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Introduction from Teresa Allen, HRA Acting Chief Executive:

Hello and welcome to the first HRA Latest of the New Year. We have many ambitious and exciting projects planned for 2017 and I see this newsletter as a vital channel through which we can communicate these changes and update you on our progress.

One of our key ambitions is to increase our focus on customer service and improve our responsiveness to queries received from our research applicants and wider stakeholders. I’m very keen to hear how HRA Latest readers think we are performing in this area, so I’d encourage anyone who would like to provide feedback to do so via hra.comms@nhs.net

Another project we are particularly excited about is our new website, which is due to be launched this summer. We want our website to be more user-focused and easier for you to access the information you need. We have taken on board feedback received so far and firmly believe that by listening to your views and incorporating your experiences into the design process we will produce the most effective result. Read on if you'd like to be involved.


We are also encouraging researchers to take a more proportionate approach to the process of seeking consent for participation in research.

One of my New Year’s resolutions is to celebrate success more and what better way than to highlight the work of three Research Ethics Committee chairs who were recognised in the Queen’s New Year’s Honours.
 

HRA Latest January 2017

 

Contents


I’d like to extend my personal congratulations to Professor Andrew George, Stephanie Ellis and Professor Peter Heasman, who have all made outstanding contributions to research ethics and been fantastic friends to the HRA for many years. Find out more about Andrew, Stephanie and Peter’s achievements and how they feel about being recognised.

As readers will be aware HRA Approval, which simplifies the approvals process for research, was fully rolled out in April 2016. As well as our usual update on performance this issue also features a researcher who has used the process and found it of great benefit.

You will also find updates on our new patient and the public website pages and our plans for public involvement workshops. So read on and don’t forget to tell us what you would like to read more about in our next issue by emailing hra.comms@nhs.net.
 
 

 

Have your say about the HRA website


We’re about to begin work to improve the HRA website – we want to make it easier to access the information you need. We’d love to hear your thoughts on what you like and don’t like about our current site, and what new features would make your life easier. 

If this sounds like something you would be interested in helping us with please visit the HRA website.



HRA publishes new proportionate consent guidance 

The HRA is encouraging researchers to take a more proportionate approach to the process of seeking consent for participation in research.

To find out more about how the guidance fits into wider HRA work and to read the document itself, visit the HRA website.


Research Ethics Committee work recognised in New Year's Honours


The work of three Research Ethics Committee chairs has been recognised in the Queen’s New Year’s Honours for a combined total of nearly 45 years’ service to the research ethics service.

Professor Andrew George, deputy vice-chancellor of Brunel University London, has been awarded an MBE for services to research participants and ethical governance of clinical research. Stephanie Ellis, chair of London – Hampstead research ethics committee and Peter Heasman, professor of periodontology at the University of Newcastle, are recipients of the British Empire Medal for services to the research ethics service, and services to providing ethical review and support to researchers respectively.

Click here to read the full story.

Left to right: Professor Peter Heasman, Professor Andrew George and Stephanie Elllis.

HRA Approval Simplifying study set-up 

Performance of HRA Approval has improved and stabilised following the unpredictable surge in amendments over the summer. As a result we are seeing reduced approval timelines. The bigger picture is that overall we have removed significant waste and delay across the research system.

We explain here what this means for current applicants, give some advice on what you can do to further speed up the process, and outline further developments we are working on.

Applicants whose study will be reviewed by a full REC can now expect to receive an initial assessment letter before the committee meets, as long as all the documents expected for assessment have been received in time.

New applications are therefore being processed through REC review and assessment in parallel, cutting out the waste seen prior to HRA Approval implementation, when there was often a gap of several months or even years between REC and R&D applications.

Applicants who use our tools and learning resources are more likely to get their study set-up sooner. 

Industry applicants working with the NIHR Clinical Research Network are reminded to engage early with the network to take advantage of the Study Support Service, and to get the Industry Costing Template validated prior to submission to HRA.

Applicants can also set up NHS sites in parallel to this review, by providing the standard local information pack to sites once the applicant has received the initial assessment letter from the HRA. There is no longer a review or approval process by NHS R&D offices in England.

The R&D offices (and where applicable, local clinical research networks) will collaborate with the local research team and sponsor to put arrangements in place and then, once HRA Approval is issued, confirm that the study can start. Information about local site performance management is provided by NIHR.

All applications receive an assessment that is proportionate to the type and nature of the study, and the legal/compliance issues raised.

The arrangements for working with NHS sites are also proportionate to the study, and are set out in the initial assessment letter and HRA Approval letter. We are pleased to be hearing feedback from applicants about how they are finding it easier to set up large scale studies when HRA Approval processes are followed.

Please continue to send queries and feedback (including those about sponsor or site alignment with HRA Approval) to hra.approval@nhs.net.


Work in progress…
As well as beginning work with colleagues in Northern Ireland, Scotland and Wales on some significant developments to IRAS, we are making progress on a number of related projects:
  • revising guidance on the HRA website in response to feedback
  • revising template correspondence in response to feedback
  • internal changes to further refine and integrate internal processes to improve interactions with applicants particularly trying to ensure that where possible applicants receive communications from HRA REC and Approval at the same time
  • publishing clarification for companies on the use of the DH Master Indemnity Agreement for devices
  • revision of the model Clinical Trial Agreement for commercial contract research
  • working with the NHS information governance community to provide clear and consistent standards for research
  • working with non-commercial funders to reduce duplication in collection of information about site level funding arrangements.

HRA Approval in action

Few things seem daunting to an orthopaedic surgeon, but for Daniel Perry, a paediatric specialist planning a research study on rare hip diseases, getting 143 hospitals coordinated to recruit patients instantaneously was one of them.

Fortunately for Daniel, HRA Approval streamlined the process by reviewing his study on behalf of all the NHS organisations in England, without the need for approval in each centre.

Daniel said: “I now only have to liaise with a central body for many aspects of the study, and I know that I don’t have to go through a committee in each hospital to approve the research. A universal system of approval makes complete sense.”

Prior to the launch of HRA Approval, getting projects like this off the ground was a back-breaking and time-consuming affair.

To set up a multi-centre trial, for example, each local NHS research team had to apply to its own research office, which would conduct its own local legal checks. All essential, and all done for the right reasons – to protect and reassure patients and participants. But this was inefficient, and often out of the control of the companies trying to set up the study.

Today, the approvals service under the HRA is a simpler process, mirroring those in other countries and removes the extra hurdle of local approvals. There is now just one application for ethics and legal review, and companies can now work directly with NHS sites to set up studies and sign off contracts.

NHS sites in England are all part of the National Institute for Health Research (NIHR)’s Clinical Research Network, supporting charities, research funders and the life-sciences industry by providing infrastructure for high-quality clinical research. They work with patients and the public to make sure their needs are placed at the heart of all research – ultimately allowing patients to gain earlier access to new and better treatments through research participation.

The new process means less duplication and bureaucracy by incorporating assessments within the HRA alongside the independent opinion of the HRA’s Research Ethics Committee. It means one application, one assessment and one approval for research in the NHS in England.




HRA Approval is one strand of the HRA’s wider mission to facilitate timely, high quality research by operating a unified approval process and creating and promoting consistent and proportionate compliance and inspection standards.

This leaves local NHS trusts free to concentrate on setting up and delivering the study and, as Daniel has seen, is particularly beneficial for studies that take place across multiple NHS sites.

He said: “Overall it has been a positive experience. I don’t think I could have got to the stage I am at now without national approval across every site in an instant. We are now running in 143 hospitals! The new system is excellent. It’s more than just an ethical approval streamlined system. It’s an NHS streamlined approach.”

Please see the e-learning for commercial and non-commercial studies on the HRA Approval training resources page and the guidance on the HRA website for detailed information about working with HRA Approval.

New patient and public webpages


We recently launched new patient and public pages on our website. If you’re not one of the many people who have seen the new section of the site, please visit the pages and tell us what you think.

We wanted to make it simpler for patients to understand how they can get involved in research, promote the ways we involve the public in our work and explain why safeguarding the safety, dignity, rights and well-being of people taking part in research is so important to the HRA.

In line with our commitment to public involvement, the new pages were created collaboratively with a group of public contributors who were involved in the process from inception to launch.



Hundreds of users have already visited the pages and we’ve had some really encouraging feedback, including from one of our public contributors who said: “Congratulations! The new pages are very attractive and easy to navigate.”

Andrea Horwood, Public Involvement Manager for the HRA, said: “While it’s great to hear positive feedback, we’re an organisation that never wishes to rest on its laurels and we are constantly striving to improve and involve the public in that process.

“We took forward as many of the suggestions as we could from our public contributors and hope that when our new website is launched we will be able to act on even more so that our patient and public webpages will be even more user-friendly and accessible to everyone.

“We would love to hear what you think, so I’d encourage HRA Latest to contact me via: hrapublicinvolvement@nhs.net or 020 797 22545 with any feedback.”

 
 

HRA working to promote and support public involvement in research


At the HRA we understand the value that public involvement has in helping to deliver high quality, relevant health and social care research, and we are aware of the key role we can play in facilitating and supporting good public involvement.

This year, the HRA public involvement team is leading an ambitious programme of work to support and enable the spread of public involvement in research.



As part of this work we will be looking at ways we can improve our guidance and the information we ask applicants to provide on how they have involved the public in their research.

We are planning to work collaboratively with the research community to inform and shape this programme and we will be developing opportunities for you to share your views to help us determine how we take this work forward.

We will update you with further details in future editions of HRA Latest. In the meantime, if you would like to talk to us about any aspect of our work on public involvement, please contact the HRA public involvement team via: hrapublicinvolvement@nhs.net or 020 7972 2545.

 
 
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