What is HRA Approval?
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 as well as an assessment of regulatory compliance and related matters undertaken by dedicated HRA staff. Although HRA Approval will include a study-wide review in line with the UK-wide agreed standards, the assessment will go beyond this to include new standards and assurances for example, assessment will include the coordination of clinical support assurances for pharmacy and radiation.
When HRA Approval is fully rolled out, it will remove the need for NHS permission to be issued by each participating organisation and will replace the local R&D approval process. HRA Approval will support and complement local processes relating to assessing, arranging and confirming local capacity and capability to undertake the study. When HRA Approval is in place and local capacity and capability confirmed, sites will be able to confirm with the sponsor their readiness to recruit and the study will start at the site.
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. 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.
When will it happen?
HRA has an ambition to implement HRA Approval by December 2015. Implementation will be in a controlled roll out by study type.
HRA Approval will apply to all research studies in England involving the NHS. The phased roll out will involve 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 benefits to set up times as the HRA Approval begins to bring improvement and efficiency across current systems.
- Live consultation and calls for comment
- NEW: we have an open call for studies that will fall into the study type for Cohort 1 of HRA Approval. The purpose of the call is to identify studies that we can shadow through the process before we go live for HRA Approval and to identify studies which will be among the first to apply for HRA Approval so that we can support those studies well. More information can be found here (PDF)
- Protocol guidance and template for use in a Clinical Trial of an Investigational Medicinal Product (CTIMP) – for consultation in use (open until May 2015)
Progress so far
- After confirmation of funding for the programme at the end of March 2014, HRA began a recruitment process to establish a programme team.
- The standards associated guidance for all parts of the assessment are well underway – but there is more work to do.
- The development of the necessary standard operating procedures (SOPs) that HRA staff will use has begun. The HRA is working with several sponsors to identify studies which we can use as a dry run in order to test and refine our SOP
- The pharmacy and medical exposure technical assurance elements have begun their controlled roll out
- We have begun to recruit the operational staff for HRA Approval. A training programme for all new staff will be put in place.
- HRA Approval will be implemented in a controlled, phased roll out approach by study type. These will be announced as the time gets nearer.
Questions and Answers
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.
Useful Links & Documents
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.
- NEW: 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)
- HRA Approval presentation with dialogue (slideshow hosted on YouTube)
- HRA Summary Plans for Assessment and Approval gives some context as to why we are undertaking this programme.
- 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.
- Study-wide review of non-portfolio studies in England (PDF) 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 Programme Initiation Document gives more details on how we will approach the development and implementation of the HRA Approval HRA Approval Programme Initiation Document (PDF)
- The Additional Information paper explains the Programme Initiation Document in a format that is more relevant to the research community Additional information: HRA Approval PID (PDF)
- The Benefits Realisation Plan provides details of how the benefits process will be applied to the HRA Approval programme.
If you wish to subscribe to HRA communications, please email email@example.com
To keep up to date with the latest developments on the HRA Approval, please follow us via