With a chair and chief executive now in place, the UK’s new Health Research Authority (HRA) is moving ahead with its remit to protect and promote the interests of patients and the public in health research while unifying and streamlining the research approvals process.
Professor Jonathan Montgomery has been appointed chair of the HRA, which was launched initially as a Special Health Authority within the National Health Service on 1 December 2011.
Montgomery is currently Professor of Health Care Law at the University of Southampton, chair of the Nuffield Council on Bioethics and chair of Hampshire Primary Care Trust. He will withdraw from his role as chair of Hampshire Primary Care Trust as soon as hand-over arrangements have been agreed.
Dr Janet Wisely has been confirmed as chief executive of the HRA. She has been interim chief executive of the Authority since it was launched last December and is also director of the National Research Ethics Service (NRES), which was incorporated as a core component of the HRA from the outset.
Approvals through IRASThe HRA has also launched plans for a comprehensive schedule of work that includes establishing IRAS, the Integrated Research Application System launched by the UK Clinical Research Collaboration in January 2008, as a platform for unified approvals of health research projects.
IRAS was set up as an online service to collates all of the information needed for research applications to seven regulatory bodies: the Administration of Radioactive Substances Advisory Committee, the Gene Therapy Advisory Committee, the Medicines and Healthcare products Regulatory Agency (MHRA), the Ministry of Justice (National Offender Management Service), NHS / Health and Social Care (HSC) R&D offices, NRES/ NHS / HSC Research Ethics Committees, and the Patient Information Advisory Group.
With responsibility for IRAS now passing to the HRA, the aim is for the system to provide a co-ordinated route for research approvals, rather than the Authority signing these off itself.
“In this way, the HRA will support proportionate review, within a wider context of effective and efficient oversight, to protect and promote the interests of patients and the public in health research,” it says.
Electronic submission of applications to the MHRA and Research Ethics Committees are part of the first package of the updates to IRAS.
Specifically, the HRA will:
• Provide a single route through IRAS for all research approvals and permissions.
• Provide clear signposting through the process, with easy access to advice and support.
• Embed the principles and standards of review bodies to ensure approval activities are “worthwhile, relevant and proportionate”.
• Coordinate the activities of review bodies to eliminate unnecessary duplication.
• Assign tasks to the relevant organisation at the appropriate time and support the exchange of assurances across the system.
• Maintain a UK-wide overall approach that recognises and incorporates the individual requirements of the IRAS partners.
Setting up the Health Research Authority was one of the commitments in the UK government’s Plan for Growth, published alongside the national budget in March 2011.
The Special Health Authority status, which effectively limits the HRA’s remit to England, was a temporary arrangement that reflected partly the need to find a new home for the NRES as the National Patient Safety Agency – where the NRES previously resided – was wound down following the Department of Health’s review of arm’s-length bodies.
The HRA will have a broader scope once it is established, with due parliamentary scrutiny, as a non-departmental public body. Draft legislation towards this end was included in the Queen’s speech last month. The broader remit should eventually include approving exceptional use of confidential patient information for research.
In the meantime, the HRA has published summary business plans describing the work it will take forward towards providing a unified approval process and promoting proportionate standards for compliance and inspection.
Further activities include setting up a comprehensive advice and training service to build on the success of the NRES model; and will working with other organisations, including INVOLVE and the Association of Medical Research Charities, to develop plans for public and patient involvement in health research.
The HRA also put together a multi-agency project to shape the role the Authority will play nationally.
This team carried out a process review, from initial idea to development, funding, approval, conduct, compliance/inspection, publication and translation, of clinical and health services research conducted in the NHS. Findings were presented to the Department of Health at the end of April 2012.