MPs and peers recommend that HRA should take lead in streamlining regulation

Posted on March 19, 2013 by

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The committee of MPs and peers looking at the draft Care and Support Bill have published their recommendations for how the bill can be improved.

The draft Bill is interesting for medical research as it includes clauses to establish the Health Research Authority (HRA) and Health Education England (HEE) and allow the government to abolish the Human Fertilisation and Embryology Authority (HFEA) and Human Tissue Authority (HTA).

The committee has recommended that:

  • the duty on HEE to “have regard to the need to promote research” should be strengthened to simply “promote research” and there should be a greater emphasis on research in health and social care training.
  • the promotion of health research should be a key objective of the HRA
  • the promotion of transparency – ensuring the data and findings of clinical research are accessible – should become a statutory duty on the HRA and they should encourage Research Ethics Committees to play a role in ensuring researchers  both plan to make their findings available and comply with these plans.
  • the HRA should play a coordinating role in the regulation of health research – they are recommending that the existing regulators such as the HFEA should remain with their functions unchanged but  the HRA will take the lead, having primary responsibility for coordinating and standardising the regulatory practice of all health and social care research to ensure it is all joined up.
  • that the HFEA and HTA should not be abolished and the clauses that would have given government the power to do this should be removed.

The Department of Health has also gathered evidence on the Bill, publishing a report of the responses in December. We now expect the government to respond to both that report and today’s recommendations together.

Background

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 to 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 (HRA) and Health Education England (HEE) as non-departmental public bodies, both of which play an important role in embedding research throughout the NHS.

The government held a public consultation on the draft Bill – AMRC responded jointly with charities and other organisations funding and supporting medical research in the UK – and published a summary of these responses in December.

A joint committee of peers and MPs also called for evidence and invited individuals in to parliament to answer their questions and have now published a report summarising what they found and making recommendations to improve the Bill.

What do they say about research?

Health Education England

The committee recommend strengthening the duty on HEE to promote the use of research – this would make the duty to promote research on HEE consistent with that across the Secretary of State, the NHS Commissioning Board and Clinical Commissioning Groups.

315. Clause 57(2) should be amended so that HEE has, like the Secretary of State, the NHS Commissioning Board, and Clinical Commissioning Groups, a duty to promote research on matters relevant to the health service. In the case of HEE this duty should extend to the other matters listed in paragraph (a), which include social care services.

Health Research Authority

They recommend that the HRA should be responsible for promoting health and social care research

there is no single body with the primary responsibility for promoting health and social care research, and it seems to us that the HRA would be well placed to carry out this task. Clause 67(2) should be amended to make the facilitation and promotion of health and social care research the first of the main objectives of the HRA.

On the regulation of health research – they recommend that the HFEA remain, functions unaltered but that the HRA should take a lead with a coordinating role of all regulation of health research.

It seems to us that the coordination of research will be easier if a single body has the responsibility for taking the lead, and that the HRA would be well placed for this. Where aspects of health and social care research are the responsibility of bodies other than the HRA, the duty of the HRA should include the coordination of that research with the research for which the HRA has responsibility

323. The Government should consider giving the HRA primary responsibility for coordinating and standardising the regulatory practice of all health and social care research carried out by the persons and bodies listed in clause 68(1) and by any others with similar responsibilities.

Patient data – They touch on issues around the use of patient data for research and the difficulties posed by the need for consent for consent – where researchers may need to look at information from medical records to find patients who are eligible to invite to take part in a clinical trial. But they recognise that Fiona Caldicott is currently reviewing the balance between protecting patient information and its sharing, to improve patient care, so do not make any recommendations in this area at present.

There is a section focused on transparency of research results – ensuring that data and findings from clinical research are accessible which is the focus of the current AllTrials campaign. The committee recommends that promoting transparency and full publication should be made a statutory objective of the HRA, and that Research Ethics Committees should have an obligation to ensure that researchers plan to publish and that their plans are complied with.

334. We continue to have concerns that, too often, researchers may be selective in the results they publish, giving more publicity to favourable results than to negative ones; that they publish summary results rather than full results; and that they use patient confidentiality as an excuse for any lack of transparency. We believe that the HRA and RECs have an important part to play in dealing with this situation.

335. Clause 67(2) of the draft Bill must be amended so that promoting transparency in research and ensuring full publication of the results of research, consistently with preservation of patient confidentiality, becomes a statutory objective of the HRA.

336. In its guidance to Research Ethics Committees, the HRA must place on them an obligation to include provisions on the publication of research when granting approval for the conduct of research, and an obligation to ensure that such provisions are complied with.

The HFEA and HTA

There is a chapter on the HFEA and HTA which states that the overwhelming majority of responses received by the committee expressed support for maintaining these regulators but thought that more work should be done to streamline the regulatory process. Alongside their recommendation for the HRA to take a lead, coordinating the different regulators involved in health research, the committee recommend maintaining the HFEA and HTA and removing the clause that had been proposed in this bill to allow government to abolish them.

We believe that ministers should not have the power to abolish the HFEA or the HTA, and we recommend that clause 75 should be deleted.

Following a consultation on the future of the HFEA and HTA, the Department of Health has launched a short review into how they can work together and with other regulators more effectively and consider options for a future merger. This is expected to publish in April.

What next?

The Department of Health has also gathered evidence on the Bill, publishing a report of the responses in December. We now expect the government to respond to both this report and today’s recommendations together. A revised Care and Support Bill may then be introduced into a future session of parliament to be debated as a normal Bill.

Posted in: Policy