6th Dec 2013

Update from the Health Research Authority

The HRA policy framework for supporting research in the NHS

The HRA has set out an ambition to make it easier to do good quality research in the NHS. A number of projects and initiatives that have been reported in previous editions of HRA Latest are already bringing practical improvements in the UK, and the HRA has presented business cases and an options appraisal to the Department of Health (DH) for HRA Assessment and Approval of research in the NHS. The DH has welcomed the proposals and supports them in principle. The HRA will continue to work through the financial arrangements and due process with the DH before a final decision can be made.

When the HRA becomes a Non-Departmental Public Body, which is expected in late 2014, it will take responsibility for the Research Governance Framework. Ahead of this, there is UK-wide agreement that the HRA begins to fundamentally review the principles on which the framework is based. This means that when the HRA becomes a NDPB, it will be ready to consult on a new document (having already consulted on changes that underpin the revision) to create a policy context to underpin the practical improvements that will deliver the ambition to makes it easier to do good quality research in the UK.

The clauses that will establish the HRA give the HRA specific duties. They also give others responsible for the regulation of research duties to collaborate with the HRA and for care providers in the NHS to pay due regard to HRA guidance.

Current position

The HRA has identified five key areas for exploration before it starts drafting the new framework. These are:

  • Consideration of what research the NHS can and should support and how it can best do this. The project will report early in the New Year and has been looking for evidence of where different types of studies may face particular difficulties. The survey is available here.

  • Early indications are that the particular challenges are for student research, the quality of applications and the ability of some Universities to sponsor student research in the NHS. Through this project, the HRA is looking at alternative models for some student research and how it can better support the educational value of doing research at an undergraduate level. This project is also looking at where local clinical protocols may be incompatible with a research protocol and how it aligns the different requirements, for example local variation in clinical protocols preventing research nurses delivering research within an approved research protocol. The project lead is Amanda Hunn, and the steering group for the project is Chaired by Professor John Saunders.

  • Gathering evidence to demonstrate the risk of research to research participants. The HRA is mindful that the approach to the ethics and governance of research often starts with the view that research is a risky activity. This project is specifically gathering evidence of risk to participants, for example looking at reported breaches and misconduct from the perspective of risk to participants, and reviewing safety reports. This is an internal project being led by Catherine Blewett and Hugh Davies. The findings will be presented in May next year.

  • Exploring how the perception that research raises risks to delivery of care, finance, resources and reputation for NHS organisations is a barrier to the delivery of research in the NHS. This project, led by David Montgomery, is exploring these issues specifically with staff in the NHS and NIHR networks that have responsibilities for the governance and support of research in the NHS. The findings will be presented by April next year.

  • Exploring if Research Ethics Committee decision-making and operation present barriers to research. This is an internal project pulling together the HRA data on approvals (and over 90% of applications to RECs do get approved); looking at practical hurdles in REC operation; setting out the legislation that may limit a policy approach as well as considering if there are other more effective research designs that are avoided because of this policy context. This will include the report from the HRA event in December on cluster randomisation. The report will be available next May.

  • Scoping the landscape for social care research UK-wide. The HRA will take responsibility for social care research when it becomes a NDPB and one area which will need careful consideration is the different arrangements for social care research across the UK. This scoping project will start early in the New Year.
    The re-write will also be informed by the public engagement work that the HRA completed earlier this year and will have a dedicated public involvement workstream within the HRA public involvement strategy.

Next steps

These separate projects will be brought under a HRA policy work programme early in the New Year, with Steve Tebbutt as the programme manager. Key issues to consider will be:

  • Scope - how much of the research journey do we cover in the new framework?
  • Presentation of the framework - prescriptive or a set of principles?
  • Will we bring GAfREC into the same document or keep it as a linked document?

The project team will meet for the first time early in January. The anticipated timing of key milestones is:

January 2014: Convene project team and advertise for policy lead to draft framework
Now - April 2014: Sub-projects and public involvement continue as discrete pieces of work
May 2014: Communicate and consult on findings from sub-projects
July 2014: Review and consider consultation findings and issue recommendations
October / November 2014: Issue and consult on new framework

R&D Forum 2014 - in association with HRA

The HRA is pleased to announce that it is working together with the NHS R&D Forum team to deliver the 2014 Annual Forum, on 9-10 June in Birmingham. In February 2013, the HRA held a separate event. By combining the two in 2014, it will cover a wider range of topics together in a more integrated way in just two days.

Patient involvement increases public confidence in health research studies

Patient and public involvement in research has long been considered as an important element in ensuring more robust study designs, minimising dropout rates and leading to more meaningful patient outcomes. Health researchers are often encouraged to involve patients and the public in the design of their studies, but some researchers may not have understood this. They therefore may not have consistently communicated the benefits to potential participants in the recruitment process.

After a series of workshops and surveys the HRA has now published its
final reports on this topic.

HRA response to Science and Technology Committee report on Clinical Trials

The HRA welcomed the publication of the House of Commons Science and Technology Committee report into Clinical Trials and the recognition of our role. It has already taken steps in the many of the areas identified by the Committee to improve awareness, promote transparency and improve efficiency in the regulation of health research in the UK.

Please click here for further details.

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