If your study is led from England and involves the NHS in England, you should now use HRA Approval. Before you apply for REC review, please go to the applicant guidance section of our website for information about how to apply.
This section contains links to updates on HRA Approval:
- What is HRA Approval
- What difference will it make to health research?
- When did the change happen?
- Key Resources
- Questions and Answers
- Useful links and documents
What is HRA Approval?
HRA Approval is the new process for the NHS in England that brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent REC opinion provided through the UK Health Departments’ Research Ethics Service. It replaces the need for local checks of legal compliance and related matters by each participating organisation in England. This allows participating organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study.
The new system simplifies the approvals process for research, making it easier for research studies to be set up. The elimination of duplicate application routes 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.
The phased roll out of HRA Approval started on 11 May 2015. The roll out was complete on 31 March 2016 and HRA Approval is now the process for applying for approvals for all project-based research in the NHS led from England.
During the phased roll out, the HRA closely monitored studies going through HRA Approval and reviewed and revised processes as part of learning from and building on experience. Each phased roll out built on the previous one. The HRA will continue to review and develop HRA Approval and feedback is encouraged to firstname.lastname@example.org
Studies which have already applied for REC review but have not applied for R&D review, or need to add new NHS sites in England, or have new amendments, should follow the specific HRA Approval processes for these situations, so that NHS sites can work with sponsors in the new way. NIHR CSP has closed to new submissions and amendments.
HRA Approval applies only to the NHS in England. Studies with sites in Northern Ireland, Scotland or Wales will be supported through existing UK-wide compatibility systems, by which each country accepts the centralised assurances, as far as they apply, from national coordinating functions without unnecessary duplication.
- Guidance for applicants applying for HRA Approval
- Guidance for applicants who need to open new sites to pre-HRA Approval studies
- Guidance for NHS organisations in England
- Information about submitting amendments
- Information on student studies led from England
Over the coming months, Radiation and Pharmacy Technical Assurances will be incorporated into HRA Approval as they roll out across the NHS.
- Questions and Answers updated
NEW: We have updated our Q&A document
The Q&As are constantly evolving and we welcome questions from the research community or public about HRA Approval. This is our current document. Please contact us if you have any questions.
- Leaflets for the research community
We have published a suite of leaflets for sponsors and Chief Investigators
- Training materials for sponsors, Chief investigators, NHS R&D staff and Local Clinical Research Networks
NEW: We have updated the handout pack (31 March 2016)
- Template for amendment emails
NEW: We have provided suggested template emails for use by sponsors
- Template confirmation email
NEW: A template email for NHS organisations to use to confirm capacity and capability
- HRA Approval in Primary Care Settings
- NEW: Working with the NHS R&D Forum Primary Care Working Group we have provided principle and examples for primary care setting
- Collaborative working where formal confirmation of capacity and capability is not required
NEW: We have provided additional information for studies which do not require confirmation of capacity and capability
- Standards and criteria for assessment
NEW: We have updated the standards and criteria for assessment (March 2016)
- Statement of Activities and Schedule of Events
NEW: We have updated the Statement of Activities (March 2016)
- Illustrative example of HRA Approval documents
NEW: We have updated the Initial Assessment and HRA Approval template
A range of papers, templates and presentations have been created as HRA Approval has been developed and is rolled out. Listed below are links to some of the key documents and a brief explanation of their purpose.
- Listening to feedback– how we have responded to feedback
- Assessing, Arranging and Confirming: Clarifications on HRA Terminology: to support NHS organisations and sponsors this document gives more information on the terminology used by the HRA for activities relating to site.
- Local research support functions following HRA Approval implementation: 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.
- HRA Approval in Primary Care Settings: This paper has been developed in collaboration with the NHS R&D Forum Primary Care Working Group and the NIHR CRN to provide further clarity about the set up of HRA Approval studies in primary care settings.
- The Clinical Research Network has published principles of good practicein assessing, arranging and confirming local capacity and capability for participating organisations and sponsors delivery CRN Portfolio studies.
- The NHS R&D Forum Primary Care Working Group has published a companion document which focuses on the local support functions which primary care research offices can provide.
- Phases for roll-out of HRA Approval: to support key stakeholders in their planning for HRA Approval implementation, we have provided the current definition of each of the cohorts.
- The Benefits Realisation Plancontinues to be refined and provides details of how the benefits process will be applied to the HRA Approval Programme.
- NHS R&D Forum Resources Exchange provides examples from NHS organisations on their implementation of HRA Approval.
- The HRA Approval portal is a web-based portal provided by the HRA so NHS organisations can see the HRA Approval status of a study that they are participating in.
- The Programme Initiation Document gives more details on how we have approached the development and implementation of the HRA Approval Programme Initiation Document.
- The Additional Information paper explains the Programme Initiation Document in a format that is more relevant to the research community.
- HRA Summary Plans: for Assessment and Approval. This is a historic document which gave some context as to why we undertook this programme. Some sections will no longer be relevant, but it is retained as a record of the development of the programme.