This section contains links to updates on HRA Approval:
- What is HRA Approval
- What difference will it make to health research?
- When will it happen?
- What’s new?
- Progress so far
- 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 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 will simplify 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 for NHS staff research in England that does not require review by an NHS Research Ethics Committee. From 10 August 2015, studies taking place in primary care independent contractor settings only in England only became eligible for HRA Approval. Studies other than clinical trials and clinical investigations were accepted from 30 November 2015.
From January 2016, the HRA started accepting clinical trials and clinical investigations on a test basis. In addition, studies with a single site that is also the NHS sponsor were accepted with proportionate arrangements reflecting the role of the organisation as both sponsor and site. The roll out of HRA Approval will be completed by the end of March 2016.
During this implementation phase, studies that are solely for educational purposes remain excluded from HRA Approval, and further information will be communicated by the end of March.
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.
The HRA closely monitors studies going through HRA Approval and will review and revise processes as part of learning from and building on experience. Each roll out has built on the previous one.
- Applicant guidance updated
NEW: We have updated our applicant guidance.
- HRA Approval Cohort definitions
NEW: We have updated the document describing the definition of cohort definitions.
- After confirmation of funding for the programme at the end of March 2014, the HRA began a recruitment process to establish a programme team.
- The phased roll out of HRA Approval started on 11 May 2015 for NHS staff research in England that does not require review by an NHS Research Ethics Committee. From 10 August 2015, studies taking place in primary care independent contractor settings only in England only also became eligible for HRA Approval.
- The third phase of HRA Approval roll out began on 30 November 2015 and extended HRA Approval to a broad range of studies other than clinical trials or clinical investigations taking place in secondary care in the NHS.
- HRA Approval was made available on a test basis to clinical trials and clinical investigations from January 2016.
- The HRA Approval Programme team has built on the experiences of early implementation phases and feedback from applicants and other stakeholders to further develop the HRA Approval process.
- The standards and criteria against which studies will be assessed have been updated.
- A template Statement of Activities and Schedule of Events is being tested for non-commercial studies as part of the local information package provided to sites in England.
- The standard operating procedures (SOPs) for HRA assessment that HRA staff will use are in place and will be developed as we move through the phased implementation.
- The HRA is working with several sponsors and other stakeholders to be able to realise the benefits of the HRA Approval Programme
- The pharmacy and medical exposure technical assurance elements are being expanded and an evaluation of the pilot for a single pharmacy assurance has been published.
- We have recruited most of the operational staff for HRA Approval. A training programme for all new staff is in place.
- We are rolling out training to a wide range of applicants, often using train-the-trainer approaches to reach a broad audience.
The Q&As are constantly evolving and we welcome questions from the research community or public about HRA Approval.
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.
- 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.
- Assessing, Arranging and Confirming: Clarifications on HRA Terminilogy: 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.
- 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.
- The Clinical Research Network has published principles of good practice in assessing, arranging and confirming local capacity and capability for participating organisations and sponsors delivery CRN Portfolio studies.
- The Benefits Realisation Plan continues 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.