Science and Technology CommitteeWritten evidence submitted by the Health Research Authority (HRA)

In this submission, the Health Research Authority (HRA) is responding in general terms to the call for evidence but in particular to the matter: What is the role of the HRA in relation to clinical trials and how effective has it been to date?

Background and Remit

1. The HRA is a Special Health Authority with a remit to promote and protect the interests of patients and the public in health research.

2. The HRA is one of a number of bodies with responsibilities for the regulation and governance of research in the UK. However, it is in the unique position, as described below, to consider the overall framework of both the regulation and governance of research, and linked key roles for those responsible for funding, sponsoring, hosting, publishing and responding to research.

3. The HRA is widely recognised as having transformed the systems for ethical review in the UK by providing an efficient, proportionate and effective system for NHS Research Ethics Committees (RECs) which approve research, including clinical trials, within the research governance framework. The HRA has also already taken responsibility for the Gene Therapy Advisory Committee (GTAC) and will take on further functions at the end of March when the National Information Governance Board closes and responsibility for approving the processing of confidential patient information transfers to the HRA.

4. The Government intends to legislate to establish the HRA as a non-departmental public body, and the draft Care and Support Bill has now been published for pre-legislative scrutiny.

The HRAMaking it Easier to do Good Quality Ethical Research in the UK

5. As well as making it easier to do good quality ethical research in the UK, the HRA has set out an ambitious programme of work to deliver practical solutions and inform further improvements to the framework for managing and supporting research in the NHS. To this end, the HRA has established a Collaboration and Development Steering Group to oversee a set of projects to improve the environment for research in the UK. Recognising that the HRA has a lead role, it will need to work effectively with partner organisations to deliver improvement and unify processes for application and approval, so that tasks are worthwhile, proportionate and undertaken once by the most appropriate organisation to remove unnecessary activity and duplication, and the associated delays and inefficiencies.

6. The HRA received around 6,000 applications from across the UK last year, 1,000 of which were Clinical Trial Investigational Medicinal Products and needed expert review from the Medicines and Healthcare products Regulatory Agency (MHRA), which is coordinated and managed through a Memorandum of Understanding. In addition, a further 1,000 applications now proceed through the REC Proportionate Review Service, and are completed in an average of eight days.

7. The HRA is currently testing the potential benefits of a simplified and streamlined HRA assessment for all research in the NHS, including clinical trials, in one of a portfolio of projects under the HRA Collaboration and Development Steering Group. The assessment would combine and replace aspects of the current review by NHS Research and Development (R&D) and RECs. Scoping work for the project has suggested that a quality-assured HRA assessment could potentially improve both study set-up times and the quality and consistency of ethical review. NHS organisations would be able to rely on the HRA assurance and devote their review to confirming their capacity and capability to host and deliver the research, whilst RECs would be able to focus their expertise on projects raising ethical issues. If successful, this radical simplification across R&D and ethics review would potentially provide a simplified platform for other improvements planned by the HRA and other partners.

Working with others to Support Research

8. The HRA recognises that to deliver its ambition to make it easier to do good quality research in the UK it needs, not only to work in collaboration with other bodies, but also to influence and lead change with them. The collaborations forged through the National Research Ethics Service (NRES, now part of the HRA) and Integrated Research Application System (IRAS) partnership demonstrate the HRA’s successful track record of improving the UK research environment.

9. The HRA also has well-established partnerships with the MHRA, the Human Tissue Authority, the UK Health Departments, and other organisations regulating and governing research.

10. The HRA coordinates a UK-wide steering group to ensure that identified solutions are adopted widely to maximise further improvement. The HRA chairs the UK Ethics Committee Authority (UKECA), which has responsibility for establishing, recognising and monitoring ethics committees under the Medicines for Human Use (Clinical Trials) Regulations 2004.

Influencing EU Regulations for Clinical Trials

11. The HRA is an active member of the MHRA steering group, which is formulating the UK response to the revision of the EU regulations for clinical trials, and with them contributes to negotiations in Europe.

Transparency in Research

12. The HRA is committed to transparency, in the conduct of its own business and in promoting transparency in research and improving public confidence in research. As part of the IRAS application process, researchers are asked to provide information about the registration of their study on a publicly accessible database, and their plans for dissemination of results; and these aspects are reviewed by RECs.

13. As well as publishing research summaries for all applications, the HRA is developing a policy framework for transparent research. It is engaging key stakeholders in developing the framework to describe the HRA’s role in promoting transparency of research, through registration, publication, dissemination, access to data, access to tissue and providing results to study participants.

14. The HRA fully supports the European Commission’s ambition, as part of the revision of the EU Clinical Trials Directive, to increase and improve transparency in clinical trials.

Declaration of Interest

The author has no declarations of interest.

February 2013

Prepared 16th September 2013