Health and social care researchers used to be faced with a very complex regulatory system – everyone agreed we needed a new approach. So we consulted with a wide range of stakeholders to develop HRA Approval, which brings together the assessment of legal compliance and the ethics review into one streamlined system.
HRA Approval was fully implemented in March 2016. One year on, we look back at what’s been achieved and look ahead to planned developments.
Where are we now?
HRA Approval is now the approvals process for research projects in the NHS in England. By bringing together the assessment of legal compliance (previously undertaken locally at each NHS organisation) and the ethics review, we’ve made it simpler and quicker to set up studies.
The assessment and the independent ethics review are now integrated in one process: one application and one collated approval. NHS staff can rely on assurances from the HRA and don’t need to do the checks themselves. This means they can focus on getting studies up and running.
Image 1 – A flowchart outlining the HRA Approval process.
1. Applicant submits one application to the HRA
2. HRA completes ethics review and assessment, including collating other approvals
3. The applicant responds to queries
4. HRA Approval
HRA Approval has introduced a single application instead of separate Research Ethics Committee (REC) and R&D forms, with review undertaken in parallel.
Our new standard process for setting up research sites in NHS organisations in England uses a Local Information Pack that the sponsor can provide to sites as soon as the HRA Initial Assessment Letter is issued. This allows sponsors to see and manage site set-up processes from beginning to end. Most funders, including NIHR, have now changed the timing of funding release so that funding is available earlier to allow researchers to apply for approvals and undertake site set-up in parallel.
For the majority of studies the time to issue REC approval, with clock stops for applicant response, is achieved within 40 days for studies reviewed by full committee. The median elapsed time to REC approval, i.e. without stopping clocks, is around 60 days. For studies submitted in December 2016, the median time from REC approval (or from valid application for non-REC studies) to HRA Approval was about 20 elapsed calendar days, i.e. including the time for applicants to respond and any other approvals (e.g. clinical trial authorisation) to be issued.
TOP: median timelines from REC application to first participant recruited for clinical trials across the NHS, October to December 2015, using the old NHS permission system. Many studies had sequential review by REC then R&D. The timeline from transfer of the Site-Specific Information (SSI) form to the site to submission to R&D was not measured and was often not visible to sponsors. This phase is shown with question marks for the timeline.
BOTTOM: comparison with the equivalent period for 2016, with parallel review through HRA Approval. Although this is early data it demonstrates the potential to reduce wasted time during study set-up
CASE STUDY: HRA Approval in action – first patient recruited in a global study
Biotechnology company Amgen wanted to carry out a large-scale international study into a new treatment for patients with an aggressive form of cancer. Amgen’s Head of Clinical Operations Sarah Durston explains how the study achieved both the first site set up and first patient in the UK.
Listening to user feedback
We made improvements to HRA Approval during a phased roll out in response to feedback. After the March 2016 launch an unexpectedly high volume of existing studies moved to the new system so we brought in extra resources to handle these. Any early delays in processing have been cleared, and we are continuing to improve the turnaround of new applications.
HRA Approval is now ‘business as usual’ and we are confident that it is clarifying the roles of everyone involved and improving the quality and consistency of research set-up. We are continuing to learn from the experiences of researchers and colleagues from partner organisations to adapt and improve the system.
CASE STUDY: HRA Approval in action – first study completes
A research study into interagency work to safeguard adults, the first study ever to go through HRA Approval, has now completed. Clare Symms, research manager at South Norfolk Clinical Commissioning Group, which sponsored the study, reflects on how the process went and shares her learning.
HRA Approval is a springboard for further improvement and we are actively pursuing opportunities for efficiency across the whole research approval system in collaboration with other organisations.
Within HRA Approval itself, we are developing greater integration of assessment and REC processes. Our continuous improvement approach to streamline our processes and information systems means we can process applications in a proportionate way and provide a seamless service to applicants.
Our centralised service means that we can work with the research community flexibly to cope with new research challenges. We use our initial assessment letter to communicate key information to participating NHS organisations to ensure consistent handling of study set-up, particularly for very large studies or those with minimal impact on the NHS. Where a query has been raised by a site, we have been able to issue a single clarification for all sites to avoid confusion and inconsistency. As this process is embedded we expect greater consistency of site set-up across the NHS in England.
Consistent approaches across England, Scotland, Wales and Northern Ireland
We’re also working closely with the devolved administrations to introduce consistent approaches across the UK, which will include:
- a consistent nationwide approach to sharing information between sponsor and sites
- a single ethics and R&D online submission from the Integrated Research Application System (IRAS), and
- an improved UK-wide approach to amendments.
The aim is to ensure compatible and consistent ways of working across England, Scotland, Wales and Northern Ireland, further developing the UK as a cohesive and streamlined place to undertake research within the global economy. Sponsors of both commercial and non-commercial research will benefit from these changes, particularly when setting up studies with sites in more than one UK country.
Increasing efficiency across the whole system
Following pilots in selected early phase trials, we will be rolling out a UK-wide process to further standardise and streamline review of ionising radiation in research across the NHS. We’re working with the Administration of Radioactive Substances Advisory Committee (ARSAC) to simplify certification arrangements for studies involving radiopharmaceutical products. We have already published generic risk statements for radiation for use in participant information sheets.
We are also working with colleagues to provide a single UK-wide technical review of pharmacy aspects of studies involving medicines. This will ensure that applicants know what information to provide at what time, and reduce the burden on NHS pharmacy departments, allowing them to focus on the practical aspects of setting up studies.
Contract and cost negotiation can be time consuming for companies setting up studies across the NHS. With the Association of the British Pharmaceutical Industry (ABPI) we are reviewing variations introduced by companies into model agreements, and will be seeking views on revised versions soon. We recommend that NHS organisations accept the Industry Costing Template, and we are working with the NIHR Clinical Research Network and others to review and update it.
For non-commercial studies, identifying the correct attribution and source for costs is important to avoid set up delays. We will be piloting with some funders how our Schedule of Events can be used early on in the grant application process to identify financial implications sooner and reduce re-working. We want to reduce the burden for sponsors of providing the correct study documents to participating sites, so in the longer term we will be exploring whether we can add this functionality to the Integrated Research Application System (IRAS).
We will also be exploring whether HRA Approval can be extended to a wider range of care settings in England.
Help us continue to develop HRA Approval
We continue to work together with NHS organisations and with commercial and non-commercial sponsors to make sure all our processes are aligned – key to making the whole system more efficient.
Ultimately, HRA Approval helps ensure that health research is safe, legal and ethical, meaning evidence can be generated to create better care for patients.
HRA Approval continues to evolve and we value your feedback to ensure our work benefits the whole community.
Contact us: firstname.lastname@example.org