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
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 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 will also be eligible for HRA Approval.
- Guidance for applicants applying for HRA Approval
- Guidance for NHS organisations
- Information on the second phase of roll out (primary care studies)
- Call for studies to provide support to sponsors and applicants [PDF]
HRA Approval is the new approval that will be required for research to commence in the NHS in England. It is a new process that comprises a review by a Research Ethics Committee (where applicable) as well as an assessment of regulatory compliance and related matters undertaken by dedicated HRA staff. 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.
From 30 November 2015 studies taking place within the NHS that are NOT a clinical trial or clinical investigation will become eligible for HRA Approval i.e. studies fitting one of the following types in IRAS:
- Basic science study involving procedures with human participants
- Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology
- Study involving qualitative methods only
- Study limited to working with human tissue samples (or other human biological samples) and data (specific project only)
- Study limited to working with data (specific project only)
These studies may have sites across the UK.
For all the above categories, the study must also:
- Not be solely undertaken for educational purposes.
- Be multi-site or single site (except where the single site is also sponsor).
Further information and advance guidance for applicants applying for HRA Approval from 30 November 2015 onwards can be found on our website here.
The HRA will closely monitor studies going through the initial phases of HRA Approval roll out and will further develop processes as part of learning from and building on experience. Each roll out will build on the previous one. There will be changes to IRAS to accommodate future roll outs. The timing of the next roll out phase will be announced once the HRA has reviewed the implementation of the first three phases.
- Advance guidance for applicants applying for HRA Approval from 30 November 2015
NEW: we have published advance guidance which includes updated standards and criteria against which studies will be assessed and updates to Statement of Activity and Schedule of Events templates for use from 30 November 2015. Note: this guidance is as we expect it to appear to accompany go live of cohort 3 of HRA Approval. It may however be necessary to make some adjustments before final publication on the applicant guidance pages of HRA website.
- HRA Approval Cohort definitions
NEW: We have updated the document describing the definition of cohort definitions.
- Illustrative examples of HRA Approval documentation
NEW: We have created some illustrative documentation for fictional studies granted HRA Approval to support organisations preparing for HRA Approval. Example documents include: HRA Initial Assessment Complete letter, HRA Approval letter, Template Statement of Activities for different site types.
- User guide for HRA Approval Portal
NEW: The HRA Approval Portal is a web-based portal which is provided by the HRA in order that NHS organisations can check the HRA Approval status of a study that they are participating in.
- 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 also became eligible for HRA Approval.
- The scheduled go live for Cohort 3 is 30 November 2015, subject to the continued evaluation of cohort 2 and confirmation of readiness.
- The HRA Approval Programme team have 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 published for the existing HRA Approval applications and updates for future cohorts will be developed and published.
- A template Statement of Activities and Schedule of Events is being tested as part of the local information package provided to sites in England.
- The necessary standard operating procedures (SOPs) 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 have begun their controlled roll out and an evaluation of the pilot for a single pharmacy assurance has been published here.
- We have recruited many of the operational staff for HRA Approval. A training programme for all new staff is in place. As the phased roll out continues more staff will be recruited.
- HRA Approval will be implemented in a controlled, phased roll out approach by study type. Details will be announced as the time gets nearer for each phase.
The Q&As are constantly evolving, and we welcome questions from the research community or public about HRA Approval.
The current version of our Q&As have been segmented for ease of use.
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 released a paper providing the current definition of each of the cohorts (PDF)
- Local research support functions: following HRA Approval implementation (PDF). 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 (PDF) which focuses on the local support functions which primary care research offices can provide.
- The Benefits Realisation Plan 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 check the HRA Approval status of a study that they are participating in.
- The HRA Approval Programme Initiation Document (PDF) gives more details on how we will approach the development and implementation of the HRA Approval.
- The Additional information: HRA Approval PID (PDF) 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.
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