HRA Latest
September 2019
Only four days left to have your say on research transparency

Welcome to Professor Sir Terence

Our new report on sharing anonymised patient data

Inside the Social Care Research Ethics Committee

Feedback on our Combined Ways of Working process

Updated data transparency wording

The Local Information Pack - template email reminder

Pharmacy Assurance roll-out update

Radiation Assurance - reviewers wanted

News from the UK research community

Introduction from Teresa Allen,
HRA Chief Executive
Hello and welcome to this September edition of HRA Latest. September is traditionally the end of the summer period, and this year there’s also notable change for the HRA as we welcome our new Chair and see the end of our Make it Public consultation.

I’m delighted to welcome Sir Terence Stephenson as the new Chair of our organisation. Sir Terence, an eminent clinical academic and experienced Chair, most recently at the General Medical Council, brings with him highly relevant experience and a passion for excellent service to patients. I look forward to working with him to progress the work we do to protect and promote the interests of patients and the public in health and social care research. 

I would also like to say a huge thank you to outgoing Chair Professor Sir Jonathan Montgomery, who has held the role since the organisation was founded. Professor Sir Jonathan has guided the HRA through significant change, including the launch of HRA Approval, and we are stronger because of him. We send best wishes for his new role.

We are now in the final few days of our 12-week Make it Public consultation, and what a 12 weeks it’s been! We’ve visited London, Manchester, Cardiff and Belfast to hear your views and had an excellent response to our online survey so far. We are extremely grateful to everyone who has contributed and I’m excited to see the improvements we can make together.

Our final face to face workshop is this Friday 6 September in Edinburgh, which also marks the end of the consultation. Research Transparency is so important to improving patients’ lives. Please do take this last opportunity to share your views in our online survey if you haven’t yet had chance to do so. You can read more about our highlights of the consultation and what our next steps are below. 

Today we’re also proud to publish a piece of empirical research carried out with the University of Sheffield looking at public attitudes to data sharing. Data-driven health and social care research offers great promise for the NHS. It’s already being used to improve the early diagnosis of heart disease and lung cancer, to match patients to clinical trials, and to support the planning of care for patients with complex needs. But in this emerging area it’s crucial for researchers, funders and regulators to understand how those whose data underpins apps, algorithms and ultimately their outcomes feel about being involved in this way. 

You may have read last month that the National Institute of Health Research (NIHR) announced £2.5m of funding for social care research, and an annual call for proposals under its Research for Patient Benefit programme. The funding is intended to improve social care by generating high quality evidence and building capacity for research in this field. We asked Susan Harrison from the Social Care Research Ethics Committee about good social care research.

I’m pleased to share an update with you on the phased implementation of our technical assurance processes and news that we are inviting further applications from relevant experts to become registered reviewers for both our Radiation and Pharmacy Assurance. 

I’d like to let you know that the recommended wording for data transparency has been updated on our website, and remind you about using the Local Information Pack, including the email templates, to ensure that everybody benefits from the consistency this package brings to the study set up process. 

I’m also pleased to say we’ve had positive feedback on our Combined Ways of Working (CWoW) pilot from researchers who attended a recent feedback workshop in London. 

And finally, as you will no doubt be aware, the UK will leave the European Union on 31 October 2019. Whilst the government is working hard to secure a deal, the risk of a no deal exit still remains. Our website curates guidance from the Medicine and Healthcare products Regulatory Agency (MHRA) and others, and is being regularly updated as soon as new information is available. 

Applications should continue to be made to the HRA as usual, and should this situation change at any point, our website and social media channels, as well as this email, will keep you up to date.

I hope you enjoy reading this month’s HRA Latest. As always, we are keen to know if the way we provide information to our stakeholders is helpful, or if there are any areas in which you think we could improve do get in touch via
Our Make it Public consultation - four days left to have your say
There are just four days left to give us your views on our draft strategy on transparency in health and social care research.

The Make it Public consultation closes on Friday 6 September, when we'll collate all of the feedback we've received.

Early evaluation of responses reveals some great ideas about how to improve research transparency in the interests of professionals and public alike. 
Welcome to Sir Terence
Professor Sir Terence Stephenson has taken up the role of Chair of the Health Research Authority.

We welcome him to his new role!
Sharing anonymised patient-level data where there's mixed public and private benefit - a new report
We're proud to have published a new joint report with the University of Sheffield.

In a series of workshops, participants were asked whether it would be acceptable to share anonymised patient data with commercial organisations for reasons other than direct care.  The report explores the implications for health data researchers.
Inside the Social Care REC - a decade of protecting and promoting patients and the public
As the NIHR reveals the latest projects funded as part of its commitment to social care studies, we ask Susan Harrison, Vice Chair, to give us an insight into the work of the HRA's Social Care Research Ethics Committee in this, it's tenth anniversary year.
Feedback on our Combined Ways of Working pilot
A more streamlined application process and quicker approval times are some of the best things about our Combined Ways of Working (CWoW) pilot – according to researchers attending a recent feedback workshop in London.

The pilot is also helping to prepare the UK for the future regulatory landscape. 
Update to data transparency wording

Our standard wording for data transparency, to support compliance with the General Data Protection Regulation (GDPR) has been updated. 


Following stakeholder consultation, and with public involvement, template information on how data is used in research has been updated to take account of feedback and provide a clearer, more layered approach.

UK Local Information Packs and template emails
The UK Local Information Pack was introduced on 5 June 2019 to provide a consistent set of documents to streamline the set-up of research across the UK.

To support the UK Local Information Pack, a series of standard email templates, available in IRAS, were developed to support sponsors in sharing a complete pack with participating organisations and with the right contacts.

Early feedback indicates that the email templates are not always used for sharing the Local Information Pack with NHS/HSC organisations.

We’re asking sponsors to please remind research coordinating teams to use the template emails to ensure organisations receive the correct documentation to proceed with review and study set up.
Pharmacy Assurance roll out update

The HRA is rolling out the next phase of Pharmacy Assurance in England and Wales from Monday 30 September 2019.


Based on feedback, some changes are being made to the process and our submissions guidance ready for the roll-out of the next phase. 

There is more information, including how you can apply to become a registered reviewer, on the HRA website.

Recruiting Reviewers for Radiation Assurance
The HRA is inviting Medical Physics Experts (MPEs) and Clinical Radiation Experts (CREs) to become registered reviewers in preparation for the launch of the next phase of Radiation Assurance

There is more information about the roll-out on the HRA website.

News from across UK research
Wellcome Trust appoints leader for new Clinical Trials project.

Professor Martin Landray has been appointed by Wellcome Trust to lead a new initiative to develop new guidelines for clinical trial regulation. The HRA looks forward to working with him on this vital project to ensure the UK continues to be a great place for health & social care research. 

BioIndustry Association (BIA) regulatory innovation conference
The BIA is holding a regulatory innovation conference on 17 September in London.

The conference, titled ‘Innovation and regulatory science in an evolving environment’, will hear from senior expert speakers from the life science industry, UK and EU regulatory authorities, the Department of Health and Social Care, NHS England, the National Institute for Health and Care Excellence (NICE), academia, research charities, and patient organisations.
European Forum for Good Clinical Practice (EFGCP) webinar on e-Consent
The EFGCP is holding an e-Consent Webinar on 23 September 2019.

The webinar will hear from regulators, industry and academics about the ongoing debate on bringing e-consent into clinical research. This will be followed by a Q&A discussion with an opportunity to ask questions to the panel. 


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