Copy
HRA Latest
April 2019
NHS
Contents

The first Research Transparency Strategy Group meeting

What’s the point of research transparency? A blog by Juliet Tizzard

Setting up NHS / HSC research in the UK– preparing for change on 5 June 2019

Review of non-NHS sites: changes to the application process

Human Resources Good Practice Resource Pack

What does AI mean for the HRA and health research in the UK?

How the launch of Radiation Assurance is making an impact

The Combined Ways of Working pilot encourages applications

Test yourself on Human Tissue Authority (HTA) legislation

Upcoming NHS R&D Forum






 

Introduction from Teresa Allen, HRA Chief Executive

Hello and welcome to this April edition of HRA Latest. It feels as though Spring has finally arrived and as well as better weather, the change of seasons has brought lots of exciting projects and opportunities for the HRA.

Earlier this month our new Research Transparency Strategy Group met for the first time. This exceptional group of people who support, carry out, fund and benefit from research, came together to devise a new transparency strategy for the HRA. You can now read the minutes from this meeting on our website and our Director of Policy, Juliet Tizzard, has written her reflections about the first meeting in the blog below.  

At the HRA we continue to strive to find ways to make it easier to conduct high quality research in the UK. This month’s edition of HRA Latest showcases just a few examples of some of the work we have been doing with our partners to improve the research regulation environment.

Last month I highlighted the work we have being carrying out with partners across the four nations to make it easier to carry out research in the UK. This month we release more information in preparation for the launch of the UK Local Information Pack on 5 June 2019. This includes a section of FAQs regarding the changes, which I hope researchers will find useful.

On the 5 June we will also see a change to the process for submitting research applications involving non-NHS sites. We wanted to give researchers plenty of notice ahead of this date to help you plan your applications accordingly. You can read more about how this will affect certain sites and studies below.

We also bring you news that the Human Resources Good Practice Resource Pack has been reviewed and updated to align with data protection laws. This key document describes the process for handling HR arrangements for researchers. We provide more details below.

At the HRA, we are working to embrace the opportunities which technology creates for us as an organisation, as well as to consider how we may need to operate in the future so that digital products can be efficiently and ethically assessed and trialled in our NHS. Our new Non-Executive Director, Dr Nicole Mather, has written a blog to help us understand what Artificial Intelligence (AI) is, how it is currently used in healthcare, and what the future could hold for health research.

As a regulator that touches every part of the healthcare research system, we need to be agile, proportionate and pro-active to meet researchers’ needs so that patients can benefit from their work as quickly as possible. As we prepare for the roll-out of phase three of our Radiation Assurance process later this year, we thought we would take the opportunity to highlight how the process works in practice, which you can read below.
 
This edition also features a reminder that our Combined Ways of Working (CWoW) pilot project, to make applying for approval for Clinical Trials of Investigational Medicinal Products (CTIMPs) quicker and simpler for researchers, continues to encourage new studies to take part. We’re delighted that recent feedback from sponsors has been very good.

Finally, I’d like to highlight that the annual Research and Development (R&D) Forum conference will be taking place next month. As every year, the conference programme contains a wealth of inspiring and informative sessions and speakers. This year our Senior Development Manager, Catherine Blewett, will be talking about the future regulatory landscape for clinical trials, and the work we are doing to prepare for EU Exit. We also encourage you to take a look at the link from our partners, the Human Tissue Authority, at the bottom of the newsletter which provides a useful resource for health professionals who work with human bodies, tissue, cells and organs.

I hope you enjoy reading this month’s HRA Latest. As always, we are keen to determine if the way we provide information to our stakeholders is helpful, or if there are any areas in which you think we could improve. Please direct any feedback or queries to communications@hra.nhs.uk

The first Research Transparency Strategy Group meeting

The Health Research Authority has formed the Research Transparency Strategy Group in response to the House of Commons Science and Technology Committee Report on clinical trials transparency.

You can read more about the first meeting of our expert group, including the minutes by clicking the link.

  READ MORE    
What’s the point of research transparency? A blog by Juliet Tizzard
Our Director of Policy, Juliet Tizzard outlines what we are trying to achieve with the transparency strategy. The blog covers some of the topics discussed at the first Research Transparency Strategy Group, including themes such as open science, reproducibility, public accountability and accessibility.
READ MORE
Setting up NHS/HSC research in the UK – preparing for change on 5 June 2019
A UK Local Information Pack will be introduced on the 5 June 2019 to support the set-up of NHS/HSC research in the UK. Researchers working with NHS/HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK.

The UK Local Information Pack is the set of documents that NHS/HSC organisations use to formally start preparing to deliver the study. More information is given in the Local Information Pack section of IRAS Help but you can read about some of the key features on our website. 

 
READ MORE
Review of non-NHS sites: changes to the application process
From 5 June 2019, it will no longer be necessary for research applications involving non-NHS Sites to complete a non-NHS Site Specific Information form in IRAS. An assessment will continue to be made in relation to the suitability of the site and Principal Investigator, but this will be undertaken in a more proportionate way based on the type of study.
READ MORE
Human Resources Good Practice Resource Pack
The Human Resources Good Practice Resource Pack has been reviewed and updated in light of the Data Protection Act 2018 (DPA 2018) and the General Data Protection Regulation (GDPR). The resource pack describes the process for handling HR arrangements for researchers and provides a streamlined approach for confirming details of the pre-engagement checks they have undergone with the NHS.
READ MORE
What does AI mean for the HRA and health research in the UK?
What does AI really mean and how can it best be harnessed to improve medical research and transform patient care in the NHS? 

Find out the answers to these questions, along with what AI means for the HRA, in this blog by Dr Nicole Mather, one of our Non-Executive Directors.

 
READ MORE
How the launch of Radiation Assurance is making an impact

Radiation Assurance is a UK-wide process fully managed by the HRA on behalf of the four nations.

Following a pilot period, phase one of Radiation Assurance was launched in April 2018. Ahead of the roll-out of phase three later this year, here’s how the process works in practice.

 
READ MORE
The Combined Ways of Working pilot encourages applications
The HRA has an important role to play, working in partnership with other organisations to make our systems as easy to use and efficient as possible.

The CWoW pilot offers applicants a more streamlined process for the submission and review of applications to run CTIMPs in the UK. Capacity is limited, but the HRA and MHRA are now looking for new organisations who would like to take part.
READ MORE
Test yourself on Human Tissue Authority (HTA) legislation
The HTA have developed a series of online tests on the requirements of the Human Tissue Act 2004 (HT Act), the Quality and Safety of Organs Intended for Transplantation Regulations 2012 (Organ Regulations), and the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations).

You can find the tests by clicking the link.

If you have any queries on the online tests, please contact the HTA.
READ MORE
Upcoming NHS R&D Forum
The 2019 Annual NHS R&D Forum will be held in Brighton from the 12-14 May 2019.

The 2019 Programme provides a wide range of topics and speakers.
READ MORE
                                       






This email was sent to <<Email Address>>
why did I get this?    unsubscribe from this list    update subscription preferences
Health Research Authority · Skipton House, 80 London Road · London, E5 8TT · United Kingdom