of how researchers plan to publish their results and data when they are considering applications. However at the moment, they do not monitor compliance with these plans once the research has been approved. The HRA is now looking at whether researchers usually publish as outlined and how they might audit this in future. Including a duty to promote transparency in the HRA’s responsibilities was also discussed. There was support for this but a strong sense that the HRA cannot deliver this alone; it needs to work alongside other bodies.
  • How we can develop metrics to measure how well the HRA is delivering and better understand where the delays are and how we can address them. There was a discussion about the need for this to include non-quantitative measures to gauge the confidence of researchers, the public and patients in the work the HRA is doing.
  • How the HRA talks to the public about what they think safe and ethical  research should look like and acts on this. The HRA has just got funding from Sciencewise to hold a series of events with people around the UK to talk about how they want to be involved in research and how the HRA should work so that they can be confident in the system. The HRA are just setting this up now, if you are linked in with patient groups who would like to be involved, do get in touch.
  • The HRA’s new responsibility deciding whether researchers should be able to access identifiable patient data – The HRA will be taking over the responsibility from the Secretary of State for Health for deciding whether researchers can access identifiable information where obtaining individual patient consent is not possible. The committee talked about the challenges of opening up patient data safely and securely for research and some of the initiatives underway, including the Clinical Practice Research Datalink (CPRD), and the Caldicott Review looking at the balance between protecting patient information and sharing it to improve patient care. AMRC gave evidence to this review and we expect a report to be published later this year.
  • The role of HRA in regulating social care research alongside health research – The HRA’s responsibilities cover both health and social care research but most of the discussion has focused around health research. The committee requested more information on the HRA’s role and link overseeing social care research.
  • The HRA’s ability to horizon-scan for new regulatory challenges and work with other regulators to respond to these. As science progresses, regulation may need to evolve. We are seeing this as we move towards more stratified and personalised medicine where new treatments will be targeted to smaller populations, needing a new, more adaptive approach to licensing.  The HRA needs to be looking ahead and working closely with other regulators (harking back to the duties of cooperation mentioned before) to respond to the changing environment.

Also discussed by the parliamentarians today was Health Education England (HEE) which will play an important role in supporting and training NHS staff to get involved with research. We want to see the duty on HEE to “have regard to the need to promote research” strengthened to be consistent with the duties across the NHS from the Secretary of State down to Clinical Commissioning Groups.

What next?

The committee has a lot more of the draft Care and Support Bill to discuss. Once they have finished, they will publish some recommendations for how the final bill could be improved. They are due to publish these by 7 March.

The government will then take these away and look at redrafting the Bill and introducing a new and improved “final” version in a future session of parliament.

Posted in: Policy