HRA ApprovalApproved

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).

 

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.

This slideshow (with commentary) explains more.

As we develop this programme of work we will add to the Q&As:

HRA Approval – Questions and Answers No 1, 31.3.14

HRA Approval – Questions and Answers No 2, 6.6.14

 

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.

[read more…]