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HRA Approval - Listening to Feedback

The HRA has encouraged feedback from stakeholders as the HRA Approval Programme was developed and implemented through workshops, conversations, emails and feedback forms. Whilst not all feedback and suggestions can be implemented, all feedback is reviewed. A full report of feedback and our actions is on the HRA website.

We have particularly invited feedback on the Statement of Activities and Schedule of Events as these have been ‘tested in use’ as part of the local document package to support study set up at site for non-commercial studies. We know that some people have found them straightforward to complete while others who have not undertaken cost attribution before have found if more difficult. We have modified the format and revised the guidance in response to feedback. Importantly, our experiences have contributed to discussions across the UK on developing a standard UK-wide local information package.

More generally there are some recurring themes in feedback about the complexity of the amendment process, suggestions for improving the interaction between REC review and assessment and requests for improved navigation around the HRA website.

HRA Latest Volume 22


Contents

 
We are working with the devolved administrations to both clarify the existing system and review potential future developments.

Work is underway in continually refining internal interactions between the REC review and HRA assessment processes. We are working on reducing duplication in guidance between IRAS and the HRA website.
 
We have also heard that some sponsors are finding difficulties emailing the local information package to sites, as different documents were previously sent at different times, so we are exploring arrangements in other countries for secure transfer of information to sites. 

Please continue to feedback on your experiences with HRA Approval: hra.approvalprogramme@nhs.net
HRA Approval - Performance
We are delighted to report that the backlog of amendments and requests to bring existing studies in under HRA Approval is now cleared, following the surge in volume in the first few months after the roll-out. We would like to apologise for any inconvenience caused and reassure that with numbers now being received much closer to predicted levels, and streamlined internal approaches, the situation is under control. Centralisation in England has exposed just how wasteful the amendment burden is and we will be working UK-wide to introduce further streamlining and proportionate approaches.

Volumes of applications for HRA Approval for new studies continue to be made at predicted levels. The timelines are good although not yet meeting all the targets we have set and we know that we need to improve the initial assessment timeline component within the overall metric. A detailed report on performance is available on the HRA website. This focuses on timelines which we know will be the most important metric for many. However HRA Approval is about a service and centralisation, with support to deliver a broader service and adapt to particular scenarios nationally which will bring greater benefit (see Genomics England example as reported in this edition). We welcome early approaches to provide guidance and advice as well detailed feedback to inform case studies and learning material.

Median timelines at August 2016

Time to REC decision means all additional conditions being met and does not include the clock stop for provisional opinion. REC timelines are reported separately and remain very competitive. Note that REC non-commercial includes a wide range of study types requiring full REC review. REC commercial are nearly all clinical trials.


The significant change in systems has shed a light on a number of areas where we were aware of problems with previous approval arrangements. Instituting a single submission instead of sequential REC and R&D applications avoids delays between REC and R&D submissions and incentivises an early focus on practical delivery of research studies. The large volume of studies received in the first few months of HRA Approval that had received REC approval between 2013 and 2015, but not received any previous R&D review, demonstrates the significant lag period for some studies between REC and R&D review under previous systems in England.

Where site set-up is undertaken in parallel with the HRA Approval process as recommended, the current median timeline of 60-70 elapsed days from application to HRA Approval (including all regulatory approvals) is already consistent with the DH clinical trial benchmark. For NHS organisations this benchmark is 70 days from provision of local information pack to first recruitment, even though historically REC and other regulatory approvals were often made well before site set-up. With further focus on the initial assessment there is potential for improved timelines.

The change to a single process for amendments across England has allowed us to work with the devolved administrations to review the UK-wide process for amendments. Plans for simplifying and streamlining the UK process are now underway.

We are grateful for the support from the research community as we collectively work through the transition. We now have the framework in place and have completed the bulk of the handover from the old system to the new. We are now well-placed to focus on improving the efficiency of the service we offer to achieve our ambition to simplify and streamline the regulatory approvals process.
Spotlight on: HRA Collaboration and Development  

The Collaboration and Development team is happy to welcome Nicola Gilzeane as Collaboration and Development Support Officer. Nicola’s background as a researcher and HRA Assessor will bring additional skills and a further perspective to the work of the team.

The Collaboration and Development team works with partners and stakeholders, many of whom are members of the Collaboration and Development Forum, to help bring about improvements to different areas of the research process. These projects and collaborations complement other projects undertaken solely by the HRA where we work with a number of teams. The learning derived from collaborative approaches to novel projects that cross several stakeholder organisations helps inform HRA strategic planning as well as the discussions at the forum and within member organisations.

Nicola’s work will initially focus on two distinct areas. She will begin scoping the HRA’s role in the regulation of research activities that are not discrete projects. Nicola will also take forward earlier exploratory discussions about the multi-agency requirements upon researchers for different types of routine progress reporting. This will include an analysis of current processes and examination of options for a more streamlined approach in collaboration with other agencies.

Nicola can be contacted about this work by email. For further information about the team more generally or the Collaboration and Development Forum please contact Collaboration and Development Manager, Will Bowen or Head of Collaboration and Development, Jonathan Fennelly-Barnwell.
Collaboration and Development case study: Genomics England 

Our Collaboration and Development team, along with the wider HRA, has been working closely with Genomics England to set up  the ground-breaking 100,000 Genomes Project in a way that supports the project’s innovative vision while satisfying regulatory and ethical requirements.

Genomics England’s Head of Ethics, Laura Riley explains how this collaborative approach to obtaining ethical approval has ensured the success of the project. She says there were many hurdles to overcome at the start:

 “There were lots of challenges! For example we explained to HRA that the need for Genomics England to obtain local R&D approval, at what could have been hundreds of NHS sites where our project could potentially be recruiting, would make it impossible for us to undertake the project in its planned form.

“This requirement would have negatively affected equity of participant access and skewed the NHS transformative agenda amongst other issues.

“The HRA was fortunately able to confirm for us that our project’s activity in creating a research resource for other researchers did not constitute research under the Research Governance Framework (RGF). This assurance, which permitted one central approval process, was key to starting our project within the planned time scale and budget.

“Because of the HRA’s ‘open door’ approach of supporting us with regulatory experience and creativity from the earliest stages, even to the extent of working jointly with other regulators like HTA, we can feel confident that our project approvals are in line with the appropriate regulatory requirements and good ethical practice, while also allowing us to use innovative care and research to tackle unmet patient need. We’ve never had to make our own assumptions about what might be admissible, or to self-limit our REC submissions unnecessarily due to a lack of prompt, project-specific advice.

“The UK is a fantastic place for health research using patient records available via our NHS systems. This, combined with pragmatic regulation, is helping to develop the key infrastructure required for genomic medicine and to create new opportunities for research to take place.

“The transformative steps the NHS and research community is taking towards genomic medicine together will ultimately help patients and support research in the NHS and beyond.

“This couldn’t have happened without lots of hard work behind the scenes between HRA and Genomics England and I would encourage others who are seeking to set up large scale and complex projects to come and start the same dialogue early. Don’t feel like every detail of your idea all has to be completely worked up before you make contact. We just said to the HRA, ‘this is our vision for how this could work’ and we went from there.”
HRA Training: Non-commercial sponsor workshop - adapting to HRA Approval
9 November 2016, 10.00 – 1630, Friends Meeting House, 173 Euston Road, London, NW1 2BJ

The HRA is working collaboratively with the Medical Research Council and the R&D Forum to deliver this workshop. It will provide an opportunity for those who act on behalf of non-commercial sponsors to share best practice and identify a way forward in working alongside HRA Approval. As such audience participation will feature highly.

It is aimed at those who make and/or manage sponsorship decisions in the non-commercial sector (HEI, NHS, MRC as well as those working in the commercial sector who oversee academic and NHS collaboration) and those managing sponsorship in the Devolved Administrations, where HRA Approval can impact local processes.

The workshop is not aimed at researchers or purely commercial sponsors.

The expectation is that delegates will have operational knowledge of their organisation’s sponsorship processes and a suitable level of seniority to effect change where desired (e.g. equivalent to an NHS R&D manager). The event will provide non-commercial sponsors with opportunities to:
  • voice current experiences and concerns
  • discuss processes and identify opportunities to make alterations so that they align well with HRA Approval
  • learn more about the new HRA Approval process, the new approach to site set up in England and handling amendments with any miscommunications/myths being dispelled
  • identify gaps in training provisions and any learning resources needed to support non-commercial sponsors and their researchers
The event will cost £60 per delegate - to book please register here.
Last chance for call for comments: reporting and dissemination of study results

Thank you to those who have already responded to our call for comments being undertaken by the EQUATOR Network on how to modify the current question A51 on the IRAS ethics application, ‘How do you intend to report and disseminate the results of the study?’ We have had a strong response so far which will help us ensure that researchers understand the full extent of their commitment to responsibly share research findings.

If you haven’t yet responded you can do so on the EQUATOR Network’s website until the call for comments closes today, 30 September.

We would be grateful if interested stakeholders would assist our future developments by completing this short online survey which takes about 10 minutes. Thank you in advance for your consideration.
Updated Research Ethics Service Standard Operating Procedures

The Research Ethics Service (RES) Standard Operating Procedures (SOPs) have been updated and version 7 was published on 1 September 2016. This document is now available via the resources page on the HRA website.

The updated version contains only minor changes and clarifications but it is strongly advised that anyone needing to refer to the RES SOPs access version 7 only. A summary of changes is also available with the revised SOPs so that any updates and revisions can be easily identified.

If you have any questions regarding the RES SOPs please contact nres.sop@nhs.net
HRA response to the National Data Guardian for Health and Care's Review of data security, consent and opt-outs public consultation
 
This consultation follows the independent review of data security, consent and opt-outs by National Data Guardian Dame Fiona Caldicott.

Views were sought on the proposed data security standards and the consent and opt-outs model from health and care professionals, organisations and the public.

Our response can be found here.
HRA Response to the EU Commission's Directorate General for Health and Food Safety (DG SANTE) Clinical Trials Regulation public consultation
 
The EU Commission’s Directorate General for Health and Food Safety (DG SANTE) Clinical Trials Regulation has recently consulted on four documents developed in preparation for the implementation for the Clinical Trials Regulation (EU) No 536/2014.

Our response to each of these documents can be found here.
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