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HRA Latest
January 2018
NHS
Contents
Data protection changes in 2018: what does that mean for research?

Consultation: Simplifying arrangements for research in the NHS

Janet Wisely awarded an OBE

Confidentiality Advisory Group chair appointed

Could you be a member of confidentiality group?

Our strategic ambitions

Improved validation process being rolled out following successful HRA pilot

Researchers are ‘missing a trick’ with public involvement

New licensing system for administration of radioactive substances

An exciting opportunity for those interested in research ethics

Webinar: Applying for HRA Approval – getting it right first time
 

Research to be recognised by regulators for its role in improving patient care

Patients First: Pioneering Partnerships Conference

Improvements in research involving pharmacy or radiation

Introduction from Teresa Allen,
HRA Interim Chief Executive
Hello and welcome to the first HRA Latest of 2018. It’s great to start the year with good news, and I’d like to offer my personal congratulations to Janet Wisely who was awarded an OBE in the New Year’s Honours list. Janet has made a truly meaningful impact on the health and social care research landscape and I’m delighted her hard work and dedication have been recognised in this way.
 
I’d also like to congratulate Dr Tony Calland on his appointment as Chair of the Confidentiality Advisory Group (CAG). Tony has already made an excellent contribution to CAG as Vice Chair and I’m sure he will continue the fine work done by our previous Chair, Dr Mark Taylor. The health and social care research sector relies so much on volunteers who give their time and expertise, and this issue contains information about how you can apply to become a CAG member, or join one of our Research Ethics Committees.
 
This year we will increase our efforts to make life easier for our applicants, which is why we have outlined what researchers can expect when the new EU General Data Protection Regulation (GDPR) comes into force later this year. Our five strategic ambitions also aim ensure we continue to drive forward such improvements and make our systems as easy to use and efficient as possible.This newsletter further includes a reminder about a consultation we are involved in which seeks to simplify research in the NHS, and I would encourage all members of the research community take a look before it closes on 1 February.
 
The HRA seeks to continuously improve the service we provide, and this edition of HRA Latest includes stories about our improved validation process, our plans to help applicants provide more useful and relevant information about involving the public in research and our new webinar to help researchers get it right first time. There’s also a note on our work with the Care Quality Commission and others to develop research indicators as part of their inspection programme with NHS trusts.
 
Finally, there is information about a conference aimed at those in the research community with an interest in partnership working, as well as details of our imminent roll out of Pharmacy Assurance and Radiation Assurance.

To support these service improvements, we now have approval to make some upgrades to our core systems HARP and IRAS and we will be inviting researchers to work with us as we plan the changes that will improve the user experience. Watch this space over the next few months for ways that you can get involved.
 
Thank you as always for taking the time to read HRA Latest. Like everything we do we are always seeking to improve, so if you have any suggestions or feedback please direct them to hra.comms@nhs.net.
Data protection changes in 2018: what does that mean for research?
The rules for handling information relating to research participants will change on 25 May 2018, when the new EU General Data Protection Regulation (GDPR) comes into force.

The HRA has published detailed guidance about operational arrangements that researchers and organisations may need to put in place.
 
The guidance is published as a living document that will be updated over the coming weeks.
READ MORE
Consultation: Simplifying arrangements for research in the NHS
NHS England is running a consultation looking at how arrangements for research in the NHS could be simplified.
 
The proposals set out how NHS England, the NIHR Clinical Research Network and the HRA can work together to implement changes to better manage excess treatment costs, and to further improve commercial clinical research set-up.
READ MORE
Janet Wisely awarded an OBE
Janet Wisely has been awarded an OBE for services to health and social care research.
 
Janet has worked in health and social care research for nearly 25 years, and announced in August that she is to step down as HRA Chief Executive.
 
Hear from Janet and our Chair, Professor Jonathan Montgomery, in our website news story.
READ MORE
Confidentiality Advisory Group chair appointed
A new Chair has been appointed to the Confidentiality Advisory Group (CAG).
 
Dr Tony Calland, a former GP, is taking over the role of Chair from Dr Mark Taylor. Tony was previously the Vice Chair of CAG.
 
Find out more about Tony’s appointment, CAG and what he hopes to bring to the group.
READ MORE
Could you be a member of confidentiality group?
While the Confidentiality Advisory Group has a newly appointed chair, we are looking to increase our CAG membership from April 2018.
 
CAG’s voluntary members robustly assess applications for use of confidential patient information without consent in England and Wales within our regulatory framework, and develop principles to advise whether the activity is in the public interest.
READ MORE
Our strategic ambitions
We are proud of our achievements in promoting and protecting the interests of patients and the public in healthcare research, as well as the support we provide to the research community.

We have set five strategic ambitions to ensure we continue to drive forward improvements, leading or working in partnership with other organisations to make our systems as easy to use and efficient as possible.
Improved validation process being rolled out following successful HRA pilot
An updated HRA Approval validation process is being rolled out following successful piloting.
 
We began the roll out of our new validation email templates in early December, with full implementation to all HRA Approval applications expected by the end of February.
  READ MORE    
Researchers are ‘missing a trick’ with public involvement
A new study has shown that researchers applying for approvals to start their projects rarely describe their public involvement in enough detail.
 
Good public involvement can help smooth the process through ethical review, lead to better designed research and improve participant recruitment. The study found applications often lack enough information for those reviewing them to know what involvement has happened and what difference this has made.
 
Our Public Involvement Lead Jim Elliott discusses what public involvement means in practical terms, as well as our plans to help applicants provide more useful and relevant information.
READ MORE
New licensing system for administration of radioactive substances
Researchers running or planning projects incorporating the administration of radioactive substances will need to be aware of changes to the approval process.
 
The Administration of Radioactive Substances Advisory Committee (ARSAC) has published more details.
READ MORE
An exciting opportunity for those interested in research ethics
Research Ethics Committee (REC) members are volunteers who review research taking place in the UK from an ethical viewpoint, protecting patients and the public while promoting good ethical research.
 
Each member is assigned to a specific committee which has about 15 members who are a mix of expert and lay. Every member’s contribution is valued equally.
 
We are looking for new members: people with a strong commitment to protecting patients and the public and also a commitment to promoting good ethical research. There are more details on our website.
READ MORE
Webinar: Applying for HRA Approval – getting it right first time
We are trialling the use of training webinars for researchers and stakeholders who are new to the HRA Approval process.
 
The first is specifically aimed at researchers within universities preparing to submit an application to the HRA and wanting to understand how the process works. 
READ MORE

Research to be recognised by regulators for its role in improving patient care

Recent evidence suggests that hospitals that support high quality patient-centred research can show better healthcare outcomes for patients.

This has led to a partnership between the HRA, the National Institute of Health Research (NIHR) and the Medicines and Healthcare Products Regulatory Agency (MHRA), together with the Care Quality Commission (CQC), to develop new research indicators for use as part of CQC’s monitoring and inspection programme.
READ MORE
Patients First: Pioneering Partnerships Conference
On 20 March the Association of Medical Research Charities (AMRC) and the Association of the British Pharmaceutical Industry (ABPI) are jointly hosting a conference that will explore many benefits in establishing, managing and growing partnerships that aim to benefit patients sooner.

In its second year, Patients First: Pioneering Partnerships will cover partnerships of all types, through a wealth of case studies, and is aimed at medical research charities, industry, and those from the medical research community with an interest in partnership working.
READ MORE
Improvements in research involving pharmacy or radiation
As part of our commitment to continuously improving the support we provide to the research community, we are nearing the imminent roll out of Pharmacy Assurance and Radiation Assurance.

Both processes have been developed with sector experts and respond directly to user feedback that gaining sign off for studies involving radiation, and sites’ understanding the pharmacy implications of studies, has been proving difficult.
READ MORE
                                       






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