Janet Messer of the Health Research Authority tells us what their single approval for NHS R&D means for charities, patients and researchers.
On 31 March Earl Howe used his opening speech at the Health Research Authority Stakeholder Forum to announce that the HRA’s business plan, including the plan for a single approval system through HRA Assessment and Approval, has been funded.
This funding means that we can start implementing the proposals that we have been discussing with many of you – to streamline and simplify the approvals system.
The HRA’s Assessment and Approval addresses the practical, legal and ethical aspects of the study – considerations that are currently split between the HRA and local NHS organisations. This will leave local NHS Trusts free to concentrate on setting up and delivering the study and is particularly beneficial for studies that will take place across multiple NHS sites. (See this FAQ for more details.)
This is great news for medical research charities as it means that donations from patients and the public for research into the diseases and conditions that they care passionately about will be used more effectively. And more efficient study start-up means that it’s more likely that research will complete on schedule and get written up promptly, so the results are more likely to be put into practice.
The new process means that we will be able to reduce duplication and bureaucracy by incorporating assessments by NHS staff within the HRA alongside the independent Research Ethics Committee opinion. That will mean one application, one assessment and one approval for research in the NHS in England. These proposals will build on recent improvements in timelines for approvals, will radically simplify the regulation of research and will remove complexity for researchers.
The HRA is already beginning to recruit a team to develop and implement the plans with key partners. We intend on keeping all our partners well-informed about progress and involved in making change happen, particularly the NIHR Clinical Research Network. We will also work closely with the devolved administrations to maintain UK compatibility.
A summary of the plan approved by the Department of Health is published here, along with further details.
The forum also heard about plenty of other great developments. The HRA has recently achieved significant improvements to the review times for gene therapy studies, research where the UK has real expertise. There has also been a really positive response from industry, academics and charities to our new requirements for research to be registered. When research is registered, charities and patients can easily find out what research has already taken place so money isn’t wasted on unnecessary duplication of research. We are busy on lots of other projects to improve research in the UK – more details on our website – and we’re keen to talk to funders about any programmes that you may be working on to maximise the benefit of research you fund.
You can contact the HRA and subscribe to their newsletter at email@example.com, and follow them on Twitter (@HRA_Latest).