On 31 March 2014, Earl Howe, Parliamentary Under-Secretary of State for Quality, announced funding for the HRA Approval (full details in the press release).
If you have any queries or comments, contact the HRA Approval Team.
What is HRA Approval?
HRA Approval will provide a single approval for research in the NHS that will incorporate assessments by NHS staff employed by the HRA alongside the independent Research Ethics Committee opinion. This will allow decisions at local sites about participation to be made on local capacity and capability alone. The process will be coordinated with those in the devolved administrations and with other regulatory approvals to unify the approval process for research in the UK. HRA Approval will be available to NIHR portfolio studies and non-portfolio studies in England.
HRA Approval will provide authoritative assurance to NHS organisations about the suitability, compliance and quality of research proposals.
What difference will it make to health research?
The new system will simplify the approvals process for research, making it easier for research studies to be set up. This means that the answers to research questions about how to improve patient care or about new treatments will be answered quicker. Patients will benefit from research funding being dedicated to delivery of research rather than being wasted in navigating complex systems. By removing duplication of reviews of research by NHS support teams, the NHS will be freed up to focus on delivering research.
When will it happen?
After receipt of confirmation of funding for the programme at the end of March 2014, HRA undertook a recruitment process to establish a programme team as there was no available resource within the small existing workforce.
Over the summer, the team came into post and the details of the standards of the components of HRA Approval and the process were explored.
Currently, the details of the first stages of roll out are being developed. HRA Approval will be implemented in a controlled, phased approach.
HRA has an ambition to implement HRA Approval by December 2015.
HRA Approval will apply to all studies in England involving the NHS, within a UK-wide coordinated framework. HRA implementation will include staff responsible for implementing and supporting the changes inside and outside the HRA, so studies not in the early phase of roll out can still expect to see early improvement to set up times as the HRA supports further improvement and efficiency across current systems.
Useful links and documents
A range of papers, templates and presentations have been developed as HRA Approval has been developed and is rolled out. Linked to below are links to some of the key documents, followed by a brief explanation of their purpose.
- Consultation on revised model Non-Commercial Agreement (mNCA) (web page)
- Study-wide review of non-portfolio studies in England (PDF)
- UK Study wide governance criteria for R&D Review (PDF)
- Assurance template (.docx)
As part of the preparation for implementation of HRA Approval, this review paper outlines our plans to test the UK study-wide criteria and assurance template with NHS organisations. The criteria and template were developed by the UK Wide NHS Permissions Compatibility Group. We would like to encourage NHS organisations in England hosting studies that are not processed via NIHR CSP to use the criteria and assurance template as they review studies.
- Research support functions following HRA Approval implementation (PDF)
- HRA Approval presentation (slideshow hosted on YouTube)
- Questions and Answers 14 January 2015 (replacing previous versions)
This paper outlines the research support functions that will not be incorporated into HRA Approval but which may be put in place locally at research sites in England to provide a supportive environment for research delivery. The presentation (with commentary) explains more. The Q&As are constantly evolving, and we welcome questions from the research community or public about HRA Approval.
- HRA Approval Programme Initiation Document (PDF)
- Additional information: HRA Approval PID (PDF)
- HRA Summary Plans for Assessment and Approval give more details on our plans.
The Programme Initiation Document gives more details on how we are approaching the development and implementation of the HRA Approval. The Additional Information paper explains these plans in a way more relevant to the research community. The HRA Summary Plans for Assessment and Approval give more details on our plans.