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Hello and welcome to the April edition of HRA Latest. We have our sights firmly set on activities that are helping us to meet our goal of ensuring the UK is the best place in the world to do research. We’re continuing to make improvements to our services so that it is easier for studies to be set up, research to be carried out and applicants to design and carry out high quality research projects.

This theme of continuous improvement will run throughout this newsletter and, indeed, all the work we carry out this year – but we’re always keen to hear how you think we could develop further. So if you have any feedback on what we could improve that would make a difference to you, please email hra.comms@nhs.net.

Making life easier for our applicants is what HRA Approval was designed to do – it was fully implemented one year ago. We have compiled an anniversary article which summarises where we are now and what’s next for HRA Approval. We also share the views of two HRA applicants – the first study to complete under the new process and the first patient to be recruited to a global study.

We have also created a short animation explaining how HRA Approval works and is continuing to evolve. Please share it with anyone with an interest or involvement in health research in the NHS in England, as it gives an accessible overview of what HRA Approval is. Additionally, we’re going to be tweeting a series of tips for HRA Approval applicants, linking to useful resources on the HRA and Integrated Research Application System (IRAS) websites. Follow us on Twitter @HRA_Latest and look out for #HRAtips.
 

HRA Latest April 2017

 

Contents

  • Bringing HRA Approval to life
  • HRA Approval – one year on
  • New National Research and Ethics Advisors' Panel starts work
  • New statements to explain radiation risk 
  • Improving consistency for cross-border research within the UK
  • UK-wide guidance on submitting amendments
  • R&D Forum 2017 May 15 and 16
  • Confidentiality Advisory Group: understanding public views on using personal data
  • HRA website development project progress to date
There is also an update on the work we are doing with our counterparts in the four nations to improve consistency for cross-border research within the UK. We share information about the changes we are planning together, including guidance on good practice in managing the submission of amendments for projects taking place in the NHS.

We are keeping up our engagement activity and have already held some significant events this year, including a public and stakeholder event to understand views on the use of personal data and the National Research and Ethics Advisory Panel (NREAP) new members’ event. We are looking forward to the Annual NHS R&D Forum in May and hope many of you will join us there. Please carry on reading for further information on all of these events.

Finally, development work on our new website has begun in earnest to make the new site more streamlined and easier to use, reflecting our goal to continuously improve and make life easier for all those who use our services and interact with the HRA. We plan to launch the redeveloped site in the summer and we will continue to make small-scale changes in the meantime in response to feedback.

I really hope you enjoy this issue of HRA Latest. Any feedback or comments are always welcome, please direct them to hra.comms@nhs.net.

 
 Bringing HRA Approval to life

We’ve worked with the NHS R&D Forum to create a short animation to explain HRA Approval and to illustrate the experience of researchers applying for approvals before and after its development.

The animation is designed for anyone with an interest or involvement in research in the NHS in England. It explains the HRA Approval’s role in simplifying the approval process, so feel free to share this widely.

It gives an accessible overview of what HRA Approval is and that it provides a single assurance that studies are safe, legal and ethical – contributing to making the UK a great place to do research.

It also outlines how HRA Approval continues to evolve and invites feedback.

You can watch the animation here.

 
HRA Approval one year on

HRA Approval was fully rolled out in March 2016 – one year on, we take a look back at what’s been achieved and look ahead to planned developments.

The review includes timeline comparisons before and after the launch of HRA Approval, and case studies outlining the experiences of applicants from both commercial and NHS organisations.

Read the review here.
New National Research and Ethics Advisors' Panel starts work

The range of independent advice and expertise available to us has been broadened with the recent expansion of our panel of experts.

For a number of years the National Research Ethics Advisors’ Panel has provided independent, multidisciplinary expert opinion on a range of ethical issues that help research ethics committees deliver robust, consistent and fair decisions.

It has undergone a subtle but important name change to become the National Research and Ethics Advisors’ Panel, which is reflective of the expansion of our remit and statutory functions, as well as the considerable increase in the size of the panel and the experience and expertise offered by its members.

Read the full story here.

 

New statements to explain radiation risk 

We have produced some generic statements to help researchers seeking to explain the risks of ionising radiation to study participants.

More information and the guidance itself can be read here.

 
Improving consistency for cross-border research within the UK

We are working with our counterparts across the four nations of the UK to implement a consistent approach to sharing information between sponsors and sites, a single ethics and R&D online submission form and an improved nationwide approach to amendments.
 
Detailed information and the guidance itself can be found online.  

 
UK-wide guidance on submitting amendments 
 
Good practice guidance on amendment submission for projects taking place in the NHS and Health and Social Care in Northern Ireland (HSC) has been agreed across the four UK nations and is available on the IRAS help pages.
The guidance explains and clarifies:
  • the categorisation system used across the NHS/HSC to identify which amendments require action by NHS/HSC R&D offices and which do not
  • what kind of activities do not need to be notified as amendments
  • good practice for grouping amendments together
  • good practice for new site amendments
  • the process for submitting amendments – which varies depending on which UK nation the lead NHS/HSC R&D office for the study is based.
The guidance can be accessed without the need to log in to IRAS.

Mary Cubitt, Four Nations NHS/HSC Compatibility Programme Implementation Manager, said: “It may sound obvious but we strongly recommend that people submitting amendments carefully read all the correspondence they receive after submitting amendments as it will provide information on what to do next and prevent delays and wasted effort.”

At the HRA we are continuing to review our own internal processes to build on the ongoing UK-wide work to improve amendment handling, with the aim of increasing efficiency and applicant experience. This started in 2016 when we developed a more streamlined process so that the actions of validating substantial amendments for REC review, categorising amendments and determining which amendments need a separate assessment are done once by the same member of staff.

We have made further refinements following piloting and feedback, and the process is now business as usual. It was good to receive a large amount of positive feedback from applicants about the more joined up communications they receive.

Amendments are currently categorised with five working days and assessed, where required, in a median time of 13 days. Assessment times can vary as confirmation of other regulatory approvals, including REC, must be in place before the assessment can be issued.
 
R&D Forum May 15 and 16

The Annual NHS R&D Forum is taking place in Manchester on May 15 and 16 – the must-attend meeting of the year for those working in health and care research management, support and leadership.

Once again, the event is run in association with the HRA and members of our team will be speaking at or facilitating a number of sessions.

Our Acting Chief Executive, Teresa Allen, will be chairing a session on leaving the EU while our Chair, Professor Jonathan Montgomery will be chairing a plenary session and summarising the conference itself.

Other key health organisations such as the NIHR, MHRA, NHS England and NHS Digital will also be taking part in the event.

The theme ‘Adding Value Together’ for 2017 aims to showcase the value in an R&D function and how by coming together as a national community of practice we add value to the NHS, research and policy, patients and the public, and of course each other.

The full programme, delegate booking and further information can be found on the event webpage.

 
Confidentiality Advisory Group: understanding public views on using personal data

Our Confidentiality Advisory Group (CAG) recently held two workshops in order for members of the public and other stakeholders to meet members and find out more about its work.

The workshops provided an opportunity for members to hear their views on the use of confidential patient and service user information without consent for purposes beyond direct patient care, and the criteria that CAG should consider in reviewing applications.

Read on for more detail about the workshops and the work of CAG.


 
HRA website project – progress to date

As regular readers will be aware, we are currently redeveloping the HRA website.

We have had a busy few months reviewing user research, speaking to individuals both inside and outside of the organisation, as well as hosting a series of workshops.

We now have a supplier on board and the work continues to gather pace.

We would like to say a special thank you to those of you that took the time to complete the survey publicised in the last issue – your honest and open views were gratefully received and have formed a key part of our development work.

Over the coming months the website will start to take shape and we will start to look at the structure and the visual design, as well as the content that you, our core audience, would like to see.

We will provide you with an update on our progress during the next issue of HRA Latest.

We will be continuing to test our thoughts and ideas with our users to ensure that the website we produce will be beneficial now and in the future. If this sounds like something you would like to get involved with there is still time to do so. Please email hra.comms@nhs.net for more information.


 
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