HRA given go-ahead for feasibility study: HRA assessment for approval of research in the NHS
Published on 30 October 2012
The Health Research Authority is pleased to announce that the Department of Health has agreed to its proposal to test the potential benefits of a simplified and streamlined HRA assessment for all research in the NHS.
This is one of a portfolio of projects being taken forward by the HRA under the umbrella of a HRA Collaboration and Development Steering Group. This UK-wide group leads on projects to improve the research journey. 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.
Commenting on the launch of the project, Health Minister Lord Howe said:
Janet Wisely, Chief Executive of the Health Research Authority, said:
Dr Jonathan Sheffield, Chief Executive of the National Institute for Health Research Clinical Research Network, said:
Notes to editors:
It ensures that research involving members of the public is ethically reviewed and approved, that they are provided with the information they need to help them decide whether they wish to take part, and that their opportunity to do so is maximised by simplifying the processes by which high quality research is assessed.
The HRA is a Special Health Authority pending its establishment as a Non-Departmental Public Body.
2. The HRA published business plans in May 2012, these included recommendations that the HRA consider:
- the acceptability and benefit of initial assessment by HRA of all shared documentation within the Integrated Research Application System (IRAS) as part of a coordinated validation and early assessment process within the unified approval process;
- the option of a single ‘legal review’ within a HRA-described framework to reduce the duplication of review of issues such as data protection, insurance and indemnity, within a unified approval process and to consider the role of NIHR CSP (Coordinated System for gaining NHS Permission) within a unified approval process.
Early work on these recommendations has resulted in the proposal for the feasibility study.
3. Further details on this and other projects, including those within the remit of the UK-wide steering group can be found on the HRA website www.hra.nhs.uk.
4. The study will examine the feasibility of establishing an HRA assessment that would enable:
local NHS Trust decisions to be made on the basis of capacity and capability
Research Ethics Committees to make decisions based on this assessment and their review of novel ethical issues.
To determine if this would:
- successfully support the delivery of the ambitions of the HRA, including making it easier to do good quality research in the UK
- provide efficiencies for those involved in doing, regulating and managing research
- be practical and possible.
5. The HRA’s establishment as an NDPB, as set out in the draft Care and Support Bill, is subject to the Bill’s introduction in parliament and parliamentary agreement.