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 at firstname.lastname@example.org
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.
The HRA Approval will provide authoritative assurance to NHS organisations about the suitability, compliance and quality of research proposals.
As part of the preparation for implementation of HRA Approval, this 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.
This brief 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.
This paper explains how we will support theNHS locally through the implementation of the HRA Approval and gives details of local contacts.
This slideshow (with commentary) explains more.
The Programme Initiation Document has now been signed off, and gives more details on how we will approach the development and implementation of the HRA Approval. We have also published a paper which explains these plans in a way more relevant to the research community.
As we develop this programme of work we will add to the Q&As:
HRA Approval – Questions and Answers No 3, 7 October 2014 (replacing Q&A 1 and 2)
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.
The HRA summary plans for Assessment and Approval give more details on our plans.
When will it happen?
Initially HRA will establish a programme team to plan and manage the process. Once these plans and timetables are agreed with relevant stakeholders, HRA Approval will be rolled out, on an application type basis. Roll out is anticipated to be completed by the end of 2015 and will be for all studies in England 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.