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.
The assessment would combine and replace aspects of the current review by NHS Research and Development (R&D) and Research Ethics Committees (RECs). Scoping work for this 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. RECs would be able to focus their expertise on projects raising ethical issues.
Work on the feasibility project will begin immediately. Collaborative workshops will consider specific areas and will lead to a pilot project in Spring 2013, after which a decision will be made on whether to move to full implementation.
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:
"Health research helps patients benefit from developments in the quality of care. I am delighted that the HRA is looking at new ways of making it easier to do good research in the NHS and speeding up the approval process."
Janet Wisely, Chief Executive of the Health Research Authority, said:
"The Health Research Authority welcomes the opportunity to lead this, and other work, to make it easier to do good quality research in the UK. The potential for improvement by radically simplifying how we assess research is significant, and we plan to work closely and effectively with others to determine how this can best be achieved."
Dr Jonathan Sheffield, Chief Executive of the National Institute for Health Research Clinical Research Network, said:
"It is vital that all organisations operating in the research environment work together to improve the efficiency of study set-up and delivery, for the benefit of the whole research community and – ultimately – for patients. We wholeheartedly support this feasibility project, and look forward to collaborating with the HRA to ensure that initiatives led by both our organisations align for best effect."
Frequently Asked Questions
Notes to editors: 1.
The Health Research Authority promotes and protects the interests of patients and the public in order to support both their confidence and participation in health research, and improvements in the nation’s health.
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.
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.
Dr Shaun Griffin
Director of Communications, HRA
Mob 07917 551 609